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1. Profile of atezolizumab in the treatment of metastatic non-small-cell lung cancer: patient selection and perspectives

Author

Facchinetti F, Bordi P, Leonetti A, Buti S, and Tiseo M

Subjects
Non-small cell lung cancer (NSCLC), Immune checkpoint blockers (ICB), PD-1, PD-L1, Atezolizumab development, Biomarkers., Therapeutics. Pharmacology, RM1-950
Abstract

Francesco Facchinetti, Paola Bordi, Alessandro Leonetti, Sebastiano Buti, Marcello Tiseo Medical Oncology Unit, University Hospital of Parma, Parma, Italy Abstract: Programed cell death-1/programed death ligand-1 (PD-1/PD-L1) blockade represents an affirmed reality in the treatment of advanced non-small-cell lung cancer (NSCLC) patients. Atezolizumab, an anti-PD-L1 agent, figures among the drugs that provide previously unenvisaged outcomes in the pretreated setting of metastatic NSCLC. Increasing evidence vouches for the early administration of PD-1/PD-L1 blockers in untreated patients, encompassing atezolizumab combinations with chemotherapy and the anti-angiogenic agent bevacizumab. Moreover, the development of atezolizumab allowed to derive several hints regarding clinical and immunological factors predictive of its activity and efficacy, some of them exclusive among this class of drugs. This review provides an overview of atezolizumab development throughout clinical trials toward its applicability in the routine practice, with a particular focus on patient selection based on clinical and immune-related factors. Keywords: non-small cell lung cancer, NSCLC, immune checkpoint blockers, ICB, PD-1, PD-L1, atezolizumab development, biomarkers

Published
2018

2. Spotlight on cabozantinib for previously untreated advanced renal cell carcinoma: evidence to date

Author

Bersanelli M, Leonardi F, and Buti S

Subjects
cabozantinib, renal cell carcinoma, first-line treatment, CABOSUN., Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Melissa Bersanelli, Francesco Leonardi, Sebastiano Buti University Hospital of Parma, Medical Oncology Unit, Parma, Italy Background: In the past few years, new drugs made their appearance in the first-line setting of treatment for metastatic renal cell carcinoma (mRCC), and cabozantinib is one among them. The present systematic review aims to point out any evidence published to date about first-line treatment with cabozantinib for mRCC patients, describing their outcome in all end points explored by the literature. Methods: PRISMA guidelines were followed. A systematic assessment of literature and peer-reviewed presentations was performed by searching PubMed and major oncology meeting resources, from the database inception until June 25, 2018. The following keywords were used: “cabozantinib or cabozantinib-s-malate or XL184” and “renal cell carcinoma or kidney cancer or clear cell renal carcinoma or renal cancer” and “first-line or untreated or treatment-naïve or primary treatment”. All types of original clinical studies were included, evaluating either cabozantinib monotherapy or any systemic drug combination containing cabozantinib for previously untreated patients with mRCC. Results: From potential 75 titles and abstracts, seven publications were selected. One was the main report of a randomized clinical trial (the CABOSUN study); four papers reported updated results, secondary or subgroup analyses from the same study population; and further two reports consisted of network meta-analyses. From the additional search for ongoing clinical trials, six studies currently in progress were reported. Conclusion: According to the reported evidence, cabozantinib may be a viable first-line option in mRCC patients with intermediate or poor risk according to International Metastatic Renal Cell Carcinoma Database Consortium model. It offers an undoubtful advantage in terms of progression-free survival, despite quite high rates of G3–4 toxicity, modest objective response rate, and no survival advantage. Nevertheless, given the availability of an immunotherapy combination that significantly improved overall survival for the same population in a Phase III trial and the indisputable efficacy of cabozantinib as second-line treatment, this drug may be devoted as a rescue option in patients progressive to primary therapy. Keywords: cabozantinib, renal cell carcinoma, first-line treatment, CABOSUN

Published
2018

3. Clinical use of lenvatinib in combination with everolimus for the treatment of advanced renal cell carcinoma

Author

Leonetti A, Leonardi F, Bersanelli M, and Buti S

Subjects
lenvatinib, everolimus, evidence-based review, renal cell carcinoma, RCC., Therapeutics. Pharmacology, RM1-950
Abstract

Alessandro Leonetti, Francesco Leonardi, Melissa Bersanelli, Sebastiano Buti Medical Oncology Unit, University Hospital of Parma, Parma, Italy Introduction: Renal cell carcinoma (RCC) represents 2%–3% of all cancers in adults, and its pathogenesis is mainly related to altered cellular response to hypoxia. Lenvatinib, a novel multitarget tyrosine kinase inhibitor (TKI), represents a therapeutic option, in combination with mammalian target of rapamycin (mTOR) inhibitor everolimus, for the treatment of metastatic RCC (mRCC).Aim: The objective of this article is to review the evidence about the treatment of mRCC with combination of lenvatinib plus everolimus.Evidence review: Phase I studies supported clinical activity of lenvatinib in mRCC. A randomized, Phase II, open-label, multicenter trial demonstrated the clinical efficacy of combination treatment with lenvatinib plus everolimus in patients with progressive mRCC after prior therapy with TKI. Median progression-free survival was improved by 9 months with the combination therapy compared to the single-agent everolimus, with an overall response rate of 43% for the experimental regimen. Lenvatinib plus everolimus appeared to be slightly less toxic than single-agent lenvatinib and more toxic than single-agent everolimus; grade 3–4 adverse events occurred in 71% of patients. Currently, lenvatinib plus everolimus has US Food and Drug Administration approval for its use in mRCC after failure of previous treatment with TKI.Conclusion: The combination therapy with lenvatinib plus everolimus might be a promising choice for second-line treatment of mRCC patients. Based on the results of the Phase II trial, it is possible to speculate that the combination therapy could be appropriate for patients with high disease burden or strongly symptomatic patients. Keywords: lenvatinib, everolimus, evidence-based review, renal cell carcinoma, RCC

