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1. The lung immuno-oncology prognostic score (LIPS-3): a prognostic classification of patients receiving first-line pembrolizumab for PD-L1 ≥ 50% advanced non-small-cell lung cancer

Author

Banna, G.L., Cortellini, A., Cortinovis, D.L., Tiseo, M., Aerts, J.G.J.V., Barbieri, F., Giusti, R., Bria, E., Grossi, F., Pizzutilo, P., Berardi, R., Morabito, A., Genova, C., Mazzoni, F., Di Noia, V., Signorelli, D., Gelibter, A., Macerelli, M., Rastelli, F., Chiari, R., Rocco, D., Gori, S., De Tursi, M., Di Marino, P., Mansueto, G., Zoratto, F., Filetti, M., Montrone, M., Citarella, F., Marco, R., Cantini, L., Nigro, O., D'Argento, E., Buti, S., Minuti, G., Landi, L., Guaitoli, G., Lo Russo, G., De Toma, A., Donisi, C., Friedlaender, A., De Giglio, A., Metro, G., Porzio, G., Ficorella, C., and Addeo, A.

Published
2021
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2. MA18.09 Carboplatin, Etoposide, Bevacizumab, and Atezolizumab in Patients with Extensive-Stage SCLC - GOIRC-01-2019 CeLEBrATE Trial

Author

Lamberti, G., primary, Rihawi, K., additional, Riccardi, F., additional, Mazzoni, F., additional, Follador, A., additional, Bonetti, A., additional, Giardina, D., additional, Genova, C., additional, Bertolini, F., additional, Frassoldati, A., additional, Brighenti, M., additional, Colantonio, I., additional, Pasello, G., additional, Ficorella, C., additional, Cinieri, S., additional, Tiseo, M., additional, Fancelli, S., additional, Andrini, E., additional, Targato, G., additional, Tognetto, M., additional, Boni, L., additional, and Ardizzoni, A., additional

Published
2023
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3. Osimertinib beyond disease progression in T790M EGFR-positive NSCLC patients: a multicenter study of clinicians’ attitudes

Author

Cortellini, A., Leonetti, A., Catino, A., Pizzutillo, P., Ricciuti, B., De Giglio, A., Chiari, R., Bordi, P., Santini, D., Giusti, R., De Tursi, M., Brocco, D., Zoratto, F., Rastelli, F., Citarella, F., Russano, M., Filetti, M., Marchetti, P., Berardi, R., Torniai, M., Cortinovis, D., Sala, E., Maggioni, C., Follador, A., Macerelli, M., Nigro, O., Tuzi, A., Iacono, D., Migliorino, M. R., Banna, G., Porzio, G., Cannita, K., Ferrara, M. G., Bria, E., Galetta, D., Ficorella, C., and Tiseo, M.

Published
2020
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7. Efficacy and safety of Everolimus and Exemestane in hormone-receptor positive (HR+) human-epidermal-growth-factor negative (HER2−) advanced breast cancer patients: New insights beyond clinical trials. The EVA study

Author

Alù, M., Ancona, C., Andreis, D., Bajardi, E., Benedetto, C., Berardi, R., Bordin, E., Butti, C., Capri, G., Cicchiello, F., Cocciolone, V., Dester, M., D'Onofrio, L., Febbraro, A., Ferrarini, I., Fotia, V., Gervasi, E., Guaitoli, G., Licata, L., Liscia, N., Mentuccia, L., Miraglio, E., Nicolini, M., Paternò, E., Pedani, F., Pellegrini, D., Petrucelli, L., De Laurentiis, M., Pizzuti, L., Pogliani, C., Riva, F., Cazzaniga, M.E., Airoldi, M., Arcangeli, V., Artale, S., Atzori, F., Ballerio, A., Bianchi, G.V., Blasi, L., Campidoglio, S., Ciccarese, M., Cursano, M.C., Piezzo, M., Fabi, A., Ferrari, L., Ferzi, A., Ficorella, C., Frassoldati, A., Fumagalli, A., Garrone, O., Gebbia, V., Generali, D., La Verde, N., Maur, M., Michelotti, A., Moretti, G., Musolino, A., Palumbo, R., Pistelli, M., Porpiglia, M., Sartori, D., Scavelli, C., Schirone, A., Turletti, A., Valerio, M.R., Vici, P., Zambelli, A., Clivio, L., and Torri, V.

Published
2017
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8. Host immune-inflammatory markers to unravel the heterogeneous outcome and assessment of patients with PD-L1 ≥50% metastatic non-small cell lung cancer and poor performance status receiving first-line immunotherapy

Author

Banna, G, Tiseo, M, Cortinovis, D, Facchinetti, F, Aerts, J, Baldessari, C, Giusti, R, Bria, E, Grossi, F, Berardi, R, Morabito, A, Catino, A, Genova, C, Mazzoni, F, Gelibter, A, Rastelli, F, Macerelli, M, Chiari, R, Gori, S, Mansueto, G, Citarella, F, Cantini, L, Rijavec, E, Bertolini, F, Cappuzzo, F, De Toma, A, Friedlaender, A, Metro, G, Pensieri, M, Porzio, G, Ficorella, C, Pinato, D, Cortellini, A, Addeo, A, Banna GL, Tiseo M, Cortinovis D, Facchinetti F, Aerts JGJV, Baldessari C, Giusti R, Bria E, Grossi F, Berardi R, Morabito A, Catino A, Genova C, Mazzoni F, Gelibter A, Rastelli F, Macerelli M, Chiari R, Gori S, Mansueto G, Citarella F, Cantini L, Rijavec E, Bertolini F, Cappuzzo F, De Toma A, Friedlaender A, Metro G, Pensieri MV, Porzio G, Ficorella C, Pinato DJ, Cortellini A, Addeo A, Banna, G, Tiseo, M, Cortinovis, D, Facchinetti, F, Aerts, J, Baldessari, C, Giusti, R, Bria, E, Grossi, F, Berardi, R, Morabito, A, Catino, A, Genova, C, Mazzoni, F, Gelibter, A, Rastelli, F, Macerelli, M, Chiari, R, Gori, S, Mansueto, G, Citarella, F, Cantini, L, Rijavec, E, Bertolini, F, Cappuzzo, F, De Toma, A, Friedlaender, A, Metro, G, Pensieri, M, Porzio, G, Ficorella, C, Pinato, D, Cortellini, A, Addeo, A, Banna GL, Tiseo M, Cortinovis D, Facchinetti F, Aerts JGJV, Baldessari C, Giusti R, Bria E, Grossi F, Berardi R, Morabito A, Catino A, Genova C, Mazzoni F, Gelibter A, Rastelli F, Macerelli M, Chiari R, Gori S, Mansueto G, Citarella F, Cantini L, Rijavec E, Bertolini F, Cappuzzo F, De Toma A, Friedlaender A, Metro G, Pensieri MV, Porzio G, Ficorella C, Pinato DJ, Cortellini A, and Addeo A

Abstract

Background: Patients with programmed cell death-ligand 1 (PD-L1) ≥50% metastatic non-small cell lung cancer (mNSCLC) and ECOG performance status (PS) of 2 treated with first-line immunotherapy have heterogeneous clinical assessment and outcomes. Methods: To explore the role of immune-inflammatory surrogates by the validated lung immuno-oncology prognostic score (LIPS) score, including the neutrophil-to-lymphocyte ratio (NLR) and the pretreatment use of steroids, alongside other prognostic variables. A retrospective analysis of 128 patients with PS2 and PD-L1 ≥50% mNSCLC treated between April 2018 and September 2019 with first-line pembrolizumab in a real-world setting was performed. Results: With a median follow-up of 15.3 months, the 1-year overall survival (OS) and median progression-free survival (PFS) were 32.3% (95% CI: 30.9–33.9) and 3.3 months (95% CI: 1.8–4.7), respectively. The NLR, lactate dehydrogenase (LDH) and pretreatment steroids results were the only significant prognostic factors on the univariate analysis and independent prognostic factors by the multivariate analysis on both OS and PFS. The LIPS score, including the NLR and pretreatment steroids, identified 29 (23%) favourable-risk patients, with 0 factors, 1-year OS of 67.6% and median PFS of 8.2 months; 57 (45%) intermediate-risk patients, with 1 factor, 1-year OS 32.1% and median PFS 2.7 months; 42 (33%) poor-risk patients, with both factors, 1-year OS of 10.7% and median PFS of 1.2 months. Conclusions: The assessment of pre-existing imbalance of the host immune response by combined blood and clinical immune-inflammatory markers may represent a way to unravel the heterogeneous outcome and assessment of patients with mNSCLC and poor PS in the immune-oncology setting.

Published
2022

9. Predictive ability of a drug-based score in patients with advanced non-small-cell lung cancer receiving first-line immunotherapy

Author

Buti, S, Bersanelli, M, Perrone, F, Bracarda, S, Di Maio, M, Giusti, R, Nigro, O, Cortinovis, D, Aerts, J, Guaitoli, G, Barbieri, F, Ferrara, M, Bria, E, Grossi, F, Bareggi, C, Berardi, R, Torniai, M, Cantini, L, Sforza, V, Genova, C, Chiari, R, Rocco, D, Della Gravara, L, Gori, S, De Tursi, M, Di Marino, P, Mansueto, G, Zoratto, F, Filetti, M, Citarella, F, Russano, M, Mazzoni, F, Garassino, M, De Toma, A, Signorelli, D, Gelibter, A, Siringo, M, Follador, A, Bisonni, R, Tuzi, A, Minuti, G, Landi, L, Ricciardi, S, Migliorino, M, Tabbò, F, Olmetto, E, Metro, G, Adamo, V, Russo, A, Spinelli, G, Banna, G, Addeo, A, Friedlaender, A, Cannita, K, Porzio, G, Ficorella, C, Carmisciano, L, Pinato, D, Mazzaschi, G, Tiseo, M, Cortellini, A, Buti S, Bersanelli M, Perrone F, Bracarda S, Di Maio M, Giusti R, Nigro O, Cortinovis D, Aerts JGJV, Guaitoli G, Barbieri F, Ferrara MG, Bria E, Grossi F, Bareggi C, Berardi R, Torniai M, Cantini L, Sforza V, Genova C, Chiari R, Rocco D, Della Gravara L, Gori S, De Tursi M, Di Marino P, Mansueto G, Zoratto F, Filetti M, Citarella F, Russano M, Mazzoni F, Garassino MC, De Toma A, Signorelli D, Gelibter A, Siringo M, Follador A, Bisonni R, Tuzi A, Minuti G, Landi L, Ricciardi S, Migliorino MR, Tabbò F, Olmetto E, Metro G, Adamo V, Russo A, Spinelli GP, Banna GL, Addeo A, Friedlaender A, Cannita K, Porzio G, Ficorella C, Carmisciano L, Pinato DJ, Mazzaschi G, Tiseo M, Cortellini A, Buti, S, Bersanelli, M, Perrone, F, Bracarda, S, Di Maio, M, Giusti, R, Nigro, O, Cortinovis, D, Aerts, J, Guaitoli, G, Barbieri, F, Ferrara, M, Bria, E, Grossi, F, Bareggi, C, Berardi, R, Torniai, M, Cantini, L, Sforza, V, Genova, C, Chiari, R, Rocco, D, Della Gravara, L, Gori, S, De Tursi, M, Di Marino, P, Mansueto, G, Zoratto, F, Filetti, M, Citarella, F, Russano, M, Mazzoni, F, Garassino, M, De Toma, A, Signorelli, D, Gelibter, A, Siringo, M, Follador, A, Bisonni, R, Tuzi, A, Minuti, G, Landi, L, Ricciardi, S, Migliorino, M, Tabbò, F, Olmetto, E, Metro, G, Adamo, V, Russo, A, Spinelli, G, Banna, G, Addeo, A, Friedlaender, A, Cannita, K, Porzio, G, Ficorella, C, Carmisciano, L, Pinato, D, Mazzaschi, G, Tiseo, M, Cortellini, A, Buti S, Bersanelli M, Perrone F, Bracarda S, Di Maio M, Giusti R, Nigro O, Cortinovis D, Aerts JGJV, Guaitoli G, Barbieri F, Ferrara MG, Bria E, Grossi F, Bareggi C, Berardi R, Torniai M, Cantini L, Sforza V, Genova C, Chiari R, Rocco D, Della Gravara L, Gori S, De Tursi M, Di Marino P, Mansueto G, Zoratto F, Filetti M, Citarella F, Russano M, Mazzoni F, Garassino MC, De Toma A, Signorelli D, Gelibter A, Siringo M, Follador A, Bisonni R, Tuzi A, Minuti G, Landi L, Ricciardi S, Migliorino MR, Tabbò F, Olmetto E, Metro G, Adamo V, Russo A, Spinelli GP, Banna GL, Addeo A, Friedlaender A, Cannita K, Porzio G, Ficorella C, Carmisciano L, Pinato DJ, Mazzaschi G, Tiseo M, and Cortellini A

Abstract

Background: We previously demonstrated the cumulative poor prognostic role of concomitant medications on the clinical outcome of patients with advanced cancer treated with immune checkpoint inhibitors, creating and validating a drug-based prognostic score to be calculated before immunotherapy initiation in patients with advanced solid tumours. This ‘drug score’ was calculated assigning score 1 for each between proton-pump inhibitor and antibiotic administration until a month before cancer therapy initiation and score 2 in case of corticosteroid intake. The good risk group included patients with score 0, intermediate risk with score 1–2 and poor risk with score 3–4. Methods: Aiming at validating the prognostic and putative predictive ability depending on the anticancer therapy, we performed the present comparative analysis in two cohorts of advanced non–small-cell lung cancer (NSCLC), respectively, receiving first-line pembrolizumab or chemotherapy through a random case-control matching and through a pooled multivariable analysis including the interaction between the computed score and the therapeutic modality (pembrolizumab vs chemotherapy). Results: Nine hundred fifty and 595 patients were included in the pembrolizumab and chemotherapy cohorts, respectively. After the case-control random matching, 589 patients from the pembrolizumab cohort and 589 from the chemotherapy cohort were paired, with no statistically significant differences between the characteristics of the matched subjects. Among the pembrolizumab-treated group, good, intermediate and poor risk evaluable patients achieved an objective response rate (ORR) of 50.0%, 37.7% and 23.4%, respectively, (p < 0.0001), whereas among the chemotherapy-treated group, patients achieved an ORR of 37.0%, 40.0% and 32.4%, respectively (p = 0.4346). The median progression-free survival (PFS) of good, intermediate and poor risk groups was 13.9 months, 6.3 months and 2.8 months, respectively, within the pembrolizumab coh

Published
2021

10. Differential influence of antibiotic therapy and other medications on oncological outcomes of patients with non-small cell lung cancer treated with first-line pembrolizumab versus cytotoxic chemotherapy

Author

Cortellini, A, Di Maio, M, Nigro, O, Leonetti, A, Cortinovis, D, Aerts, J, Guaitoli, G, Barbieri, F, Giusti, R, Ferrara, M, Bria, E, D'Argento, E, Grossi, F, Rijavec, E, Guida, A, Berardi, R, Torniai, M, Sforza, V, Genova, C, Mazzoni, F, Garassino, M, De Toma, A, Signorelli, D, Gelibter, A, Siringo, M, Marchetti, P, Macerelli, M, Rastelli, F, Chiari, R, Rocco, D, Della Gravara, L, Inno, A, Michele, T, Grassadonia, A, Di Marino, P, Mansueto, G, Zoratto, F, Filetti, M, Santini, D, Citarella, F, Russano, M, Cantini, L, Tuzi, A, Bordi, P, Minuti, G, Landi, L, Ricciardi, S, Migliorino, M, Passiglia, F, Bironzo, P, Metro, G, Adamo, V, Russo, A, Spinelli, G, Banna, G, Friedlaender, A, Addeo, A, Cannita, K, Ficorella, C, Porzio, G, Pinato, D, Cortellini A, Di Maio M, Nigro O, Leonetti A, Cortinovis D, Aerts JG, Guaitoli G, Barbieri F, Giusti R, Ferrara MG, Bria E, D'Argento E, Grossi F, Rijavec E, Guida A, Berardi R, Torniai M, Sforza V, Genova C, Mazzoni F, Garassino MC, De Toma A, Signorelli D, Gelibter A, Siringo M, Marchetti P, Macerelli M, Rastelli F, Chiari R, Rocco D, Della Gravara L, Inno A, Michele T, Grassadonia A, Di Marino P, Mansueto G, Zoratto F, Filetti M, Santini D, Citarella F, Russano M, Cantini L, Tuzi A, Bordi P, Minuti G, Landi L, Ricciardi S, Migliorino MR, Passiglia F, Bironzo P, Metro G, Adamo V, Russo A, Spinelli GP, Banna GL, Friedlaender A, Addeo A, Cannita K, Ficorella C, Porzio G, Pinato DJ, Cortellini, A, Di Maio, M, Nigro, O, Leonetti, A, Cortinovis, D, Aerts, J, Guaitoli, G, Barbieri, F, Giusti, R, Ferrara, M, Bria, E, D'Argento, E, Grossi, F, Rijavec, E, Guida, A, Berardi, R, Torniai, M, Sforza, V, Genova, C, Mazzoni, F, Garassino, M, De Toma, A, Signorelli, D, Gelibter, A, Siringo, M, Marchetti, P, Macerelli, M, Rastelli, F, Chiari, R, Rocco, D, Della Gravara, L, Inno, A, Michele, T, Grassadonia, A, Di Marino, P, Mansueto, G, Zoratto, F, Filetti, M, Santini, D, Citarella, F, Russano, M, Cantini, L, Tuzi, A, Bordi, P, Minuti, G, Landi, L, Ricciardi, S, Migliorino, M, Passiglia, F, Bironzo, P, Metro, G, Adamo, V, Russo, A, Spinelli, G, Banna, G, Friedlaender, A, Addeo, A, Cannita, K, Ficorella, C, Porzio, G, Pinato, D, Cortellini A, Di Maio M, Nigro O, Leonetti A, Cortinovis D, Aerts JG, Guaitoli G, Barbieri F, Giusti R, Ferrara MG, Bria E, D'Argento E, Grossi F, Rijavec E, Guida A, Berardi R, Torniai M, Sforza V, Genova C, Mazzoni F, Garassino MC, De Toma A, Signorelli D, Gelibter A, Siringo M, Marchetti P, Macerelli M, Rastelli F, Chiari R, Rocco D, Della Gravara L, Inno A, Michele T, Grassadonia A, Di Marino P, Mansueto G, Zoratto F, Filetti M, Santini D, Citarella F, Russano M, Cantini L, Tuzi A, Bordi P, Minuti G, Landi L, Ricciardi S, Migliorino MR, Passiglia F, Bironzo P, Metro G, Adamo V, Russo A, Spinelli GP, Banna GL, Friedlaender A, Addeo A, Cannita K, Ficorella C, Porzio G, and Pinato DJ

Abstract

Background Some concomitant medications including antibiotics (ATB) have been reproducibly associated with worse survival following immune checkpoint inhibitors (ICIs) in unselected patients with non-small cell lung cancer (NSCLC) (according to programmed death-ligand 1 (PD-L1) expression and treatment line). Whether such relationship is causative or associative is matter of debate. Methods We present the outcomes analysis according to concomitant baseline medications (prior to ICI initiation) with putative immune-modulatory effects in a large cohort of patients with metastatic NSCLC with a PD-L1 expression >= 50%, receiving first-line pembrolizumab monotherapy. We also evaluated a control cohort of patients with metastatic NSCLC treated with first-line chemotherapy. The interaction between key medications and therapeutic modality (pembrolizumab vs chemotherapy) was validated in pooled multivariable analyses. Results 950 and 595 patients were included in the pembrolizumab and chemotherapy cohorts, respectively. Corticosteroid and proton pump inhibitor (PPI) therapy but not ATB therapy was associated with poorer performance status at baseline in both the cohorts. No association with clinical outcomes was found according to baseline statin, aspirin, beta-blocker and metformin within the pembrolizumab cohort. On the multivariable analysis, ATB emerged as a strong predictor of worse overall survival (OS) (HR=1.42 (95% CI 1.13 to 1.79); p=0.0024), and progression free survival (PFS) (HR=1.29 (95% CI 1.04 to 1.59); p=0.0192) in the pembrolizumab but not in the chemotherapy cohort. Corticosteroids were associated with shorter PFS (HR=1.69 (95% CI 1.42 to 2.03); p<0.0001), and OS (HR=1.93 (95% CI 1.59 to 2.35); p<0.0001) following pembrolizumab, and shorter PFS (HR=1.30 (95% CI 1.08 to 1.56), p=0.0046) and OS (HR=1.58 (95% CI 1.29 to 1.94), p<0.0001), following chemotherapy. PPIs were associated with worse OS (HR=1.49 (95% CI 1.26 to 1.77); p<0.0001) with pem

Published
2021

11. Smoking status during first-line immunotherapy and chemotherapy in NSCLC patients: A case-control matched analysis from a large multicenter study

