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3. Identification of population-informative markers from high-density genotyping data through combined feature selection and machine learning algorithms: Application to European autochthonous and cosmopolitan pig breeds

Author

Università di Bologna, European Commission, CSIC - Instituto Nacional de Investigación y Tecnología Agraria y Alimentaria (INIA), Schiavo, Giuseppina [0000-0002-3497-1337], Bertolini, F. [0000-0003-4181-3895], Bovo, Samuele [0000-0002-5712-8211], Galimberti, Giuliano [0000-0002-9161-9671], Bozzi, Riccardo [0000-0001-8854-0834], Čandek-Potokar, M. [0000-0003-0231-126X], Óvilo Martín, Cristina [0000-0002-5738-8435], Fontanesi, Luca [0000-0001-7050-3760], Schiavo, Giuseppina, Bertolini, F., Bovo, Samuele, Galimberti, Giuliano, Muñoz, María, Bozzi, Riccardo, Čandek-Potokar, M., Óvilo Martín, Cristina, Fontanesi, Luca, Università di Bologna, European Commission, CSIC - Instituto Nacional de Investigación y Tecnología Agraria y Alimentaria (INIA), Schiavo, Giuseppina [0000-0002-3497-1337], Bertolini, F. [0000-0003-4181-3895], Bovo, Samuele [0000-0002-5712-8211], Galimberti, Giuliano [0000-0002-9161-9671], Bozzi, Riccardo [0000-0001-8854-0834], Čandek-Potokar, M. [0000-0003-0231-126X], Óvilo Martín, Cristina [0000-0002-5738-8435], Fontanesi, Luca [0000-0001-7050-3760], Schiavo, Giuseppina, Bertolini, F., Bovo, Samuele, Galimberti, Giuliano, Muñoz, María, Bozzi, Riccardo, Čandek-Potokar, M., Óvilo Martín, Cristina, and Fontanesi, Luca

Abstract

Large genotyping datasets, obtained from high-density single nucleotide polymorphism (SNP) arrays, developed for different livestock species, can be used to describe and differentiate breeds or populations. To identify the most discriminating genetic markers among thousands of genotyped SNPs, a few statistical approaches have been proposed. In this study, we applied the Boruta algorithm, a wrapper of the machine learning random forest algorithm, on a database of 23 European pig breeds (20 autochthonous and three cosmopolitan breeds) genotyped with a 70k SNP chip, to pre-select informative SNPs. To identify different sets of SNPs, these pre-selected markers were then ranked with random forest based on their mean decrease accuracy and mean decrease gene indexes. We evaluated the efficiency of these subsets for breed classification and the usefulness of this approach to detect candidate genes affecting breed-specific phenotypes and relevant production traits that might differ among breeds. The lowest overall classification error (2.3%) was reached with a subpanel including only 398 SNPs (ranked based on their mean decrease accuracy), with no classification error in seven breeds using up to 49 SNPs. Several SNPs of these selected subpanels were in genomic regions in which previous studies had identified signatures of selection or genes associated with morphological or production traits that distinguish the analysed breeds. Therefore, even if these approaches have not been originally designed to identify signatures of selection, the obtained results showed that they could potentially be useful for this purpose.

Published
2024

5. Sirt1 in focus: unveiling molecular insights and therapeutic prospects in calcific aortic stenosis with sglt2i inhibitors

Author

Valerio, V, primary, Massaiu, I, additional, Franchi, M, additional, Bonomi, A, additional, Pellegrini, G, additional, Moschetta, D, additional, Trombara, F, additional, Rusconi, V, additional, Bertolini, F, additional, Myasoedova, V A, additional, Marenzi, G, additional, Corrao, G, additional, Genovese, S, additional, and Poggio, P, additional

Published
2024
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6. Real-world outcomes of Italian patients with advanced non-squamous lung cancer treated with first-line pembrolizumab plus platinum-pemetrexed

Author

Leonetti, A, Perrone, F, Puntoni, M, Maglietta, G, Bordi, P, Bria, E, Vita, E, Gelsomino, F, De Giglio, A, Gelibter, A, Siringo, M, Mazzoni, F, Caliman, E, Genova, C, Bertolini, F, Guaitoli, G, Passiglia, F, Delcuratolo, M, Montrone, M, Cerea, G, Pasello, G, Roca, E, Belluomini, L, Cecere, F, Guida, A, Manzo, A, Adamo, V, Rastelli, F, Bulotta, A, Citarella, F, Toschi, L, Zoratto, F, Cortinovis, D, Berardi, R, Follador, A, Carta, A, Camerini, A, Salerno, F, Silva, R, Baldini, E, Cortellini, A, Brighenti, M, Santoni, M, Malorgio, F, Caminiti, C, Tiseo, M, Leonetti, Alessandro, Perrone, Fabiana, Puntoni, Matteo, Maglietta, Giuseppe, Bordi, Paola, Bria, Emilio, Vita, Emanuele, Gelsomino, Francesco, De Giglio, Andrea, Gelibter, Alain, Siringo, Marco, Mazzoni, Francesca, Caliman, Enrico, Genova, Carlo, Bertolini, Federica, Guaitoli, Giorgia, Passiglia, Francesco, Delcuratolo, Marco Donatello, Montrone, Michele, Cerea, Giulio, Pasello, Giulia, Roca, Elisa, Belluomini, Lorenzo, Cecere, Fabiana Letizia, Guida, Annalisa, Manzo, Anna, Adamo, Vincenzo, Rastelli, Francesca, Bulotta, Alessandra, Citarella, Fabrizio, Toschi, Luca, Zoratto, Federica, Cortinovis, Diego Luigi, Berardi, Rossana, Follador, Alessandro, Carta, Annamaria, Camerini, Andrea, Salerno, Flavio, Silva, Rosa Rita, Baldini, Editta, Cortellini, Alessio, Brighenti, Matteo, Santoni, Matteo, Malorgio, Francesco, Caminiti, Caterina, Tiseo, Marcello, Leonetti, A, Perrone, F, Puntoni, M, Maglietta, G, Bordi, P, Bria, E, Vita, E, Gelsomino, F, De Giglio, A, Gelibter, A, Siringo, M, Mazzoni, F, Caliman, E, Genova, C, Bertolini, F, Guaitoli, G, Passiglia, F, Delcuratolo, M, Montrone, M, Cerea, G, Pasello, G, Roca, E, Belluomini, L, Cecere, F, Guida, A, Manzo, A, Adamo, V, Rastelli, F, Bulotta, A, Citarella, F, Toschi, L, Zoratto, F, Cortinovis, D, Berardi, R, Follador, A, Carta, A, Camerini, A, Salerno, F, Silva, R, Baldini, E, Cortellini, A, Brighenti, M, Santoni, M, Malorgio, F, Caminiti, C, Tiseo, M, Leonetti, Alessandro, Perrone, Fabiana, Puntoni, Matteo, Maglietta, Giuseppe, Bordi, Paola, Bria, Emilio, Vita, Emanuele, Gelsomino, Francesco, De Giglio, Andrea, Gelibter, Alain, Siringo, Marco, Mazzoni, Francesca, Caliman, Enrico, Genova, Carlo, Bertolini, Federica, Guaitoli, Giorgia, Passiglia, Francesco, Delcuratolo, Marco Donatello, Montrone, Michele, Cerea, Giulio, Pasello, Giulia, Roca, Elisa, Belluomini, Lorenzo, Cecere, Fabiana Letizia, Guida, Annalisa, Manzo, Anna, Adamo, Vincenzo, Rastelli, Francesca, Bulotta, Alessandra, Citarella, Fabrizio, Toschi, Luca, Zoratto, Federica, Cortinovis, Diego Luigi, Berardi, Rossana, Follador, Alessandro, Carta, Annamaria, Camerini, Andrea, Salerno, Flavio, Silva, Rosa Rita, Baldini, Editta, Cortellini, Alessio, Brighenti, Matteo, Santoni, Matteo, Malorgio, Francesco, Caminiti, Caterina, and Tiseo, Marcello

Abstract

Purpose: The aim of this multi-center, retrospective/prospective cohort observational study was to evaluate outcomes in routine clinical practice of first-line chemo-immunotherapy with cis/carboplatin, pemetrexed and pembrolizumab in patients with advanced non-squamous non-small cell lung cancer (NSCLC) in 33 Italian centers. Methods: The outcome measure was to evaluate overall survival (OS) in a real-world patient population. Secondary endpoints were: progression-free survival (PFS), objective response rate (ORR), duration of response (DoR) and incidence of treatment-related adverse events (AEs). Results: 1068 patients were enrolled at the time of data cut-off (January 31st, 2023), and 812 (76.0%) belonged to the retrospective cohort. Median age was 66 years (27−85), ECOG PS was ≥ 2 in 91 (8.6%) patients; 254 (23.8%) patients had brain metastases at baseline; 38 (3.6%) patients had tumor with PD-L1 expression ≥ 50%. After a median follow-up of 17.0 months (95% CI, 16.1–17.9), median OS was 16.1 months (95% CI, 14.4–18.8) and PFS was 9.9 months (95% CI, 8.8–11.2). Median DoR (n = 493) was 14.7 months (95% CI, 13.6–17.1). ORR was 43.4% (95% CI, 40.4–46.4). Any-grade AEs occurred in 636 (59.6%) patients and grade ≥ 3 in 253 (23.7%) patients. Most common grade ≥ 3 AEs were neutropenia (6.3%) and anemia (6.3%). Conclusions: First-line chemo-immunotherapy was effective and tolerable in this large, real-world Italian study of patients with advanced non-squamous NSCLC. Our results were in line with the KEYNOTE-189 registration study, also considering the low number of PD-L1 ≥ 50% patients included in our study.

Published
2024

7. Clinical trajectories of individuals with severe mental illness continuing and discontinuing long-acting antipsychotics: a one-year mirror-image analysis from the STAR Network Depot study

Author

Ostuzzi, G, Tedeschi, F, Bertolini, F, Cotugno, C, Aguglia, A, Bartoli, F, Carrà, G, D’Agostino, A, Martinotti, G, Barbui, C, Gastaldon, C, Papola, D, Ostuzzi G., Tedeschi F., Bertolini F., Cotugno C., Aguglia A., Bartoli F., Carrà G., D’Agostino A., Martinotti G., Barbui C., Gastaldon C., Papola D., Ostuzzi, G, Tedeschi, F, Bertolini, F, Cotugno, C, Aguglia, A, Bartoli, F, Carrà, G, D’Agostino, A, Martinotti, G, Barbui, C, Gastaldon, C, Papola, D, Ostuzzi G., Tedeschi F., Bertolini F., Cotugno C., Aguglia A., Bartoli F., Carrà G., D’Agostino A., Martinotti G., Barbui C., Gastaldon C., and Papola D.

Abstract

Evidence on long-acting antipsychotics (LAIs) in unselected populations with severe mental illness is scant. In this mirror-image study, we compared multiple clinical outcomes 1 year before and after a first LAI prescription in adults with severe mental illness, describing clinical trajectories of LAI continuers and discontinuers. We compared LAI continuers and discontinuers through Mann–Whitney U test, Kaplan–Meier survival curves, regression for interval-censored data, and a maximum-likelihood mixed-model with individual random-effect and time as predictor. Of the 261 participants analyzed, 71.3% had schizophrenia-spectrum disorders, and 29.5% discontinued the LAI before 1 year. At baseline, LAI discontinuers had a shorter illness duration, lower attitude and adherence scores. The mirror-image analysis showed reduced hospital admissions only for LAI continuers. Over time, continuers spent less days hospitalized, but had more adverse events and more antipsychotics prescribed, with higher overall doses. In conclusion, this study shows that LAIs might be beneficial in unselected patient populations, provided that adherence is maintained. LAI continuers spent less time hospitalized, but received more antipsychotics and suffered from more cumulative adverse events over time. Therefore, the choice of initiating and maintaining a LAI should be carefully weighed on a case-by-case basis.