Published
2017

6. Validation of the Meet-URO score in patients with metastatic renal cell carcinoma receiving first-line nivolumab and ipilimumab in the Italian Expanded Access Program

Author

Rebuzzi, S.E., Signori, A., Buti, S., Banna, G.L., Murianni, V., Damassi, A., Maruzzo, M., Giannarelli, D., Tortora, G., Galli, L., Rizzo, M., De Giorgi, U., Antonuzzo, L., Bracarda, S., Cartenì, G., Atzori, F., Tamberi, S., Procopio, G., Fratino, L., Lo Re, G., Santoni, M., Baldessari, C., Astone, A., Calabrò, F., Brunelli, M., Porta, C., Rescigno, P., Basso, U., and Fornarini, G.

Published
2022
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8. 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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10. Papillary Renal Cell Carcinoma (pRCC): Outcomes of patients receiving first-line immune-based combinations or Tyrosine Kinase Inhibitors (TKIs) from the ARON-1 study

Author

Mollica, V., primary, Massari, F., additional, Fiala, O., additional, Kucharz, J., additional, Molina-Cerrillo, J., additional, Seront, E., additional, Bourlon, M.T., additional, Pichler, R., additional, Myint, Z.W., additional, Kanesvaran, R., additional, Marchetti, A., additional, Rosellini, M., additional, Rescigno, P., additional, de Liano, A.G., additional, Zakopoulou, R., additional, Buti, S., additional, Porta, C., additional, Grande, E., additional, and Santoni, M., additional

Published
2024
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11. Prognostic Impact of Blood Lipid Profile in Patients With Advanced Solid Tumors Treated With Immune Checkpoint Inhibitors:A Multicenter Cohort Study

Author

Pecci, F, Cantini, L, Cognigni, V, Perrone, F, Mazzaschi, G, Agostinelli, V, Mentrasti, G, Favari, E, Maffezzoli, M, Cortellini, A, Rossi, F, Chiariotti, R, Venanzi, FM, Lo Russo, G, Galli, G, Proto, C, Ganzinelli, M, Tronconi, F, Morgese, F, Campolucci, C, Moretti, M, Vignini, A, Tiseo, M, Minari, R, Rocchi, MLB, Buti, S, Berardi, Rossana, Pecci, F, Cantini, L, Cognigni, V, Perrone, F, Mazzaschi, G, Agostinelli, V, Mentrasti, G, Favari, E, Maffezzoli, M, Cortellini, A, Rossi, F, Chiariotti, R, Venanzi, FM, Lo Russo, G, Galli, G, Proto, C, Ganzinelli, M, Tronconi, F, Morgese, F, Campolucci, C, Moretti, M, Vignini, A, Tiseo, M, Minari, R, Rocchi, MLB, Buti, S, and Berardi, Rossana

Abstract

Background: Specific components of lipid profile seem to differently impact on immune activity against cancer and unraveling their prognostic role in patients with solid cancer treated with immune checkpoint inhibitors (ICIs) is needed. Materials and Methods: We retrospectively collected baseline clinicopathological characteristics including circulating lipid profile (total cholesterol [TC], triglycerides [TG], low-density lipoproteins [LDL], high-density lipoproteins [HDL]) of patients with consecutive solid cancer treated with ICIs, and we investigated their role in predicting clinical outcomes. Results: At a median follow-up of 32.9 months, among 430 enrolled patients, those with TC ≥ 200 mg/dl showed longer median progression-free survival (mPFS; 6.6 vs. 4.7 months, P = .4), although not reaching statistical significance, and significantly longer median overall survival (mOS; 19.4 vs. 10.8 months, P = .02) compared to those with TC < 200 mg/dl. Conversely, patients with TG ≥150 mg/dl displayed shorter PFS (3.4 vs. 5.1 months, P = .02) and OS (7.1 vs. 12.9 months, P = .009) compared to those with TG <150 mg/dl. TC and TG were then combined in a “LIPID score” identifying three subgroups: good-risk (GR) (TC ≥200 mg/dl and TG <150 mg/dl), intermediate-risk (IR) (TC <200 mg/dl and TG <150 mg/dl or TC ≥200 mg/dl and TG ≥150 mg/dl) and poor-risk (PR) (TC <200 mg/dl and TG ≥150 mg/dl). The mPFS of GR, IR, and PR groups was 7.8, 4.3, and 2.5 months, respectively (P = .005); mOS of GR, IR, and PR was 20.4, 12.4, and 5.3 months, respectively (P < .001). At multivariable analysis, the PR profile represented an independent poor prognostic factor for both PFS and OS. Conclusions: We developed a lipid score that defined subgroups of patients with cancer who differently benefit from ICIs. Further mechanistic insights are warranted to clarify the prognostic and predictive role of lipid profile components in patients treated with ICIs.