Author

Cortellini, A, De Giglio, A, Cannita, K, Cortinovis, D, Cornelissen, R, Baldessari, C, Giusti, R, D'Argento, E, Grossi, F, Santoni, M, Catino, A, Berardi, R, Sforza, V, Rossi, G, Antonuzzo, L, Di Noia, V, Signorelli, D, Gelibter, A, Occhipinti, M, Follador, A, Rastelli, F, Chiari, R, Gravara, L, Inno, A, De Tursi, M, Di Marino, P, Mansueto, G, Zoratto, F, Filetti, M, Montrone, M, Citarella, F, Pensieri, M, Russano, M, Cantini, L, Nigro, O, Leonetti, A, Bordi, P, Minuti, G, Landi, L, De Toma, A, Donisi, C, Ricciardi, S, Migliorino, M, Napoli, V, Leone, G, Metro, G, Banna, G, Friedlaender, A, Addeo, A, Ficorella, C, Porzio, G, Cortellini A, De Giglio A, Cannita K, Cortinovis D, Cornelissen R, Baldessari C, Giusti R, D'Argento E, Grossi F, Santoni M, Catino A, Berardi R, Sforza V, Rossi G, Antonuzzo L, Di Noia V, Signorelli D, Gelibter A, Occhipinti MA, Follador A, Rastelli F, Chiari R, Gravara LD, Inno A, De Tursi M, Di Marino P, Mansueto G, Zoratto F, Filetti M, Montrone M, Citarella F, Pensieri MV, Russano M, Cantini L, Nigro O, Leonetti A, Bordi P, Minuti G, Landi L, De Toma A, Donisi C, Ricciardi S, Migliorino MR, Napoli VM, Leone G, Metro G, Banna GL, Friedlaender A, Addeo A, Ficorella C, Porzio G, Cortellini, A, De Giglio, A, Cannita, K, Cortinovis, D, Cornelissen, R, Baldessari, C, Giusti, R, D'Argento, E, Grossi, F, Santoni, M, Catino, A, Berardi, R, Sforza, V, Rossi, G, Antonuzzo, L, Di Noia, V, Signorelli, D, Gelibter, A, Occhipinti, M, Follador, A, Rastelli, F, Chiari, R, Gravara, L, Inno, A, De Tursi, M, Di Marino, P, Mansueto, G, Zoratto, F, Filetti, M, Montrone, M, Citarella, F, Pensieri, M, Russano, M, Cantini, L, Nigro, O, Leonetti, A, Bordi, P, Minuti, G, Landi, L, De Toma, A, Donisi, C, Ricciardi, S, Migliorino, M, Napoli, V, Leone, G, Metro, G, Banna, G, Friedlaender, A, Addeo, A, Ficorella, C, Porzio, G, Cortellini A, De Giglio A, Cannita K, Cortinovis D, Cornelissen R, Baldessari C, Giusti R, D'Argento E, Grossi F, Santoni M, Catino A, Berardi R, Sforza V, Rossi G, Antonuzzo L, Di Noia V, Signorelli D, Gelibter A, Occhipinti MA, Follador A, Rastelli F, Chiari R, Gravara LD, Inno A, De Tursi M, Di Marino P, Mansueto G, Zoratto F, Filetti M, Montrone M, Citarella F, Pensieri MV, Russano M, Cantini L, Nigro O, Leonetti A, Bordi P, Minuti G, Landi L, De Toma A, Donisi C, Ricciardi S, Migliorino MR, Napoli VM, Leone G, Metro G, Banna GL, Friedlaender A, Addeo A, Ficorella C, and Porzio G

Abstract

Background: Improved outcome in tobacco smoking patients with non-small cell lung cancer (NSCLC) following immunotherapy has previously been reported. However, little is known regarding this association during first-line immunotherapy in patients with high PD-L1 expression. In this study we compared clinical outcomes according to the smoking status of two large multicenter cohorts. Methods: We compared clinical outcomes according to the smoking status (never smokers vs. current/former smokers) of two retrospective multicenter cohorts of metastatic NSCLC patients, treated with first-line pembrolizumab and platinum-based chemotherapy. Results: A total of 962 NSCLC patients with PD-L1 expression ≥50% who received first-line pembrolizumab and 462 NSCLC patients who received first-line platinum-based chemotherapy were included in the study. Never smokers were confirmed to have a significantly higher risk of disease progression (hazard ratio [HR] = 1.49 [95% CI: 1.15–1.92], p = 0.0022) and death (HR = 1.38 [95% CI: 1.02–1.87], p = 0.0348) within the pembrolizumab cohort. On the contrary, a nonsignificant trend towards a reduced risk of disease progression (HR = 0.74 [95% CI: 0.52–1.05], p = 0.1003) and death (HR = 0.67 [95% CI: 0.45–1.01], p = 0.0593) were reported for never smokers within the chemotherapy cohort. After a random case–control matching, 424 patients from both cohorts were paired. Within the matched pembrolizumab cohort, never smokers had a significantly shorter progression-free survival (PFS) (HR = 1.68 [95% CI: 1.17–2.40], p = 0.0045) and a nonsignificant trend towards a shortened overall survival (OS) (HR = 1.32 [95% CI: 0.84–2.07], p = 0.2205). On the contrary, never smokers had a significantly longer PFS (HR = 0.68 [95% CI: 0.49–0.95], p = 0.0255) and OS (HR = 0.66 [95% CI: 0.45–0.97], p = 0,0356) compared to current/former smoker patients within the matched chemotherapy cohort. On pooled multivariable analysis, the interaction term between smoking stat

Published
2021

12. The lung immuno-oncology prognostic score (LIPS-3): a prognostic classification of patients receiving first-line pembrolizumab for PD-L1 ≥ 50% advanced non-small-cell lung cancer

Author

Banna, G, Cortellini, A, Cortinovis, D, Tiseo, M, Aerts, J, Barbieri, F, Giusti, R, Bria, E, Grossi, F, Pizzutilo, P, Berardi, R, Morabito, A, Genova, C, Mazzoni, F, Di Noia, V, Signorelli, D, Gelibter, A, Macerelli, M, Rastelli, F, Chiari, R, Rocco, D, Gori, S, De Tursi, M, Di Marino, P, Mansueto, G, Zoratto, F, Filetti, M, Montrone, M, Citarella, F, Marco, R, Cantini, L, Nigro, O, D'Argento, E, Buti, S, Minuti, G, Landi, L, Guaitoli, G, Lo Russo, G, De Toma, A, Donisi, C, Friedlaender, A, De Giglio, A, Metro, G, Porzio, G, Ficorella, C, Addeo, A, Banna GL, Cortellini A, Cortinovis D, Tiseo M, Aerts JGJV, Barbieri F, Giusti R, Bria E, Grossi F, Pizzutilo P, Berardi R, Morabito A, Genova C, Mazzoni F, Di Noia V, Signorelli D, Gelibter A, Macerelli M, Rastelli F, Chiari R, Rocco D, Gori S, De Tursi M, Di Marino P, Mansueto G, Zoratto F, Filetti M, Montrone M, Citarella F, Marco R, Cantini L, Nigro O, D'Argento E, Buti S, Minuti G, Landi L, Guaitoli G, Lo Russo G, De Toma A, Donisi C, Friedlaender A, De Giglio A, Metro G, Porzio G, Ficorella C, Addeo A., Banna, G, Cortellini, A, Cortinovis, D, Tiseo, M, Aerts, J, Barbieri, F, Giusti, R, Bria, E, Grossi, F, Pizzutilo, P, Berardi, R, Morabito, A, Genova, C, Mazzoni, F, Di Noia, V, Signorelli, D, Gelibter, A, Macerelli, M, Rastelli, F, Chiari, R, Rocco, D, Gori, S, De Tursi, M, Di Marino, P, Mansueto, G, Zoratto, F, Filetti, M, Montrone, M, Citarella, F, Marco, R, Cantini, L, Nigro, O, D'Argento, E, Buti, S, Minuti, G, Landi, L, Guaitoli, G, Lo Russo, G, De Toma, A, Donisi, C, Friedlaender, A, De Giglio, A, Metro, G, Porzio, G, Ficorella, C, Addeo, A, Banna GL, Cortellini A, Cortinovis D, Tiseo M, Aerts JGJV, Barbieri F, Giusti R, Bria E, Grossi F, Pizzutilo P, Berardi R, Morabito A, Genova C, Mazzoni F, Di Noia V, Signorelli D, Gelibter A, Macerelli M, Rastelli F, Chiari R, Rocco D, Gori S, De Tursi M, Di Marino P, Mansueto G, Zoratto F, Filetti M, Montrone M, Citarella F, Marco R, Cantini L, Nigro O, D'Argento E, Buti S, Minuti G, Landi L, Guaitoli G, Lo Russo G, De Toma A, Donisi C, Friedlaender A, De Giglio A, Metro G, Porzio G, Ficorella C, and Addeo A.

Abstract

Background: To stratify the prognosis of patients with programmed cell death-ligand 1 (PD-L1) ≥ 50% advanced non-small-cell lung cancer (aNSCLC) treated with first-line immunotherapy. Methods: Baseline clinical prognostic factors, the neutrophil-to-lymphocyte ratio (NLR), PD-L1 tumour cell expression level, lactate dehydrogenase (LDH) and their combination were investigated by a retrospective analysis of 784 patients divided between statistically powered training (n = 201) and validation (n = 583) cohorts. Cut-offs were explored by receiver operating characteristic (ROC) curves and a risk model built with validated independent factors by multivariate analysis. Results: NLR < 4 was a significant prognostic factor in both cohorts (P < 0.001). It represented 53% of patients in the validation cohort, with 1-year overall survival (OS) of 76.6% versus 44.8% with NLR > 4, in the validation series. The addition of PD-L1 ≥ 80% (21% of patients) or LDH < 252 U/l (25%) to NLR < 4 did not result in better 1-year OS (of 72.6% and 74.1%, respectively, in the validation cohort). Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 2 [P < 0.001, hazard ratio (HR) 2.04], pretreatment steroids (P < 0.001, HR 1.67) and NLR < 4 (P < 0.001, HR 2.29) resulted in independent prognostic factors. A risk model with these three factors, namely, the lung immuno-oncology prognostic score (LIPS)-3, accurately stratified three OS risk-validated categories of patients: favourable (0 risk factors, 40%, 1-year OS of 78.2% in the whole series), intermediate (1 or 2 risk factors, 54%, 1-year OS 53.8%) and poor (>2 risk factors, 5%, 1-year OS 10.7%) prognosis. Conclusions: We advocate the use of LIPS-3 as an easy-to-assess and inexpensive adjuvant prognostic tool for patients with PD-L1 ≥ 50% aNSCLC.

Published
2021

13. Post-progression outcomes of NSCLC patients with PD-L1 expression ≥ 50% receiving first-line single-agent pembrolizumab in a large multicentre real-world study

Author

Cortellini, A, Cannita, K, Tiseo, M, Cortinovis, D, Aerts, J, Baldessari, C, Giusti, R, Ferrara, M, D'Argento, E, Grossi, F, Guida, A, Berardi, R, Morabito, A, Genova, C, Antonuzzo, L, Mazzoni, F, De Toma, A, Signorelli, D, Gelibter, A, Targato, G, Rastelli, F, Chiari, R, Rocco, D, Gori, S, De Tursi, M, Mansueto, G, Zoratto, F, Filetti, M, Bracarda, S, Citarella, F, Russano, M, Cantini, L, Nigro, O, Buti, S, Minuti, G, Landi, L, Ricciardi, S, Migliorino, M, Natalizio, S, Simona, C, De Filippis, M, Metro, G, Adamo, V, Russo, A, Spinelli, G, Di Maio, M, Banna, G, Friedlaender, A, Addeo, A, Pinato, D, Ficorella, C, Porzio, G, Cortellini A, Cannita K, Tiseo M, Cortinovis D, Aerts JGJV, Baldessari C, Giusti R, Ferrara MG, D'Argento E, Grossi F, Guida A, Berardi R, Morabito A, Genova C, Antonuzzo L, Mazzoni F, De Toma A, Signorelli D, Gelibter A, Targato G, Rastelli F, Chiari R, Rocco D, Gori S, De Tursi M, Mansueto G, Zoratto F, Filetti M, Bracarda S, Citarella F, Russano M, Cantini L, Nigro O, Buti S, Minuti G, Landi L, Ricciardi S, Migliorino MR, Natalizio S, Simona C, De Filippis M, Metro G, Adamo V, Russo A, Spinelli GP, Di Maio M, Banna GL, Friedlaender A, Addeo A, Pinato DJ, Ficorella C, Porzio G, Cortellini, A, Cannita, K, Tiseo, M, Cortinovis, D, Aerts, J, Baldessari, C, Giusti, R, Ferrara, M, D'Argento, E, Grossi, F, Guida, A, Berardi, R, Morabito, A, Genova, C, Antonuzzo, L, Mazzoni, F, De Toma, A, Signorelli, D, Gelibter, A, Targato, G, Rastelli, F, Chiari, R, Rocco, D, Gori, S, De Tursi, M, Mansueto, G, Zoratto, F, Filetti, M, Bracarda, S, Citarella, F, Russano, M, Cantini, L, Nigro, O, Buti, S, Minuti, G, Landi, L, Ricciardi, S, Migliorino, M, Natalizio, S, Simona, C, De Filippis, M, Metro, G, Adamo, V, Russo, A, Spinelli, G, Di Maio, M, Banna, G, Friedlaender, A, Addeo, A, Pinato, D, Ficorella, C, Porzio, G, Cortellini A, Cannita K, Tiseo M, Cortinovis D, Aerts JGJV, Baldessari C, Giusti R, Ferrara MG, D'Argento E, Grossi F, Guida A, Berardi R, Morabito A, Genova C, Antonuzzo L, Mazzoni F, De Toma A, Signorelli D, Gelibter A, Targato G, Rastelli F, Chiari R, Rocco D, Gori S, De Tursi M, Mansueto G, Zoratto F, Filetti M, Bracarda S, Citarella F, Russano M, Cantini L, Nigro O, Buti S, Minuti G, Landi L, Ricciardi S, Migliorino MR, Natalizio S, Simona C, De Filippis M, Metro G, Adamo V, Russo A, Spinelli GP, Di Maio M, Banna GL, Friedlaender A, Addeo A, Pinato DJ, Ficorella C, and Porzio G

Abstract

Background: Treatment sequencing with first-line immunotherapy, followed by second-line chemotherapy, is still a viable option for NSCLC patients with PD-L1 expression ≥50%. Methods: We evaluated post-progression treatment pathways in a large real-world cohort of metastatic NSCLC patients with PD-L1 expression ≥ 50% treated with first-line pembrolizumab monotherapy. Results: Overall, 974 patients were included. With a median follow-up of 22.7 months (95%CI: 21.6–38.2), the median overall survival (OS) of the entire population was 15.8 months (95%CI: 13.5–17.5; 548 events). At the data cutoff, among the 678 patients who experienced disease progression, 379 (55.9%) had not received any further treatment, and 359 patients (52.9%) had died. Patients who did not receive post-progression therapies were older (p = 0.0011), with a worse ECOG-PS (p < 0.0001) and were on corticosteroids prior to pembrolizumab (p = 0.0024). At disease progression, 198 patients (29.2%) received a switched approach and 101 (14.9%) received pembrolizumab ByPD either alone (64 [9.4%]) or in combination with local ablative treatments (37 [5.5%]) (LATs). After a random-case control matching according to ECOG-PS, CNS metastases, bone metastases, and (previous) best response to pembrolizumab, patients receiving pembrolizumab ByPD plus LATs were confirmed to have a significantly longer post-progression OS compared to patients receiving pembrolizumab ByPD alone 13.9 months versus 7.8 months (p = 0.0179) 241 patients (35.5%) among the 678 who had experienced PD, received a second-line systemic treatment (regardless of previous treatment beyond PD). As compared to first-line treatment commencement, patients’ features at the moment of second-line initiation showed a significantly higher proportion of patients aged under 70 years (p = 0.0244), with a poorer ECOG-PS (p < 0.0001) and having CNS (p = 0.0001), bone (p = 0.0266) and liver metastases (p = 0.0148). Conclusions: In the real-world scenario NSC

Published
2021

14. The prognostic relevance of HER2-positivity gain in metastatic breast cancer in the ChangeHER trial

Author

Pizzuti, L, Barba, M, Mazzotta, M, Krasniqi, E, Maugeri-Sacca, M, Gamucci, T, Berardi, R, Livi, L, Ficorella, C, Natoli, C, Cortesi, E, Generali, D, La Verde, N, Cassano, A, Bria, E, Moscetti, L, Michelotti, A, Adamo, V, Zamagni, C, Tonini, G, Sergi, D, Marinelli, D, Paoletti, G, Tomao, S, Botticelli, A, Marchetti, P, Tinari, N, Grassadonia, A, Valerio, M, Mirabelli, R, Fabbri, M, D'Ostilio, N, Veltri, E, Corsi, D, Garrone, O, Paris, I, Sarobba, G, Meattini, I, Pistelli, M, Giotta, F, Lorusso, V, Garufi, C, Russo, A, Cazzaniga, M, Del Medico, P, Roselli, M, Vaccaro, A, Perracchio, L, di Benedetto, A, Daralioti, T, Sperduti, I, De Maria, R, Di Leo, A, Sanguineti, G, Ciliberto, G, Vici, P, Pizzuti L., Barba M., Mazzotta M., Krasniqi E., Maugeri-Sacca M., Gamucci T., Berardi R., Livi L., Ficorella C., Natoli C., Cortesi E., Generali D., La Verde N., Cassano A., Bria E., Moscetti L., Michelotti A., Adamo V., Zamagni C., Tonini G., Sergi D., Marinelli D., Paoletti G., Tomao S., Botticelli A., Marchetti P., Tinari N., Grassadonia A., Valerio M. R., Mirabelli R., Fabbri M. A., D'Ostilio N., Veltri E., Corsi D., Garrone O., Paris I., Sarobba G., Meattini I., Pistelli M., Giotta F., Lorusso V., Garufi C., Russo A., Cazzaniga M., Del Medico P., Roselli M., Vaccaro A., Perracchio L., di Benedetto A., Daralioti T., Sperduti I., De Maria R., Di Leo A., Sanguineti G., Ciliberto G., Vici P., Pizzuti, L, Barba, M, Mazzotta, M, Krasniqi, E, Maugeri-Sacca, M, Gamucci, T, Berardi, R, Livi, L, Ficorella, C, Natoli, C, Cortesi, E, Generali, D, La Verde, N, Cassano, A, Bria, E, Moscetti, L, Michelotti, A, Adamo, V, Zamagni, C, Tonini, G, Sergi, D, Marinelli, D, Paoletti, G, Tomao, S, Botticelli, A, Marchetti, P, Tinari, N, Grassadonia, A, Valerio, M, Mirabelli, R, Fabbri, M, D'Ostilio, N, Veltri, E, Corsi, D, Garrone, O, Paris, I, Sarobba, G, Meattini, I, Pistelli, M, Giotta, F, Lorusso, V, Garufi, C, Russo, A, Cazzaniga, M, Del Medico, P, Roselli, M, Vaccaro, A, Perracchio, L, di Benedetto, A, Daralioti, T, Sperduti, I, De Maria, R, Di Leo, A, Sanguineti, G, Ciliberto, G, Vici, P, Pizzuti L., Barba M., Mazzotta M., Krasniqi E., Maugeri-Sacca M., Gamucci T., Berardi R., Livi L., Ficorella C., Natoli C., Cortesi E., Generali D., La Verde N., Cassano A., Bria E., Moscetti L., Michelotti A., Adamo V., Zamagni C., Tonini G., Sergi D., Marinelli D., Paoletti G., Tomao S., Botticelli A., Marchetti P., Tinari N., Grassadonia A., Valerio M. R., Mirabelli R., Fabbri M. A., D'Ostilio N., Veltri E., Corsi D., Garrone O., Paris I., Sarobba G., Meattini I., Pistelli M., Giotta F., Lorusso V., Garufi C., Russo A., Cazzaniga M., Del Medico P., Roselli M., Vaccaro A., Perracchio L., di Benedetto A., Daralioti T., Sperduti I., De Maria R., Di Leo A., Sanguineti G., Ciliberto G., and Vici P.

Abstract

In metastatic breast cancer (mBC), the change of human epidermal growth factor receptor 2 (HER2) status between primary and metastatic lesions is widely recognized, however clinical implications are unknown. Our study address the question if relevant differences exist between subjects who preserve the HER2 status and those who gain the HER2 positivity when relapsed. Data of patients affected by HER2-positive mBC, treated with pertuzumab and/or trastuzumab-emtansine (T-DM1) in a real-world setting at 45 Italian cancer centers were retrospectively collected and analyzed. From 2003 to 2017, 491 HER2‐positive mBC patients were included. Of these, 102 (20.7%) had been initially diagnosed as HER2-negative early BC. Estrogen and/or progesterone receptor were more expressed in patients with HER2-discordance compared to patients with HER2-concordant status (p < 0.0001 and p = 0.006, respectively). HER2-discordant tumors were characterized also by a lower rate of brain metastases (p = 0.01) and a longer disease free interval (p < 0.0001). Median overall survival was longer, although not statistically significant, in the subgroup of patients with HER2-discordant cancer with respect to patients with HER2-concordant status (140 vs 78 months, p = 0.07). Our findings suggest that patients with HER2-positive mBC with discordant HER2 status in early BC may have different clinical, biological and prognostic behavior compared to HER2-concordant patients.