Published
2023

8. 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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9. The evolving story of catadromy in the European eel (Anguilla anguilla)

Author

Durif, C M F, primary, Arts, M, additional, Bertolini, F, additional, Cresci, A, additional, Daverat, F, additional, Karlsbakk, E, additional, Koprivnikar, J, additional, Moland, E, additional, Olsen, E M, additional, Parzanini, C, additional, Power, M, additional, Rohtla, M, additional, Skiftesvik, A B, additional, Thorstad, E, additional, Vøllestad, L A, additional, and Browman, H I, additional

Published
2023
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10. Immune-Checkpoint-Inhibitor-Related Lung Toxicity: A Multicentre Real-Life Retrospective Portrait from Six Italian Centres

Author

Cameli, P, Faverio, P, Ferrari, K, Bonti, V, Marsili, S, Mazzei, M, Mazzoni, F, Bartolucci, M, Scotti, V, Bertolini, F, Barbieri, F, Baldessari, C, Veronese, C, Boffi, R, Brighenti, M, Cortinovis, D, Dominici, M, Pesci, A, Bargagli, E, Luppi, F, Cameli P., Faverio P., Ferrari K., Bonti V., Marsili S., Mazzei M. A., Mazzoni F., Bartolucci M., Scotti V., Bertolini F., Barbieri F., Baldessari C., Veronese C., Boffi R., Brighenti M., Cortinovis D., Dominici M., Pesci A., Bargagli E., Luppi F., Cameli, P, Faverio, P, Ferrari, K, Bonti, V, Marsili, S, Mazzei, M, Mazzoni, F, Bartolucci, M, Scotti, V, Bertolini, F, Barbieri, F, Baldessari, C, Veronese, C, Boffi, R, Brighenti, M, Cortinovis, D, Dominici, M, Pesci, A, Bargagli, E, Luppi, F, Cameli P., Faverio P., Ferrari K., Bonti V., Marsili S., Mazzei M. A., Mazzoni F., Bartolucci M., Scotti V., Bertolini F., Barbieri F., Baldessari C., Veronese C., Boffi R., Brighenti M., Cortinovis D., Dominici M., Pesci A., Bargagli E., and Luppi F.

Abstract

Background: Immune checkpoint inhibitors (ICIs) have revolutionized the therapeutic horizons of various cancers. However, immune-related adverse events have been reported, including interstitial lung diseases. Our aim was to describe the clinical and radiological features and survival of a multicentre cohort of patients who developed ICI-related lung toxicity. Methods: Six Italian centres were involved in the study. Patients who were treated with anti-PD-1/PD-L1 and CTLA-4 mAbs and developed ICI-related lung toxicity were recruited retrospectively to study clinical, radiological, immunological and survival data. Results: A total of 41 patients (25 males, 66.8 ± 9.9 years) were enrolled. Lung toxicity occurred after 204.3 ± 208.3 days of therapy, with ground glass opacities being the most common HRCT pattern (23 cases). Male sex, lung cancer and acute respiratory failure were associated with a shorter latency of toxicity (p = 0.0030, p = 0.0245 and p = 0.0390, respectively). Patients who required high-flow oxygen therapy showed significantly worse survival (p = 0.0028). Conclusions: Our cohort showed heterogeneous clinical and radiological aspects of ICI-related lung toxicity, with a latency not limited to the first year of treatment. Severity was mainly mild to moderate, although life-threatening events did occur. Our data indicate that strict long-term follow-up is needed to enable early diagnosis and appropriate management.

Published
2022

11. Comparing 1-year effectiveness and acceptability of once-monthly paliperidone palmitate and aripiprazole monohydrate for schizophrenia spectrum disorders: Findings from the STAR Network Depot Study

Author

Bartoli, F, Cavaleri, D, Callovini, T, Riboldi, I, Crocamo, C, D'Agostino, A, Martinotti, G, Bertolini, F, Ostuzzi, G, Barbui, C, Carra, G, Bartoli F., Cavaleri D., Callovini T., Riboldi I., Crocamo C., D'Agostino A., Martinotti G., Bertolini F., Ostuzzi G., Barbui C., Carra G., Bartoli, F, Cavaleri, D, Callovini, T, Riboldi, I, Crocamo, C, D'Agostino, A, Martinotti, G, Bertolini, F, Ostuzzi, G, Barbui, C, Carra, G, Bartoli F., Cavaleri D., Callovini T., Riboldi I., Crocamo C., D'Agostino A., Martinotti G., Bertolini F., Ostuzzi G., Barbui C., and Carra G.

Abstract

In this prospective study, we assessed the effectiveness and acceptability of paliperidone palmitate 1-month (PP1M) and aripiprazole monohydrate (AM) over 1-year follow-up. We included 195 subjects (117 treated with PP1M and 78 with AM) with schizophrenia spectrum disorders from real-world settings. We estimated no differences in hospitalization (Odds Ratio=1.59; p = 0.12), symptoms improvement (p = 0.90 adjusted for baseline severity), and discontinuation (Hazard Ratio=0.72; p = 0.20) at study endpoint. Although current evidence suggests the possible superiority of AM over PP1M, our findings showed comparable effectiveness between these drugs. Additional studies in real-world settings with direct comparisons between these two LAIs are needed.

Published
2022

12. Evaluating the impact of chemotherapy-induced nausea and vomiting on daily functioning in patients receiving dexamethasone-sparing antiemetic regimens with NEPA (netupitant/palonosetron) in the cisplatin setting: results from a randomized phase 3 study

Author

Celio, L, Cortinovis, D, Cogoni, A, Cavanna, L, Martelli, O, Carnio, S, Collovà, E, Bertolini, F, Petrelli, F, Cassano, A, Chiari, R, Zanelli, F, Pisconti, S, Vittimberga, I, Letizia, A, Misino, A, Gernone, A, Bonizzoni, E, Pilotto, S, De Placido, S, Bria, E, Celio L, Cortinovis D, Cogoni AA, Cavanna L, Martelli O, Carnio S, Collovà E, Bertolini F, Petrelli F, Cassano A, Chiari R, Zanelli F, Pisconti S, Vittimberga I, Letizia A, Misino A, Gernone A, Bonizzoni E, Pilotto S, De Placido S, Bria E, Celio, L, Cortinovis, D, Cogoni, A, Cavanna, L, Martelli, O, Carnio, S, Collovà, E, Bertolini, F, Petrelli, F, Cassano, A, Chiari, R, Zanelli, F, Pisconti, S, Vittimberga, I, Letizia, A, Misino, A, Gernone, A, Bonizzoni, E, Pilotto, S, De Placido, S, Bria, E, Celio L, Cortinovis D, Cogoni AA, Cavanna L, Martelli O, Carnio S, Collovà E, Bertolini F, Petrelli F, Cassano A, Chiari R, Zanelli F, Pisconti S, Vittimberga I, Letizia A, Misino A, Gernone A, Bonizzoni E, Pilotto S, De Placido S, and Bria E

Abstract

Background: The non-inferiority of dexamethasone (DEX) on day 1, with or without low-dose DEX on days 2 and 3, combined with oral NEPA (netupitant/palonosetron), compared with the guideline-consistent use of DEX was demonstrated in cisplatin. Here, we complete the analysis by assessing the impact of emesis on daily lives of patients receiving DEX-sparing regimens using the Functional Living Index-Emesis (FLIE). Methods: Chemotherapy-naïve patients undergoing cisplatin (≥70 mg/m2), were given NEPA and DEX (12 mg) on day 1 and randomized to receive either 1) no further DEX (DEX1), 2) oral DEX (4 mg daily) on days 2–3 (DEX3), or 3) DEX (4 mg twice daily) on days 2–4 (DEX4; control). Patients completed the FLIE questionnaire on day 6 of cycle 1. Endpoints included the FLIE nausea domain, vomiting domain, and overall combined domain scores, as well as the proportion of patients with no impact on daily life (NIDL; overall score > 108). This was a protocol-planned analysis. Results: In the DEX1 group, no significant differences were observed in the FLIE nausea score (48.9 [±1.8; SE] vs. 53.7 [±1.5]), vomiting score (56.6 [±1.4] vs. 58.7 [±0.8]) and overall score (105.6 [±2.8] vs.112.4 [±1.9]) versus DEX4 control; similar results were observed in the DEX3 group for nausea score (49.6 [±1.7]), vomiting score (58.2 [±1]) and overall score (107.8 [±2.4]) versus control. There were no significant between-group differences in the proportion of patients reporting NIDL. Conclusion: Reducing DEX, when administered with NEPA, does not seem to adversely impact the daily functioning in patients undergoing cisplatin. Trial registration: ClinicalTrials.govNCT04201769. Registration date: 17/12/2019 - Retrospectively registered.

Published
2022

13. 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

14. Hematological disorders after salvage PARPi treatment for ovarian cancer: Cytogenetic and molecular defects and clinical outcomes

Author

Todisco, E, Gigli, F, Ronchini, C, Amato, V, Sammassimo, S, Pastano, R, Parma, G, Lapresa, M, Bertolini, F, Corsini, C, Gregato, G, Poletti, C, Pelicci, P, Alcalay, M, Colombo, N, Tarella, C, Todisco E., Gigli F., Ronchini C., Amato V., Sammassimo S., Pastano R., Parma G., Lapresa M. T., Bertolini F., Corsini C., Gregato G., Poletti C., Pelicci P. G., Alcalay M., Colombo N., Tarella C., Todisco, E, Gigli, F, Ronchini, C, Amato, V, Sammassimo, S, Pastano, R, Parma, G, Lapresa, M, Bertolini, F, Corsini, C, Gregato, G, Poletti, C, Pelicci, P, Alcalay, M, Colombo, N, Tarella, C, Todisco E., Gigli F., Ronchini C., Amato V., Sammassimo S., Pastano R., Parma G., Lapresa M. T., Bertolini F., Corsini C., Gregato G., Poletti C., Pelicci P. G., Alcalay M., Colombo N., and Tarella C.

Abstract

Inhibitors of poly(ADP-ribose) polymerase (PARPi) are increasingly employed as salvage therapy in epithelial ovarian cancer (EOC), but cytotoxic drug exposure along with PARP inhibition may favor development of hematological disorders. In our study, of 182 women with EOC treated with PARPi, 16 (8.7%) developed therapy-related myeloid neoplasms (t-MNs), with 12 cases of myelodysplasia and 4 of acute myeloid leukemia. All experienced persistent cytopenia after PARPi discontinuation. Seven patients had del(5q)/−5 and/or del(7q)/−7, nine had a complex karyotype and TP53 mutations, recently reported as risk factor for t-MNs in EOC post-PARPi, were found in 12 out of 13 tested patients. Four patients had a rapid and fatal outcome, one had stable disease, eleven underwent induction therapy, followed by allogeneic hematopoietic cell transplantation in seven. Three of these 11 patients experienced refractory disease, and 8 had complete remission. During a 6.8 months (range 2.3-49) median observation time, 3 out of 16 patients were alive, with one surviving patient free of both solid and hematological tumors. Ten patients died because of leukemia, two because of transplant-related events, one from heart failure. Five more patients experienced persistent cell blood count abnormalities following PARPi discontinuation, without reaching MDS diagnostic criteria. A customized Myelo-panel showed clonal hematopoiesis in all five patients. These findings confirm the actual risk of t-MNs in EOC patients after chemotherapy and prolonged PARPi therapy. The management of these patients is complex and outcomes are extremely poor. Careful diagnostic procedures are strongly recommended whenever unusual cytopenias develop in patients receiving PARPi therapy.

Published
2022

15. Innovative treatments for severe refractory asthma: how to choose the right option for the right patient?

Author

Menzella F, Galeone C, Bertolini F, Castagnetti C, and Facciolongo N

Subjects
severe asthma, phenotypes, monoclonal antibodies, IL-5, bronchial thermoplasty, biomarkers, Immunologic diseases. Allergy, RC581-607
Abstract

Francesco Menzella,1 Carla Galeone,1 Francesca Bertolini,2 Claudia Castagnetti,1 Nicola Facciolongo1 1Department of Medical Specialties, Pneumology Unit, IRCCS- Arcispedale Santa Maria Nuova, Reggio Emilia, Italy; 2Department of Animal Science, Iowa State University, Ames, IA, USA Abstract: The increasing understanding of the molecular biology and the etiopathogenetic mechanisms of asthma helps in identification of numerous phenotypes and endotypes, particularly for severe refractory asthma. For a decade, the only available biologic therapy that met the unmet needs of a specific group of patients with severe uncontrolled allergic asthma has been omalizumab. Recently, new biologic therapies with different mechanisms of action and targets have been approved for marketing, such as mepolizumab. Other promising drugs will be available in the coming years, such as reslizumab, benralizumab, dupilumab and lebrikizumab. Moreover, since 2010, bronchial thermoplasty has been successfully introduced for a limited number of patients. This is a nonpharmacologic endoscopic procedure which is considered a promising therapy, even though several aspects still need to be clarified. Despite the increasing availability of new therapies, one of the major problems of each treatment is still the identification of the most suitable patients. This sudden abundance of therapeutic options, sometimes partially overlapping with each other, increases the importance to identify new biomarkers useful to guide the clinician in selecting the most appropriate patients and treatments, without forgetting the drug-economic aspects seen in elevated direct cost of new therapies. The aim of this review is, therefore, to update the clinician on the state of the art of therapies available for refractory asthma and, above all, to give useful directions that will help understand the different choices that sometimes partially overlap and to dispel the possible doubts that still exist. Keywords: severe asthma, phenotypes, monoclonal antibodies, IL-5, bronchial thermoplasty, biomarkers

Published
2017

16. Immunotherapy: ANTI-GD2 CAR T CELLS AGAINST SMALL CELL LUNG CANCER

Author

Neri, G., primary, Chiavelli, C., additional, Trudu, L., additional, Prapa, M., additional, Golinelli, G., additional, Pugliese, G., additional, Silingardi, M., additional, Rovesti, G., additional, Grisendi, G., additional, Bestagno, M., additional, Spano, C., additional, Benati, D., additional, Recchia, A., additional, Masciale, V., additional, Bertolini, F., additional, and Dominici, M., additional

Published
2023
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17. The evolving story of catadromy in the European eel (Anguilla anguilla)

Author

Durif, C. M. F., Arts, M., Bertolini, F., Cresci, A., Daverat, F., Karlsbakk, E., Koprivnikar, J., Moland, E., Olsen, E. M., Power, M., Parzanini, C., Rohtla, M., Skiftesvik, A. B., Thorstad, E., Vollestad, L. A., Browman, H., Durif, C. M. F., Arts, M., Bertolini, F., Cresci, A., Daverat, F., Karlsbakk, E., Koprivnikar, J., Moland, E., Olsen, E. M., Power, M., Parzanini, C., Rohtla, M., Skiftesvik, A. B., Thorstad, E., Vollestad, L. A., and Browman, H.