Published
2024

12. Resistance to osimertinib in advanced EGFR-mutated NSCLC: a prospective study of molecular genotyping on tissue and liquid biopsies

Author

Leonetti, A., primary, Verzè, M., additional, Minari, R., additional, Perrone, F., additional, Gnetti, L., additional, Bordi, P., additional, Pluchino, M., additional, Nizzoli, R., additional, Azzoni, C., additional, Bottarelli, L., additional, Lagrasta, C. A. M., additional, Mazzaschi, G., additional, Buti, S., additional, Gasparro, D., additional, Cosenza, A., additional, Ferri, L., additional, Majori, M., additional, De Filippo, M., additional, Ampollini, L., additional, La Monica, S., additional, Alfieri, R., additional, Silini, E. M., additional, and Tiseo, M., additional

Published
2023
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15. 238P Exploring blood immune cell dynamics to unravel the immunomodulatory effect of radiotherapy in NSCLC patients undergoing immune checkpoint inhibitors

Author

Mazzaschi, G., primary, Tamarozzi, P., additional, Lorusso, B., additional, Verzè, M., additional, Pluchino, M., additional, Trentini, F., additional, Dalla Valle, B., additional, Minari, R., additional, Perrone, F., additional, Bordi, P., additional, Leonetti, A., additional, Moron Dalla Tor, L., additional, Leo, L., additional, Milanese, G., additional, Balbi, M., additional, Buti, S., additional, Roti, G., additional, Quaini, F., additional, Sverzellati, N., additional, and Tiseo, M., additional

Published
2022
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16. Nivolumab + ipilimumab (NIVO + IPI) adjuvant versus placebo dans le carcinome rénal localisé à haut risque de récidive après néphrectomie : résultats de l’étude de phase 3 randomisée Checkmate 914 (CM914)

Author

Barthélémy, P., primary, Motzer, R., additional, Russo, P., additional, Grünwald, V., additional, Tomita, Y., additional, Zurawski, B., additional, Parikh, O., additional, Buti, S., additional, Goh, J., additional, Ye, D., additional, Lingua, A., additional, Lattouf, J., additional, Escudier, B., additional, George, S., additional, Shuch, B., additional, Simsek, B., additional, Spiridigliozzi, J., additional, Chudnovsky, A., additional, and Bex, A., additional

Published
2022
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17. 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

18. 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

19. 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

20. 1462P Clinical outcome of patients with non-clear metastatic renal cell carcinoma treated with pembrolizumab-axitinib combination: NEMESIA (non-clear metastatic renal cell carcinoma pembrolizumab axitinib) study, a subgroup analysis of I-RARE observational study (Meet-URO 23a)

Author

Stellato, M., primary, Buti, S., additional, Maruzzo, M., additional, Bersanelli, M., additional, Ermacora, P., additional, Maiorano, B.A., additional, Prati, V., additional, De Giorgi, U.F.F., additional, Pierantoni, F., additional, Malgeri, A., additional, Mennitto, A., additional, Cavo, A., additional, Vitale, M.G., additional, Santoni, M., additional, Carella, C., additional, Procopio, G., additional, Verzoni, E., additional, and Santini, D., additional

Published
2022
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21. 1476P Immunohistochemical (mIHC) analyses of the immune tumor microenvironment (I-TME) in metastatic renal cell carcinoma (mRCC) patients (pts) receiving immunotherapy: Main results from the Meet-URO 18 study

Author

Rebuzzi, S.E., primary, Rescigno, P., additional, Signori, A., additional, Brunelli, M., additional, Galuppini, F., additional, Vellone, V.G., additional, Gaggero, G., additional, Maruzzo, M., additional, Milella, M., additional, Vignani, F., additional, Cavo, A., additional, Basso, U., additional, Catalano, F., additional, Murianni, V., additional, Cremante, M., additional, Damassi, A., additional, Llaja Obispo, M.A., additional, Banna, G.L., additional, Buti, S., additional, and Fornarini, G., additional

Published
2022
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22. P1.15-04 Dynamic Profiling of Blood Immunophenotypes and Radiomic Features to Predict Immunotherapy Response in Advanced Non-small Cell Lung Cancer

Author

Mazzaschi, G., primary, Moron Dalla Tor, L., additional, Milanese, G., additional, Balbi, M., additional, Tognazzi, D., additional, Lorusso, B., additional, Verzè, M., additional, Pluchino, M., additional, Minari, R., additional, Leo, L., additional, Ledda, R.E., additional, Bordi, P., additional, Leonetti, A., additional, Buti, S., additional, Roti, G., additional, Quaini, F., additional, Sverzellati, N., additional, and Tiseo, M., additional

Published
2022
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24. LBA77 Fecal microbiota transplantation (FMT) versus placebo in patients receiving pembrolizumab plus axitinib for metastatic renal cell carcinoma: Preliminary results of the randomized phase II TACITO trial

Author

Ciccarese, C., Porcari, S., Buti, S., Fornarini, G., Primi, F., Giudice, G.C., Damassi, A., Giron Berrios, J.R., Stumbo, L., Arduini, D., Severino, A., Rondinella, D., Masucci, L., Sanguinetti, M., Gasbarrini, A., Cammarota, G., Segata, N., Tortora, G., Ianiro, G., and Iacovelli, R.