Published
2021

15. Oxaliplatin plus fluoropyrimidines as adjuvant therapy for colon cancer in older patients: A subgroup analysis from the TOSCA trial

Author

Rosati, G, Lonardi, S, Galli, F, Di Bartolomeo, M, Ronzoni, M, Zampino, M, Banzi, M, Zaniboni, A, Pasini, F, Bozzarelli, S, Garattini, S, Ferrari, D, Montesarchio, V, Mambrini, A, Ciuffreda, L, Pusceddu, V, Carlomagno, C, Bidoli, P, Amoroso, D, Bochicchio, A, Frassineti, L, Corsi, D, Bilancia, D, Pastorino, A, De Stefano, A, Labianca, R, Iaffaioli, R, Nasti, G, Daniele, B, Zagonel, V, Pella, N, Aprile, G, Marchetti, R, Romiti, A, Foa, P, Mosconi, S, Sobrero, A, Cazzaniga, M, Beretta, G, Cortesi, E, Barni, S, Petrelli, F, Allione, P, D'Arco, A, Valmadre, G, Piazza, E, Veltri, E, Ramus, G, Giustini, L, Tumulo, S, Cascinu, S, Granetto, C, Testore, F, Giordano, M, Moroni, M, Di Seri, M, Nuzzo, A, Angelelli, L, Gori, S, Farina, G, Aglietta, M, Franchi, R, Comande, M, Giordani, P, Tonini, G, Bucci, E, Ballestrero, A, Benasso, M, Graiff, C, Bravi, S, Caffo, O, Silva, R, Frontini, L, Rota, S, Cozzi, L, Cantore, M, Maiello, E, Cinieri, S, Silvestris, N, Romito, S, Gebbia, V, Santoro, A, Artioli, F, Mattioli, R, Contu, A, Di Costanzo, F, Leonardi, F, Cavanna, L, Passalacqua, R, Sozzi, P, D'Amico, M, Amadori, D, Turci, D, Ravaioli, A, Pasquini, E, Gambi, A, Faedi, M, Cruciani, G, Bajetta, E, Gianni, L, Ionta, M, Massidda, B, Scartozzi, M, Ciarlo, A, Di Leo, A, Frustaci, S, Rangoni, G, Arizzoia, A, Pavesi, L, Verusio, C, Pinotti, G, Iop, A, De Placido, S, Adamo, V, Ficorella, C, Natale, D, Greco, E, Rulli, E, Poli, D, Porcu, L, Torri, V, Rosati G., Lonardi S., Galli F., Di Bartolomeo M., Ronzoni M., Zampino M. G., Banzi M., Zaniboni A., Pasini F., Bozzarelli S., Garattini S. K., Ferrari D., Montesarchio V., Mambrini A., Ciuffreda L., Pusceddu V., Carlomagno C., Bidoli P., Amoroso D., Bochicchio A. M., Frassineti L., Corsi D., Bilancia D., Pastorino A., De Stefano A., Labianca R., Iaffaioli R. V., Nasti G., Daniele B., Zagonel V., Pella N., Aprile G., Marchetti R. P., Romiti A., Foa P., Mosconi S., Sobrero A., Cazzaniga M., Beretta G. D., Cortesi E., Barni S., Petrelli F., Allione P., D'Arco A. M., Valmadre G., Piazza E., Veltri E., Ramus G. V., Giustini L., Tumulo S., Cascinu S., Granetto C., Testore F., Giordano M., Moroni M., Di Seri M., Nuzzo A., Angelelli L., Gori S., Farina G., Aglietta M., Franchi R., Comande M., Giordani P., Tonini G., Bucci E., Ballestrero A., Benasso M., Graiff C., Bravi S., Caffo O., Silva R. R., Frontini L., Rota S., Cozzi L., Cantore M., Maiello E., Cinieri S., Silvestris N., Romito S., Gebbia V., Santoro A., Artioli F., Mattioli R., Contu A., Di Costanzo F., Leonardi F., Cavanna L., Passalacqua R., Sozzi P., D'Amico M., Amadori D., Turci D., Ravaioli A., Pasquini E., Gambi A., Faedi M., Cruciani G., Bajetta E., Gianni L., Ionta M. T., Massidda B., Scartozzi M., Ciarlo A., Di Leo A., Frustaci S., Rangoni G., Arizzoia A., Pavesi L., Verusio C., Pinotti G., Iop A., De Placido S., Adamo V., Ficorella C., Natale D., Greco E., Rulli E., Poli D., Porcu L., Torri V., Rosati, G, Lonardi, S, Galli, F, Di Bartolomeo, M, Ronzoni, M, Zampino, M, Banzi, M, Zaniboni, A, Pasini, F, Bozzarelli, S, Garattini, S, Ferrari, D, Montesarchio, V, Mambrini, A, Ciuffreda, L, Pusceddu, V, Carlomagno, C, Bidoli, P, Amoroso, D, Bochicchio, A, Frassineti, L, Corsi, D, Bilancia, D, Pastorino, A, De Stefano, A, Labianca, R, Iaffaioli, R, Nasti, G, Daniele, B, Zagonel, V, Pella, N, Aprile, G, Marchetti, R, Romiti, A, Foa, P, Mosconi, S, Sobrero, A, Cazzaniga, M, Beretta, G, Cortesi, E, Barni, S, Petrelli, F, Allione, P, D'Arco, A, Valmadre, G, Piazza, E, Veltri, E, Ramus, G, Giustini, L, Tumulo, S, Cascinu, S, Granetto, C, Testore, F, Giordano, M, Moroni, M, Di Seri, M, Nuzzo, A, Angelelli, L, Gori, S, Farina, G, Aglietta, M, Franchi, R, Comande, M, Giordani, P, Tonini, G, Bucci, E, Ballestrero, A, Benasso, M, Graiff, C, Bravi, S, Caffo, O, Silva, R, Frontini, L, Rota, S, Cozzi, L, Cantore, M, Maiello, E, Cinieri, S, Silvestris, N, Romito, S, Gebbia, V, Santoro, A, Artioli, F, Mattioli, R, Contu, A, Di Costanzo, F, Leonardi, F, Cavanna, L, Passalacqua, R, Sozzi, P, D'Amico, M, Amadori, D, Turci, D, Ravaioli, A, Pasquini, E, Gambi, A, Faedi, M, Cruciani, G, Bajetta, E, Gianni, L, Ionta, M, Massidda, B, Scartozzi, M, Ciarlo, A, Di Leo, A, Frustaci, S, Rangoni, G, Arizzoia, A, Pavesi, L, Verusio, C, Pinotti, G, Iop, A, De Placido, S, Adamo, V, Ficorella, C, Natale, D, Greco, E, Rulli, E, Poli, D, Porcu, L, Torri, V, Rosati G., Lonardi S., Galli F., Di Bartolomeo M., Ronzoni M., Zampino M. G., Banzi M., Zaniboni A., Pasini F., Bozzarelli S., Garattini S. K., Ferrari D., Montesarchio V., Mambrini A., Ciuffreda L., Pusceddu V., Carlomagno C., Bidoli P., Amoroso D., Bochicchio A. M., Frassineti L., Corsi D., Bilancia D., Pastorino A., De Stefano A., Labianca R., Iaffaioli R. V., Nasti G., Daniele B., Zagonel V., Pella N., Aprile G., Marchetti R. P., Romiti A., Foa P., Mosconi S., Sobrero A., Cazzaniga M., Beretta G. D., Cortesi E., Barni S., Petrelli F., Allione P., D'Arco A. M., Valmadre G., Piazza E., Veltri E., Ramus G. V., Giustini L., Tumulo S., Cascinu S., Granetto C., Testore F., Giordano M., Moroni M., Di Seri M., Nuzzo A., Angelelli L., Gori S., Farina G., Aglietta M., Franchi R., Comande M., Giordani P., Tonini G., Bucci E., Ballestrero A., Benasso M., Graiff C., Bravi S., Caffo O., Silva R. R., Frontini L., Rota S., Cozzi L., Cantore M., Maiello E., Cinieri S., Silvestris N., Romito S., Gebbia V., Santoro A., Artioli F., Mattioli R., Contu A., Di Costanzo F., Leonardi F., Cavanna L., Passalacqua R., Sozzi P., D'Amico M., Amadori D., Turci D., Ravaioli A., Pasquini E., Gambi A., Faedi M., Cruciani G., Bajetta E., Gianni L., Ionta M. T., Massidda B., Scartozzi M., Ciarlo A., Di Leo A., Frustaci S., Rangoni G., Arizzoia A., Pavesi L., Verusio C., Pinotti G., Iop A., De Placido S., Adamo V., Ficorella C., Natale D., Greco E., Rulli E., Poli D., Porcu L., and Torri V.

Abstract

Background: Previous studies on oxaliplatin and fluoropyrimidines as adjuvant therapy in older patients with stage III colon cancer (CC) produced conflicting results. Patients and methods: We assessed the impact of age on time to tumour recurrence (TTR), disease-free survival (DFS), cancer-specific survival (CSS), and overall survival (OS) in 2360 patients with stage III CC (1667 aged <70 years and 693 ≥ 70 years) randomised to receive 3 or 6 months of FOLFOX or CAPOX within the frame of the phase III, TOSCA study. Results: Older patients compared with younger ones presented more frequently an Eastern Cooperative Oncology Group performance status equal to 1 (10.5% vs 3.3%, p < 0.001), a greater number of right-sided tumours (40.9% vs 26.6%, p < 0.001), and were at higher clinical risk (37.2% vs 33.2%, p = 0.062). The treatments were almost identical in the two cohorts (p = 0.965). We found a greater proportion of dose reductions (46.7% vs 41.4%, p = 0.018), treatment interruptions (26.1% vs 19.3%, p < 0.001) and a higher proportion of recurrences (24.2% vs 20.3%, p = 0.033) in the older patients. The multivariable analysis of the TTR did not indicate a statistically significant effect of age (hazard ratio [HR]: 1.19; 95% confidence interval [CI]: 0.98–1.44; p = 0.082). The HR comparing older with younger patients was 1.34 (95% CI: 1.12–1.59; p = 0.001) for DFS, 1.58 (95% CI: 1.26–1.99; p < 0.001) for OS, and 1.28 (95% CI: 0.96–1.70; p = 0.089) for CSS. Conclusions: Worse prognostic factors and reduced treatment compliance have a negative impact on the efficacy of oxaliplatin-based adjuvant therapy in older patients.

Published
2021

16. EP14.01-006 CeLEBrATE: Phase II trial of CarbopLatin, Etoposide, Bevacizumab and Atezolizumab in Patients with exTEnsive-Stage SCLC-GOIRC-01-2019

Author

Andrini, E., primary, Lamberti, G., additional, Mazzoni, F., additional, Riccardi, F., additional, Bonetti, A., additional, Follador, A., additional, Giardina, D., additional, Genova, C., additional, Guaitoli, G., additional, Frassoldati, A., additional, Brighenti, M., additional, Colantonio, I., additional, Pasello, G., additional, Ficorella, C., additional, Cinieri, S., additional, Tiseo, M., additional, Gelsomino, F., additional, Tognetto, M., additional, Rihawi, K., additional, and Ardizzoni, A., additional

Published
2022
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17. Corrigendum: “Real world data of cemiplimab in locally advanced and metastatic cutaneous squamous cell carcinoma” (European Journal of Cancer (2021) 157 (250–258), (S0959804921005360), (10.1016/j.ejca.2021.08.018))

Author

Baggi, A., Quaglino, P., Rubatto, M., Depenni, R., Guida, M., Ascierto, P. A., Trojaniello, C., Queirolo, P., Saponara, M., Peris, Ketty, Spagnolo, F., Bianchi, L., De Galitiis, F., Potenza, M. C., Proietti, I., Marconcini, R., Botticelli, A., Barbieri, Pietro Vittorio, Licitra, L., Alfieri, S., Ficorella, C., Cortellini, A., Fargnoli, Maria Concetta, Troiani, T., Tondulli, L., Zamparini, M., Bossi, P., Peris K. (ORCID:0000-0002-5237-0463), Barbieri V., Fargnoli M. C., Baggi, A., Quaglino, P., Rubatto, M., Depenni, R., Guida, M., Ascierto, P. A., Trojaniello, C., Queirolo, P., Saponara, M., Peris, Ketty, Spagnolo, F., Bianchi, L., De Galitiis, F., Potenza, M. C., Proietti, I., Marconcini, R., Botticelli, A., Barbieri, Pietro Vittorio, Licitra, L., Alfieri, S., Ficorella, C., Cortellini, A., Fargnoli, Maria Concetta, Troiani, T., Tondulli, L., Zamparini, M., Bossi, P., Peris K. (ORCID:0000-0002-5237-0463), Barbieri V., and Fargnoli M. C.

Abstract

The authors regret that some Author information was incorrectly given in the published article. Author Manuel Zamparini was missed in the Author list, and the listed affiliation for Paola Queirolo was incorrect. The full and correct details for the Authors are: Paola Queirolo Division of Melanoma, Sarcomas and Rare Tumors, IEO, European Institute of Oncology, IRCCS, Milan, Italy Manuel Zamparini University of Brescia, Department of Medical-Surgical Specialties, Radiological Sciences and Public Health, Medical Oncology, ASST-Spedali Civili, Brescia, Lombardia, ItalyThe Authors also note that values in the first column of Table 4 were mistakenly reversed for ‘Antibiotic intake (within 1 month before therapy)’ and ‘Haemoglobin’. The correct table in full is given here.

Published
2022

18. Osimertinib beyond disease progression in T790M EGFR-positive NSCLC patients: a multicenter study of clinicians' attitudes

Author

Cortellini, A, Leonetti, A, Catino, A, Pizzutillo, P, Ricciuti, B, De Giglio, A, Chiari, R, Bordi, P, Santini, D, Giusti, R, De Tursi, M, Brocco, D, Zoratto, F, Rastelli, F, Citarella, F, Russano, M, Filetti, M, Marchetti, P, Berardi, R, Torniai, M, Cortinovis, D, Sala, E, Maggioni, C, Follador, A, Macerelli, M, Nigro, O, Tuzi, A, Iacono, D, Migliorino, M, Banna, G, Porzio, G, Cannita, K, Ferrara, M, Bria, E, Galetta, D, Ficorella, C, Tiseo, M, Cortellini A, Leonetti A, Catino A, Pizzutillo P, Ricciuti B, De Giglio A, Chiari R, Bordi P, Santini D, Giusti R, De Tursi M, Brocco D, Zoratto F, Rastelli F, Citarella F, Russano M, Filetti M, Marchetti P, Berardi R, Torniai M, Cortinovis D, Sala E, Maggioni C, Follador A, Macerelli M, Nigro O, Tuzi A, Iacono D, Migliorino MR, Banna G, Porzio G, Cannita K, Ferrara MG, Bria E, Galetta D, Ficorella C, Tiseo M., Cortellini, A, Leonetti, A, Catino, A, Pizzutillo, P, Ricciuti, B, De Giglio, A, Chiari, R, Bordi, P, Santini, D, Giusti, R, De Tursi, M, Brocco, D, Zoratto, F, Rastelli, F, Citarella, F, Russano, M, Filetti, M, Marchetti, P, Berardi, R, Torniai, M, Cortinovis, D, Sala, E, Maggioni, C, Follador, A, Macerelli, M, Nigro, O, Tuzi, A, Iacono, D, Migliorino, M, Banna, G, Porzio, G, Cannita, K, Ferrara, M, Bria, E, Galetta, D, Ficorella, C, Tiseo, M, Cortellini A, Leonetti A, Catino A, Pizzutillo P, Ricciuti B, De Giglio A, Chiari R, Bordi P, Santini D, Giusti R, De Tursi M, Brocco D, Zoratto F, Rastelli F, Citarella F, Russano M, Filetti M, Marchetti P, Berardi R, Torniai M, Cortinovis D, Sala E, Maggioni C, Follador A, Macerelli M, Nigro O, Tuzi A, Iacono D, Migliorino MR, Banna G, Porzio G, Cannita K, Ferrara MG, Bria E, Galetta D, Ficorella C, and Tiseo M.

Abstract

Background: In most cases, T790M EGFR-positive NSCLC patients receiving osimertinib developed “non-drugable” progression, as the patients with common EGFR-sensitizing mutations were treated with first-line osimertinib. In both settings, chemotherapy represents the standard treatment and local ablative treatments (LATs) are potential useful options in the case of oligo-progression. Methods: We conducted a study on “post-progression” (pp) outcomes of T790M EGFR-positive NSCLC patients treated with osimertinib, according to the therapeutic strategy applied: osimertinib beyond progression (± LATs), “switched therapies” or best supportive care only (BSC). Results: 144 consecutive patients were evaluated: 53 (36.8%) did not received post-progression treatments (BSC), while 91 (63.2%) patients received at least 1 subsequent treatment; 50 patients (54.9%) received osimertinib beyond disease progression [19 (20.9%) of them with adjunctive LATs] and 41 (45.1%) a switched therapy. Median ppPFS (progression-free survival) and median ppOS (overall survival) of patients who received osimertinib beyond progression vs. switched therapies were 6.4 months vs. 4.7 months, respectively [HR 0.57 (95% CI 0.35–0.92), p = 0.0239] and 11.3 months vs 7.8 months, respectively [HR 0.57 (95% CI 0.33–0.98), p = 0.0446]. Among patients who received osimertinib beyond progression with and without LATs median ppPFS was 6.4 months and 5.7 months, respectively [HR 0.90 (95% CI 0.68–1.18), p = 0.4560], while median ppOS was 20.2 months and 9.9 months, respectively [HR 0.73 (95% CI 0.52–1.03), p = 0.0748]. At the univariate analysis, the only factor significantly related to the ppPFS was the therapeutic strategy in favor of osimertinib beyond progression (± LATs). Moreover, the only variable which was significantly related to ppOS at the multivariate analysis was osimertinib beyond progression (± LATs). Conclusion: Our study confirmed that in clinical practice, in case of “non-druggable” disease progre

Published
2020

19. Immune-related Adverse Events of Pembrolizumab in a Large Real-world Cohort of Patients With NSCLC With a PD-L1 Expression ≥ 50% and Their Relationship With Clinical Outcomes

Author

Cortellini, A, Friedlaender, A, Banna, G, Porzio, G, Bersanelli, M, Cappuzzo, F, Aerts, J, Giusti, R, Bria, E, Cortinovis, D, Grossi, F, Migliorino, M, Galetta, D, Passiglia, F, Berardi, R, Mazzoni, F, Di Noia, V, Signorelli, D, Tuzi, A, Gelibter, A, Marchetti, P, Macerelli, M, Rastelli, F, Chiari, R, Rocco, D, Inno, A, Di Marino, P, Mansueto, G, Zoratto, F, Santoni, M, Tudini, M, Ghidini, M, Filetti, M, Catino, A, Pizzutilo, P, Sala, L, Occhipinti, M, Citarella, F, Marco, R, Torniai, M, Cantini, L, Follador, A, Sforza, V, Nigro, O, Ferrara, M, D'Argento, E, Leonetti, A, Pettoruti, L, Antonuzzo, L, Scodes, S, Landi, L, Guaitoli, G, Baldessari, C, Bertolini, F, Della Gravara, L, Dal Bello, M, Belderbos, R, De Filippis, M, Cecchi, C, Ricciardi, S, Donisi, C, De Toma, A, Proto, C, Addeo, A, Cantale, O, Ricciuti, B, Genova, C, Morabito, A, Santini, D, Ficorella, C, Cannita, K, Cortellini A, Friedlaender A, Banna GL, Porzio G, Bersanelli M, Cappuzzo F, Aerts JGJV, Giusti R, Bria E, Cortinovis D, Grossi F, Migliorino MR, Galetta D, Passiglia F, Berardi R, Mazzoni F, Di Noia V, Signorelli D, Tuzi A, Gelibter A, Marchetti P, Macerelli M, Rastelli F, Chiari R, Rocco D, Inno A, Di Marino P, Mansueto G, Zoratto F, Santoni M, Tudini M, Ghidini M, Filetti M, Catino A, Pizzutilo P, Sala L, Occhipinti MA, Citarella F, Marco R, Torniai M, Cantini L, Follador A, Sforza V, Nigro O, Ferrara MG, D'Argento E, Leonetti A, Pettoruti L, Antonuzzo L, Scodes S, Landi L, Guaitoli G, Baldessari C, Bertolini F, Della Gravara L, Dal Bello MG, Belderbos RA, De Filippis M, Cecchi C, Ricciardi S, Donisi C, De Toma A, Proto C, Addeo A, Cantale O, Ricciuti B, Genova C, Morabito A, Santini D, Ficorella C, Cannita K., Cortellini, A, Friedlaender, A, Banna, G, Porzio, G, Bersanelli, M, Cappuzzo, F, Aerts, J, Giusti, R, Bria, E, Cortinovis, D, Grossi, F, Migliorino, M, Galetta, D, Passiglia, F, Berardi, R, Mazzoni, F, Di Noia, V, Signorelli, D, Tuzi, A, Gelibter, A, Marchetti, P, Macerelli, M, Rastelli, F, Chiari, R, Rocco, D, Inno, A, Di Marino, P, Mansueto, G, Zoratto, F, Santoni, M, Tudini, M, Ghidini, M, Filetti, M, Catino, A, Pizzutilo, P, Sala, L, Occhipinti, M, Citarella, F, Marco, R, Torniai, M, Cantini, L, Follador, A, Sforza, V, Nigro, O, Ferrara, M, D'Argento, E, Leonetti, A, Pettoruti, L, Antonuzzo, L, Scodes, S, Landi, L, Guaitoli, G, Baldessari, C, Bertolini, F, Della Gravara, L, Dal Bello, M, Belderbos, R, De Filippis, M, Cecchi, C, Ricciardi, S, Donisi, C, De Toma, A, Proto, C, Addeo, A, Cantale, O, Ricciuti, B, Genova, C, Morabito, A, Santini, D, Ficorella, C, Cannita, K, Cortellini A, Friedlaender A, Banna GL, Porzio G, Bersanelli M, Cappuzzo F, Aerts JGJV, Giusti R, Bria E, Cortinovis D, Grossi F, Migliorino MR, Galetta D, Passiglia F, Berardi R, Mazzoni F, Di Noia V, Signorelli D, Tuzi A, Gelibter A, Marchetti P, Macerelli M, Rastelli F, Chiari R, Rocco D, Inno A, Di Marino P, Mansueto G, Zoratto F, Santoni M, Tudini M, Ghidini M, Filetti M, Catino A, Pizzutilo P, Sala L, Occhipinti MA, Citarella F, Marco R, Torniai M, Cantini L, Follador A, Sforza V, Nigro O, Ferrara MG, D'Argento E, Leonetti A, Pettoruti L, Antonuzzo L, Scodes S, Landi L, Guaitoli G, Baldessari C, Bertolini F, Della Gravara L, Dal Bello MG, Belderbos RA, De Filippis M, Cecchi C, Ricciardi S, Donisi C, De Toma A, Proto C, Addeo A, Cantale O, Ricciuti B, Genova C, Morabito A, Santini D, Ficorella C, and Cannita K.