Abstract

Anguillid eels were once considered to be the classic example of catadromy. However, alternative life cycles have been reported, including skipping the freshwater phase and habitat shifting between fresh, brackish, and saltwater throughout the growth phase. There is a lack of knowledge regarding these alternate life strategies, for example, the proportion of individuals in the population that adopt them compared to classic catadromy. We provide a description of these alternate life cycle strategies in temperate anguillids, their possible drivers, and the methods available to investigate them. These methods (lethal and non-lethal), include otolith microchemistry, fatty acid and stable isotope analyses, parasite identification, blood transcriptomics, and electronic tags. We argue that since the current management framework for the European eel and other temperate eels is based mainly on the freshwater component of the population, it ignores eels growing in saline waters. Many of the factors that are thought to be responsible for the precipitous decline of the eel population are more prevalent in freshwater systems. Therefore, the contribution of saline eels may be more important than currently estimated. The habitat-shifting ability of eels may be all the more crucial for the persistence and recovery of those species that are endangered.

Published
2023

18. Dexamethasone-Sparing Regimens with Oral Netupitant and Palonosetron for the Prevention of Emesis Caused by High-Dose Cisplatin: A Randomized Noninferiority Study

Author

Celio, L, Cortinovis, D, Cogoni, A, Cavanna, L, Martelli, O, Carnio, S, Collovà, E, Bertolini, F, Petrelli, F, Cassano, A, Chiari, R, Zanelli, F, Pisconti, S, Vittimberga, I, Letizia, A, Misino, A, Gernone, A, Bonizzoni, E, Pilotto, S, De Placido, S, Bria, E, Celio L, Cortinovis D, Cogoni AA, Cavanna L, Martelli O, Carnio S, Collovà E, Bertolini F, Petrelli F, Cassano A, Chiari R, Zanelli F, Pisconti S, Vittimberga I, Letizia A, Misino A, Gernone A, Bonizzoni E, Pilotto S, De Placido S, Bria E, Celio, L, Cortinovis, D, Cogoni, A, Cavanna, L, Martelli, O, Carnio, S, Collovà, E, Bertolini, F, Petrelli, F, Cassano, A, Chiari, R, Zanelli, F, Pisconti, S, Vittimberga, I, Letizia, A, Misino, A, Gernone, A, Bonizzoni, E, Pilotto, S, De Placido, S, Bria, E, Celio L, Cortinovis D, Cogoni AA, Cavanna L, Martelli O, Carnio S, Collovà E, Bertolini F, Petrelli F, Cassano A, Chiari R, Zanelli F, Pisconti S, Vittimberga I, Letizia A, Misino A, Gernone A, Bonizzoni E, Pilotto S, De Placido S, and Bria E

Abstract

Background: To reduce the overall exposure to dexamethasone (DEX) in patients receiving cisplatin-based chemotherapy, we evaluated the noninferiority of DEX on day 1, with or without low-dose DEX on days 2 and 3, combined with an oral fixed-dose combination of netupitant and palonosetron (NEPA), compared with the guideline-consistent use of 4-day DEX. Patients and Methods: In this open-label, multicenter study, chemotherapy-naïve patients undergoing high-dose cisplatin (≥70 mg/m2), were given NEPA and DEX (12 mg) on day 1 and randomized (1:1:1 ratio) to receive either (a) no further DEX (DEX1), (b) oral DEX (4 mg daily) on days 2–3 (DEX3), or (c) DEX (4 mg twice daily) on days 2–4 (DEX4). The primary efficacy endpoint was complete response (CR: no emesis and no rescue medication) during the 5-day overall phase. The noninferiority margin was set at −15% difference (DEX1 or DEX3 minus DEX4). Secondary efficacy endpoints included complete protection (CP: CR and none or mild nausea). Results: Two-hundred twenty-eight patients, 76 in each arm, were assessable. Noninferiority was met for both DEX-sparing regimens and the reference arm, with overall phase CR rates of 76.3% in each of the DEX1 and DEX3 arms and 75.0% in the DEX4 arm (95% confidence interval, −12.3% to 15% for each comparison). During the overall phase, CP rates were similar between groups. Conclusion: A simplified regimen of NEPA plus single-dose DEX offers comparable chemotherapy-induced nausea and vomiting prevention throughout 5 days post-chemotherapy with the advantage of sparing patients additional doses of DEX in the high–emetic-risk setting of cisplatin-based chemotherapy. Implications for Practice: Dexamethasone (DEX) has traditionally played an integral role in the management of chemotherapy-induced emesis. Although generally considered safe, even short-term DEX use is associated with various side effects, and some evidence suggests that concurrent steroids may reduce the efficacy of immunotherapi

Published
2021

19. Comparing Long-Acting Antipsychotic Discontinuation Rates Under Ordinary Clinical Circumstances: A Survival Analysis from an Observational, Pragmatic Study

Author

Bertolini, F, Ostuzzi, G, Pievani, M, Aguglia, A, Bartoli, F, Bortolaso, P, Callegari, C, Caroleo, M, Carra, G, Corbo, M, D'Agostino, A, De Fazio, P, Magliocco, F, Martinotti, G, Ostinelli, E, Piccinelli, M, Tedeschi, F, Barbui, C, Boschello, F, Gastaldon, C, Mazzi, M, Nose, M, Papola, D, Perini, G, Piccoli, A, Purgato, M, Ruggeri, M, Terlizzi, S, Turrini, G, Raffaele, G, Cavallotti, S, Chirico, M, Ferrato, F, Limosani, I, Mastromo, D, Monzani, E, Porcellana, M, Restaino, F, Annese, P, Bolognesi, S, Cerretini, M, De Capua, A, Debolini, S, Del Zanna, M, Fargnoli, F, Giannini, A, Luccarelli, L, Lucii, C, Pierantozzi, E, Tozzi, F, Bardicchia, F, Cardamone, G, Facchi, E, Magnani, N, Soscia, F, Biancosino, B, Zotos, S, Giacomin, M, Pompei, F, Spano, M, Zonta, F, Buzzi, A, Calzolari, R, Caselli, I, Diurni, M, Giana, E, Ielmini, M, Milano, A, Poloni, N, Sani, E, Zizolfi, D, Alberini, G, Cazzamalli, S, Costantini, C, Di Caro, A, Paronelli, C, Piantanida, S, Alessandro, P, Barbanti, S, D'Ippolito, C, Gozzi, M, Moretti, V, Campese, O, Di Capro, L, di Giannantonio, M, Fiori, F, Lorusso, M, Mancini, V, Viceconte, D, Calandra, C, Luca, M, Signorelli, M, Suraniti, F, Balzarro, B, Boncompagni, G, Caretto, V, Emiliani, R, Lupoli, P, Menchetti, M, Rossi, E, Storbini, V, Tarricone, I, Terzi, L, Boso, M, Catania, C, De Paoli, G, Risaro, P, Aspesi, F, Bava, M, Bono, A, Brambilla, G, Castagna, G, Lucchi, S, Nava, R, Provenzi, M, Tabacchi, T, Tremolada, M, Verrengia, E, Barchiesi, M, Oriani, M, Pacetti, M, Ferro, M, Ghio, L, Beneduce, R, Laffranchini, L, Magni, L, Rossi, G, Tura, G, Addeo, L, Balletta, G, De Vivo, E, Di Benedetto, R, Parise, V, Carpiniello, B, Pinna, F, Pecile, D, Mattei, C, Bonavigo, T, Fabrici, E, Panarello, S, Peresson, G, Vitucci, C, Gardellin, F, Strizzolo, S, Cossetta, E, Fizzotti, C, Moretti, D, Di Gregorio, L, Sozzi, F, Colli, G, La Barbera, D, Laurenzi, S, Bertolini F., Ostuzzi G., Pievani M., Aguglia A., Bartoli F., Bortolaso P., Callegari C., Caroleo M., Carra G., Corbo M., D'Agostino A., De Fazio P., Magliocco F., Martinotti G., Ostinelli E. G., Piccinelli M. P., Tedeschi F., Barbui C., Boschello F., Gastaldon C., Mazzi M. A., Nose M., Papola D., Perini G., Piccoli A., Purgato M., Ruggeri M., Terlizzi S., Turrini G., Raffaele G., Cavallotti S., Chirico M., Ferrato F., Limosani I., Mastromo D., Monzani E., Porcellana M., Restaino F., Annese P. M., Bolognesi S., Cerretini M., De Capua A., Debolini S., Del Zanna M., Fargnoli F., Giannini A., Luccarelli L., Lucii C., Pierantozzi E., Tozzi F., Bardicchia F., Cardamone G., Facchi E., Magnani N., Soscia F., Biancosino B., Zotos S., Giacomin M., Pompei F., Spano M., Zonta F., Buzzi A., Calzolari R., Caselli I., Diurni M., Giana E., Ielmini M., Milano A., Poloni N., Sani E., Zizolfi D., Alberini G., Cazzamalli S., Costantini C., Di Caro A., Paronelli C., Piantanida S., Piccinelli M., Alessandro P., Barbanti S. V., D'Ippolito C., Gozzi M., Moretti V., Campese O., Di Capro L., di Giannantonio M., Fiori F., Lorusso M., Mancini V., Viceconte D., Calandra C., Luca M., Signorelli M. S., Suraniti F., Balzarro B., Boncompagni G., Caretto V., Emiliani R., Lupoli P., Menchetti M., Rossi E., Storbini V., Tarricone I., Terzi L., Boso M., Catania C., De Paoli G., Risaro P., Aspesi F., Bava M., Bono A., Brambilla G., Castagna G., Lucchi S., Nava R., Provenzi M., Tabacchi T., Tremolada M., Verrengia E., Barchiesi M., Oriani M. G., Pacetti M., Ferro M., Ghio L., Beneduce R., Laffranchini L., Magni L. R., Rossi G., Tura G. B., Addeo L., Balletta G., De Vivo E., Di Benedetto R., Parise V. F., Carpiniello B., Pinna F., Pecile D., Mattei C., Bonavigo T., Fabrici E. P., Panarello S., Peresson G., Vitucci C., Gardellin F., Strizzolo S., Cossetta E., Fizzotti C., Moretti D., Di Gregorio L., Sozzi F., Colli G., La Barbera D., Laurenzi S., Bertolini, F, Ostuzzi, G, Pievani, M, Aguglia, A, Bartoli, F, Bortolaso, P, Callegari, C, Caroleo, M, Carra, G, Corbo, M, D'Agostino, A, De Fazio, P, Magliocco, F, Martinotti, G, Ostinelli, E, Piccinelli, M, Tedeschi, F, Barbui, C, Boschello, F, Gastaldon, C, Mazzi, M, Nose, M, Papola, D, Perini, G, Piccoli, A, Purgato, M, Ruggeri, M, Terlizzi, S, Turrini, G, Raffaele, G, Cavallotti, S, Chirico, M, Ferrato, F, Limosani, I, Mastromo, D, Monzani, E, Porcellana, M, Restaino, F, Annese, P, Bolognesi, S, Cerretini, M, De Capua, A, Debolini, S, Del Zanna, M, Fargnoli, F, Giannini, A, Luccarelli, L, Lucii, C, Pierantozzi, E, Tozzi, F, Bardicchia, F, Cardamone, G, Facchi, E, Magnani, N, Soscia, F, Biancosino, B, Zotos, S, Giacomin, M, Pompei, F, Spano, M, Zonta, F, Buzzi, A, Calzolari, R, Caselli, I, Diurni, M, Giana, E, Ielmini, M, Milano, A, Poloni, N, Sani, E, Zizolfi, D, Alberini, G, Cazzamalli, S, Costantini, C, Di Caro, A, Paronelli, C, Piantanida, S, Alessandro, P, Barbanti, S, D'Ippolito, C, Gozzi, M, Moretti, V, Campese, O, Di Capro, L, di Giannantonio, M, Fiori, F, Lorusso, M, Mancini, V, Viceconte, D, Calandra, C, Luca, M, Signorelli, M, Suraniti, F, Balzarro, B, Boncompagni, G, Caretto, V, Emiliani, R, Lupoli, P, Menchetti, M, Rossi, E, Storbini, V, Tarricone, I, Terzi, L, Boso, M, Catania, C, De Paoli, G, Risaro, P, Aspesi, F, Bava, M, Bono, A, Brambilla, G, Castagna, G, Lucchi, S, Nava, R, Provenzi, M, Tabacchi, T, Tremolada, M, Verrengia, E, Barchiesi, M, Oriani, M, Pacetti, M, Ferro, M, Ghio, L, Beneduce, R, Laffranchini, L, Magni, L, Rossi, G, Tura, G, Addeo, L, Balletta, G, De Vivo, E, Di Benedetto, R, Parise, V, Carpiniello, B, Pinna, F, Pecile, D, Mattei, C, Bonavigo, T, Fabrici, E, Panarello, S, Peresson, G, Vitucci, C, Gardellin, F, Strizzolo, S, Cossetta, E, Fizzotti, C, Moretti, D, Di Gregorio, L, Sozzi, F, Colli, G, La Barbera, D, Laurenzi, S, Bertolini F., Ostuzzi G., Pievani M., Aguglia A., Bartoli F., Bortolaso P., Callegari C., Caroleo M., Carra G., Corbo M., D'Agostino A., De Fazio P., Magliocco F., Martinotti G., Ostinelli E. G., Piccinelli M. P., Tedeschi F., Barbui C., Boschello F., Gastaldon C., Mazzi M. A., Nose M., Papola D., Perini G., Piccoli A., Purgato M., Ruggeri M., Terlizzi S., Turrini G., Raffaele G., Cavallotti S., Chirico M., Ferrato F., Limosani I., Mastromo D., Monzani E., Porcellana M., Restaino F., Annese P. M., Bolognesi S., Cerretini M., De Capua A., Debolini S., Del Zanna M., Fargnoli F., Giannini A., Luccarelli L., Lucii C., Pierantozzi E., Tozzi F., Bardicchia F., Cardamone G., Facchi E., Magnani N., Soscia F., Biancosino B., Zotos S., Giacomin M., Pompei F., Spano M., Zonta F., Buzzi A., Calzolari R., Caselli I., Diurni M., Giana E., Ielmini M., Milano A., Poloni N., Sani E., Zizolfi D., Alberini G., Cazzamalli S., Costantini C., Di Caro A., Paronelli C., Piantanida S., Piccinelli M., Alessandro P., Barbanti S. V., D'Ippolito C., Gozzi M., Moretti V., Campese O., Di Capro L., di Giannantonio M., Fiori F., Lorusso M., Mancini V., Viceconte D., Calandra C., Luca M., Signorelli M. S., Suraniti F., Balzarro B., Boncompagni G., Caretto V., Emiliani R., Lupoli P., Menchetti M., Rossi E., Storbini V., Tarricone I., Terzi L., Boso M., Catania C., De Paoli G., Risaro P., Aspesi F., Bava M., Bono A., Brambilla G., Castagna G., Lucchi S., Nava R., Provenzi M., Tabacchi T., Tremolada M., Verrengia E., Barchiesi M., Oriani M. G., Pacetti M., Ferro M., Ghio L., Beneduce R., Laffranchini L., Magni L. R., Rossi G., Tura G. B., Addeo L., Balletta G., De Vivo E., Di Benedetto R., Parise V. F., Carpiniello B., Pinna F., Pecile D., Mattei C., Bonavigo T., Fabrici E. P., Panarello S., Peresson G., Vitucci C., Gardellin F., Strizzolo S., Cossetta E., Fizzotti C., Moretti D., Di Gregorio L., Sozzi F., Colli G., La Barbera D., and Laurenzi S.