Published
2024
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25. 2014P Overall survival (OS) results in phase II trial of cabozantinib (CABO) plus durvalumab (DURVA) in patients with urothelial carcinoma (UC) or non-UC variant histologies (VH) after platinum chemotherapy (ARCADIA)

Author

Giannatempo, P., Polymeropoulos, A., Stellato, M., Ambrosini, P., Gusmaroli, E., Cavalli, C., Guadalupi, V., Claps, M., Raggi, D., Rametta, A., Ortega, C., Tucci, M., Buti, S., Pipitone, S., Iacovelli, R., Calareso, G., Alessi, A., Procopio, G., Miceli, R., and Necchi, A.

Published
2024
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26. 1981P Cabozantinib plus durvalumab in patients with advanced and chemotherapy-treated urothelial carcinoma (UC) and variant histology (VH): An open-label, phase II, single-arm proof-of-concept trial: ARCADIA study. Subgroup analysis for bone metastasis

Author

Stellato, M., Giannatempo, P., Polymeropoulos, A., Guadalupi, V., Claps, M., Ambrosini, P., Raggi, D., Rametta, A., Cavalli, C., Gusmaroli, E., Ortega, C., Tucci, M., Buti, S., Pipitone, S., Iacovelli, R., Calareso, G., Alessi, A., Procopio, G., Miceli, R., and Necchi, A.

Published
2024
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31. Validation of the Meet-URO score in patients with metastatic renal cell carcinoma receiving first-line nivolumab and ipilimumab in the Italian Expanded Access Program

Author

Rebuzzi, S. E., Signori, A., Buti, S., Banna, G. L., Murianni, V., Damassi, A., Maruzzo, M., Giannarelli, Diana, Tortora, Giampaolo, Galli, L., Rizzo, M., De Giorgi, U., Antonuzzo, L., Bracarda, S., Cartenì, G., Atzori, Francesco, Tamberi, S., Procopio, G., Fratino, L., Lo Re, G., Santoni, M., Baldessari, C., Astone, Antonio, Calabrò, F., Brunelli, M., Porta, C., Rescigno, P., Basso, U., Fornarini, G., Giannarelli D., Tortora G. (ORCID:0000-0002-1378-4962), Atzori F., Astone A. (ORCID:0000-0001-9572-309X), Rebuzzi, S. E., Signori, A., Buti, S., Banna, G. L., Murianni, V., Damassi, A., Maruzzo, M., Giannarelli, Diana, Tortora, Giampaolo, Galli, L., Rizzo, M., De Giorgi, U., Antonuzzo, L., Bracarda, S., Cartenì, G., Atzori, Francesco, Tamberi, S., Procopio, G., Fratino, L., Lo Re, G., Santoni, M., Baldessari, C., Astone, Antonio, Calabrò, F., Brunelli, M., Porta, C., Rescigno, P., Basso, U., Fornarini, G., Giannarelli D., Tortora G. (ORCID:0000-0002-1378-4962), Atzori F., and Astone A. (ORCID:0000-0001-9572-309X)

Abstract

Background: The Meet-URO score allowed a more accurate prognostication than the International Metastatic RCC Database Consortium (IMDC) for patients with pre-treated metastatic renal cell carcinoma (mRCC) by adding the pre-treatment neutrophil-to-lymphocyte ratio and presence of bone metastases.Materials and methods: A post hoc analysis was carried out to validate the Meet-URO score on the overall survival (OS) of patients with IMDC intermediate-poor-risk mRCC treated with first-line nivolumab plus ipilimumab within the prospective Italian Expanded Access Programme (EAP). We additionally considered progression-free survival (PFS) and disease response rates. Harrell's c-index was calculated to compare the accuracy of survival prediction.Results: Overall the EAP included 306 patients, with a median follow-up of 12.2 months, median OS was not reached, 1-year OS was 66.8% and median PFS was 7.9 months. By univariable analysis, both the IMDC score and the two additional variables of the Meet-URO score were associated with either OS or PFS (P < 0.001 for all comparisons). The four Meet-URO risk groups (G) had 1-year OS of 92%, 72%, 50% and 21% for G2 (29.1% of patients), G3 (28.8%), G4 (33.0%) and G5 (9.1%), respectively. OS was significantly shorter in each consecutive G (P = 0.001 for G3, P < 0.001 for both G4 and G5 compared to G2). Similarly, Meet-URO Gs 2-5 showed decreasing median PFS and response rates. The Meet-URO score showed the highest c-index for both OS (0.73) and PFS (0.67). Limitations include the post hoc nature of this analysis and the lack of a comparative arm to assess predictive value.Conclusion: The Meet-URO score appeared to show better prognostic classification than the IMDC alone in patients with mRCC at IMDC intermediate-poor risk treated with first-line nivolumab and ipilimumab.