Abstract

Background: The role of immune-related adverse events (irAEs), as a surrogate predictor of the efficacy of checkpoint inhibitors, has not yet been described in the setting of first-line, single-agent pembrolizumab for patients with metastatic non-small-cell lung-cancer (NSCLC) with a programmed death-ligand 1 (PD-L1) expression of ≥ 50%. Patients and methods: We previously conducted a multicenter retrospective analysis in patients with treatment-naive metastatic NSCLC and a PD-L1 expression of ≥ 50% receiving first-line pembrolizumab. Here, we report the results of the irAE analysis and the potential correlation between irAEs and clinical outcomes. Results: A total of 1010 patients were included in this analysis; after a 6-week landmark selection, 877 (86.8%) patients were included in the efficacy analysis. Any grade irAEs (P < .0001), grade 3/4 irAEs (P = .0025), leading to discontinuation irAEs (P = .0144), multiple-site and single-site irAEs (P < .0001), cutaneous irAEs (P = .0001), endocrine irAEs (P = .0227), pulmonary irAEs (P = .0479), and rheumatologic irAEs (P = .0018) were significantly related to a higher objective response rate. Any grade irAEs (P < .0001), single-site irAEs (P < .0001), multiple-site irAEs (P = .0005), cutaneous irAEs (P = .0042), endocrine irAEs (P < .0001), gastrointestinal irAEs (P = .0391), and rheumatologic irAEs (P = .0086) were significantly related to progression-free survival. Any grade irAEs (P < .0001), single-site irAEs (P < .0001), multiple-site irAEs (P = .0003), cutaneous irAEs (P = .0002), endocrine irAEs (P = .0001), and rheumatologic irAEs (P = .0214) were significantly related to overall survival. Conclusions: This study confirms the feasibility and the safety of first-line, single-agent pembrolizumab, in a large, real-world cohort of patients with NSCLC with PD-L1 expression ≥ 50%. The occurrence of irAEs may be a surrogate of clinical activity and improved outcomes in this setting.

Published
2020

20. Baseline BMI and BMI variation during first line pembrolizumab in NSCLC patients with a PD-L1 expression ≥ 50%: a multicenter study with external validation

Author

Cortellini, A, Ricciuti, B, Tiseo, M, Bria, E, Banna, G, Aerts, J, Barbieri, F, Giusti, R, Cortinovis, D, Migliorino, M, Catino, A, Passiglia, F, Torniai, M, Morabito, A, Genova, C, Mazzoni, F, Di Noia, V, Signorelli, D, Gelibter, A, Occhipinti, M, Rastelli, F, Chiari, R, Rocco, D, Inno, A, De Tursi, M, Di Marino, P, Mansueto, G, Zoratto, F, Grossi, F, Filetti, M, Pizzutilo, P, Russano, M, Citarella, F, Cantini, L, Targato, G, Nigro, O, Ferrara, M, Buti, S, Scodes, S, Landi, L, Guaitoli, G, Della Gravara, L, Tabbò, F, Ricciardi, S, De Toma, A, Friedlaender, A, Petrelli, F, Addeo, A, Porzio, G, Ficorella, C, Cortellini A, Ricciuti B, Tiseo M, Bria E, Banna GL, Aerts JG, Barbieri F, Giusti R, Cortinovis D, Migliorino MR, Catino A, Passiglia F, Torniai M, Morabito A, Genova C, Mazzoni F, Di Noia V, Signorelli D, Gelibter A, Occhipinti MA, Rastelli F, Chiari R, Rocco D, Inno A, De Tursi M, Di Marino P, Mansueto G, Zoratto F, Grossi F, Filetti M, Pizzutilo P, Russano M, Citarella F, Cantini L, Targato G, Nigro O, Ferrara MG, Buti S, Scodes S, Landi L, Guaitoli G, Della Gravara L, Tabbò F, Ricciardi S, De Toma A, Friedlaender A, Petrelli F, Addeo A, Porzio G, Ficorella C., Cortellini, A, Ricciuti, B, Tiseo, M, Bria, E, Banna, G, Aerts, J, Barbieri, F, Giusti, R, Cortinovis, D, Migliorino, M, Catino, A, Passiglia, F, Torniai, M, Morabito, A, Genova, C, Mazzoni, F, Di Noia, V, Signorelli, D, Gelibter, A, Occhipinti, M, Rastelli, F, Chiari, R, Rocco, D, Inno, A, De Tursi, M, Di Marino, P, Mansueto, G, Zoratto, F, Grossi, F, Filetti, M, Pizzutilo, P, Russano, M, Citarella, F, Cantini, L, Targato, G, Nigro, O, Ferrara, M, Buti, S, Scodes, S, Landi, L, Guaitoli, G, Della Gravara, L, Tabbò, F, Ricciardi, S, De Toma, A, Friedlaender, A, Petrelli, F, Addeo, A, Porzio, G, Ficorella, C, Cortellini A, Ricciuti B, Tiseo M, Bria E, Banna GL, Aerts JG, Barbieri F, Giusti R, Cortinovis D, Migliorino MR, Catino A, Passiglia F, Torniai M, Morabito A, Genova C, Mazzoni F, Di Noia V, Signorelli D, Gelibter A, Occhipinti MA, Rastelli F, Chiari R, Rocco D, Inno A, De Tursi M, Di Marino P, Mansueto G, Zoratto F, Grossi F, Filetti M, Pizzutilo P, Russano M, Citarella F, Cantini L, Targato G, Nigro O, Ferrara MG, Buti S, Scodes S, Landi L, Guaitoli G, Della Gravara L, Tabbò F, Ricciardi S, De Toma A, Friedlaender A, Petrelli F, Addeo A, Porzio G, and Ficorella C.

Abstract

Background The association between obesity and outcomes in patients receiving programmed death-1/programmed death ligand-1 (PD-L1) checkpoint inhibitors has already been confirmed in pre-treated non-small cell lung cancer (NSCLC) patients, regardless of PD-L1 tumor expression. Methods We present the outcomes analysis according to baseline body mass index (BMI) and BMI variation in a large cohort of metastatic NSCLC patients with a PD-L1 expression ≥50%, receiving first line pembrolizumab. We also evaluated a control cohort of metastatic NSCLC patients treated with first line platinum-based chemotherapy. Normal weight was set as control group. Results 962 patients and 426 patients were included in the pembrolizumab and chemotherapy cohorts, respectively. Obese patients had a significantly higher objective response rate (ORR) (OR=1.61 (95% CI: 1.04-2.50)) in the pembrolizumab cohort, while overweight patients had a significantly lower ORR (OR=0.59 (95% CI: 0.37-0.92)) within the chemotherapy cohort. Obese patients had a significantly longer progression-free survival (PFS) (HR=0.61 (95% CI: 0.45-0.82)) in the pembrolizumab cohort. Conversely, they had a significantly shorter PFS in the chemotherapy cohort (HR=1.27 (95% CI: 1.01-1.60)). Obese patients had a significantly longer overall survival (OS) within the pembrolizumab cohort (HR=0.70 (95% CI: 0.49-0.99)), while no significant differences according to baseline BMI were found in the chemotherapy cohort. BMI variation significantly affected ORR, PFS and OS in both the pembrolizumab and the chemotherapy cohorts. Conclusions Baseline obesity is associated to significantly improved ORR, PFS and OS in metastatic NSCLC patients with a PD-L1 expression of ≥50%, receiving first line pembrolizumab, but not among patients treated with chemotherapy. BMI variation is also significantly related to clinical outcomes.

Published
2020

21. Clinicopathologic correlates of first-line pembrolizumab effectiveness in patients with advanced NSCLC and a PD-L1 expression of ≥ 50

Author

Cortellini, A, Tiseo, M, Banna, G, Cappuzzo, F, Aerts, J, Barbieri, F, Giusti, R, Bria, E, Cortinovis, D, Grossi, F, Migliorino, M, Galetta, D, Passiglia, F, Santini, D, Berardi, R, Morabito, A, Genova, C, Mazzoni, F, Di Noia, V, Signorelli, D, Tuzi, A, Gelibter, A, Marchetti, P, Macerelli, M, Rastelli, F, Chiari, R, Rocco, D, Gori, S, De Tursi, M, Mansueto, G, Zoratto, F, Santoni, M, Tudini, M, Rijavec, E, Filetti, M, Catino, A, Pizzutilo, P, Sala, L, Citarella, F, Marco, R, Torniai, M, Cantini, L, Targato, G, Sforza, V, Nigro, O, Ferrara, M, D'Argento, E, Buti, S, Bordi, P, Antonuzzo, L, Scodes, S, Landi, L, Guaitoli, G, Baldessari, C, Della Gravara, L, Dal Bello, M, Belderbos, R, Bironzo, P, Carnio, S, Ricciardi, S, Grieco, A, De Toma, A, Proto, C, Friedlaender, A, Cantale, O, Ricciuti, B, Addeo, A, Metro, G, Ficorella, C, Porzio, G, Cortellini A, Tiseo M, Banna GL, Cappuzzo F, Aerts JGJV, Barbieri F, Giusti R, Bria E, Cortinovis D, Grossi F, Migliorino MR, Galetta D, Passiglia F, Santini D, Berardi R, Morabito A, Genova C, Mazzoni F, Di Noia V, Signorelli D, Tuzi A, Gelibter A, Marchetti P, Macerelli M, Rastelli F, Chiari R, Rocco D, Gori S, De Tursi M, Mansueto G, Zoratto F, Santoni M, Tudini M, Rijavec E, Filetti M, Catino A, Pizzutilo P, Sala L, Citarella F, Marco R, Torniai M, Cantini L, Targato G, Sforza V, Nigro O, Ferrara MG, D'Argento E, Buti S, Bordi P, Antonuzzo L, Scodes S, Landi L, Guaitoli G, Baldessari C, Della Gravara L, Dal Bello MG, Belderbos RA, Bironzo P, Carnio S, Ricciardi S, Grieco A, De Toma A, Proto C, Friedlaender A, Cantale O, Ricciuti B, Addeo A, Metro G, Ficorella C, Porzio G., Cortellini, A, Tiseo, M, Banna, G, Cappuzzo, F, Aerts, J, Barbieri, F, Giusti, R, Bria, E, Cortinovis, D, Grossi, F, Migliorino, M, Galetta, D, Passiglia, F, Santini, D, Berardi, R, Morabito, A, Genova, C, Mazzoni, F, Di Noia, V, Signorelli, D, Tuzi, A, Gelibter, A, Marchetti, P, Macerelli, M, Rastelli, F, Chiari, R, Rocco, D, Gori, S, De Tursi, M, Mansueto, G, Zoratto, F, Santoni, M, Tudini, M, Rijavec, E, Filetti, M, Catino, A, Pizzutilo, P, Sala, L, Citarella, F, Marco, R, Torniai, M, Cantini, L, Targato, G, Sforza, V, Nigro, O, Ferrara, M, D'Argento, E, Buti, S, Bordi, P, Antonuzzo, L, Scodes, S, Landi, L, Guaitoli, G, Baldessari, C, Della Gravara, L, Dal Bello, M, Belderbos, R, Bironzo, P, Carnio, S, Ricciardi, S, Grieco, A, De Toma, A, Proto, C, Friedlaender, A, Cantale, O, Ricciuti, B, Addeo, A, Metro, G, Ficorella, C, Porzio, G, Cortellini A, Tiseo M, Banna GL, Cappuzzo F, Aerts JGJV, Barbieri F, Giusti R, Bria E, Cortinovis D, Grossi F, Migliorino MR, Galetta D, Passiglia F, Santini D, Berardi R, Morabito A, Genova C, Mazzoni F, Di Noia V, Signorelli D, Tuzi A, Gelibter A, Marchetti P, Macerelli M, Rastelli F, Chiari R, Rocco D, Gori S, De Tursi M, Mansueto G, Zoratto F, Santoni M, Tudini M, Rijavec E, Filetti M, Catino A, Pizzutilo P, Sala L, Citarella F, Marco R, Torniai M, Cantini L, Targato G, Sforza V, Nigro O, Ferrara MG, D'Argento E, Buti S, Bordi P, Antonuzzo L, Scodes S, Landi L, Guaitoli G, Baldessari C, Della Gravara L, Dal Bello MG, Belderbos RA, Bironzo P, Carnio S, Ricciardi S, Grieco A, De Toma A, Proto C, Friedlaender A, Cantale O, Ricciuti B, Addeo A, Metro G, Ficorella C, and Porzio G.

Abstract

Background: Single-agent pembrolizumab represents the standard first-line option for metastatic non-small-cell lung cancer (NSCLC) patients with a PD-L1 (programmed death-ligand 1) expression of ≥ 50%. Methods: We conducted a multicenter retrospective study aimed at evaluating the clinicopathologic correlates of pembrolizumab effectiveness in patients with treatment-naïve NSCLC and a PD-L1 expression of ≥ 50%. Results: One thousand and twenty-six consecutive patients were included. The objective response rate (ORR) was 44.5% (95% CI 40.2–49.1), while the median progression free survival (PFS) and overall survival (OS) were 7.9 months (95% CI 6.9–9.5; 599 events) and 17.2 months (95% CI 15.3–22.3; 598 censored patients), respectively. ECOG-PS ≥ 2 (p < 0.0001) and bone metastases (p = 0.0003) were confirmed to be independent predictors of a worse ORR. Former smokers (p = 0.0002), but not current smokers (p = 0.0532) were confirmed to have a significantly prolonged PFS compared to never smokers at multivariate analysis. ECOG-PS (p < 0.0001), bone metastases (p < 0.0001) and liver metastases (p < 0.0001) were also confirmed to be independent predictors of a worse PFS. Previous palliative RT was significantly related to a shortened OS (p = 0.0104), while previous non-palliative RT was significantly related to a prolonged OS (p = 0.0033). Former smokers (p = 0.0131), but not current smokers (p = 0.3433) were confirmed to have a significantly prolonged OS compared to never smokers. ECOG-PS (p < 0.0001), bone metastases (p < 0.0001) and liver metastases (p < 0.0001) were also confirmed to be independent predictors of a shortened OS. A PD-L1 expression of ≥ 90%, as assessed by recursive partitioning, was associated with significantly higher ORR (p = 0.0204), and longer and OS (p = 0.0346) at multivariable analysis. Conclusion: Pembrolizumab was effective in a large cohort of NSCLC patients treated outside of clinical trials. Questions regarding the effe

Published
2020

22. Chemotherapy in non-small cell lung cancer patients after prior immunotherapy: The multicenter retrospective CLARITY study

Author

Bersanelli, M, Buti, S, Giannarelli, D, Leonetti, A, Cortellini, A, Russo, G, Signorelli, D, Toschi, L, Milella, M, Pilotto, S, Bria, E, Proto, C, Marinello, A, Randon, G, Rossi, S, Vita, E, Sartori, G, D'Argento, E, Qako, E, Giaiacopi, E, Ghilardi, L, Bettini, A, Rapacchi, E, Mazzoni, F, Lavacchi, D, Scotti, V, Ciccone, L, De Tursi, M, Di Marino, P, Santini, D, Russano, M, Bordi, P, Di Maio, M, Audisio, M, Filetti, M, Giusti, R, Berardi, R, Fiordoliva, I, Cerea, G, Pizzutilo, E, Bearz, A, De Carlo, E, Cecere, F, Renna, D, Camisa, R, Caruso, G, Ficorella, C, Banna, G, Cortinovis, D, Brighenti, M, Garassino, M, Tiseo, M, Bersanelli M., Buti S., Giannarelli D., Leonetti A., Cortellini A., Russo G. L., Signorelli D., Toschi L., Milella M., Pilotto S., Bria E., Proto C., Marinello A., Randon G., Rossi S., Vita E., Sartori G., D'Argento E., Qako E., Giaiacopi E., Ghilardi L., Bettini A. C., Rapacchi E., Mazzoni F., Lavacchi D., Scotti V., Ciccone L. P., De Tursi M., Di Marino P., Santini D., Russano M., Bordi P., Di Maio M., Audisio M., Filetti M., Giusti R., Berardi R., Fiordoliva I., Cerea G., Pizzutilo E. G., Bearz A., De Carlo E., Cecere F., Renna D., Camisa R., Caruso G., Ficorella C., Banna G. L., Cortinovis D., Brighenti M., Garassino M. C., Tiseo M., Bersanelli, M, Buti, S, Giannarelli, D, Leonetti, A, Cortellini, A, Russo, G, Signorelli, D, Toschi, L, Milella, M, Pilotto, S, Bria, E, Proto, C, Marinello, A, Randon, G, Rossi, S, Vita, E, Sartori, G, D'Argento, E, Qako, E, Giaiacopi, E, Ghilardi, L, Bettini, A, Rapacchi, E, Mazzoni, F, Lavacchi, D, Scotti, V, Ciccone, L, De Tursi, M, Di Marino, P, Santini, D, Russano, M, Bordi, P, Di Maio, M, Audisio, M, Filetti, M, Giusti, R, Berardi, R, Fiordoliva, I, Cerea, G, Pizzutilo, E, Bearz, A, De Carlo, E, Cecere, F, Renna, D, Camisa, R, Caruso, G, Ficorella, C, Banna, G, Cortinovis, D, Brighenti, M, Garassino, M, Tiseo, M, Bersanelli M., Buti S., Giannarelli D., Leonetti A., Cortellini A., Russo G. L., Signorelli D., Toschi L., Milella M., Pilotto S., Bria E., Proto C., Marinello A., Randon G., Rossi S., Vita E., Sartori G., D'Argento E., Qako E., Giaiacopi E., Ghilardi L., Bettini A. C., Rapacchi E., Mazzoni F., Lavacchi D., Scotti V., Ciccone L. P., De Tursi M., Di Marino P., Santini D., Russano M., Bordi P., Di Maio M., Audisio M., Filetti M., Giusti R., Berardi R., Fiordoliva I., Cerea G., Pizzutilo E. G., Bearz A., De Carlo E., Cecere F., Renna D., Camisa R., Caruso G., Ficorella C., Banna G. L., Cortinovis D., Brighenti M., Garassino M. C., and Tiseo M.