Abstract

Background: Recent guidelines suggested a wider use of long-acting injectable antipsychotics (LAI) than previously, but naturalistic data on the consequences of LAI use in terms of discontinuation rates and associated factors are still sparse, making it hard for clinicians to be informed on plausible treatment courses. Objective: Our objective was to assess, under real-world clinical circumstances, LAI discontinuation rates over a period of 12 months after a first prescription, reasons for discontinuation, and associated factors. Methods: The STAR Network ‘Depot Study’ was a naturalistic, multicentre, observational prospective study that enrolled subjects initiating a LAI without restrictions on diagnosis, clinical severity or setting. Participants from 32 Italian centres were assessed at baseline and at 6 and 12 months of follow-up. Psychopathology, drug attitude and treatment adherence were measured using the Brief Psychiatric Rating Scale, the Drug Attitude Inventory and the Kemp scale, respectively. Results: The study followed 394 participants for 12 months. The overall discontinuation rate at 12 months was 39.3% (95% confidence interval [CI] 34.4–44.3), with paliperidone LAI being the least discontinued LAI (33.9%; 95% CI 25.3–43.5) and olanzapine LAI the most discontinued (62.5%; 95% CI 35.4–84.8). The most frequent reason for discontinuation was onset of adverse events (32.9%; 95% CI 25.6–40.9) followed by participant refusal of the medication (20.6%; 95% CI 14.6–27.9). Medication adherence at baseline was negatively associated with discontinuation risk (hazard ratio [HR] 0.853; 95% CI 0.742–0.981; p = 0.026), whereas being prescribed olanzapine LAI was associated with increased discontinuation risk compared with being prescribed paliperidone LAI (HR 2.156; 95% CI 1.003–4.634; p = 0.049). Conclusions: Clinicians should be aware that LAI discontinuation is a frequent occurrence. LAI choice should be carefully discussed with the patient, tak

Published
2021

20. Clinical presentation, diagnosis and management of therapy-related hematological disorders in women with epithelial ovarian cancer treated with chemotherapy and poly-ADP-ribose polymerase inhibitors: A single-center experience

Author

Todisco, E, Gigli, F, Mantiero, M, Sammassimo, S, Pastano, R, Ronchini, C, Parma, G, Lapresa, M, Iori, A, Bertolini, F, Corsini, C, Gregato, G, Poletti, C, Colombo, N, Tarella, C, Todisco E., Gigli F., Mantiero M., Sammassimo S., Pastano R., Ronchini C., Parma G., Lapresa M. T., Iori A. P., Bertolini F., Corsini C., Gregato G., Poletti C., Colombo N., Tarella C., Todisco, E, Gigli, F, Mantiero, M, Sammassimo, S, Pastano, R, Ronchini, C, Parma, G, Lapresa, M, Iori, A, Bertolini, F, Corsini, C, Gregato, G, Poletti, C, Colombo, N, Tarella, C, Todisco E., Gigli F., Mantiero M., Sammassimo S., Pastano R., Ronchini C., Parma G., Lapresa M. T., Iori A. P., Bertolini F., Corsini C., Gregato G., Poletti C., Colombo N., and Tarella C.

Abstract

We investigated the occurrence and management of therapy-related hematological disorders (tr-HDs) in women with epithelial ovarian cancer (EOC) exposed to poly-ADP-ribose polymerase inhibitors (PARPi), after previous chemotherapy. We analyzed 130 consecutive EOC patients treated with PARPi at the European Institute of Oncology, Milan. In line with the literature, overall survival of the entire population was 37% at 5.5 years (89% were advanced stages). Cell blood counts were collected prior to start PARPi, at each new cycle and at monthly intervals. Patients displaying persistent and/or marked hematological abnormalities underwent bone marrow evaluation, with cytogenetic and molecular analysis. Nine patients (6,9%) developed tr-HDs, after a median 22.8 months of PARPi exposure. Two patients died early and could not be treated. Two patients have no indication for active treatment and are presently under close hematological monitoring. Five patients underwent chemotherapy followed, in three cases, by allogeneic hematopoietic transplantation: three patients are in complete remission of their hematological and gynecological malignancies at 13, 19, and 25 months; the remaining two patients died due to progression of their hematological disease. We show the potential risk of hematological disorders in EOC patients treated with chemotherapy and prolonged PARPi therapy. In our series, tr-HDs incidence was higher compared to recent reports in large series. Our observations suggest careful monitoring in order to conclusively define, on large series and prolonged follow-up, the actual risk of tr-HDs in patients under PARPi. Notably, prompt diagnosis of hematological abnormalities and appropriate management allow achievement of remission from severe hematological complications, at least in most patients.

Published
2021

24. Comparing Long-Acting Antipsychotic Discontinuation Rates Under Ordinary Clinical Circumstances: A Survival Analysis from an Observational, Pragmatic Study