Published
2022

32. 165P Dynamic evolution of blood immune-inflammatory descriptors in advanced non-small cell lung cancer undergoing first-line immunotherapy-based regimens

Author

Mazzaschi, G., primary, Verzè, M., additional, Tognazzi, D., additional, Lorusso, B., additional, Minari, R., additional, Pluchino, M., additional, Trentini, F., additional, Manini, M., additional, Bordi, P., additional, Leonetti, A., additional, Perrone, F., additional, Corianò, M., additional, Casali, M., additional, Toscani, I., additional, Cosenza, A., additional, Ferri, L., additional, Buti, S., additional, Sverzellati, N., additional, Quaini, F., additional, and Tiseo, M., additional

Published
2022
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33. First line avelumab in PD-L1+ve metastatic or locally advanced Urothelial Cancer (aUC) patients unfit for cisplatin: The ARIES trial

Author

Iacovelli, R., primary, Ciccarese, C., additional, Brunelli, M., additional, Battelli, N., additional, Buttigliero, C., additional, Caserta, C., additional, Buti, S., additional, Santini, D., additional, Naglieri, E., additional, Galli, L., additional, Verri, E., additional, Ermacora, P., additional, Milella, M., additional, Masini, C., additional, Aprile, G., additional, Milesi, L., additional, Spina, F., additional, Rizzo, M., additional, Sperduti, I., additional, Fornarini, G., additional, and Tortora, G., additional

Published
2022
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34. First-line avelumab for patients with PD-L1-positive metastatic or locally advanced urothelial cancer who are unfit for cisplatin

Author

Iacovelli, Roberto R, Ciccarese, C, Brunelli, M, Battelli, N, Buttigliero, C, Caserta, C, Buti, S, Santini, D, Carella, C, Galli, L, Verri, E, Ermacora, P, Merler, S, Masini, C, De Vivo, R, Milesi, L, Spina, F, Rizzo, M, Sperduti, I, Fornarini, G, and Tortora, G

Subjects
PD-L1, Carcinoma, Transitional Cell, biomarkers, Hematology, Antibodies, Monoclonal, Humanized, B7-H1 Antigen, cisplatin ineligible, Urinary Bladder Neoplasms, Oncology, Humans, bladder cancer, avelumab, immunotherapy, Cisplatin, Aged
Abstract

Cisplatin-based chemotherapy is the most recommended treatment for metastatic urothelial cancer (mUC). However, about 50% of patients are considered to be cisplatin ineligible. Anti-programmed cell death protein 1/programmed death-ligand 1 (PD-L1) therapies have, nevertheless, increased the options available to clinicians and are especially valuable for treating these patients. This study therefore tested the activity and safety of avelumab as first-line therapy for mUC.Patients with mUC who were ineligible for cisplatin-based chemotherapy were screened centrally for PD-L1 expression and only those with a tumour proportion score ≥ 5% were enrolled in the trial. The primary endpoint was 1-year overall survival (OS), and the secondary endpoints were median OS, median progression-free survival, overall response rate, duration of the response, safety and tolerability. All the survival rates were estimated with the Kaplan-Meier product-limit methodology and compared across groups using the log-rank test.A total of 198 patients were screened, with 71 (35.9%) whose PD-L1 expression was ≥5% enrolled in the study. The median age was 75 years, bladder cancer was the primary tumour in 73.2% of cases and 25.3% had liver metastases. The main reasons for the cisplatin ineligibility were a low rate of creatinine clearance (60 ml/min), present in 70.4% of patients, and an Eastern Cooperative Oncology Group performance status of 2, which affected 31%. The median OS was 10.0 months (95% confidence interval 5.5-14.5 months) and 43% of patients were alive at 1 year. A complete response was achieved in 8.5% of cases, and 15.5% had a partial response. Adverse any-grade and high-grade events occurred in 49.3% and 8.5% of patients, respectively. A grade 3 infusion reaction was the only high-grade treatment-related adverse event. No treatment-related deaths were reported.This ARIES trial confirmed the activity and safety of avelumab for treating mUC, adding a new therapy option to the armamentarium of checkpoint inhibitors already approved for platinum-ineligible, locally advanced/mUC.

Published
2022

35. Erdos: A Novel Blockchain Consensus Algorithm with Equitable Node Selection and Deterministic Block Finalization

Author

Buti Sello, Jianming Yong, and Xiaohui Tao

Subjects
Blockchain deterministic finality, Blockchain fork-resistance, Blockchain security, Decentralised ledger technology, Information technology, T58.5-58.64, Electronic computers. Computer science, QA75.5-76.95
Abstract