Abstract

Objectives: In the most of cases, for non-small cell lung cancer (NSCLC) patients who progressed to previous immune checkpoint inhibitors (CKI) administered as first- or as second-line therapy, chemotherapy (CT) remains the only viable options in the absence of “druggable” mutations. We aimed to explore the efficacy of salvage chemotherapy after immunotherapy (SCAI) in advanced NSCLC patients. Materials and Methods: We designed a retrospective, multicenter study, involving 20 Italian centers, with the primary objective of describing the clinical outcome of advanced NSCLC patients treated with SCAI at the participating institutions from November 2013 to July 2019. The primary endpoint of the study was represented by overall survival (OS), defined as the time from CT initiation to death. Secondary outcome endpoints of the SCAI (progression free survival, PFS, objective response rate, ORR and toxicity) and explorative biomarkers (lactate dehydrogenase, LDH, and neutrophil-to-lymphocyte ratio, NLR during immunotherapy) were also analyzed. Results: In our study population of 342 NSCLC patients, SCAI obtained a median OS of 6.8 months (95 % confidence interval, CI 5.5–8.1), median PFS of 4.1 months (95 % CI 3.4−4.8) and ORR of 22.8 %. A “Post-CKI score” was constructed by combining significant predictors of OS at the multivariate analyses (sex, ECOG PS, disease control with prior immunotherapy), Harrell'C was 0.65, (95 % CI:0.59−0.71). Conclusions: Despite the late-line settings, our findings support the hypothesis that previous immunotherapy might increase the sensitivity of the tumor to the subsequent chemotherapy. The “Post-CKI score” was clinically effective in successfully discriminating three distinct prognostic subgroups of patients after the failure of CKI, representing a possibly useful tool for the tailored decision-making process of advanced treatment-line settings in NSCLC.

Published
2020

23. Loss of HER2 and decreased T-DM1 efficacy in HER2 positive advanced breast cancer treated with dual HER2 blockade: the SePHER Study

Author

Bon, G, Pizzuti, L, Laquintana, V, Loria, R, Porru, M, Marchio, C, Krasniqi, E, Barba, M, Maugeri-Sacca, M, Gamucci, T, Berardi, R, Livi, L, Ficorella, C, Natoli, C, Cortesi, E, Generali, D, La Verde, N, Cassano, A, Bria, E, Moscetti, L, Michelotti, A, Adamo, V, Zamagni, C, Tonini, G, Barchiesi, G, Mazzotta, M, Marinelli, D, Tomao, S, Marchetti, P, Valerio, M, Mirabelli, R, Russo, A, Fabbri, M, D'Ostilio, N, Veltri, E, Corsi, D, Garrone, O, Paris, I, Sarobba, G, Giotta, F, Garufi, C, Cazzaniga, M, Del Medico, P, Roselli, M, Sanguineti, G, Sperduti, I, Sapino, A, De Maria, R, Leonetti, C, Di Leo, A, Ciliberto, G, Falcioni, R, Vici, P, Bon G., Pizzuti L., Laquintana V., Loria R., Porru M., Marchio C., Krasniqi E., Barba M., Maugeri-Sacca M., Gamucci T., Berardi R., Livi L., Ficorella C., Natoli C., Cortesi E., Generali D., La Verde N., Cassano A., Bria E., Moscetti L., Michelotti A., Adamo V., Zamagni C., Tonini G., Barchiesi G., Mazzotta M., Marinelli D., Tomao S., Marchetti P., Valerio M. R., Mirabelli R., Russo A., Fabbri M. A., D'Ostilio N., Veltri E., Corsi D., Garrone O., Paris I., Sarobba G., Giotta F., Garufi C., Cazzaniga M., Del Medico P., Roselli M., Sanguineti G., Sperduti I., Sapino A., De Maria R., Leonetti C., Di Leo A., Ciliberto G., Falcioni R., Vici P., Bon, G, Pizzuti, L, Laquintana, V, Loria, R, Porru, M, Marchio, C, Krasniqi, E, Barba, M, Maugeri-Sacca, M, Gamucci, T, Berardi, R, Livi, L, Ficorella, C, Natoli, C, Cortesi, E, Generali, D, La Verde, N, Cassano, A, Bria, E, Moscetti, L, Michelotti, A, Adamo, V, Zamagni, C, Tonini, G, Barchiesi, G, Mazzotta, M, Marinelli, D, Tomao, S, Marchetti, P, Valerio, M, Mirabelli, R, Russo, A, Fabbri, M, D'Ostilio, N, Veltri, E, Corsi, D, Garrone, O, Paris, I, Sarobba, G, Giotta, F, Garufi, C, Cazzaniga, M, Del Medico, P, Roselli, M, Sanguineti, G, Sperduti, I, Sapino, A, De Maria, R, Leonetti, C, Di Leo, A, Ciliberto, G, Falcioni, R, Vici, P, Bon G., Pizzuti L., Laquintana V., Loria R., Porru M., Marchio C., Krasniqi E., Barba M., Maugeri-Sacca M., Gamucci T., Berardi R., Livi L., Ficorella C., Natoli C., Cortesi E., Generali D., La Verde N., Cassano A., Bria E., Moscetti L., Michelotti A., Adamo V., Zamagni C., Tonini G., Barchiesi G., Mazzotta M., Marinelli D., Tomao S., Marchetti P., Valerio M. R., Mirabelli R., Russo A., Fabbri M. A., D'Ostilio N., Veltri E., Corsi D., Garrone O., Paris I., Sarobba G., Giotta F., Garufi C., Cazzaniga M., Del Medico P., Roselli M., Sanguineti G., Sperduti I., Sapino A., De Maria R., Leonetti C., Di Leo A., Ciliberto G., Falcioni R., and Vici P.

Abstract

Background: HER2-targeting agents have dramatically changed the therapeutic landscape of HER2+ advanced breast cancer (ABC). Within a short time frame, the rapid introduction of new therapeutics has led to the approval of pertuzumab combined with trastuzumab and a taxane in first-line, and trastuzumab emtansine (T-DM1) in second-line. Thereby, evidence of T-DM1 efficacy following trastuzumab/pertuzumab combination is limited, with data from some retrospective reports suggesting lower activity. The purpose of the present study is to investigate T-DM1 efficacy in pertuzumab-pretreated and pertuzumab naïve HER2 positive ABC patients. We also aimed to provide evidence on the exposure to different drugs sequences including pertuzumab and T-DM1 in HER2 positive cell lines. Methods: The biology of HER2 was investigated in vitro through sequential exposure of resistant HER2 + breast cancer cell lines to trastuzumab, pertuzumab, and their combination. In vitro experiments were paralleled by the analysis of data from 555 HER2 + ABC patients treated with T-DM1 and evaluation of T-DM1 efficacy in the 371 patients who received it in second line. Survival estimates were graphically displayed in Kaplan Meier curves, compared by log rank test and, when possibile, confirmed in multivariate models. Results: We herein show evidence of lower activity of T-DM1 in two HER2+ breast cancer cell lines resistant to trastuzumab+pertuzumab, as compared to trastuzumab-resistant cells. Lower T-DM1 efficacy was associated with a marked reduction of HER2 expression on the cell membrane and its nuclear translocation. HER2 downregulation at the membrane level was confirmed in biopsies of four trastuzumab/pertuzumab-pretreated patients. Among the 371 patients treated with second-line T-DM1, median overall survival (mOS) from diagnosis of advanced disease and median progression-free survival to second-line treatment (mPFS2) were 52 and 6 months in 177 patients who received trastuzumab/pertuzumab in f

Published
2020

24. Is There Still a Role for Endocrine Therapy Alone in HR+/HER2- Advanced Breast Cancer Patients? Results from the Analysis of Two Data Sets of Patients Treated with High-Dose Fulvestrant as First-Line Therapy in the Real-World Setting: The EVA and GIM-13 AMBRA Studies

Author

Cazzaniga, M, Verusio, C, Ciccarese, M, Fumagalli, A, Sartori, D, Valerio, M, Airoldi, M, Moretti, G, Ficorella, C, Gianni, L, Michelotti, A, Zambelli, A, Febbraro, A, Generali, D, Pistelli, M, Garrone, O, Musolino, A, Vici, P, Maur, M, Mentuccia, L, La Verde, N, Bianchi, G, Artale, S, Blasi, L, De Laurentiis, M, Atzori, F, Turletti, A, Porpiglia, M, Santini, D, Fabi, A, Gebbia, V, Schirone, A, Palumbo, R, Ferzi, A, Frassoldati, A, Scavelli, C, Clivio, L, Giordano, M, Donadio, M, Biganzoli, L, Del Mastro, L, Bisagni, G, Livi, L, Natoli, C, Montemurro, F, Riccardi, F, Romagnoli, E, Marchetti, P, Torri, V, Pronzato, P, Mustacchi, G, Cazzaniga M. E., Verusio C., Ciccarese M., Fumagalli A., Sartori D., Valerio M. R., Airoldi M., Moretti G., Ficorella C., Gianni L., Michelotti A., Zambelli A., Febbraro A., Generali D., Pistelli M., Garrone O., Musolino A., Vici P., Maur M., Mentuccia L., La Verde N., Bianchi G. V., Artale S., Blasi L., De Laurentiis M., Atzori F., Turletti A., Porpiglia M., Santini D., Fabi A., Gebbia V., Schirone A., Palumbo R., Ferzi A., Frassoldati A., Scavelli C., Clivio L., Giordano M., Donadio M., Biganzoli L., Del Mastro L., Bisagni G., Livi L., Natoli C., Montemurro F., Riccardi F., Romagnoli E., Marchetti P., Torri V., Pronzato P., Mustacchi G., Cazzaniga, M, Verusio, C, Ciccarese, M, Fumagalli, A, Sartori, D, Valerio, M, Airoldi, M, Moretti, G, Ficorella, C, Gianni, L, Michelotti, A, Zambelli, A, Febbraro, A, Generali, D, Pistelli, M, Garrone, O, Musolino, A, Vici, P, Maur, M, Mentuccia, L, La Verde, N, Bianchi, G, Artale, S, Blasi, L, De Laurentiis, M, Atzori, F, Turletti, A, Porpiglia, M, Santini, D, Fabi, A, Gebbia, V, Schirone, A, Palumbo, R, Ferzi, A, Frassoldati, A, Scavelli, C, Clivio, L, Giordano, M, Donadio, M, Biganzoli, L, Del Mastro, L, Bisagni, G, Livi, L, Natoli, C, Montemurro, F, Riccardi, F, Romagnoli, E, Marchetti, P, Torri, V, Pronzato, P, Mustacchi, G, Cazzaniga M. E., Verusio C., Ciccarese M., Fumagalli A., Sartori D., Valerio M. R., Airoldi M., Moretti G., Ficorella C., Gianni L., Michelotti A., Zambelli A., Febbraro A., Generali D., Pistelli M., Garrone O., Musolino A., Vici P., Maur M., Mentuccia L., La Verde N., Bianchi G. V., Artale S., Blasi L., De Laurentiis M., Atzori F., Turletti A., Porpiglia M., Santini D., Fabi A., Gebbia V., Schirone A., Palumbo R., Ferzi A., Frassoldati A., Scavelli C., Clivio L., Giordano M., Donadio M., Biganzoli L., Del Mastro L., Bisagni G., Livi L., Natoli C., Montemurro F., Riccardi F., Romagnoli E., Marchetti P., Torri V., Pronzato P., and Mustacchi G.

Abstract

Background: Different studies suggest that fulvestrant 500 mg every 28 days (HD-FUL) could be an active treatment in HR+ advanced breast cancer (ABC) patients even treated with aromatase inhibitors in the adjuvant setting. The aim of this analysis is to describe the outcome of ABC patients treated with HD-FUL as first-line treatment in terms of median duration of treatment and the overall response rate in a real-world setting. Methods: For the purpose of the present analysis, we considered two data sets of HR+ ABC patients collected in Italy between 2012 and 2015 (EVA and GIM-13 AMBRA studies). Results: Eighty-one and 91 patients have been identified from the two data sets. The median age was 63 years (range 35-82) for the EVA and 57.8 years (range 35.0-82.3) for the AMBRA patients. ORRs were 23.5 and 24.3% in the whole population, 26.9% in the patients with bone only, and 21.8 and 21.4% in those with visceral metastases. The median duration of HD-FUL was 11.6 months (range 1-48) and 12.4 months (range 2.9-70.0) in the two data sets, respectively. Conclusion: These data suggest that HD-FUL should still continue to play a significant role as first-line therapy in HR+ ABC patients.

Published
2020

25. Distinct HR expression patterns significantly affect the clinical behavior of metastatic HER2+ breast cancer and degree of benefit from novel anti-HER2 agents in the real world setting

Author

Pizzuti, L, Krasniqi, E, Barchiesi, G, Della Giulia, M, Izzo, F, Sanguineti, G, Marchetti, P, Mazzotta, M, Giusti, R, Botticelli, A, Gamucci, T, Natoli, C, Grassadonia, A, Tinari, N, Iezzi, L, Tomao, S, Tomao, F, Tonini, G, Santini, D, Astone, A, Michelotti, A, De Angelis, C, Mentuccia, L, Vaccaro, A, Magnolfi, E, Gelibter, A, Magri, V, Cortesi, E, D'Onofrio, L, Cassano, A, Rossi, E, Cazzaniga, M, Moscetti, L, Omarini, C, Piacentini, F, Fabbri, M, Scinto, A, Corsi, D, Carbognin, L, Bria, E, La Verde, N, Samaritani, R, Garufi, C, Barni, S, Mirabelli, R, Sarmiento, R, Veltri, E, D'Auria, G, Paris, I, Giotta, F, Lorusso, V, Cardillo, F, Landucci, E, Mauri, M, Ficorella, C, Roselli, M, Adamo, V, Ricciardi, G, Russo, A, Berardi, R, Pistelli, M, Fiorio, E, Cannita, K, Sini, V, D'Ostilio, N, Foglietta, J, Greco, F, Zamagni, C, Garrone, O, Di Cocco, B, Baldini, E, Livi, L, Desideri, I, Meattini, I, Sarobba, G, Del Medico, P, De Tursi, M, Generali, D, De Maria, R, Risi, E, Ciliberto, G, Sperduti, I, Villa, A, Barba, M, Di Leo, A, Vici, P, Pizzuti L., Krasniqi E., Barchiesi G., Della Giulia M., Izzo F., Sanguineti G., Marchetti P., Mazzotta M., Giusti R., Botticelli A., Gamucci T., Natoli C., Grassadonia A., Tinari N., Iezzi L., Tomao S., Tomao F., Tonini G., Santini D., Astone A., Michelotti A., De Angelis C., Mentuccia L., Vaccaro A., Magnolfi E., Gelibter A., Magri V., Cortesi E., D'Onofrio L., Cassano A., Rossi E., Cazzaniga M., Moscetti L., Omarini C., Piacentini F., Fabbri M. A., Scinto A. F., Corsi D., Carbognin L., Bria E., La Verde N., Samaritani R., Garufi C., Barni S., Mirabelli R., Sarmiento R., Veltri E. M., D'Auria G., Paris I., Giotta F., Lorusso V., Cardillo F., Landucci E., Mauri M., Ficorella C., Roselli M., Adamo V., Ricciardi G. R. R., Russo A., Berardi R., Pistelli M., Fiorio E., Cannita K., Sini V., D'Ostilio N., Foglietta J., Greco F., Zamagni C., Garrone O., Di Cocco B., Baldini E., Livi L., Desideri I., Meattini I., Sarobba G., Del Medico P., De Tursi M., Generali D., De Maria R., Risi E., Ciliberto G., Sperduti I., Villa A., Barba M., Di Leo A., Vici P., Pizzuti, L, Krasniqi, E, Barchiesi, G, Della Giulia, M, Izzo, F, Sanguineti, G, Marchetti, P, Mazzotta, M, Giusti, R, Botticelli, A, Gamucci, T, Natoli, C, Grassadonia, A, Tinari, N, Iezzi, L, Tomao, S, Tomao, F, Tonini, G, Santini, D, Astone, A, Michelotti, A, De Angelis, C, Mentuccia, L, Vaccaro, A, Magnolfi, E, Gelibter, A, Magri, V, Cortesi, E, D'Onofrio, L, Cassano, A, Rossi, E, Cazzaniga, M, Moscetti, L, Omarini, C, Piacentini, F, Fabbri, M, Scinto, A, Corsi, D, Carbognin, L, Bria, E, La Verde, N, Samaritani, R, Garufi, C, Barni, S, Mirabelli, R, Sarmiento, R, Veltri, E, D'Auria, G, Paris, I, Giotta, F, Lorusso, V, Cardillo, F, Landucci, E, Mauri, M, Ficorella, C, Roselli, M, Adamo, V, Ricciardi, G, Russo, A, Berardi, R, Pistelli, M, Fiorio, E, Cannita, K, Sini, V, D'Ostilio, N, Foglietta, J, Greco, F, Zamagni, C, Garrone, O, Di Cocco, B, Baldini, E, Livi, L, Desideri, I, Meattini, I, Sarobba, G, Del Medico, P, De Tursi, M, Generali, D, De Maria, R, Risi, E, Ciliberto, G, Sperduti, I, Villa, A, Barba, M, Di Leo, A, Vici, P, Pizzuti L., Krasniqi E., Barchiesi G., Della Giulia M., Izzo F., Sanguineti G., Marchetti P., Mazzotta M., Giusti R., Botticelli A., Gamucci T., Natoli C., Grassadonia A., Tinari N., Iezzi L., Tomao S., Tomao F., Tonini G., Santini D., Astone A., Michelotti A., De Angelis C., Mentuccia L., Vaccaro A., Magnolfi E., Gelibter A., Magri V., Cortesi E., D'Onofrio L., Cassano A., Rossi E., Cazzaniga M., Moscetti L., Omarini C., Piacentini F., Fabbri M. A., Scinto A. F., Corsi D., Carbognin L., Bria E., La Verde N., Samaritani R., Garufi C., Barni S., Mirabelli R., Sarmiento R., Veltri E. M., D'Auria G., Paris I., Giotta F., Lorusso V., Cardillo F., Landucci E., Mauri M., Ficorella C., Roselli M., Adamo V., Ricciardi G. R. R., Russo A., Berardi R., Pistelli M., Fiorio E., Cannita K., Sini V., D'Ostilio N., Foglietta J., Greco F., Zamagni C., Garrone O., Di Cocco B., Baldini E., Livi L., Desideri I., Meattini I., Sarobba G., Del Medico P., De Tursi M., Generali D., De Maria R., Risi E., Ciliberto G., Sperduti I., Villa A., Barba M., Di Leo A., and Vici P.