Author

Bertolini, F., Ostuzzi, G., Pievani, M., Aguglia, A., Bartoli, F., Bortolaso, P., Callegari, C., Caroleo, M., Carra, G., Corbo, M., D'Agostino, A., De Fazio, P., Magliocco, F., Martinotti, G., Ostinelli, E. G., Piccinelli, M. P., Tedeschi, F., Barbui, C., Boschello, F., Gastaldon, C., Mazzi, M. A., Nose, M., Papola, D., Perini, G., Piccoli, A., Purgato, M., Ruggeri, M., Terlizzi, S., Turrini, G., Raffaele, G., Cavallotti, S., Chirico, M., Ferrato, F., Limosani, I., Mastromo, D., Monzani, E., Porcellana, M., Restaino, F., Annese, P. M., Bolognesi, S., Cerretini, M., De Capua, A., Debolini, S., Del Zanna, M., Fargnoli, F., Giannini, A., Luccarelli, L., Lucii, C., Pierantozzi, E., Tozzi, F., Bardicchia, F., Cardamone, G., Facchi, E., Magnani, N., Soscia, F., Biancosino, B., Zotos, S., Giacomin, M., Pompei, F., Spano, M., Zonta, F., Buzzi, A., Callegred, C., Calzolari, R., Caselli, I., Diurni, M., Giana, E., Ielmini, M., Milano, A., Poloni, N., Sani, E., Zizolfi, D., Alberini, G., Cazzamalli, S., Costantini, C., Di Caro, A., Paronelli, C., Piantanida, S., Piccinelli, M., Alessandro, P., Barbanti, S. V., D'Ippolito, C., Gozzi, M., Moretti, V., Campese, O., Di Capro, L., di Giannantonio, M., Fiori, F., Lorusso, M., Mancini, V., Viceconte, D., Calandra, C., Luca, M., Signorelli, M. S., Suraniti, F., Balzarro, B., Boncompagni, G., Caretto, V., Emiliani, R., Lupoli, P., Menchetti, M., Rossi, E., Storbini, V., Tarricone, I., Terzi, L., Boso, M., Catania, C., De Paoli, G., Risaro, P., Aspesi, F., Bava, M., Bono, A., Brambilla, G., Castagna, G., Lucchi, S., Nava, R., Provenzi, M., Tabacchi, T., Tremolada, M., Verrengia, E., Barchiesi, M., Oriani, M. G., Pacetti, M., Ferro, M., Ghio, L., Beneduce, R., Laffranchini, L., Magni, L. R., Rossi, G., Tura, G. B., Addeo, L., Balletta, G., De Vivo, E., Di Benedetto, R., Parise, V. F., Carpiniello, B., Pinna, F., Pecile, D., Mattei, C., Bonavigo, T., Fabrici, E. P., Panarello, S., Peresson, G., Vitucci, C., Gardellin, F., Strizzolo, S., Cossetta, E., Fizzotti, C., Moretti, D., Di Gregorio, L., Sozzi, F., Colli, G., La Barbera, D., Laurenzi, S., Bertolini, F, Ostuzzi, G, Pievani, M, Aguglia, A, Bartoli, F, Bortolaso, P, Callegari, C, Caroleo, M, Carra, G, Corbo, M, D'Agostino, A, De Fazio, P, Magliocco, F, Martinotti, G, Ostinelli, E, Piccinelli, M, Tedeschi, F, Barbui, C, Boschello, F, Gastaldon, C, Mazzi, M, Nose, M, Papola, D, Perini, G, Piccoli, A, Purgato, M, Ruggeri, M, Terlizzi, S, Turrini, G, Raffaele, G, Cavallotti, S, Chirico, M, Ferrato, F, Limosani, I, Mastromo, D, Monzani, E, Porcellana, M, Restaino, F, Annese, P, Bolognesi, S, Cerretini, M, De Capua, A, Debolini, S, Del Zanna, M, Fargnoli, F, Giannini, A, Luccarelli, L, Lucii, C, Pierantozzi, E, Tozzi, F, Bardicchia, F, Cardamone, G, Facchi, E, Magnani, N, Soscia, F, Biancosino, B, Zotos, S, Giacomin, M, Pompei, F, Spano, M, Zonta, F, Buzzi, A, Calzolari, R, Caselli, I, Diurni, M, Giana, E, Ielmini, M, Milano, A, Poloni, N, Sani, E, Zizolfi, D, Alberini, G, Cazzamalli, S, Costantini, C, Di Caro, A, Paronelli, C, Piantanida, S, Alessandro, P, Barbanti, S, D'Ippolito, C, Gozzi, M, Moretti, V, Campese, O, Di Capro, L, di Giannantonio, M, Fiori, F, Lorusso, M, Mancini, V, Viceconte, D, Calandra, C, Luca, M, Signorelli, M, Suraniti, F, Balzarro, B, Boncompagni, G, Caretto, V, Emiliani, R, Lupoli, P, Menchetti, M, Rossi, E, Storbini, V, Tarricone, I, Terzi, L, Boso, M, Catania, C, De Paoli, G, Risaro, P, Aspesi, F, Bava, M, Bono, A, Brambilla, G, Castagna, G, Lucchi, S, Nava, R, Provenzi, M, Tabacchi, T, Tremolada, M, Verrengia, E, Barchiesi, M, Oriani, M, Pacetti, M, Ferro, M, Ghio, L, Beneduce, R, Laffranchini, L, Magni, L, Rossi, G, Tura, G, Addeo, L, Balletta, G, De Vivo, E, Di Benedetto, R, Parise, V, Carpiniello, B, Pinna, F, Pecile, D, Mattei, C, Bonavigo, T, Fabrici, E, Panarello, S, Peresson, G, Vitucci, C, Gardellin, F, Strizzolo, S, Cossetta, E, Fizzotti, C, Moretti, D, Di Gregorio, L, Sozzi, F, Colli, G, La Barbera, D, Laurenzi, S, Bertolini F., Ostuzzi G., Pievani M., Aguglia A., Bartoli F., Bortolaso P., Callegari C., Caroleo M., Carra G., Corbo M., D'Agostino A., De Fazio P., Magliocco F., Martinotti G., Ostinelli E.G., Piccinelli M.P., Tedeschi F., Barbui C., Boschello F., Gastaldon C., Mazzi M.A., Nose M., Papola D., Perini G., Piccoli A., Purgato M., Ruggeri M., Terlizzi S., Turrini G., Raffaele G., Cavallotti S., Chirico M., Ferrato F., Limosani I., Mastromo D., Monzani E., Porcellana M., Restaino F., Annese P.M., Bolognesi S., Cerretini M., De Capua A., Debolini S., Del Zanna M., Fargnoli F., Giannini A., Luccarelli L., Lucii C., Pierantozzi E., Tozzi F., Bardicchia F., Cardamone G., Facchi E., Magnani N., Soscia F., Biancosino B., Zotos S., Giacomin M., Pompei F., Spano M., Zonta F., Buzzi A., Callegred C., Calzolari R., Caselli I., Diurni M., Giana E., Ielmini M., Milano A., Poloni N., Sani E., Zizolfi D., Alberini G., Cazzamalli S., Costantini C., Di Caro A., Paronelli C., Piantanida S., Piccinelli M., Alessandro P., Barbanti S.V., D'Ippolito C., Gozzi M., Moretti V., Campese O., Di Capro L., di Giannantonio M., Fiori F., Lorusso M., Mancini V., Viceconte D., Calandra C., Luca M., Signorelli M.S., Suraniti F., Balzarro B., Boncompagni G., Caretto V., Emiliani R., Lupoli P., Menchetti M., Rossi E., Storbini V., Tarricone I., Terzi L., Boso M., Catania C., De Paoli G., Risaro P., Aspesi F., Bava M., Bono A., Brambilla G., Castagna G., Lucchi S., Nava R., Provenzi M., Tabacchi T., Tremolada M., Verrengia E., Barchiesi M., Oriani M.G., Pacetti M., Ferro M., Ghio L., Beneduce R., Laffranchini L., Magni L.R., Rossi G., Tura G.B., Addeo L., Balletta G., De Vivo E., Di Benedetto R., Parise V.F., Carpiniello B., Pinna F., Pecile D., Mattei C., Bonavigo T., Fabrici E.P., Panarello S., Peresson G., Vitucci C., Gardellin F., Strizzolo S., Cossetta E., Fizzotti C., Moretti D., Di Gregorio L., Sozzi F., Colli G., La Barbera D., and Laurenzi S.

Subjects
Male, Pediatrics, respectively), 0302 clinical medicine, Delayed-Action Preparation, Brief Psychiatric Rating Scale, Pharmacology (medical), he STAR Network ‘Depot Study’ prospectively followed 394 subjects initiating treatment with long-acting injections (LAIs) of antipsychotics under naturalistic conditions for 12 months. LAI discontinuation was frequent in everyday clinical practice in Italy, Original Research Article, Prospective Studies, Prospective cohort study, treatment, Mental Disorders, Hazard ratio, whereas more than half of participants initiating risperidone LAI and olanzapine LAI discontinued during the 12 months of follow-up (51.4 and 62.5%, Psychiatric Status Rating Scale, Middle Aged, side efects, Psychiatry and Mental health, Italy, Mental Disorder, Female, he STAR Network ‘Depot Study’ prospectively followed 394 subjects initiating treatment with long-acting injections (LAIs) of antipsychotics under naturalistic conditions for 12 months. LAI discontinuation was frequent in everyday clinical practice in Italy, occurring in almost 40% of the entire sample, side efects, participant refusal to continue LAIs and LAIs no longer being required were the most frequently reported reasons for discontinuation. Paliperidone LAI and aripiprazole LAI were the least discontinued medications (33.9 and 35.4%, respectively), whereas more than half of participants initiating risperidone LAI and olanzapine LAI discontinued during the 12 months of follow-up (51.4 and 62.5%, respectively). In multivariate analysis, being prescribed olanzapine LAI and poor medication adherence at baseline were signifcantly associated with higher discontinuation risk, Human, Antipsychotic Agents, medicine.drug, Psychopathology, Adult, medicine.medical_specialty, Discontinuation, Follow-Up Studie, Medication Adherence, 03 medical and health sciences, medicine, Humans, Paliperidone, Adverse effect, Settore MED/25 - Psichiatria, discontinuation rates, Psychiatric Status Rating Scales, respectively). In multivariate analysis, business.industry, Long-Acting Antipsychotic, long-acting injectable antipsychotics, Survival Analysis, Confidence interval, participant refusal to continue LAIs and LAIs no longer being required were the most frequently reported reasons for discontinuation. Paliperidone LAI and aripiprazole LAI were the least discontinued medications (33.9 and 35.4%, 030227 psychiatry, Prospective Studie, Antipsychotic Agent, occurring in almost 40% of the entire sample, Delayed-Action Preparations, Neurology (clinical), business, 030217 neurology & neurosurgery, being prescribed olanzapine LAI and poor medication adherence at baseline were signifcantly associated with higher discontinuation risk, Follow-Up Studies
Abstract

Background Recent guidelines suggested a wider use of long-acting injectable antipsychotics (LAI) than previously, but naturalistic data on the consequences of LAI use in terms of discontinuation rates and associated factors are still sparse, making it hard for clinicians to be informed on plausible treatment courses. Objective Our objective was to assess, under real-world clinical circumstances, LAI discontinuation rates over a period of 12 months after a first prescription, reasons for discontinuation, and associated factors. Methods The STAR Network ‘Depot Study’ was a naturalistic, multicentre, observational prospective study that enrolled subjects initiating a LAI without restrictions on diagnosis, clinical severity or setting. Participants from 32 Italian centres were assessed at baseline and at 6 and 12 months of follow-up. Psychopathology, drug attitude and treatment adherence were measured using the Brief Psychiatric Rating Scale, the Drug Attitude Inventory and the Kemp scale, respectively. Results The study followed 394 participants for 12 months. The overall discontinuation rate at 12 months was 39.3% (95% confidence interval [CI] 34.4–44.3), with paliperidone LAI being the least discontinued LAI (33.9%; 95% CI 25.3–43.5) and olanzapine LAI the most discontinued (62.5%; 95% CI 35.4–84.8). The most frequent reason for discontinuation was onset of adverse events (32.9%; 95% CI 25.6–40.9) followed by participant refusal of the medication (20.6%; 95% CI 14.6–27.9). Medication adherence at baseline was negatively associated with discontinuation risk (hazard ratio [HR] 0.853; 95% CI 0.742–0.981; p = 0.026), whereas being prescribed olanzapine LAI was associated with increased discontinuation risk compared with being prescribed paliperidone LAI (HR 2.156; 95% CI 1.003–4.634; p = 0.049). Conclusions Clinicians should be aware that LAI discontinuation is a frequent occurrence. LAI choice should be carefully discussed with the patient, taking into account individual characteristics and possible obstacles related to the practicalities of each formulation. Supplementary Information The online version contains supplementary material available at 10.1007/s40263-021-00809-w.

Published
2021

25. EP08.01-007 Real-World Outcomes of Patients with Advanced Lung Adenocarcinoma Treated with First-Line Chemo-Immunotherapy in Italy

Author

F. Perrone, A. Leonetti, primary, Puntoni, M., additional, Bordi, P., additional, Maglietta, G., additional, Carpana, C., additional, Gelsomino, F., additional, Passiglia, F., additional, Genova, C., additional, Montrone, M., additional, Caliman, E., additional, Cerea, G., additional, Pasello, G., additional, Cecere, F., additional, Manzo, A., additional, Adamo, V., additional, Citarella, F., additional, Toschi, L., additional, Gelibter, A., additional, Rastelli, F., additional, Carta, A., additional, Guida, A., additional, Camerini, A., additional, Paoloni, F., additional, Bertolini, F., additional, and Tiseo, M., additional

Published
2022
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26. 1124P Pralsetinib in RET fusion-positive non-small cell lung cancer: A real-world data (RWD) analysis from the Italian expanded access program (EAP)

Author

Passaro, A., primary, Lo Russo, G., additional, Passiglia, F., additional, D'Arcangelo, M., additional, Sbrana, A., additional, Russano, M., additional, Bonanno, L., additional, Giusti, R., additional, Metro, G., additional, Bertolini, F., additional, Grisanti, S., additional, Carta, A., additional, Cecere, F.L., additional, Montrone, M., additional, Massa, G., additional, Attili, I., additional, and de Marinis, F., additional

Published
2022
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27. EP16.03-042 BET Inhibitors Stimulate NK Cytotoxic Activity in NSCLC through Attenuation of YAP/TAZ and SMAD3 Transcriptional Programs

Author

Reggiani, F., primary, Orecchioni, S., additional, Sauta, E., additional, Torricelli, F., additional, Talarico, G., additional, Mitola, G., additional, Gobbi, G., additional, Paci, M., additional, Lococo, F., additional, Zanetti, E., additional, Piana, S., additional, Ciarrocchi, A., additional, Bertolini, F., additional, and Sancisi, V., additional

Published
2022
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28. 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

29. Clinical correlates of paliperidone palmitate and aripiprazole monohydrate prescription for subjects with schizophreniaspectrum disorders: Findings from the STAR Network Depot Study