Abstract The introduction of blockchain technology has brought about significant transformation in the realm of digital transactions, providing a secure and transparent platform for peer-to-peer interactions that cannot be tampered with. The decentralised and distributed nature of blockchains guarantees the integrity and authenticity of the data, eliminating the need for intermediaries. The applications of this technology are not limited to the financial sector, but extend to various areas, such as supply chain management, identity verification, and governance. At the core of these blockchains is the consensus mechanism, which plays a crucial role in ensuring the reliability and integrity of a system. Consensus mechanisms are essential for achieving an agreement amongst network participants regarding the validity of transactions and the order in which they are recorded on the blockchain. By incorporating consensus mechanisms, blockchains ensure that all honest nodes in the network reach a consensus on whether to accept or reject a block, based on predefined rules and criteria. The aim of this study is to introduce a novel consensus mechanism named Erdos, which seeks to address the shortcomings of existing consensus algorithms, such as the Proof of Work and Proof of Stake. Erdos emphasises security, decentralisation, and fairness. One notable feature of this mechanism is its equitable node-selection algorithm, which ensures equal opportunities for all nodes to engage in block creation and validation. In addition, Erdos implements a deterministic block finalisation process that guarantees the integrity and authenticity of the blockchain. The main contribution of this research lies in its innovative approach to deterministic block finalisation, which effectively mitigates the various security risks associated with blockchain systems.

Published
2024
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36. 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

37. 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

38. 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

40. 10P Family history of cancer correlates with improved outcome from immunotherapy in NSCLC independent of somatic DNA damage response gene status

Author

Cortellini, A., primary, Filetti, M., additional, Citarella, F., additional, Giusti, R., additional, Russano, M., additional, Grossi, F., additional, Gelibter, A.J., additional, Pecci, F., additional, De Tursi, M., additional, Macerelli, M., additional, Nigro, O., additional, Ferrara, M.G., additional, Buti, S., additional, Mazzoni, F., additional, Cantini, L., additional, Migliorino, M.R., additional, Addeo, A., additional, Adamo, V., additional, Russo, A., additional, and Pinato, D.J., additional

Published
2021
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41. 17P Dynamic changes of CT-radiomic and systemic immune-inflammatory features predict the response to immune checkpoint inhibitors in advanced NSCLC patients

Author

Mazzaschi, G., primary, Milanese, G., additional, Moron Dalla Tor, L., additional, Leo, L., additional, Balbi, M., additional, Trentini, F., additional, Manini, M., additional, Pavone, C., additional, Silva, M., additional, Ledda, R.E., additional, Minari, R., additional, Bordi, P., additional, Buti, S., additional, Leonetti, A., additional, Roti, G., additional, Quaini, F., additional, Sverzellati, N., additional, and Tiseo, M., additional

Published
2021
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42. 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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43. 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

44. P57.08 High Performance Radiomic Classifier to Predict the Response to Immunotherapy in Advanced NSCLC

Author

Mazzaschi, G., primary, Scandino, R., additional, Milanese, G., additional, Pavone, C., additional, Balbi, M., additional, Ledda, R., additional, Minari, R., additional, Trentini, F., additional, Bordi, P., additional, Buti, S., additional, Leonetti, A., additional, Quaini, F., additional, Sverzellati, N., additional, Romanel, A., additional, and Tiseo, M., additional

Published
2021
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45. 1352P A highly predictive blood-radiomics classifier in advanced NSCLC treated with immunotherapy

Author

Mazzaschi, G., primary, Scandino, R., additional, Milanese, G., additional, Pavone, C., additional, Maurizio, B., additional, Silva, M., additional, Ledda, R., additional, Minari, R., additional, Trentini, F., additional, Buti, S., additional, Bordi, P., additional, Leonetti, A., additional, Quaini, F., additional, Sverzellati, N., additional, Romanel, A., additional, and Tiseo, M., additional

Published
2021
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46. 654MO A phase II prospective trial of frontline cabozantinib in metastatic collecting ducts renal cell carcinoma: The BONSAI trial (Meeturo 2)

Author

Procopio, G., primary, Claps, M., additional, Sepe, P., additional, Buti, S., additional, de Cecco, L., additional, Devecchi, A., additional, Dugo, M., additional, Gargiuli, C., additional, Guadalupi, V., additional, Ottini, A., additional, Sensi, M., additional, De Braud, F., additional, and Verzoni, E., additional

Published
2021
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47. 696P Is it possible to improve the prognostic ability of the IMDC score? Validation of the Meet-URO score in metastatic renal cell carcinoma (mRCC) patients (pts) receiving first-line nivolumab plus ipilimumab in the Italian Expanded Access Program (EAP)

Author

Rebuzzi, S.E., primary, Signori, A., additional, Maruzzo, M., additional, Tortora, G., additional, Galli, L., additional, Rizzo, M., additional, De Giorgi, U., additional, Antonuzzo, L., additional, Bracarda, S., additional, Cartenì, G., additional, Atzori, F., additional, Tamberi, S., additional, Procopio, G., additional, Fratino, L., additional, Santoni, M., additional, Baldessari, C., additional, Astone, A., additional, Calabro', F., additional, Buti, S., additional, and Fornarini, G., additional

Published
2021
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48. Safety and efficacy of nivolumab for metastatic renal cell carcinoma: real-world results from an expanded access programme