Abstract

We analyzed data from 738 HER2-positive metastatic breast cancer (mbc) patients treated with pertuzumab-based regimens and/or T-DM1 at 45 Italian centers. Outcomes were explored in relation to tumor subtype assessed by immunohistochemistry (IHC). The median progression-free survival at first-line (mPFS1) was 12 months. Pertuzumab as first-line conferred longer mPFS1 compared to other first-line treatments (16 vs. 9 months, p = 0.0001), regardless of IHC subtype. Median PFS in second-line (mPFS2) was 7 months, with no difference by IHC subtype, but it was more favorable with T-DM1 compared to other agents (7 vs. 6 months, p = 0.03). There was no PFS2 gain in patients with tumors expressing both hormonal receptors (HRs; p = 0.17), while a trend emerged for tumors with one HR (p = 0.05). Conversely, PFS2 gain was significant in HRs-negative tumors (p = 0.04). Median overall survival (mOS) was 74 months, with no significant differences by IHC subtypes. Survival rates at 2 and 3 years in patients treated with T-DM1 in second-line after pertuzumab were significantly lower compared to pertuzumab-naïve patients (p = 0.01). When analyzed by IHC subtype, the outcome was confirmed if both HRs or no HRs were expressed (p = 0.02 and p = 0.006, respectively). Our results confirm that HRs expression impacts the clinical behavior and novel treatment-related outcomes of HER2-positive tumors when treatment sequences are considered. Moreover, multivariate analysis showed that HRs expression had no effect on PFS and OS. Further studies are warranted to confirm our findings and clarify the interplay between HER2 and estrogen receptor pathways in HER2-positive (mbc) patients

Published
2020

26. Corrigendum to 'Real world data of cemiplimab in locally advanced and metastatic cutaneous squamous cell carcinoma' [Eur J Canc 157 (2021) 250-258]

Author

Baggi, A, Quaglino, P, Rubatto, M, Depenni, R, Guida, M, Ascierto, Pa, Trojaniello, C, Queirolo, P, Saponara, M, Peris, K, Spagnolo, F, Bianchi, L, De Galitiis, F, Potenza, Mc, Proietti, I, Marconcini, R, Botticelli, A, Barbieri, V, Licitra, L, Alfieri, S, Ficorella, C, Cortellini, A, Fargnoli, Mc, Troiani, T, Tondulli, L, Zamparini, M, and Bossi, P

Subjects
Cancer Research, Settore MED/35, Oncology
Published
2022

27. Efficacy and safety of Everolimus and Exemestane in hormone-receptor positive (HR+) human-epidermal-growth-factor negative (HER2−) advanced breast cancer patients: New insights beyond clinical trials. The EVA study

Author

Cicchiello, F., Riva, F., Cazzaniga, M. E., Pedani, F., Nicolini, Matteo, Butti, C., Liscia, N., Pogliani, C., Capri, Giorgia, Alu', Matteo, Febbraro, A., Petrucelli, L., D'Onofrio, L., De Laurentiis, M., Pellegrini, D., Mentuccia, L., Cocciolone, V., Miraglio, E., Bajardi, E., Dester, M., Paternò, Enrico, Guaitoli, G., Ferrarini, I., Gervasi, Elisea, Licata, L., Benedetto, C., Andreis, D., Bordin, E., Ancona, C., Pizzuti, L., Fotia, V., Berardi, R., Airoldi, M., Arcangeli, V., Artale, S., Atzori, F., Ballerio, A., Bianchi, G. V., Blasi, L., Campidoglio, S., Ciccarese, M., Cursano, M. C., Piezzo, M., Fabi, A., Ferrari, L., Ferzi, A., Ficorella, C., Frassoldati, A., Fumagalli, A., Garrone, O., Gebbia, V., Generali, D., La Verde, N., Maur, M., Michelotti, A., Moretti, G., Musolino, Anna, Palumbo, R., Pistelli, M., Porpiglia, M., Sartori, D., Scavelli, C., Schirone, A., Turletti, A., Valerio, M. R., Vici, P., Zambelli, Ruggero Astolfo, Clivio, L., Torri, V., Cicchiello, F, Riva, F, Cazzaniga, M, Pedani, F, Nicolini, M, Butti, C, Liscia, N, Pogliani, C, Capri, G, Alu, M, Febbraro, A, Petrucelli, L, D'Onofrio, L, De Laurentiis, M, Pellegrini, D, Mentuccia, L, Cocciolone, V, Miraglio, E, Bajardi, E, Dester, M, Paterno, E, Guaitoli, G, Ferrarini, I, Gervasi, E, Licata, L, Benedetto, C, Andreis, D, Bordin, E, Ancona, C, Pizzuti, L, Fotia, V, Berardi, R, Airoldi, M, Arcangeli, V, Artale, S, Atzori, F, Ballerio, A, Bianchi, G, Blasi, L, Campidoglio, S, Ciccarese, M, Cursano, M, Piezzo, M, Fabi, A, Ferrari, L, Ferzi, A, Ficorella, C, Frassoldati, A, Fumagalli, A, Garrone, O, Gebbia, V, Generali, D, La Verde, N, Maur, M, Michelotti, A, Moretti, G, Musolino, A, Palumbo, R, Pistelli, M, Porpiglia, M, Sartori, D, Scavelli, C, Schirone, A, Turletti, A, Valerio, M, Vici, P, Zambelli, A, Clivio, L, Torri, V, Cazzaniga, M. E, Bianchi, G. V, Cursano, M. C, Valerio, M. R, Torri, V., De Laurentiis, Michelino, Cicchiello, F., Riva, F., Cazzaniga, M. E., Pedani, F., Nicolini, M., Butti, C., Liscia, N., Pogliani, C., Capri, G., Alù, M., Febbraro, A., Petrucelli, L., D'Onofrio, L., De Laurentiis, M., Pellegrini, D., Mentuccia, L., Cocciolone, V., Miraglio, E., Bajardi, E., Dester, M., Paternò, E., Guaitoli, G., Ferrarini, I., Gervasi, E., Licata, L., Benedetto, C., Andreis, D., Bordin, E., Ancona, C., Pizzuti, L., Fotia, V., Berardi, R., Airoldi, M., Arcangeli, V., Artale, S., Atzori, F., Ballerio, A., Bianchi, G. V., Blasi, L., Campidoglio, S., Ciccarese, M., Cursano, M. C., Piezzo, M., Fabi, A., Ferrari, L., Ferzi, A., Ficorella, C., Frassoldati, A., Fumagalli, A., Garrone, O., Gebbia, V., Generali, D., La Verde, N., Maur, M., Michelotti, A., Moretti, G., Musolino, A., Palumbo, R., Pistelli, M., Porpiglia, M., Sartori, D., Scavelli, C., Schirone, A., Turletti, A., Valerio, M. R., Vici, P., Zambelli, A., Clivio, L., Cazzaniga, M., Ala, M., ARRIVAS BAJARDI, E., Paternã², E., Bianchi, G., Cursano, M., and Valerio, M.

Subjects
0301 basic medicine, Oncology, Receptor, ErbB-2, chemistry.chemical_compound, ErbB-2, 0302 clinical medicine, Dose-intensity, Exemestane, 80 and over, Neoplasm Metastasis, Fulvestrant, Aged, 80 and over, education.field_of_study, Advanced breast cancer, Dose-intensity, Everolimus, Fulvestrant, Hormone-receptor positive, Advanced breast cancer, Everolimus, Hormone-receptor positive, Adult, Aged, Androstadienes, Breast Neoplasms, Female, Follow-Up Studies, Humans, Middle Aged, Neoplasm Staging, Surgery, General Medicine, Everolimu, 030220 oncology & carcinogenesis, Receptor, medicine.drug, medicine.medical_specialty, Population, Socio-culturale, 03 medical and health sciences, Breast cancer, Internal medicine, medicine, Adverse effect, education, Gynecology, business.industry, fungi, Cancer, medicine.disease, Clinical trial, 030104 developmental biology, chemistry, business
Abstract

Background The BOLERO-2 trial reported efficacy and safety of Everolimus (EVE) and Exemestane (EXE) combination in HR+ advanced breast cancer (ABC) patients. The BALLET trial further evaluated the safety of EVE-EXE in HR+ ABC patients, without reporting efficacy data. Aim of the EVA real-life study was to collect data of efficacy and safety of EVE-EXE combination in the clinical setting, as well as exploring efficacy according to EVE Dose-Intensity (DI) and to previous treatment with Fulvestrant. Patients and methods This study aimed to describe the outcome of ABC pts treated with EVE-EXE combination in terms of median duration of EVE treatment and ORR in a real-life setting. Results From July 2013 to December 2015, the EVA study enrolled 404 pts. Median age was 61 years (33–83). Main metastatic sites were: bone (69.1%), soft tissue (34.7%) and viscera (33.2%). Median number of previous treatments was 2 (1–7). 43.3% of the pts had received Fulvestrant. Median exposure to EVE was 31.0 weeks (15.4–58.3) in the whole population. No difference was observed in terms of EVE exposure duration according to DI (p for trend = 0.27) or type of previous treatments (p = 0.33). ORR and Disease Control Rate (DCR) were observed in 31.6% and 60.7% of the patients, respectively, with the lowest ORRs confined in CHT pre-treated patients or in those who received the lowest DI of EVE. Grade 3-4 adverse events (AEs) were reported in 37.9% of the patients. Main AEs were: stomatitis (11.2%), non-infectious pneumonitis - NIP (3.8%), anaemia (3.8%) and fatigue (3.2%). Conclusions The EVA study provided new insights in the use of EVE-EVE combination in HR+ ABC pts many years after the publication of the pivotal trial. The combination is safe and the best response could be obtained in patients receiving the full dose of EVE and/or after hormone-therapy as Fulvestrant in ABC.

Published
2017

30. Palbociclib plus endocrine therapy in HER2 negative, hormonal receptor-positive, advanced breast cancer: A real-world experience

Author

Pizzuti, L, Giordano, A, Michelotti, A, Mazzotta, M, Natoli, C, Gamucci, T, De Angelis, C, Landucci, E, Diodati, L, Iezzi, L, Mentuccia, L, Fabbri, A, Barba, M, Sanguineti, G, Marchetti, P, Tomao, S, Mariani, L, Paris, I, Lorusso, V, Vallarelli, S, Cassano, A, Airoldi, F, Orlandi, A, Moscetti, L, Sergi, D, Sarobba, M, Tonini, G, Santini, D, Sini, V, Veltri, E, Vaccaro, A, Ferrari, L, De Tursi, M, Tinari, N, Grassadonia, A, Greco, F, Botticelli, A, La Verde, N, Zamagni, C, Rubino, D, Cortesi, E, Magri, V, Pomati, G, Scagnoli, S, Capomolla, E, Kayal, R, Scinto, A, Corsi, D, Cazzaniga, M, Laudadio, L, Forciniti, S, Mancini, M, Carbognin, L, Seminara, P, Barni, S, Samaritani, R, Roselli, M, Portarena, I, Russo, A, Ficorella, C, Cannita, K, Carpano, S, Pistelli, M, Berardi, R, De Maria, R, Sperduti, I, Ciliberto, G, Vici, P, Pizzuti L., Giordano A., Michelotti A., Mazzotta M., Natoli C., Gamucci T., De Angelis C., Landucci E., Diodati L., Iezzi L., Mentuccia L., Fabbri A., Barba M., Sanguineti G., Marchetti P., Tomao S., Mariani L., Paris I., Lorusso V., Vallarelli S., Cassano A., Airoldi F., Orlandi A., Moscetti L., Sergi D., Sarobba M. G., Tonini G., Santini D., Sini V., Veltri E., Vaccaro A., Ferrari L., De Tursi M., Tinari N., Grassadonia A., Greco F., Botticelli A., La Verde N., Zamagni C., Rubino D., Cortesi E., Magri V., Pomati G., Scagnoli S., Capomolla E., Kayal R., Scinto A. F., Corsi D., Cazzaniga M., Laudadio L., Forciniti S., Mancini M., Carbognin L., Seminara P., Barni S., Samaritani R., Roselli M., Portarena I., Russo A., Ficorella C., Cannita K., Carpano S., Pistelli M., Berardi R., De Maria R., Sperduti I., Ciliberto G., Vici P., Pizzuti, L, Giordano, A, Michelotti, A, Mazzotta, M, Natoli, C, Gamucci, T, De Angelis, C, Landucci, E, Diodati, L, Iezzi, L, Mentuccia, L, Fabbri, A, Barba, M, Sanguineti, G, Marchetti, P, Tomao, S, Mariani, L, Paris, I, Lorusso, V, Vallarelli, S, Cassano, A, Airoldi, F, Orlandi, A, Moscetti, L, Sergi, D, Sarobba, M, Tonini, G, Santini, D, Sini, V, Veltri, E, Vaccaro, A, Ferrari, L, De Tursi, M, Tinari, N, Grassadonia, A, Greco, F, Botticelli, A, La Verde, N, Zamagni, C, Rubino, D, Cortesi, E, Magri, V, Pomati, G, Scagnoli, S, Capomolla, E, Kayal, R, Scinto, A, Corsi, D, Cazzaniga, M, Laudadio, L, Forciniti, S, Mancini, M, Carbognin, L, Seminara, P, Barni, S, Samaritani, R, Roselli, M, Portarena, I, Russo, A, Ficorella, C, Cannita, K, Carpano, S, Pistelli, M, Berardi, R, De Maria, R, Sperduti, I, Ciliberto, G, Vici, P, Pizzuti L., Giordano A., Michelotti A., Mazzotta M., Natoli C., Gamucci T., De Angelis C., Landucci E., Diodati L., Iezzi L., Mentuccia L., Fabbri A., Barba M., Sanguineti G., Marchetti P., Tomao S., Mariani L., Paris I., Lorusso V., Vallarelli S., Cassano A., Airoldi F., Orlandi A., Moscetti L., Sergi D., Sarobba M. G., Tonini G., Santini D., Sini V., Veltri E., Vaccaro A., Ferrari L., De Tursi M., Tinari N., Grassadonia A., Greco F., Botticelli A., La Verde N., Zamagni C., Rubino D., Cortesi E., Magri V., Pomati G., Scagnoli S., Capomolla E., Kayal R., Scinto A. F., Corsi D., Cazzaniga M., Laudadio L., Forciniti S., Mancini M., Carbognin L., Seminara P., Barni S., Samaritani R., Roselli M., Portarena I., Russo A., Ficorella C., Cannita K., Carpano S., Pistelli M., Berardi R., De Maria R., Sperduti I., Ciliberto G., and Vici P.

Abstract

Data from 423 human epidermal growth factor receptor 2-negative (HER2−), hormone receptor-positive (HR+) advanced breast cancer (aBC) patients treated with palbociclib and endocrine therapy (ET) were provided by 35 Italian cancer centers and analyzed for treatment outcomes. Overall, 158 patients were treated in first line and 265 in second/later lines. We observed 19 complete responses and 112 partial responses. The overall response rate (ORR) was 31% (95% confidence interval [CI], 26.6–35.4) and clinical benefit was 52.7% (95% CI, 48–57.5). ORR was negatively affected by prior exposure to everolimus/exemestane (p = 0.002) and favorably influenced by early line-treatment (p < 0.0001). At 6 months, median progression-free survival was 12 months (95% CI, 8–16) and median overall survival was 24 months (95% CI, 17–30). More favorable outcomes were associated with palbociclib in early lines, no visceral metastases and no prior everolimus/exemestane. The main toxicity reported was neutropenia. Our results provide further support to the use of palbociclib with ET in HER2−, HR+ aBC. Differences in outcomes across patients subsets remain largely unexplained.

Published
2019

32. Corrigendum to ‘The lung immuno-oncology prognostic score (LIPS-3): a prognostic classification of patients receiving first-line pembrolizumab for PD-L1 ≥ 50% advanced non-small-cell lung cancer’: [ESMO Open Volume 6, Issue 2, April 2021, 100078]

Author

Banna, G.L., Cortellini, A., Cortinovis, D.L., Tiseo, M., Aerts, J.G.J.V., Barbieri, F., Giusti, R., Bria, E., Grossi, F., Pizzutilo, P., Berardi, R., Morabito, A., Genova, C., Mazzoni, F., Di Noia, V., Signorelli, D., Gelibter, A., Macerelli, M., Rastelli, F., Chiari, R., Rocco, D., Gori, S., De Tursi, M., Di Marino, P., Mansueto, G., Zoratto, F., Filetti, M., Montrone, M., Citarella, F., Marco, R., Cantini, L., Nigro, O., D'Argento, E., Buti, S., Minuti, G., Landi, L., Guaitoli, G., Lo Russo, G., De Toma, A., Donisi, C., Friedlaender, A., De Giglio, A., Metro, G., Porzio, G., Ficorella, C., and Addeo, A.

Published
2021
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33. Corrigendum to 'The lung immuno-oncology prognostic score (LIPS-3): a prognostic classification of patients receiving first-line pembrolizumab for PD-L1 ≥ 50% advanced non-small-cell lung cancer': [ESMO Open Volume 6, Issue 2, April 2021, 100078]

Author

Banna, GL, Cortellini, A, Cortinovis, DL, Tiseo, M, Aerts, JGJV, Barbieri, F, Giusti, R, Bria, E, Grossi, F, Pizzutilo, P, Berardi, R, Morabito, A, Genova, C, Mazzoni, F, Di Noia, V, Signorelli, D, Gelibter, A, Macerelli, M, Rastelli, F, Chiari, R, Rocco, D, Gori, S, De Tursi, M, Di Marino, P, Mansueto, G, Zoratto, F, Filetti, M, Montrone, M, Citarella, F, Marco, R, Cantini, L, Nigro, O, D'Argento, E, Buti, S, Minuti, G, Landi, L, Guaitoli, G, Lo Russo, G, De Toma, A, Donisi, C, Friedlaender, A, De Giglio, A, Metro, G, Porzio, G, Ficorella, C, and Addeo, A

Abstract

ispartof: ESMO Open vol:6 issue:3 pages:100137- ispartof: location:England status: published

Published
2021

36. Smoking status during first-line immunotherapy and chemotherapy in NSCLC patients: A case–control matched analysis from a large multicenter study

Author

Cortellini, A. (Alessio), De Giglio, A. (Andrea), Cannita, K. (Katia), Cortinovis, D.L. (Diego L.), Cornelissen, R. (Robin), Baldesarri, C. (Cinzia), Giusti, R. (Raffaele), D'Argento, E. (Ettore), Grossi, F. (Francesco), Santoni, M. (Matteo), Catino, A. (Annamaria), Berardi, R. (Rossana), Sforza, V. (Vincenzo), Rossi, G. (Giovanni), Antonuzzo, L. (Lorenzo), Di Noia, V. (Vincenzo), Signorelli, D. (Diego), Gelibter, A. (Alain), Occhipinti, M.A. (Mario Alberto), Follador, A. (Alessandro), Rastelli, F. (Francesca), Chiari, R. (Rita), Gravara, L.D. (Luigi Della), Inno, A. (Alessandro), De Tursi, M. (Michele), Di Marino, P. (Pietro), Mansueto, G. (Giovanni), Zoratto, F. (Federica), Filetti, M. (Marco), Montrone, M. (Michele), Citarella, F. (Fabrizio), Pensieri, M.V. (Maria Vittoria), Russano, M. (Marco), Cantini, L. (Luca), Nigro, O. (Olga), Leonetti, A. (Alessandro), Bordi, P. (Paola), Minuti, G. (Gabriele), Landi, L. (Lorenza), De Toma, A. (Alessandro), Donisi, C. (Clelia), Ricciardi, S. (Serena), Migliorino, M.R. (Maria Rita), Napoli, V.M. (Valerio Maria), Leone, G. (Gianmarco), Metro, G. (Giulio), Banna, G.L. (Giuseppe L.), Friedlaender, A. (Alex), Addeo, A. (Alfredo), Ficorella, C. (Corrado), Porzio, G. (Giampiero), Cortellini, A. (Alessio), De Giglio, A. (Andrea), Cannita, K. (Katia), Cortinovis, D.L. (Diego L.), Cornelissen, R. (Robin), Baldesarri, C. (Cinzia), Giusti, R. (Raffaele), D'Argento, E. (Ettore), Grossi, F. (Francesco), Santoni, M. (Matteo), Catino, A. (Annamaria), Berardi, R. (Rossana), Sforza, V. (Vincenzo), Rossi, G. (Giovanni), Antonuzzo, L. (Lorenzo), Di Noia, V. (Vincenzo), Signorelli, D. (Diego), Gelibter, A. (Alain), Occhipinti, M.A. (Mario Alberto), Follador, A. (Alessandro), Rastelli, F. (Francesca), Chiari, R. (Rita), Gravara, L.D. (Luigi Della), Inno, A. (Alessandro), De Tursi, M. (Michele), Di Marino, P. (Pietro), Mansueto, G. (Giovanni), Zoratto, F. (Federica), Filetti, M. (Marco), Montrone, M. (Michele), Citarella, F. (Fabrizio), Pensieri, M.V. (Maria Vittoria), Russano, M. (Marco), Cantini, L. (Luca), Nigro, O. (Olga), Leonetti, A. (Alessandro), Bordi, P. (Paola), Minuti, G. (Gabriele), Landi, L. (Lorenza), De Toma, A. (Alessandro), Donisi, C. (Clelia), Ricciardi, S. (Serena), Migliorino, M.R. (Maria Rita), Napoli, V.M. (Valerio Maria), Leone, G. (Gianmarco), Metro, G. (Giulio), Banna, G.L. (Giuseppe L.), Friedlaender, A. (Alex), Addeo, A. (Alfredo), Ficorella, C. (Corrado), and Porzio, G. (Giampiero)

Abstract

Background: Improved outcome in tobacco smoking patients with non-small cell lung cancer (NSCLC) following immunotherapy has previously been reported. However, little is known regarding this association during first-line immunotherapy in patients with high PD-L1 expression. In this study we compared clinical outcomes according to the smoking status of two large multicenter cohorts. Methods: We compared clinical outcomes according to the smoking status (never smokers vs. current/former smokers) of two retrospective multicenter cohorts of metastatic NSCLC patients, treated with first-line pembrolizumab and platinum-based chemotherapy. Results: A total of 962 NSCLC patients with PD-L1 expression ≥50% who received first-line pembrolizumab and 462 NSCLC patients who received first-line platinum-based chemotherapy were included in the study. Never smokers were confirmed to have a significantly higher risk of disease progression (hazard ratio [HR] = 1.49 [95% CI: 1.15–1.92], p = 0.0022) and death (HR = 1.38 [95% CI: 1.02–1.87], p = 0.0348) within the pembrolizumab cohort. On the contrary, a nonsignificant trend towards a reduced risk of disease progression (HR = 0.74 [95% CI: 0.52–1.05], p = 0.1003) and death (HR = 0.67 [95% CI: 0.45–1.01], p = 0.0593) were reported for never smokers within the chemotherapy cohort. After a random case–control matching, 424 patients from both cohorts were paired. Within the matched pembrolizumab cohort, never smokers had a significantly shorter progression-free survival (PFS) (HR = 1.68 [95% CI: 1.17–2.40], p = 0.0045) and a nonsignificant trend towards a shortened overall survival (OS) (HR = 1.32 [95% CI: 0.84–2.07], p = 0.2205). On the contrary, never smokers had a significantly longer PFS (HR = 0.68 [95% CI: 0.49–0.95], p = 0.0255) and OS (HR = 0.66 [95% CI: 0.45–0.97], p = 0,0356) compared to current/former smoker patients within the matched chemotherapy cohort. On pooled multivariable analysis, the interaction term between smoking stat

Published
2021
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37. Corrigendum to 'The lung immuno-oncology prognostic score (LIPS-3):a prognostic classification of patients receiving first-line pembrolizumab for PD-L1 ≥ 50% advanced non-small-cell lung cancer': [ESMO Open Volume 6, Issue 2, April 2021, 100078

Author

Banna, G. L., Cortellini, A., Cortinovis, D. L., Tiseo, M., Aerts, J. G.J.V., Barbieri, F., Giusti, R., Bria, E., Grossi, F., Pizzutilo, P., Berardi, R., Morabito, A., Genova, C., Mazzoni, F., Di Noia, V., Signorelli, D., Gelibter, A., Macerelli, M., Rastelli, F., Chiari, R., Rocco, D., Gori, S., De Tursi, M., Di Marino, P., Mansueto, G., Zoratto, F., Filetti, M., Montrone, M., Citarella, F., Marco, R., Cantini, L., Nigro, O., D'Argento, E., Buti, S., Minuti, G., Landi, L., Guaitoli, G., Lo Russo, G., De Toma, A., Donisi, C., Friedlaender, A., De Giglio, A., Metro, G., Porzio, G., Ficorella, C., Addeo, A., Banna, G. L., Cortellini, A., Cortinovis, D. L., Tiseo, M., Aerts, J. G.J.V., Barbieri, F., Giusti, R., Bria, E., Grossi, F., Pizzutilo, P., Berardi, R., Morabito, A., Genova, C., Mazzoni, F., Di Noia, V., Signorelli, D., Gelibter, A., Macerelli, M., Rastelli, F., Chiari, R., Rocco, D., Gori, S., De Tursi, M., Di Marino, P., Mansueto, G., Zoratto, F., Filetti, M., Montrone, M., Citarella, F., Marco, R., Cantini, L., Nigro, O., D'Argento, E., Buti, S., Minuti, G., Landi, L., Guaitoli, G., Lo Russo, G., De Toma, A., Donisi, C., Friedlaender, A., De Giglio, A., Metro, G., Porzio, G., Ficorella, C., and Addeo, A.