Author

Barbui C, Nosè M, Purgato M, Turrini G, Ostuzzi G, Mazzi MA, Papola D, Gastaldon C, Terlizzi S, Bertolini F, Piccoli A, Ruggeri M, De Fazio P, Magliocco F, Caroleo M, Raffaele G, D'Agostino A, Ostinelli EG, Chirico M, Cavallotti S, Lucii C, Bolognesi S, Debolini S, Pierantozzi E, Fargnoli F, Del Zanna M, Giannini A, Luccarelli L, De Capua A, Annese PM, Cerretini M, Tozzi F, Magnani N, Cardamone G, Bardicchia F, Facchi E, Soscia F, Zotos S, Biancosino B, Zonta F, Pompei F, Callegari C, Zizolfi D, Poloni N, Ielmini M, Caselli I, Giana E, Buzzi A, Diurni M, Milano A, Sani E, Calzolari R, Bortolaso P, Piccinelli M, Cazzamalli S, Alberini G, Piantanida S, Costantini C, Paronelli C, Di Caro A, Moretti V, Gozzi M, D'Ippolito C, Barbanti SV, Papalini A, Corbo M, Martinotti G, Campese O, Fiori F, Lorusso M, Di Capro L, Viceconte D, Mancini V, Suraniti F, Signorelli MSI, Rossi E, Lupoli P, Menchetti M, Terzi L, Boso M, Risaro P, De Paoli G, Catania C, Tarricone I, Caretto V, Storbini V, Emiliani R, Balzarro B, Carrà G, Bartoli F, Tabacchi T, Nava R, Bono A, Provenzi M, Brambilla G, Aspesi F, Trotta G, Tremolada M, Castagna G, Bava M, Verrengia E, Lucchi S, Oriani MG, Barchiesi M, Pacetti M, Aguglia A, Magni LR, Rossi G, Beneduce R, Tura GB, Laffranchini L, Mastromo D, Ferrato F, Restaino F, Monzani E, Porcellana M, Limosani I, Ghio L, Ferro M, Parise VF, Balletta G, Addeo L, De Vivo E, Di Benedetto R, Pinna F, Carpiniello B, Spano M, Giacomin M, Pecile D, Mattei C, Fabrici EP, Panarello S, Peresson G, Vitucci C, Bonavigo T, Perini G, Boschello F, Strizzolo S, Gardellin F, Di Giannantonio M, Moretti D, Fizzotti C, Cossetta E, Di Gregorio L, Sozzi F, Boncompagni G, La Barbera D, Colli G, Laurenzi S, Calandra C, Luca M, Crocamo C, STAR Network Depot Investigators, Bartoli F., Ostuzzi G., Crocamo C., Corbo M., D'Agostino A., Martinotti G., Ostinelli E.G., Tabacchi T., Barbui C., Carr G., Nose M., Purgato M., Turrini G., Mazzi M.A., Papola D., Gastaldon C., Terlizzi S., Bertolini F., Piccoli A., Ruggeri M., De Fazio P., Magliocco F., Caroleo M., Raffaele G., Chirico M., Cavallotti S., Lucii C., Bolognesi S., Debolini S., Pierantozzi E., Fargnoli F., Del Zanna M., Giannini A., Luccarelli L., De Capua A., Annese P.M., Cerretini M., Tozzi F., Magnani N., Cardamone G., Bardicchia F., Facchi E., Soscia F., Zotos S., Biancosino B., Zonta F., Pompei F., Callegari C., Zizolfi D., Poloni N., Ielmini M., Caselli I., Giana E., Buzzi A., Diurni M., Milano A., Sani E., Calzolari R., Bortolaso P., Piccinelli M., Cazzamalli S., Alberini G., Piantanida S., Costantini C., Paronelli C., Di Caro A., Moretti V., Gozzi M., D'Ippolito C., Barbanti S.V., Papalini A., Campese O., Fiori F., Lorusso M., Di Capro L., Viceconte D., Mancini V., Suraniti F., Signorelli M.S., Rossi E., Lupoli P., Menchetti M., Terzi L., Boso M., Risaro P., De Paoli G., Catania C., Tarricone I., Caretto V., Storbini V., Emiliani R., Balzarro B., Carra G., Nava R., Bono A., Provenzi M., Brambilla G., Aspesi F., Trotta G., Tremolada M., Castagna G., Bava M., Verrengia E., Lucchi S., Oriani M.G., Barchiesi M., Pacetti M., Aguglia A., Magni L.R., Rossi G., Beneduce R., Tura G.B., Laffranchini L., Mastromo D., Ferrato F., Restaino F., Monzani E., Porcellana M., Limosani I., Ghio L., Ferro M., Parise V.F., Balletta G., Addeo L., De Vivo E., Di Benedetto R., Pinna F., Carpiniello B., Spano M., Giacomin M., Pecile D., Mattei C., Fabrici E.P., Panarello S., Peresson G., Vitucci C., Bonavigo T., Perini G., Boschello F., Strizzolo S., Gardellin F., Di Giannantonio M., Moretti D., Fizzotti C., Cossetta E., Di Gregorio L., Sozzi F., Boncompagni G., La Barbera D., Colli G., Laurenzi S., Calandra C., Luca M., Barbui C, Nosè M, Purgato M, Turrini G, Ostuzzi G, Mazzi MA, Papola D, Gastaldon C, Terlizzi S, Bertolini F, Piccoli A, Ruggeri M, De Fazio P, Magliocco F, Caroleo M, Raffaele G, D'Agostino A, Ostinelli EG, Chirico M, Cavallotti S, Lucii C, Bolognesi S, Debolini S, Pierantozzi E, Fargnoli F, Del Zanna M, Giannini A, Luccarelli L, De Capua A, Annese PM, Cerretini M, Tozzi F, Magnani N, Cardamone G, Bardicchia F, Facchi E, Soscia F, Zotos S, Biancosino B, Zonta F, Pompei F, Callegari C, Zizolfi D, Poloni N, Ielmini M, Caselli I, Giana E, Buzzi A, Diurni M, Milano A, Sani E, Calzolari R, Bortolaso P, Piccinelli M, Cazzamalli S, Alberini G, Piantanida S, Costantini C, Paronelli C, Di Caro A, Moretti V, Gozzi M, D'Ippolito C, Barbanti SV, Papalini A, Corbo M, Martinotti G, Campese O, Fiori F, Lorusso M, Di Capro L, Viceconte D, Mancini V, Suraniti F, Signorelli MSI, Rossi E, Lupoli P, Menchetti M, Terzi L, Boso M, Risaro P, De Paoli G, Catania C, Tarricone I, Caretto V, Storbini V, Emiliani R, Balzarro B, Carrà G, Bartoli F, Tabacchi T, Nava R, Bono A, Provenzi M, Brambilla G, Aspesi F, Trotta G, Tremolada M, Castagna G, Bava M, Verrengia E, Lucchi S, Oriani MG, Barchiesi M, Pacetti M, Aguglia A, Magni LR, Rossi G, Beneduce R, Tura GB, Laffranchini L, Mastromo D, Ferrato F, Restaino F, Monzani E, Porcellana M, Limosani I, Ghio L, Ferro M, Parise VF, Balletta G, Addeo L, De Vivo E, Di Benedetto R, Pinna F, Carpiniello B, Spano M, Giacomin M, Pecile D, Mattei C, Fabrici EP, Panarello S, Peresson G, Vitucci C, Bonavigo T, Perini G, Boschello F, Strizzolo S, Gardellin F, Di Giannantonio M, Moretti D, Fizzotti C, Cossetta E, Di Gregorio L, Sozzi F, Boncompagni G, La Barbera D, Colli G, Laurenzi S, Calandra C, Luca M, Crocamo C, STAR Network Depot Investigators, Bartoli, F, Ostuzzi, G, Crocamo, C, Corbo, M, D'Agostino, A, Martinotti, G, Ostinelli, E, Tabacchi, T, Barbui, C, and Carra, G

Subjects
Aripiprazole monohydrate, Long-acting injectable antipsychotics, Paliperidone palmitate, Schizophrenia, Adult, Antipsychotic Agents, Aripiprazole, Female, Health Knowledge, Attitudes, Practice, Humans, Male, Medication Adherence, Paliperidone Palmitate, Practice Patterns, Physicians', Schizophrenic Psychology, Young Adult, Long-acting injectable antipsychotic, medicine.medical_specialty, medicine.medical_treatment, Aripiprazole monohydrate, Long-acting injectable antipsychotics, Paliperidone palmitate, Schizophrenia, Practice Patterns, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Brief Psychiatric Rating Scale, medicine, Pharmacology (medical), Antipsychotic, Settore MED/25 - Psichiatria, Practice, Physicians', business.industry, Health Knowledge, medicine.disease, 030227 psychiatry, Psychiatry and Mental health, Attitudes, Propensity score matching, Observational study, business, 030217 neurology & neurosurgery, medicine.drug, Psychopathology
Abstract

This study, based on the 'Servizi Territoriali Associati per la Ricerca' (STAR) Network Depot Study nationwide baseline data, explored whether individual symptoms severity and clusters might influence the prescription of paliperidone palmitate 1-month (PP1M) vs. aripiprazole monohydrate. The Brief Psychiatric Rating Scale (BPRS) was used to assess psychopathology and relevant symptoms clusters. Drug Attitude Inventory, 10 items, was used to test attitude towards medications. Adherence to treatments was rated according to the Kemp seven-point scale. We assessed for eligibility 451 individuals and, among them, we included 195 subjects (n = 117 who started PPM1 and n = 78 aripiprazole monohydrate). Individuals were comparable in terms of age, gender, treatment years, recent hospitalizations, previous long-acting injectable antipsychotic treatments, additional oral treatments, attitude toward drugs, medication adherence, and alcohol/substance-related comorbidities. Subjects starting PP1M presented higher BPRS overall (P = 0.009), positive (P = 0.015), and negative (P = 0.010) symptom scores compared to subjects starting aripiprazole monohydrate. Results were confirmed by appropriate regression models and propensity score matching analysis. No differences were found comparing the other BPRS subscale scores: affect, resistance, and activation. Clinicians may be more prone to prescribe PPM1, rather than aripiprazole monohydrate, to subjects showing higher overall symptom severity, including positive and negative symptoms. No additional clinical factors influenced prescribing attitudes in our sample.

Published
2020

31. Corrigendum: A Real-World, Multicenter, Observational Retrospective Study of Durvalumab After Concomitant or Sequential Chemoradiation for Unresectable Stage III Non-Small Cell Lung Cancer (Front. Oncol., (2021), 11, (744956), 10.3389/fonc.2021.744956)

Author

Bruni, A., Scotti, V., Borghetti, P., Vagge, S., Cozzi, S., D'Angelo, E., Giaj Levra, N., Fozza, A., Taraborrelli, M., Piperno, G., Vanoni, V., Sepulcri, M., Trovo, M., Nardone, V., Lattanzi, E., Bou Selman, S., Bertolini, F., Franceschini, D., Agustoni, F., Jereczek-Fossa, B. A., Magrini, S. M., Livi, L., Lohr, F., Filippi, A. R., Bruni, A., Scotti, V., Borghetti, P., Vagge, S., Cozzi, S., D'Angelo, E., Giaj Levra, N., Fozza, A., Taraborrelli, M., Piperno, G., Vanoni, V., Sepulcri, M., Trovo, M., Nardone, V., Lattanzi, E., Bou Selman, S., Bertolini, F., Franceschini, D., Agustoni, F., Jereczek-Fossa, B. A., Magrini, S. M., Livi, L., Lohr, F., and Filippi, A. R.

Subjects
chemoradiotherapy, immunotherapy, NSCLC, stage III, unresectable
Abstract

In the original article there was an error. The survival numbers were incorrect. A correction has been made to Abstract: “1-year PFS and OS were 83.5% (95%CI: 77.6-89.7) and 97.2% (95%CI: 94.6-99.9), respectively.” “1-year PFS and OS were 65.5% (95%CI: 57.6-74.4) and 87.9% (95%CI: 82.26.6-93.9), respectively” In the original article, there was an error. The survival numbers were incorrect. A correction has been made to Results, Survival: “PFS at 12, 18, and 24 months was 83.5% (95%CI: 77.6– 89.7), 65.5 (95%CI: 57.6–74.4), and 53.1% (95%CI: 43.8–64.3), respectively. (Figure 1). OS at 12, 18, and 24 months was 97.2% (95%CI: 94.6– 99.9), 87.9% (95%CI: 82.26–93.9), and 79.3% (95%CI: 71.1–88.4), respectively (Figure 1).” “PFS at 6, 12, and 18 months was 83.5% (95%CI: 77.6– 89.7), 65.5% (95%CI: 57.6–74.4), and 53.1% (95%CI: 43.8– 64.3), respectively. (Figure 1). OS at 6, 12, and 18 months was 97.2% (95%CI: 94.6– 99.9), 87.9% (95%CI: 82.26–93.9), and 79.3% (95%CI: 71.1–88.4), respectively (Figure 1)” In the original article, there was an error. The survival numbers were incorrect. A correction has been made to Discussion: “12-month PFS was 83.5%, and OS 97.2%” “12-month PFS was 65.5%, and OS 87.9%” The authors apologize for these errors and state that this does not change the scientific conclusions of the article in any way. The original article has been updated.

Published
2021

32. Mtor pathway expression as potential predictive biomarker in patients with advanced neuroendocrine tumors treated with everolimus

Author

Gelsomino F., Casadei-Gardini A., Caputo F., Rossi G., Bertolini F., Petrachi T., Spallanzani A., Pettorelli E., Kaleci S., Luppi G., Gelsomino, F., Casadei-Gardini, A., Caputo, F., Rossi, G., Bertolini, F., Petrachi, T., Spallanzani, A., Pettorelli, E., Kaleci, S., and Luppi, G.