Author

De Giorgi, U, Carteni, G, Giannarelli, D, Basso, U, Galli, L, Cortesi, E, Caserta, C, Pignata, S, Sabbatini, R, Bearz, A, Buti, S, Lo Re, G, Berruti, A, Bracarda, S, Cognetti, F, Rastelli, F, Fornarini, G, Porta, C, Turci, D, Sternberg, Cn, Procopio, G, Falcone, A, Roila, F, Cascinu, S, Tirelli, U, Giustini, L, Sobrero, A, Cappuzzo, F, Tortora, G, Tassinari, D, Passalacqua, R, Pazzola, A, Surico, G, Maio, M, Benedetti, G, Barone, C, Adamo, V, Ricevuto, E, De Censi, A, Spada, M, Tonini, G, Pinto, C, Ciuffreda, L, Ruggeri, Em, Bengala, C, Scotti, V, Fagnani, D, Bonetti, A, Mitterer, M, Castiglione, F, Bidoli, P, Ferrau, F, Crino, L, Frassoldati, A, Marchetti, P, Mini, E, Scoppola, A, Verusio, C, Favaretto, A, Di Costanzo, F, Fasola, G, Merlano, M, Artioli, F, Di Leo, A, Romito, S, Maestri, A, Giorgio, Cg, Ionta, Mt, Verderame, F, Zampa, G, Numico, G, Minelli, M, Tagliaferri, P, Foa, P, Palmiotti, G, De Placido, S, Mattioli, R, Iuliano, F, Defraia, E, Siena, S, Clerico, M, Salvagno, L, Ceresoli, Gl, Bernardo, A, Di Lieto, M, Moroni, M, Maisano, M, Scartozzi, M, Scagliotti, G, Soraru, M, Pepe, S, Scaltriti, A, Gebbia, V, Testa, E, Lorusso, V, Bordonaro, R, De Signoribus, G, Tedde, N, Santoro, A, Francini, G, Aondio, G, De Giorgi, U., Carteni, G., Giannarelli, D., Basso, U., Galli, L., Cortesi, E., Caserta, C., Pignata, S., Sabbatini, R., Bearz, A., Buti, S., Lo Re, G., Berruti, A., Bracarda, S., Cognetti, F., Rastelli, F., Fornarini, G., Porta, C., Turci, D., Sternberg, C. N., Procopio, G., Falcone, A., Roila, F., Cascinu, S., Tirelli, U., Giustini, L., Sobrero, A., Cappuzzo, F., Tassinari, D., Passalacqua, R., Pazzola, A., Surico, G., Maio, M., Benedetti, G., Barone, C., Adamo, V., Ricevuto, E., De Censi, A., Spada, M., Tonini, G., Pinto, C., Ciuffreda, L., Ruggeri, E. M., Bengala, C., Scotti, V., Fagnani, D., Bonetti, A., Mitterer, M., Castiglione, F., Bidoli, P., Ferrau, F., Crino, L., Frassoldati, A., Marchetti, P., Mini, E., Scoppola, A., Verusio, C., Favaretto, A., Di Costanzo, F., Fasola, G., Merlano, M., Artioli, F., Di Leo, A., Romito, S., Maestri, A., Giannitto Giorgio, C., Ionta, M. T., Verderame, F., Zampa, G., Numico, G., Minelli, M., Tagliaferri, P., Foa, P., Palmiotti, G., De Placido, S., Mattioli, R., Iuliano, F., Defraia, E., Siena, S., Clerico, M., Salvagno, L., Ceresoli, G. L., Bernardo, A., Di Lieto, M., Moroni, M., Maisano, M., Scartozzi, M., Scagliotti, G., Soraru, M., Pepe, S., Scaltriti, A., Gebbia, V., Testa, E., Lorusso, V., Bordonaro, R., De Signoribus, G., Tedde, N., Santoro, A., Francini, G., Aondio, G., De Giorgi, U, Cartenì, G, Giannarelli, D, Basso, U, Galli, L, Cortesi, E, Caserta, C, Pignata, S, Sabbatini, R, Bearz, A, Buti, S, Lo Re, G, Berruti, A, Bracarda, S, Cognetti, F, Rastelli, F, Fornarini, G, Porta, C, Turci, D, Sternberg, C, Procopio, G, and Bidoli, P

Subjects
0301 basic medicine, Male, expanded access programme, nivolumab, real-world experience, renal cell cancer, Antineoplastic Agent, 0302 clinical medicine, Antineoplastic Agents, Immunological, 80 and over, Sunitinib, Medicine, Urology, Aged, 80 and over, Sulfonamides, Brain Neoplasms, Kidney Neoplasm, Common Terminology Criteria for Adverse Events, Middle Aged, Kidney Neoplasms, Progression-Free Survival, Survival Rate, Everolimu, Immunological, Response Evaluation Criteria in Solid Tumors, 030220 oncology & carcinogenesis, Retreatment, Female, Nivolumab, medicine.drug, Human, Adult, medicine.medical_specialty, Indazoles, metastatic renal cancer, Response Evaluation Criteria in Solid Tumor, Antineoplastic Agents, Bone Neoplasms, Bone Neoplasm, expanded access programme, nivolumab, real-world experience, renal cell cancer, Adult, Aged, Aged, 80 and over, Antineoplastic Agents, Antineoplastic Agents, Immunological, Bone Neoplasms, Brain Neoplasms, Carcinoma, Renal Cell, Everolimus, Female, Humans, Kidney Neoplasms, Male, Middle Aged, Nivolumab, Progression-Free Survival, Pyrimidines, Response Evaluation Criteria in Solid Tumors, Retreatment, Sulfonamides, Sunitinib, Survival Rate, Sulfonamide, Pazopanib, Brain Neoplasm, 03 medical and health sciences, Aged, Carcinoma, Renal Cell, Everolimus, Humans, Pyrimidines, Internal medicine, Progression-free survival, Survival rate, business.industry, Carcinoma, Renal Cell, 030104 developmental biology, Pyrimidine, Expanded access, business
Abstract