Published
2021

38. The Gustave Roussy Immune (GRIm)-Score Variation Is an Early-on-Treatment Biomarker of Outcome in Advanced Non-Small Cell Lung Cancer (NSCLC) Patients Treated with First-Line Pembrolizumab

Author

Lenci, E, Cantini, Luca, Pecci, F, Cognigni, V, Agostinelli, V, Mentrasti, G, Lupi, A, Ranallo, N, Paoloni, F, Rinaldi, S, Nicolardi, L, Caglio, A, Aerts, Sophie, Cortellini, A, Ficorella, C, Chiari, R, Maio, M, Dingemans, Anne-Marie, Aerts, Joachim, Berardi, R, Lenci, E, Cantini, Luca, Pecci, F, Cognigni, V, Agostinelli, V, Mentrasti, G, Lupi, A, Ranallo, N, Paoloni, F, Rinaldi, S, Nicolardi, L, Caglio, A, Aerts, Sophie, Cortellini, A, Ficorella, C, Chiari, R, Maio, M, Dingemans, Anne-Marie, Aerts, Joachim, and Berardi, R

Abstract

Background: The Gustave Roussy Immune (GRIm)-Score takes into account neutrophil-to-lymphocyte ratio (NLR), serum albumin concentration and lactate dehydrogenase (LDH) and its prognostic value has been investigated in patients treated with immune check-point inhibitors (ICIs). To further assess the prognostic and predictive value of baseline GRIm-Score (GRImT0) in advanced non-small cell lung cancer (aNSCLC) patients, we separately investigated two cohorts of patients treated with first-line pembrolizumab or chemotherapy. We also investigated whether GRIm-Score at 45 days since treatment initiation (GRImT1) and GRIm-Score difference between the two timepoints may better predict clinical outcomes (GRIm∆ = GRImT0 − GRImT1). Methods: We retrospectively evaluated 222 aNSCLC patients: 135 treated with pembrolizumab and 87 treated with chemotherapy as the first-line regimen. NLR, serum albumin and LDH concentrations were assessed at T0 and at T1. According to the GRIm-Score, patients were assigned 1 point if they had NLR > 6, LDH >upper limit normal or albumin < 3.5 g/dL. Patients with a GRIm-Score < 2 were considered as having a low Score. Results: In both cohorts, no difference in terms of overall survival (OS) between patients with low and high GRImT0 was found. Otherwise, median OS and progression free survival (PFS) of the low GRImT1 group were significantly longer than those of the high GRImT1 group in pembrolizumab-treated patients, but not in the CHT cohort (pembrolizumab cohort: low vs. high; median OS not reached vs. 9.2 months, p = 0.004; median PFS 10.8 vs. 2.3 months, p = 0.002). Patients receiving pembrolizumab with stable/positive GRIm∆ had better OS (median OS not reached vs. 12.0 months, p < 0.001), PFS (median PFS 20.6 vs. 2.6 months, p < 0.001) and objective response rate (58.2% vs. 7.6%, p = 0.003) compared to patients with negative GRIm∆. Conclusion: Our data shown that GRImT1 and GRIm∆ are more reliable peripheral blood biomarker

Published
2021

39. Real world data of cemiplimab in locally advanced and metastatic cutaneous squamous cell carcinoma

Author

Baggi, A., Quaglino, P., Rubatto, M., Depenni, R., Guida, M., Ascierto, P. A., Trojaniello, C., Queirolo, P., Saponara, M., Peris, Ketty, Spagnolo, F., Bianchi, L., De Galitiis, F., Potenza, M. C., Proietti, I., Marconcini, R., Botticelli, A., Barbieri, Pietro Vittorio, Licitra, L., Alfieri, S., Ficorella, C., Cortellini, A., Fargnoli, Maria Concetta, Troiani, T., Tondulli, L., Bossi, P., Peris K. (ORCID:0000-0002-5237-0463), Barbieri V., Fargnoli M. C., Baggi, A., Quaglino, P., Rubatto, M., Depenni, R., Guida, M., Ascierto, P. A., Trojaniello, C., Queirolo, P., Saponara, M., Peris, Ketty, Spagnolo, F., Bianchi, L., De Galitiis, F., Potenza, M. C., Proietti, I., Marconcini, R., Botticelli, A., Barbieri, Pietro Vittorio, Licitra, L., Alfieri, S., Ficorella, C., Cortellini, A., Fargnoli, Maria Concetta, Troiani, T., Tondulli, L., Bossi, P., Peris K. (ORCID:0000-0002-5237-0463), Barbieri V., and Fargnoli M. C.

Abstract

Background: Cutaneous squamous cell carcinoma (cSCC) has an overall favourable outcome, except for patients with an advanced stage disease. The programmed death protein-1 (PD-1) inhibitor cemiplimab has been approved for use in advanced cSCC. We report clinical outcomes from the named patient programme-compassionate use of cemiplimab for patients with advanced cSCC in Italy. Methods: This is a retrospective, observational, multicentre study. We analysed medical records of patients with advanced cSCC treated with cemiplimab between May 2019 and February 2020 in 17 referral Italian centres. We assessed the safety profile according to the Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE v 5.0), the clinical activity in terms of response rate, clinical benefit and duration of response and baseline clinical-pathologic characteristics associated with response. Results: 131 patients were included, with a median age of 79 years. Of them, 9.2% had a concurrent chronic lymphoproliferative disease and 8.5% a concomitant autoimmune disease. Some 42.7% of the total patients had at least one treatment-related adverse events (AEs); out of above, 9.2% had grade 3–4 adverse events, and there were two fatal adverse events. The overall response rate (ORR) was 58%, and the disease control rate (DCR) was 71.7%. Cutaneous squamous cell carcinomas (cSCCs) arising on the head and neck area (p = 0.007) and haemoglobin values in normal range (p = 0.034) were significantly associated with a better response, while cSCCs on the genitalia (p = 0.041), treatment with any systemic antibiotic within 1 month of cemiplimab initiation (p = 0.012), performance status ≥1 (p = 0.012), chronic corticosteroids therapy (p = 0.038), previous radiation therapy to lymph nodes (p = 0.052) and previous chemotherapy (p = 0.0020) were significantly associated with a worse response. Conclusions: Our real-world study showed safety and effectiveness results comparable to those obtained in clinical t

Published
2021

40. The lung immuno-oncology prognostic score (LIPS-3):a prognostic classification of patients receiving first-line pembrolizumab for PD-L1 ≥ 50% advanced non-small-cell lung cancer

Author

Banna, G. L., Cortellini, A., Cortinovis, D. L., Tiseo, M., Aerts, J. G.J.V., Barbieri, F., Giusti, R., Bria, E., Grossi, F., Pizzutilo, P., Berardi, R., Morabito, A., Genova, C., Mazzoni, F., Di Noia, V., Signorelli, D., Gelibter, A., Macerelli, M., Rastelli, F., Chiari, R., Rocco, D., Gori, S., De Tursi, M., Di Marino, P., Mansueto, G., Zoratto, F., Filetti, M., Montrone, M., Citarella, F., Marco, R., Cantini, L., Nigro, O., D'Argento, E., Buti, S., Minuti, G., Landi, L., Guaitoli, G., Lo Russo, G., De Toma, A., Donisi, C., Friedlaender, A., De Giglio, A., Metro, G., Porzio, G., Ficorella, C., Addeo, A., Banna, G. L., Cortellini, A., Cortinovis, D. L., Tiseo, M., Aerts, J. G.J.V., Barbieri, F., Giusti, R., Bria, E., Grossi, F., Pizzutilo, P., Berardi, R., Morabito, A., Genova, C., Mazzoni, F., Di Noia, V., Signorelli, D., Gelibter, A., Macerelli, M., Rastelli, F., Chiari, R., Rocco, D., Gori, S., De Tursi, M., Di Marino, P., Mansueto, G., Zoratto, F., Filetti, M., Montrone, M., Citarella, F., Marco, R., Cantini, L., Nigro, O., D'Argento, E., Buti, S., Minuti, G., Landi, L., Guaitoli, G., Lo Russo, G., De Toma, A., Donisi, C., Friedlaender, A., De Giglio, A., Metro, G., Porzio, G., Ficorella, C., and Addeo, A.

Abstract

Background: To stratify the prognosis of patients with programmed cell death-ligand 1 (PD-L1) ≥ 50% advanced non-small-cell lung cancer (aNSCLC) treated with first-line immunotherapy. Methods: Baseline clinical prognostic factors, the neutrophil-to-lymphocyte ratio (NLR), PD-L1 tumour cell expression level, lactate dehydrogenase (LDH) and their combination were investigated by a retrospective analysis of 784 patients divided between statistically powered training (n = 201) and validation (n = 583) cohorts. Cut-offs were explored by receiver operating characteristic (ROC) curves and a risk model built with validated independent factors by multivariate analysis. Results: NLR < 4 was a significant prognostic factor in both cohorts (P < 0.001). It represented 53% of patients in the validation cohort, with 1-year overall survival (OS) of 76.6% versus 44.8% with NLR > 4, in the validation series. The addition of PD-L1 ≥ 80% (21% of patients) or LDH < 252 U/l (25%) to NLR < 4 did not result in better 1-year OS (of 72.6% and 74.1%, respectively, in the validation cohort). Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 2 [P < 0.001, hazard ratio (HR) 2.04], pretreatment steroids (P < 0.001, HR 1.67) and NLR < 4 (P < 0.001, HR 2.29) resulted in independent prognostic factors. A risk model with these three factors, namely, the lung immuno-oncology prognostic score (LIPS)-3, accurately stratified three OS risk-validated categories of patients: favourable (0 risk factors, 40%, 1-year OS of 78.2% in the whole series), intermediate (1 or 2 risk factors, 54%, 1-year OS 53.8%) and poor (>2 risk factors, 5%, 1-year OS 10.7%) prognosis. Conclusions: We advocate the use of LIPS-3 as an easy-to-assess and inexpensive adjuvant prognostic tool for patients with PD-L1 ≥ 50% aNSCLC.

Published
2021

41. The prognostic relevance of HER2-positivity gain in metastatic breast cancer in the ChangeHER trial

Author

Pizzuti, L., Barba, M., Mazzotta, M., Krasniqi, E., Maugeri-Sacca, M., Gamucci, T., Berardi, R., Livi, L., Ficorella, C., Natoli, C., Cortesi, E., Generali, D., La Verde, N., Cassano, A., Bria, Emilio, Moscetti, L., Michelotti, A., Adamo, V., Zamagni, C., Tonini, G., Sergi, D., Marinelli, D., Paoletti, G., Tomao, S., Botticelli, A., Marchetti, P., Tinari, N., Grassadonia, A., Valerio, M. R., Mirabelli, R., Fabbri, M. A., D'Ostilio, N., Veltri, E., Corsi, Domenico Cristiano, Garrone, O., Paris, Ida, Sarobba, G., Meattini, I., Pistelli, M., Giotta, F., Lorusso, V., Garufi, C., Russo, A., Cazzaniga, M., Del Medico, P., Roselli, M., Vaccaro, A., Perracchio, L., di Benedetto, A., Daralioti, T., Sperduti, I., De Maria Marchiano, Ruggero, Di Leo, A., Sanguineti, G., Ciliberto, G., Vici, P., Bria E. (ORCID:0000-0002-2333-704X), Corsi D., Paris I., De Maria R. (ORCID:0000-0003-2255-0583), Pizzuti, L., Barba, M., Mazzotta, M., Krasniqi, E., Maugeri-Sacca, M., Gamucci, T., Berardi, R., Livi, L., Ficorella, C., Natoli, C., Cortesi, E., Generali, D., La Verde, N., Cassano, A., Bria, Emilio, Moscetti, L., Michelotti, A., Adamo, V., Zamagni, C., Tonini, G., Sergi, D., Marinelli, D., Paoletti, G., Tomao, S., Botticelli, A., Marchetti, P., Tinari, N., Grassadonia, A., Valerio, M. R., Mirabelli, R., Fabbri, M. A., D'Ostilio, N., Veltri, E., Corsi, Domenico Cristiano, Garrone, O., Paris, Ida, Sarobba, G., Meattini, I., Pistelli, M., Giotta, F., Lorusso, V., Garufi, C., Russo, A., Cazzaniga, M., Del Medico, P., Roselli, M., Vaccaro, A., Perracchio, L., di Benedetto, A., Daralioti, T., Sperduti, I., De Maria Marchiano, Ruggero, Di Leo, A., Sanguineti, G., Ciliberto, G., Vici, P., Bria E. (ORCID:0000-0002-2333-704X), Corsi D., Paris I., and De Maria R. (ORCID:0000-0003-2255-0583)

Abstract

In metastatic breast cancer (mBC), the change of human epidermal growth factor receptor 2 (HER2) status between primary and metastatic lesions is widely recognized, however clinical implications are unknown. Our study address the question if relevant differences exist between subjects who preserve the HER2 status and those who gain the HER2 positivity when relapsed. Data of patients affected by HER2-positive mBC, treated with pertuzumab and/or trastuzumab-emtansine (T-DM1) in a real-world setting at 45 Italian cancer centers were retrospectively collected and analyzed. From 2003 to 2017, 491 HER2‐positive mBC patients were included. Of these, 102 (20.7%) had been initially diagnosed as HER2-negative early BC. Estrogen and/or progesterone receptor were more expressed in patients with HER2-discordance compared to patients with HER2-concordant status (p < 0.0001 and p = 0.006, respectively). HER2-discordant tumors were characterized also by a lower rate of brain metastases (p = 0.01) and a longer disease free interval (p < 0.0001). Median overall survival was longer, although not statistically significant, in the subgroup of patients with HER2-discordant cancer with respect to patients with HER2-concordant status (140 vs 78 months, p = 0.07). Our findings suggest that patients with HER2-positive mBC with discordant HER2 status in early BC may have different clinical, biological and prognostic behavior compared to HER2-concordant patients.

Published
2021

42. Post-Induction Management in Patients With Left-Sided RAS and BRAF Wild-Type Metastatic Colorectal Cancer Treated With First-Line Anti-EGFR-Based Doublet Regimens: A Multicentre Study

Author

Parisi A, Cortellini A, Venditti O, Filippi R, Salvatore L, Tortora G, Ghidini M, Nigro O, Gelsomino F, Zurlo I, Fulgenzi C, Lombardi P, Keraenen S, Depetris I, Giampieri R, Morelli C, Di Marino P, Di Pietro F, Zanaletti N, Vitale P, Garajova I, Spinelli G, Zoratto F, Roberto M, Petrillo A, Aimar G, Patruno L, D'Orazio C, Ficorella C, Ferri C, and Porzio G

Subjects
FOLFIRI, FOLFOX, observation, MCRC, cetuximab, panitumumab, maintenance, de-escalation
Abstract

Background Few data regarding post-induction management following first-line anti-epidermal growth factor receptor (EGFR)-based doublet regimens in patients with left-sided RAS/BRAF wild-type metastatic colorectal cancer (mCRC) are available. Methods This multicenter, retrospective study aimed at evaluating clinicians' attitude, and the safety and effectiveness of post-induction strategies in consecutive patients affected by left-sided RAS/BRAF wild-type mCRC treated with doublet chemotherapy plus anti-EGFR as first-line regimen, who did not experience disease progression within 6 months from induction initiation, at 21 Italian and 1 Spanish Institutions. The measured clinical outcomes were: progression-free survival (PFS), overall survival (OS), adverse events, and objective response rate (ORR). Results At the data cutoff, among 686 consecutive patients with left-sided RAS/BRAF wild-type mCRC treated with doublet plus anti-EGFR as first-line regimen from March 2012 to October 2020, 355 eligible patients have been included in the present analysis. Among these, 118 (33.2%), 66 (18.6%), and 11 (3.1%) received a maintenance with 5-fluorouracil/leucovorin (5FU/LV)+anti-EGFR, anti-EGFR, and 5FU/LV, respectively, while 160 (45.1%) patients continued induction treatment (non-maintenance) until disease progression, unacceptable toxicity, patient decision, or completion of planned treatment. The median period of follow-up for the overall population was 33.7 months (95%CI = 28.9-35.6). The median PFS values of the 5FU/LV+anti-EGFR, anti-EGFR, 5FU/LV, and non-maintenance cohorts were 16.0 (95%CI = 14.3-17.7, 86 events), 13.0 (95%CI = 11.4-14.5, 56 events), 14.0 (95%CI = 8.1-20.0, 8 events), and 10.1 months (95%CI = 9.0-11.2, 136 events), respectively (p < 0.001). The median OS values were 39.6 (95%CI = 31.5-47.7, 43 events), 36.1 (95%CI = 31.6-40.7, 36 events), 39.5 (95%CI = 28.2-50.8, 4 events), and 25.1 months (95%CI = 22.6-27.6, 99 events), respectively (p < 0.001). After adjusting for key covariates, a statistically significant improvement in PFS in favor of 5FU/LV+anti-EGFR (HR = 0.59, 95%CI = 0.44-0.77, p < 0.001) and anti-EGFR (HR = 0.71, 95%CI = 0.51-0.98, p = 0.039) compared to the non-maintenance cohort was found. Compared to the non-maintenance cohort, OS was improved by 5FU/LV+anti-EGFR (HR = 0.55, 95%CI = 0.38-0.81, p = 0.002) and, with marginal significance, by anti-EGFR (HR = 0.67, 95%CI = 0.51-0.98, p = 0.051). No difference was found in ORR. Any grade non-hematological and hematological events were generally higher in the non-maintenance compared to the maintenance cohorts. Conclusion Among the treatment strategies following an anti-EGFR-based doublet first-line induction regimen in patients affected by left-sided RAS/BRAF wild-type mCRC treated in a "real-life" setting, 5FU/LV+anti-EGFR resulted the most adopted, effective, and relatively safe regimen.