Subjects
Survival prediction, MTOR inhibitor, Everolimus, Neuroendocrine tumors, Prognosis
Abstract

Background. Everolimus (Eve), which is a mammalian target of Rapamicin (mTOR) inhibitor, is part of the therapeutic armamentarium of neuroendocrine tumors (NETs). Currently, there are no validated biomarkers predicting Eve efficacy in NETs. In this study, we explore whether the expression of phosphorilated (p)-mTOR and p70S6-kinase (S6K), a downstream effector of mTOR, correlates with the outcome of patients with NET that were treated with Eve. Methods. Tissue specimens that were derived from NETs treated with Eve at our Institution were examined for the expression levels of p-mTOR and p-S6K by immunohistochemistry. Response rate (RR), progression-free survival (PFS), and overall survival (OS) were analyzed in two groups: p-mTOR/p-S6K positive (group 1) and p-mTOR/p-S6K negative (group 2). Univariate and multivariate Cox regression analysis were performed. Results. Twenty-four patients with advanced NETs that were treated with Eve were included in the analysis. Eight out 24 (33.3%) patients were both p-mTOR and p-S6K positive. A better median PFS and OS in group 1 (18.2 and 39.9 months) as compared to group 2 (13 and 32.4 months) was depicted, with a toxicity profile that was comparable with data literature. Conclusions. Our study suggests that the activation of mTOR pathway can predict better outcomes in patients with NET treated with Eve. However, these results warrant further confirmation in a prospective setting.

Published
2020

35. Personalizing Cancer Pain Therapy: Insights from the Rational Use of Analgesics (RUA) Group

Author

Varrassi, G., Coluzzi, F., Guardamagna, V. A., Puntillo, F., Sotgiu, G., Vellucci, R., Abrardi, L., Aiello, A., Albanese, G. V., Alongi, A., Altavilla, L., Ambrosio, R., Ammirati, L. A., Bacchini, G. P., Balbi, V., Ballarin, S., Balloni, A. G., Bambagioni, V., Bellavia, G., Berte', R., Bertolini, F., Bertolucci, A., Bilani, V., Bonafede, E. V., Bonato, C., Bondi, F., Bosco, M., Bottino, F., Branca, B., Brizio, A., Brogi, L., Brollo, M., Bruera, G., Brusco, G., Burato, A. M., Caiozzi, S. F., Calabrese, G., Calligaris, M., Cantisani, E., Capecchi, S., Caponi, S., Carbone, M., Carella, C., Careri, M. C., Carnicella, A., Caruso, M. L., Catania, E., Cavo, A., Cianci, G., Cocchiarella, A., Colombo, L., Corsi, G., Cortinovis, R., Costantini, S., Crispi, M., Cuccu, G., Cuomo, A., Dalia, P., D'Amato, G., De Chirico, C., De Clementi, M., De Gasperi, M., De Lisi, A., De Lucia, L., De Martino, G., De Toni, P., De Tursi, M., Defendi, S., Degl'Innocenti, M., Santi, I. D., Destro, M., Di Bartolomeo, C., Di Ciaula, G., Di Fonzo, C., Di Maggio, G., Di Matteo, S., Di Paolo, A., Di Trapani, M. C., Di Zio, I., Diodati, M., Dongiovanni, D., D'Urso, M., Fabiani, M. G., Facciuto, P., Falco, V., Faraone, E., Fasano, M., Ferrara, P., Florian, C., Fora, G., Fornaro, F., Forno, B., Fortis, M., Foti, S., Friolo, D., Gabris, A., Galanti, D., Galizia, B., Gallo, P., Gaudio, L., Gentili, G., Ginex, G., Giuliani, J., Gobber, G., Amerelli, A. G., Gorgni, S., Gucciardino, C., Ieri, T., Ingui', M., Jamara, G., La Sala, A., Lattuca, P., Mauro, M. L., Luigini, A., Luisi, D., Lungu, V., Mabilia, R., Macaluso, S., Maglio, A., Magnapera, A., Maione, A., Malorgio, F., Mancuso, A., Manni, A., Marchesi, R., Mariani, M., Martini, A., Massetti, M., Mauceri, M., Melo, M., Merlotti, R., Modugno, D., Montagna, M. C., Montanari, L., Napolitano, G., Nicodemo, M., Orlandini, G., Orlandini, F., Orsi, P., Pacifico, C., Pagliaro, E., Paladini, A., Paolucci, V., Pascazio, A., Pastore, A., Patanella, I., Pedaci, E., Pellegrini, A., Pellerito, N., Pepe, V., Petreni, P., Piazza, S., Picchi, M., Piccinelli, G., Pignatelli, A., Pinta, F., Pinto, T., Piovano, P. L., Pirajno, G., Pollastrini, C., Potenza, I., Provenzano, A., Provinciali, N., Puglia, L., Putignano, D., Ranucci, A., Ravoni, G., Redivo, L., Ricchini, F., Rizzi, F., Romoli, M., Ronga, G., Rosafio, I., Roselli, L., Russano, M., Russo, P., Saetta, A., Sarnelli, R., Sartori, S., Saviola, A., Scandone, F., Scibilia, C., Silverj, E., Sosta, E., Sparacino, M. E., Tavella, E., Tempera, S., Terranova, A., Tomasini, V., Trivellato, E., Vallisneri, C., Vannini, A., Vassillo, M., Verni, P., Visconti, E., Zaza, A., and Zizzetti, S.

Subjects
medicine.medical_specialty, Palliative care, business.industry, Pain medicine, Breakthrough pain, Cancer pain, Opioid-induced bowel dysfunction (OIBD), Opioid-induced constipation (OIC), Opioids, Delphi method, Likert scale, Anesthesiology and Pain Medicine, Opioid, Multidisciplinary approach, Interquartile range, Family medicine, Medicine, Neurology (clinical), business, medicine.drug
Abstract

A previous Delphi survey from the Rational Use of Analgesics (RUA) project involving Italian palliative care specialists revealed some discrepancies between current guidelines and clinical practice with a lack of consensus on items regarding the use of strong opioids in treating cancer pain. Those results represented the basis for a new Delphi study addressing a better approach to pain treatment in patients with cancer. The study consisted of a two-round multidisciplinary Delphi study. Specialists rated their agreement with a set of 17 statements using a 5-point Likert scale (0 = totally disagree and 4 = totally agree). Consensus on a statement was achieved if the median consensus score (MCS) (expressed as value at which at least 50% of participants agreed) was at least 4 and the interquartile range (IQR) was 3–4. This survey included input from 186 palliative care specialists representing all Italian territory. Consensus was reached on seven statements. More than 70% of participants agreed with the use of low dose of strong opioids in moderate pain treatment and valued transdermal route as an effective option when the oral route is not available. There was strong consensus on the importance of knowing opioid pharmacokinetics for therapy personalization and on identifying immediate-release opioids as key for tailoring therapy to patients’ needs. Limited agreement was reached on items regarding breakthrough pain and the management of opioid-induced bowel dysfunction. These findings may assist clinicians in applying clinical evidence to routine care settings and call for a reappraisal of current pain treatment recommendations with the final aim of optimizing the clinical use of strong opioids in patients with cancer.

Published
2021

37. Severe asthma: One disease and multiple definitions

Author

Bagnasco, D., Paggiaro, P., Latorre, M., Folli, C., Testino, E., Bassi, A., Milanese, M., Heffler, E., Manfredi, A., Riccio, A. M., De Ferrari, L., Blasi, F., Canevari, R. F., Canonica, G. W., Passalacqua, G., Guarnieri, G., Patella, V., Maria Pia, F. B., Carpagnano, G. E., Colle, A. D., Scioscia, G., Gerolamo, P., Puggioni, F., Racca, F., Favero, E., Iannacone, S., Savi, E., Montagni, M., Camiciottoli, G., Allegrini, C., Lombardi, Celestino Pio, Spadaro, G., Detoraki, C., Menzella, F., Galeone, C., Ruggiero, P., Yacoub, M. R., Berti, Andrea, Scichilone, N., Durante, C., Costantino, M. T., Roncallo, C., Braschi, M., D'Adda, A., Ridolo, E., Triggiani, M., Parente, R., Maria, D. A., Verrillo, M. V., Rolla, G., Brussino, L., Frazzetto, A. V., Cristina, Z. M., Lilli, M., Crimi, N., Bonavia, M., Corsico, A. G., Grosso, A., Del Giacco, S., Deidda, M., Ricciardi, L., Isola, S., Cicero, F., Amato, G., Vita, F., Spanevello, A., Pignatti, P., Cherubino, F., Visca, D., Massimo Ricciardolo, F. L., Anna Carriero, V. M., Bertolini, Francesca, Santus, P., Barlassina, R., Airoldi, A., Guida, Maria Grazia, Nucera, Eleonora, Aruanno, A., Rizzi, Angela, Caruso, Cristiano, Colantuono, S., Senna, G., Caminati, M., Arcolaci, A., Vianello, A., Bianchi, F. C., Marchi, M. R., Centanni, S., Luraschi, S., Ruggeri, S., Rinaldo, R., Parazzini, E., Calabrese, Anna Chiara, Flora, M., Cosmi, L., Di Pietro, L., Maggi, E., Pini, L., Macchia, L., Di Bona, D., Richeldi, Luca, Condoluci, Carola, Fuso, Leonello, Bonini, Matteo, Farsi, A., Carli, G., Montuschi, Paolo, Santini, G., Conte, M. E., Turchet, E., Barbetta, C., Mazza, F., D'Alo, S., Pucci, S., Caiaffa, M. F., Minenna, E., D'Elia, L., Pasculli, C., Viviano, V., Tarsia, P., Rolo, J., Di Proietto, M., Lo Cicero, Stefano, Lombardi C. (ORCID:0000-0001-8910-6693), Berti A., Bertolini F., Guida G., Eleonora Nucera. (ORCID:0000-0002-0565-7680), Rizzi A. (ORCID:0000-0002-6795-746X), Caruso C., Calabrese C., Richeldi L. (ORCID:0000-0001-8594-1448), Condoluci C., Fuso L. (ORCID:0000-0002-1198-6712), Bonini M. (ORCID:0000-0002-3042-0765), Montuschi P. (ORCID:0000-0001-5589-1750), Lo Cicero S., Bagnasco, D., Paggiaro, P., Latorre, M., Folli, C., Testino, E., Bassi, A., Milanese, M., Heffler, E., Manfredi, A., Riccio, A. M., De Ferrari, L., Blasi, F., Canevari, R. F., Canonica, G. W., Passalacqua, G., Guarnieri, G., Patella, V., Maria Pia, F. B., Carpagnano, G. E., Colle, A. D., Scioscia, G., Gerolamo, P., Puggioni, F., Racca, F., Favero, E., Iannacone, S., Savi, E., Montagni, M., Camiciottoli, G., Allegrini, C., Lombardi, Celestino Pio, Spadaro, G., Detoraki, C., Menzella, F., Galeone, C., Ruggiero, P., Yacoub, M. R., Berti, Andrea, Scichilone, N., Durante, C., Costantino, M. T., Roncallo, C., Braschi, M., D'Adda, A., Ridolo, E., Triggiani, M., Parente, R., Maria, D. A., Verrillo, M. V., Rolla, G., Brussino, L., Frazzetto, A. V., Cristina, Z. M., Lilli, M., Crimi, N., Bonavia, M., Corsico, A. G., Grosso, A., Del Giacco, S., Deidda, M., Ricciardi, L., Isola, S., Cicero, F., Amato, G., Vita, F., Spanevello, A., Pignatti, P., Cherubino, F., Visca, D., Massimo Ricciardolo, F. L., Anna Carriero, V. M., Bertolini, Francesca, Santus, P., Barlassina, R., Airoldi, A., Guida, Maria Grazia, Nucera, Eleonora, Aruanno, A., Rizzi, Angela, Caruso, Cristiano, Colantuono, S., Senna, G., Caminati, M., Arcolaci, A., Vianello, A., Bianchi, F. C., Marchi, M. R., Centanni, S., Luraschi, S., Ruggeri, S., Rinaldo, R., Parazzini, E., Calabrese, Anna Chiara, Flora, M., Cosmi, L., Di Pietro, L., Maggi, E., Pini, L., Macchia, L., Di Bona, D., Richeldi, Luca, Condoluci, Carola, Fuso, Leonello, Bonini, Matteo, Farsi, A., Carli, G., Montuschi, Paolo, Santini, G., Conte, M. E., Turchet, E., Barbetta, C., Mazza, F., D'Alo, S., Pucci, S., Caiaffa, M. F., Minenna, E., D'Elia, L., Pasculli, C., Viviano, V., Tarsia, P., Rolo, J., Di Proietto, M., Lo Cicero, Stefano, Lombardi C. (ORCID:0000-0001-8910-6693), Berti A., Bertolini F., Guida G., Eleonora Nucera. (ORCID:0000-0002-0565-7680), Rizzi A. (ORCID:0000-0002-6795-746X), Caruso C., Calabrese C., Richeldi L. (ORCID:0000-0001-8594-1448), Condoluci C., Fuso L. (ORCID:0000-0002-1198-6712), Bonini M. (ORCID:0000-0002-3042-0765), Montuschi P. (ORCID:0000-0001-5589-1750), and Lo Cicero S.