Objective: To report the safety and efficacy results of patients enrolled in the Italian Nivolumab Renal Cell Cancer Expanded Access Programme. Patients and Methods: Patients with metastatic renal cell cancer (mRCC) previously treated with agents targeting the vascular endothelial growth factor pathway were eligible to receive nivolumab 3 mg/kg once every 2 weeks. Patients included in the analysis had received ≥1 dose of nivolumab and were monitored for adverse events (AEs) using Common Terminology Criteria for Adverse Events (CTCAE) v.4.0. Results: A total of 389 patients were enrolled between July 2015 and April 2016, of whom 18% were aged ≥75 years, 6.7% had non-clear cell RCC, 49.6% had bone and 8.2% brain metastases, and 79% had received ≥2 previous lines of therapy. The most common any-grade treatment-related AEs were fatigue (13%) and rash (9%). Twenty-two patients (5.7%) discontinued treatment because of AEs. There were no treatment-related deaths. The objective response rate was 23.1%. At a median follow-up of 12 months, the median progression-free survival was 4.5 months (95% confidence interval 3.7–6.2) and the 12-month overall survival rate was 63%. Similar survival rates were reported among patients with non-clear-cell histology, elderly patients, those with bone and/or brain metastases, and those who had received prior first-line sunitinib or pazopanib, or prior everolimus. Conclusion: The safety and efficacy observed were consistent with those reported in the pivotal Checkmate 025 trial. Results in patients with non-clear-cell mRCC who were elderly, pretreated with everolimus, and had bone and/or brain metastases encourage the use of nivolumab in these categories of patients. © 2018 The Authors BJU International

Published
2019

49. Association of systemic inflammation index and body mass index with survival in patients with renal cell cancer treated with nivolumab

Author

De Giorgi, U, Procopio, G, Giannarelli, D, Sabbatini, R, Bearz, A, Buti, S, Basso, U, Mitterer, M, Ortega, C, Bidoli, P, Ferraù, F, Crinò, L, Frassoldati, A, Marchetti, P, Mini, E, Scoppola, A, Verusio, C, Fornarini, G, Cartenì, G, Caserta, C, Sternberg, C, De Giorgi U, Procopio G, Giannarelli D, Sabbatini R, Bearz A, Buti S, Basso U, Mitterer M, Ortega C, Bidoli P, Ferraù F, Crinò L, Frassoldati A, Marchetti P, Mini E, Scoppola A, Verusio C, Fornarini G, Cartenì G, Caserta C, Sternberg CN., De Giorgi, U, Procopio, G, Giannarelli, D, Sabbatini, R, Bearz, A, Buti, S, Basso, U, Mitterer, M, Ortega, C, Bidoli, P, Ferraù, F, Crinò, L, Frassoldati, A, Marchetti, P, Mini, E, Scoppola, A, Verusio, C, Fornarini, G, Cartenì, G, Caserta, C, Sternberg, C, De Giorgi U, Procopio G, Giannarelli D, Sabbatini R, Bearz A, Buti S, Basso U, Mitterer M, Ortega C, Bidoli P, Ferraù F, Crinò L, Frassoldati A, Marchetti P, Mini E, Scoppola A, Verusio C, Fornarini G, Cartenì G, Caserta C, and Sternberg CN.

Abstract

Purpose: Inflammation indexes and body mass index (BMI) are easily evaluated, predict survival, and are potentially modifiable. We evaluated the potential association of inflammatory indexes and BMI with the clinical outcome of patients with renal cell carcinoma (RCC) undergoing immune checkpoint inhibitor therapy. Experimental Design: A prospective cohort of patients with metastatic RCC treated with nivolumab enrolled in the Italian Expanded Access Program from July 2015 through April 2016 was examined. Reference measures of inflammation were identified for neutrophil-to-lymphocyte ratio (NLR)

Published
2019

50. 1901P Specific dynamic changes of peripheral blood immune profile (PBIP) associate with clinical response to nivolumab (NIVO) in patients (pts) with metastatic renal cell carcinoma (mRCC): The I-RENE trial (meet-URO 8)

Author

Verzoni, E., Procopio, G., Bottiglieri, A., Stellato, M., Rametta, A., Zucali, P.A., Perrucci, B., G. fornarini, Buti, S., Maruzzo, M., Cova, A., Squarcina, P., Lalli, L., Mereu, A., Cerioli, N., Agnelli, L., Todoerti, K., Busico, A., Rivoltini, L., and Huber, V.

Published
2023
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