Published
2021

43. Oxaliplatin plus fluoropyrimidines as adjuvant therapy for colon cancer in older patients: A subgroup analysis from the TOSCA trial

Author

Rosati, Gerardo, primary, Lonardi, Sara, additional, Galli, Fabio, additional, Di Bartolomeo, Maria, additional, Ronzoni, Monica, additional, Zampino, Maria G., additional, Banzi, Maria, additional, Zaniboni, Alberto, additional, Pasini, Felice, additional, Bozzarelli, Silvia, additional, Garattini, Silvio K., additional, Ferrari, Daris, additional, Montesarchio, Vincenzo, additional, Mambrini, Andrea, additional, Ciuffreda, Libero, additional, Galli, Francesca, additional, Pusceddu, Valeria, additional, Carlomagno, Chiara, additional, Bidoli, Paolo, additional, Amoroso, Domenico, additional, Bochicchio, Anna M., additional, Frassineti, Luca, additional, Corsi, Domenico, additional, Bilancia, Domenico, additional, Pastorino, Alessandro, additional, De Stefano, Alfonso, additional, Labianca, Roberto, additional, Bilancia, D., additional, Rosati, G., additional, Montesarchio, V., additional, Iaffaioli, R.V., additional, Nasti, G., additional, Daniele, B., additional, Zagonel, V., additional, Lonardi, S., additional, Pella, N., additional, Aprile, G., additional, Pasini, F., additional, Marchetti, Roma P., additional, Romiti, A., additional, Ciuffreda, L., additional, Ferrari, D., additional, Foa, P., additional, Zaniboni, A., additional, Labianca, R., additional, Mosconi, S., additional, Sobrero, A., additional, Bidoli, P., additional, Cazzaniga, M., additional, Beretta, G.D., additional, Corsi, D.C., additional, Cortesi, E., additional, Barni, S., additional, Petrelli, F., additional, Allione, P., additional, D'Arco, A.M., additional, Valmadre, G., additional, Piazza, E., additional, Veltri, E., additional, Ramus, G. Vietti, additional, Giustini, L., additional, Tumulo, S., additional, Cascinu, S., additional, Granetto, C., additional, Testore, F., additional, Giordano, M., additional, Moroni, M., additional, Di Seri, M., additional, Nuzzo, A., additional, Angelelli, L., additional, Gori, S., additional, Farina, G., additional, Aglietta, M., additional, Franchi, R., additional, Comandé, M., additional, Giordani, P., additional, Tonini, G., additional, Bucci, E., additional, Ballestrero, A., additional, Benasso, M., additional, Graiff, C., additional, Bravi, S., additional, Caffo, O., additional, Silva, R.R., additional, Frontini, L., additional, Rota, S., additional, Cozzi, L., additional, Cantore, M., additional, Maiello, E., additional, Cinieri, S., additional, Silvestris, N., additional, Romito, S., additional, Gebbia, V., additional, Banzi, M., additional, Santoro, A., additional, Artioli, F., additional, Mattioli, R., additional, Contu, A., additional, Di Costanzo, F., additional, Leonardi, F., additional, Cavanna, L., additional, Passalacqua, R., additional, Amoroso, D., additional, Sozzi, P., additional, D'Amico, M., additional, Amadori, D., additional, Frassineti, L., additional, Turci, D., additional, Ravaioli, A., additional, Pasquini, E., additional, Gambi, A., additional, Faedi, M., additional, Cruciani, G., additional, Bajetta, E., additional, Di Bartolomeo, M., additional, Gianni, L., additional, Ronzoni, M., additional, Ionta, M.T., additional, Massidda, B., additional, Scartozzi, M., additional, Zampino, M.G., additional, Bochicchio, A.M., additional, Ciarlo, A., additional, Di Leo, A., additional, Frustaci, S., additional, Rangoni, G., additional, Arizzoia, A., additional, Pavesi, L., additional, Verusio, C., additional, Pinotti, G., additional, Iop, A., additional, De Placido, S., additional, Carlomagno, C., additional, Adamo, V., additional, Ficorella, C., additional, Natale, D., additional, Greco, E., additional, Rulli, E., additional, Galli, F., additional, Poli, D., additional, Porcu, L., additional, and Torri, V., additional

Published
2021
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44. 117P Family history of cancer and improved outcomes with first-line immunotherapy in NSCLC patients

Author

Cortellini, A., primary, Buti, S., additional, Di Maio, M., additional, Giusti, R., additional, Nigro, O., additional, Cantini, L., additional, Bria, E., additional, Grossi, F., additional, Torniai, M., additional, De Tursi, M., additional, Citarella, F., additional, Mazzoni, F., additional, Gelibter, A.J., additional, Macerelli, M., additional, Migliorino, M.R., additional, Russo, A., additional, Addeo, A., additional, Porzio, G., additional, Ficorella, C., additional, and Pinato, D.J., additional

Published
2021
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45. Everolimus (EVE) and exemestane (EXE) in patients with advanced breast cancer aged ≥ 65 years: New lessons for clinical practice from the EVA study

Author

Cazzaniga, M., Verusio, C., Ciccarese, M., Fumagalli, A., Sartori, D., Ancona, C., Airoldi, M., Moretti, G., Ficorella, C., Arcangeli, V., Diodati, L., Zambelli, A., Febbraro, A., Generali, D., Pistelli, M., Garrone, O., Musolino, A., Vici, P., Maur, M., Mentuccia, L., La Verde, N., Bianchi, G., Artale, S., Blasi, L., Piezzo, M., Atzori, F., Turletti, A., Benedetto, C., Cursano, M. C., Fabi, A., Gebbia, V., Schirone, A., Palumbo, R., Ferzi, A., Frassoldati, A., Scavelli, C., Clivio, L., Torri, V., On behalf of The EVA Study Group, Cazzaniga, Marina, Verusio, Claudio, Ciccarese, Mariangela, Fumagalli, Alberto, Sartori, Donata, D'Ancona, Cristina, Airoldi, Mario, Moretti, Gabriella, Ficorella, Corrado, Arcangeli, Valentina, Diodati, Lucrezia, Zambelli, Alberto, Febbraro, Antonio, Generali, Daniele, Pistelli, Mirco, Garrone, Ornella, Musolino, Antonino, Vici, Patrizia, Maur, Michela, Mentuccia, Lucia, La Verde, Nicla, Bianchi, Giulia, Artale, Salvatore, Blasi, Livio, Piezzo, Matilde, Atzori, Francesco, Turletti, Anna, Benedetto, Chiara, Cursano, Maria Concetta, Fabi, Alessandra, Gebbia, Vittorio, Schirone, Antonio, Palumbo, Raffaella, Ferzi, Antonella, Frassoldati, Antonio, Scavelli, Claudio, Clivio, Luca, Torri, Valter, Cazzaniga, M, Verusio, C, Ciccarese, M, Fumagalli, A, Sartori, D, Ancona, C, Airoldi, M, Moretti, G, Ficorella, C, Arcangeli, V, Diodati, L, Zambelli, A, Febbraro, A, Generali, D, Pistelli, M, Garrone, O, Musolino, A, Vici, P, Maur, M, Mentuccia, L, La Verde, N, Bianchi, G, Artale, S, Blasi, L, Piezzo, M, Atzori, F, Turletti, A, Benedetto, C, Cursano, M, Fabi, A, Gebbia, V, Schirone, A, Palumbo, R, Ferzi, A, Frassoldati, A, Scavelli, C, Clivio, L, Torri, V, On behalf of The EVA Study, G, Cazzaniga M., Verusio C., Ciccarese M., Fumagalli A., Sartori D., Valerio MR., Airoldi M., Moretti G., Ficorella C., Arcangeli V., Diodati L., Zambelli A., Febbraro A., Generali D., Pistelli M., Garrone O., Musolino A., Vici P., Maur M., Mentuccia L., La Verde N., Bianchi G., Artale S., Blasi L., Piezzo M., Atzori F., Turletti A., Benedetto C., Cursano M.C., Fabi A., Gebbia V., Schirone A., Palumbo R., Ferzi A., Frassoldati A., Scavelli C., Clivio L., Torri V., and On behalf of The EVA Study Group

Subjects
medicine.medical_specialty, Socio-culturale, Hormone-receptor positive, Exemestane, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Breast cancer, Elderly, Weight loss, Internal medicine, Advanced breast cancer, Everolimus, Oncology, medicine, 030212 general & internal medicine, Stomatitis, Pneumonitis, business.industry, Cancer, medicine.disease, Rash, Everolimu, chemistry, 030220 oncology & carcinogenesis, MED/06 - ONCOLOGIA MEDICA, medicine.symptom, business, Research Paper, medicine.drug
Abstract

BACKGROUND: The present analysis focuses on real-world data of Everolimus- Exemestane in advanced HR+ve, HER2-ve elderly breast cancer patients (aged 65 years) included in the EVA study, with unique findings in those aged 70 years. METHODS: Data are collected from clinical records and analysed according to age cut-off (< 65 years; 65 - 69 years and [greater than or equal to] 70 years). Relationship of analyzed variables with response were tested by mean of a Mantel- Haenszel chi square test. Time to event analysis was described by Kaplan Meier approach and association with baseline characteristics was analysed by stratified log-rank test and proportional hazard model. RESULTS: From July 2013 to December 2015, the EVA study enrolled overall 404 pts. 154 patients out of 404 (38,1%) were aged [greater than or equal to] 65 years, of whom 87 were [greater than or equal to] 70 years. Median duration of EVE treatment was 28.5 weeks (95% CI 19.0 - 33.8) in patients aged 65-69 years and 24,4 weeks (95% CI 19,2 - 33,2) in those aged [greater than or equal to] 70 years. Fewer patients aged 65 years received the highest EVE Dose-Intensity (> 7.5 mg/day) in comparison to younger patients (49,6% vs. 66,8%). Grade 3-4 toxicities occurred to 55 patients (35,7%), mainly stomatitis (10,9%), rash (5,8%) and non-infectious pneumonitis (NIP) (3,6%). Some toxicities, such as weight loss and anaemia were peculiarly observed in patients aged [greater than or equal to] 70 years. Five treatment-related deaths were collected (3,2%). CONCLUSIONS: EVE-EXE combination remains one of the potential treatments in HR+ patients also for elderly ones.

Published
2018

46. FP12.06 GRIm-Score Variations Predict Outcome in Metastatic NSCLC Patients Treated with First-Line Pembrolizumab

Author

Lenci, E., primary, Cantini, L., additional, Rinaldi, S., additional, Pecci, F., additional, Cognigni, V., additional, Agostinelli, V., additional, Mentrasti, G., additional, Ranallo, N., additional, Lupi, A., additional, Paoloni, F., additional, Cortellini, A., additional, Ficorella, C., additional, Chiari, R., additional, Di Maio, M., additional, Aerts, J., additional, Dingemans, A., additional, Nicolardi, L., additional, Caglio, A., additional, Aerts, S., additional, and Berardi, R., additional

Published
2021
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47. Everolimus (EVE) and exemestane (EXE) in patients with advanced breast cancer aged ≥ 65 years: New lessons for clinical practice from the EVA study

Author

Cazzaniga, M, Verusio, C, Ciccarese, M, Fumagalli, A, Sartori, D, Ancona, C, Airoldi, M, Moretti, G, Ficorella, C, Arcangeli, V, Diodati, L, Zambelli, A, Febbraro, A, Generali, D, Pistelli, M, Garrone, O, Musolino, A, Vici, P, Maur, M, Mentuccia, L, La Verde, N, Bianchi, G, Artale, S, Blasi, L, Piezzo, M, Atzori, F, Turletti, A, Benedetto, C, Cursano, M, Fabi, A, Gebbia, V, Schirone, A, Palumbo, R, Ferzi, A, Frassoldati, A, Scavelli, C, Clivio, L, Torri, V, On behalf of The EVA Study, G, Cazzaniga M., Verusio C., Ciccarese M., Fumagalli A., Sartori D., Ancona C., Airoldi M., Moretti G., Ficorella C., Arcangeli V., Diodati L., Zambelli A., Febbraro A., Generali D., Pistelli M., Garrone O., Musolino A., Vici P., Maur M., Mentuccia L., La Verde N., Bianchi G., Artale S., Blasi L., Piezzo M., Atzori F., Turletti A., Benedetto C., Cursano M. C., Fabi A., Gebbia V., Schirone A., Palumbo R., Ferzi A., Frassoldati A., Scavelli C., Clivio L., Torri V., On behalf of The EVA Study Group, Cazzaniga, M, Verusio, C, Ciccarese, M, Fumagalli, A, Sartori, D, Ancona, C, Airoldi, M, Moretti, G, Ficorella, C, Arcangeli, V, Diodati, L, Zambelli, A, Febbraro, A, Generali, D, Pistelli, M, Garrone, O, Musolino, A, Vici, P, Maur, M, Mentuccia, L, La Verde, N, Bianchi, G, Artale, S, Blasi, L, Piezzo, M, Atzori, F, Turletti, A, Benedetto, C, Cursano, M, Fabi, A, Gebbia, V, Schirone, A, Palumbo, R, Ferzi, A, Frassoldati, A, Scavelli, C, Clivio, L, Torri, V, On behalf of The EVA Study, G, Cazzaniga M., Verusio C., Ciccarese M., Fumagalli A., Sartori D., Ancona C., Airoldi M., Moretti G., Ficorella C., Arcangeli V., Diodati L., Zambelli A., Febbraro A., Generali D., Pistelli M., Garrone O., Musolino A., Vici P., Maur M., Mentuccia L., La Verde N., Bianchi G., Artale S., Blasi L., Piezzo M., Atzori F., Turletti A., Benedetto C., Cursano M. C., Fabi A., Gebbia V., Schirone A., Palumbo R., Ferzi A., Frassoldati A., Scavelli C., Clivio L., Torri V., and On behalf of The EVA Study Group

Abstract

BACKGROUND: The present analysis focuses on real-world data of Everolimus- Exemestane in advanced HR+ve, HER2-ve elderly breast cancer patients (aged 65 years) included in the EVA study, with unique findings in those aged 70 years. METHODS: Data are collected from clinical records and analysed according to age cut-off (< 65 years; 65 - 69 years and [greater than or equal to] 70 years). Relationship of analyzed variables with response were tested by mean of a Mantel- Haenszel chi square test. Time to event analysis was described by Kaplan Meier approach and association with baseline characteristics was analysed by stratified log-rank test and proportional hazard model. RESULTS: From July 2013 to December 2015, the EVA study enrolled overall 404 pts. 154 patients out of 404 (38,1%) were aged [greater than or equal to] 65 years, of whom 87 were [greater than or equal to] 70 years. Median duration of EVE treatment was 28.5 weeks (95% CI 19.0 - 33.8) in patients aged 65-69 years and 24,4 weeks (95% CI 19,2 - 33,2) in those aged [greater than or equal to] 70 years. Fewer patients aged 65 years received the highest EVE Dose-Intensity (> 7.5 mg/day) in comparison to younger patients (49,6% vs. 66,8%). Grade 3-4 toxicities occurred to 55 patients (35,7%), mainly stomatitis (10,9%), rash (5,8%) and non-infectious pneumonitis (NIP) (3,6%). Some toxicities, such as weight loss and anaemia were peculiarly observed in patients aged [greater than or equal to] 70 years. Five treatment-related deaths were collected (3,2%). CONCLUSIONS: EVE-EXE combination remains one of the potential treatments in HR+ patients also for elderly ones.

Published
2018

48. Correction: Everolimus (Eve) and exemestane (EXE) in patients with advanced breast cancer aged ≥ 65 years: New lessons for clinical practice from the EVA study (Oncotarget (2018) 9:77 (34639-34640) DOI: 10.18632/oncotarget.25874)

Author

Cazzaniga M., Cazzaniga, M, Verusio, C, Ciccarese, M, Fumagalli, A, Sartori, D, Valerio, M, Airoldi, M, Moretti, G, Ficorella, C, Arcangeli, V, Diodati, L, Zambelli, A, Febbraro, A, Generali, D, Pistelli, M, Garrone, O, Musolino, A, Vici, P, Maur, M, Mentuccia, L, La Verde, N, Bianchi, G, Artale, S, Blasi, L, Piezzo, M, Atzori, F, Turletti, A, Benedetto, C, Cursano, M, Fabi, A, Gebbia, V, Schirone, A, Palumbo, R, Ferzi, A, Frassoldati, A, Scavelli, C, Clivio, L, Torri, V, Cazzaniga M., Verusio C., Ciccarese M., Fumagalli A., Sartori D., Valerio M. R., Airoldi M., Moretti G., Ficorella C., Arcangeli V., Diodati L., Zambelli A., Febbraro A., Generali D., Pistelli M., Garrone O., Musolino A., Vici P., Maur M., Mentuccia L., La Verde N., Bianchi G., Artale S., Blasi L., Piezzo M., Atzori F., Turletti A., Benedetto C., Cursano M. C., Fabi A., Gebbia V., Schirone A., Palumbo R., Ferzi A., Frassoldati A., Scavelli C., Clivio L., Torri V., Cazzaniga M., Cazzaniga, M, Verusio, C, Ciccarese, M, Fumagalli, A, Sartori, D, Valerio, M, Airoldi, M, Moretti, G, Ficorella, C, Arcangeli, V, Diodati, L, Zambelli, A, Febbraro, A, Generali, D, Pistelli, M, Garrone, O, Musolino, A, Vici, P, Maur, M, Mentuccia, L, La Verde, N, Bianchi, G, Artale, S, Blasi, L, Piezzo, M, Atzori, F, Turletti, A, Benedetto, C, Cursano, M, Fabi, A, Gebbia, V, Schirone, A, Palumbo, R, Ferzi, A, Frassoldati, A, Scavelli, C, Clivio, L, Torri, V, Cazzaniga M., Verusio C., Ciccarese M., Fumagalli A., Sartori D., Valerio M. R., Airoldi M., Moretti G., Ficorella C., Arcangeli V., Diodati L., Zambelli A., Febbraro A., Generali D., Pistelli M., Garrone O., Musolino A., Vici P., Maur M., Mentuccia L., La Verde N., Bianchi G., Artale S., Blasi L., Piezzo M., Atzori F., Turletti A., Benedetto C., Cursano M. C., Fabi A., Gebbia V., Schirone A., Palumbo R., Ferzi A., Frassoldati A., Scavelli C., Clivio L., and Torri V.

Abstract

This article has been corrected: The correct author names are given below: Chiara Ancona and Michela Piezzo.

Published
2018

49. Erratum: Everolimus (EVE) and exemestane (EXE) in patients with advanced breast cancer aged ≥ 65 years: New lessons for clinical practice from the EVA study (Oncotarget (2018) 9 (31877-31887) DOI: 10.18632/oncotarget.25874)

Author

Cazzaniga M., Cazzaniga, M, Verusio, C, Ciccarese, M, Fumagalli, A, Sartori, D, Valerio, M, Airoldi, M, Moretti, G, Ficorella, C, Arcangeli, V, Diodati, L, Zambelli, A, Febbraro, A, Generali, D, Pistelli, M, Garrone, O, Musolino, A, Vici, P, Maur, M, Mentuccia, L, La Verde, N, Bianchi, G, Artale, S, Blasi, L, Piezzo, M, Atzori, F, Turletti, A, Benedetto, C, Cursano, M, Fabi, A, Gebbia, V, Schirone, A, Palumbo, R, Ferzi, A, Frassoldati, A, Scavelli, C, Clivio, L, Torri, V, Cazzaniga M., Verusio C., Ciccarese M., Fumagalli A., Sartori D., Valerio M. R., Airoldi M., Moretti G., Ficorella C., Arcangeli V., Diodati L., Zambelli A., Febbraro A., Generali D., Pistelli M., Garrone O., Musolino A., Vici P., Maur M., Mentuccia L., La Verde N., Bianchi G., Artale S., Blasi L., Piezzo M., Atzori F., Turletti A., Benedetto C., Cursano M. C., Fabi A., Gebbia V., Schirone A., Palumbo R., Ferzi A., Frassoldati A., Scavelli C., Clivio L., Torri V., Cazzaniga M., Cazzaniga, M, Verusio, C, Ciccarese, M, Fumagalli, A, Sartori, D, Valerio, M, Airoldi, M, Moretti, G, Ficorella, C, Arcangeli, V, Diodati, L, Zambelli, A, Febbraro, A, Generali, D, Pistelli, M, Garrone, O, Musolino, A, Vici, P, Maur, M, Mentuccia, L, La Verde, N, Bianchi, G, Artale, S, Blasi, L, Piezzo, M, Atzori, F, Turletti, A, Benedetto, C, Cursano, M, Fabi, A, Gebbia, V, Schirone, A, Palumbo, R, Ferzi, A, Frassoldati, A, Scavelli, C, Clivio, L, Torri, V, Cazzaniga M., Verusio C., Ciccarese M., Fumagalli A., Sartori D., Valerio M. R., Airoldi M., Moretti G., Ficorella C., Arcangeli V., Diodati L., Zambelli A., Febbraro A., Generali D., Pistelli M., Garrone O., Musolino A., Vici P., Maur M., Mentuccia L., La Verde N., Bianchi G., Artale S., Blasi L., Piezzo M., Atzori F., Turletti A., Benedetto C., Cursano M. C., Fabi A., Gebbia V., Schirone A., Palumbo R., Ferzi A., Frassoldati A., Scavelli C., Clivio L., and Torri V.

Abstract

This article has been corrected: The correct author name is given below:.

Published
2018

50. Evaluation of second-line anti-VEGF after first-line anti-EGFR based therapy in RAS wild-type metastatic colorectal cancer. The multicenter 'SLAVE' study

Author

Parisi, A., Cortellini, A., Cannita, K., Venditti, O., Camarda, F., Calegari, M. A., Salvatore, L., Tortora, G., Rossini, D., Germani, M. M., Boccaccino, A., Dell&apos, aquila, E., Fulgenzi, C., Santini, D., De Tursi, M., Tinari, N., Di Marino, P., Lombardi, P., Keranen, S. R., Alvaro, M. H., Zurlo, I. V., Corsi, D. C., Emiliani, A., Zanaletti, N., Troiani, T., Vitale, P., Giampieri, R., Merloni, F., Occhipinti, M., Marchetti, P., Roberto, M., Mazzuca, F., Ghidini, M., Indini, A., Garajova, I., Zoratto, F., Monache, S. D., Porzio, G., and Ficorella, C.

Subjects
aflibercept, anti-angiogenics, bevacizumab, cetuximab, panitumumab, ras wild-type mcrc, second-line treatment
Published
2020

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