Abstract

Introduction: There is, so far, no universal definition of severe asthma. This definition usually relies on: number of exacerbations, inhaled therapy, need for oral corticosteroids, and respiratory function. The use of such parameters varies in the different definitions used. Thus, according to the parameters chosen, each patient may result in having severe asthma or not. The aim of this study was to evaluate how the choice of a specific definition of severe asthma can change the allocation of patients. Methods: Data collected from the Severe Asthma Network Italy (SANI) registry were analyzed. All the patients included were then reclassified according to the definitions of U-BIOPRED, NICE, WHO, ATS/ERS, GINA, ENFUMOSA, and TENOR. Results: 540 patients, were extracted from the SANI database. We observed that 462 (86%) met the ATS/ERS criteria as well as the GINA criteria, 259 (48%) the U-Biopred, 222 (41%) the NICE, 125 (23%) the WHO, 313 (58%) the Enfumosa, and 251 (46%) the TENOR criteria. The mean eosinophil value were similar in the ATS/ERS, U-Biopred, and Enfumosa (528, 532 and 516 cells/mcl), higher in WHO and Tenor (567 and 570 cells/mcl) and much higher in the NICE classification (624 cells/mcl). Lung function tests resulted similarly in all groups, with WHO (67%) and ATS/ERS-GINA (73%), respectively, showing the lower and upper mean FEV1 values. Conclusions: The present observations clearly evidence the heterogeneity in the distribution of patients when different definitions of severe asthma are used. However, the recent definition of severe asthma, provided by the GINA document, is similar to that indicated in 2014 by ATS/ERS, allowing mirror reclassification of the patients examined. This lack of homogeneity could complicate the access to biological therapies. The definition provided by the GINA document, which reflects what suggested by ATS/ERS, could partially overcome the problem.

Published
2021

38. Economic impact of mepolizumab in uncontrolled severe eosinophilic asthma, in real life

Author

Bagnasco, D., Povero, M., Pradelli, L., Brussino, L., Rolla, G., Caminati, M., Menzella, F., Heffler, E., Canonica, G. W., Paggiaro, P., Senna, G., Milanese, M., Lombardi, C., Bucca, C., Manfredi, A., Canevari, R. F., Passalacqua, G., Guarnieri, G., Patella, V., Maria Pia, F. B., Carpagnano, E., Colle, A. D., Scioscia, G., Gerolamo, P., Latorre, M., Puggioni, F., Racca, F., Favero, E., Iannacone, S., Savi, E., Montagni, M., Camiciottoli, G., Allegrini, C., Spadaro, G., Detoraki, C., Galeone, C., Ruggiero, P., Yacoub, M. R., Berti, Andrea, Colombo, G., Scichilone, N., Durante, C., Costantino, M. T., Roncallo, C., Braschi, M., Blasi, F., D'Adda, A., Ridolo, E., Triggiani, M., Parente, R., Maria, D. A., Verrillo, M. V., Cristina, Z. M., Lilli, M., Crimi, N., Bonavia, M., Corsico, A. G., Grosso, A., Del Giacco, S., Deidda, M., Ricciardi, L., Isola, S., Cicero, F., Amato, G., Vita, F., Spanevello, A., Pignatti, P., Cherubino, F., Visca, D., Aletti, E., Massimo Ricciardolo, F. L., Anna Carriero, V. M., Bertolini, Francesca, Santus, P., Barlassina, R., Airoldi, A., Guida, Maria Grazia, Nucera, Eleonora, Aruanno, A., Rizzi, Angela, Caruso, C., Colantuono, S., Arcolaci, A., Vianello, A., Bianchi, F. C., Marchi, M. R., Centanni, S., Luraschi, S., Ruggeri, S., Rinaldo, R., Parazzini, E., Calabrese, Anna Chiara, Flora, M., Cosmi, L., Di Pietro, L., Maggi, E., Pini, L., Macchia, L., Di Bona, D., Richeldi, Luca, Condoluci, Carola, Fuso, Leonello, Bonini, Matteo, Farsi, A., Carli, G., Montuschi, Paolo, Santini, G., Conte, M. E., Turchet, E., Barbetta, C., Mazza, F., D'Alo, S., Pucci, S., Caiaffa, M. F., Minenna, E., D'Elia, L., Pasculli, C., Viviano, V., Tarsia, P., Rolo, J., Di Proietto, M., Lo Cicero, Stefano, Berti A., Bertolini F., Guida G., Eleonora N. (ORCID:0000-0002-0565-7680), Rizzi A. (ORCID:0000-0002-6795-746X), Calabrese C., Richeldi L. (ORCID:0000-0001-8594-1448), Condoluci C., Fuso L. (ORCID:0000-0002-1198-6712), Bonini M. (ORCID:0000-0002-3042-0765), Montuschi P. (ORCID:0000-0001-5589-1750), Lo Cicero S., Bagnasco, D., Povero, M., Pradelli, L., Brussino, L., Rolla, G., Caminati, M., Menzella, F., Heffler, E., Canonica, G. W., Paggiaro, P., Senna, G., Milanese, M., Lombardi, C., Bucca, C., Manfredi, A., Canevari, R. F., Passalacqua, G., Guarnieri, G., Patella, V., Maria Pia, F. B., Carpagnano, E., Colle, A. D., Scioscia, G., Gerolamo, P., Latorre, M., Puggioni, F., Racca, F., Favero, E., Iannacone, S., Savi, E., Montagni, M., Camiciottoli, G., Allegrini, C., Spadaro, G., Detoraki, C., Galeone, C., Ruggiero, P., Yacoub, M. R., Berti, Andrea, Colombo, G., Scichilone, N., Durante, C., Costantino, M. T., Roncallo, C., Braschi, M., Blasi, F., D'Adda, A., Ridolo, E., Triggiani, M., Parente, R., Maria, D. A., Verrillo, M. V., Cristina, Z. M., Lilli, M., Crimi, N., Bonavia, M., Corsico, A. G., Grosso, A., Del Giacco, S., Deidda, M., Ricciardi, L., Isola, S., Cicero, F., Amato, G., Vita, F., Spanevello, A., Pignatti, P., Cherubino, F., Visca, D., Aletti, E., Massimo Ricciardolo, F. L., Anna Carriero, V. M., Bertolini, Francesca, Santus, P., Barlassina, R., Airoldi, A., Guida, Maria Grazia, Nucera, Eleonora, Aruanno, A., Rizzi, Angela, Caruso, C., Colantuono, S., Arcolaci, A., Vianello, A., Bianchi, F. C., Marchi, M. R., Centanni, S., Luraschi, S., Ruggeri, S., Rinaldo, R., Parazzini, E., Calabrese, Anna Chiara, Flora, M., Cosmi, L., Di Pietro, L., Maggi, E., Pini, L., Macchia, L., Di Bona, D., Richeldi, Luca, Condoluci, Carola, Fuso, Leonello, Bonini, Matteo, Farsi, A., Carli, G., Montuschi, Paolo, Santini, G., Conte, M. E., Turchet, E., Barbetta, C., Mazza, F., D'Alo, S., Pucci, S., Caiaffa, M. F., Minenna, E., D'Elia, L., Pasculli, C., Viviano, V., Tarsia, P., Rolo, J., Di Proietto, M., Lo Cicero, Stefano, Berti A., Bertolini F., Guida G., Eleonora N. (ORCID:0000-0002-0565-7680), Rizzi A. (ORCID:0000-0002-6795-746X), Calabrese C., Richeldi L. (ORCID:0000-0001-8594-1448), Condoluci C., Fuso L. (ORCID:0000-0002-1198-6712), Bonini M. (ORCID:0000-0002-3042-0765), Montuschi P. (ORCID:0000-0001-5589-1750), and Lo Cicero S.

Abstract

Background and aims: Severe asthma is burdened by frequent exacerbations and use of oral corticosteroids (OCS) which worsen patients’ health and increase healthcare spending. Aim of this study was to assess the clinical and economic effect of adding mepolizumab (MEP) for the treatment of these patients. Methods: Patients >18 years old, referred to 8 asthma clinics, starting MEP between May 2017 and December 2018, were enrolled and followed-up for 12 months. Information in the 12 months before mepolizumab were collected retrospectively. The evaluation parameters included: OCS use, number of exacerbations/hospitalizations, concomitant therapies, comorbidity, and annual number of working days lost due to the disease. The primary objective was to compare the annual total cost per patient pre- and post-MEP. Secondary outcomes included rates of exacerbations and number of OCS-dependent patients. Results: 106 patients were enrolled in the study: 46 male, median age 58 years. Mean annual cost pre- and post-MEP (cost of biologic excluded) was €3996 and €1,527, respectively. Total savings due to MEP resulted in €2469 (95%CI 1945–2993), 62% due to exacerbations reduction and 33% due to productivity increase. Such savings could fund about 22% of the total cost of MEP for one year. The introduction of MEP induced a clinical benefit by reducing both OCS-dependent patients (OR = 0.12, 95%CI 0.06–0.23) and exacerbation rate (RR = 0.19, 95%CI 0.15–0.24). Conclusions: Patients with severe eosinophilic asthma experienced a clinical benefit in asthma control adding MEP to standard therapy. Biologic therapy can be, partially, funded by the savings produced by patients’ improvement.

Published
2021

43. Global treatment patterns and outcomes among patients with recurrent and/or metastatic head and neck squamous cell carcinoma: Results of the GLANCE H&N study

Author

Grunwald V, Chirovsky D, Cheung W, Bertolini F, Ahn M, Yang M, Castro G, Berrocal A, Sjoquist K, Kuyas H, Auclair V, Guillaume X, Joo S, Shah R, and Harrington K

Abstract

OBJECTIVES: Given a lack of universally-accepted standard-of-care treatment for patients with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC), study objectives were to assess treatment utilization and survival outcomes for R/M HNSCC in the real-world setting. MATERIALS AND METHODS: A multi-site retrospective chart review was conducted in Europe (Germany, United Kingdom, Italy, Spain), Asia Pacific (Australia, South Korea, Taiwan), and Latin/North America (Brazil and Canada) to identify patients who initiated first-line systemic therapy for R/M HNSCC between January 2011 and December 2013. Patients were followed through December 2015 to collect clinical characteristics, treatment and survival data. RESULTS: Among 733 R/M HNSCC patients across 71 sites, median age was 60years (inter-quartile range 54-67), 84% male, and 70% Eastern Cooperative Oncology Group performance status 0-1; 32% had oral cavity and 30% oropharyngeal cancers. The most common first-line regimen across all countries consisted of platinum-based combinations (73%), including platinum+5-fluorouracil (5-FU) (26%), cetuximab+platinum±5-FU (22%), or taxane+platinum±5-FU (16%). However, use of different platinum-based combinations varied substantially; administration of cetuximab+platinum±5-FU was frequent in Italy (81%), Germany (46%) and Spain (38%), whereas use in other countries was limited. Median follow-up was 22.6months (95% confidence interval [CI]: 21.5-24.6months). Median real-world overall survival was only 8.0months (95% CI: 7.0-8.0), with one-year survival reaching only 30.9% (95% CI: 27.5-34.3). CONCLUSION: Systemic therapies used in clinical practice for patients with R/M HNSCC vary substantially across countries. Prognosis remains poor in this patient population, highlighting the need for newer, more efficacious treatments.

Published
2020

44. Erratum: Safety of psychotropic medications in people with COVID-19: Evidence review and practical recommendations (BMC Medicine (2020) 18 (215) DOI: 10.1186/s12916-020-01685-9)

Author

Ostuzzi, G., Papola, D., Gastaldon, C., Schoretsanitis, G., Bertolini, F., Amaddeo, F., Cuomo, A., Emsley, R., Fagiolini, A., Imperadore, G., Kishimoto, T., Michencigh, G., Nose, M., Purgato, M., Dursun, S., Stubbs, B., Taylor, D., Thornicroft, G., Ward, P. B., Hiemke, C., Correll, C. U., and Barbui, C.

Published
2020

45. Reasons for initiating long-acting antipsychotics in psychiatric practice: findings from the STAR Network Depot Study

Author

Barbui, C, Bertolini, F, Bartoli, F, Calandra, C, Callegari, C, Carrà, G, D'Agostino, A, Lucii, C, Martinotti, G, Mastromo, D, Moretti, D, Monzani, E, Porcellana, M, Prestia, D, Ostuzzi, G, Barbui, Corrado, Bertolini, Federico, Bartoli, Francesco, Calandra, Carmela, Callegari, Camilla, Carrà, Giuseppe, D'Agostino, Armando, Lucii, Claudio, Martinotti, Giovanni, Mastromo, Daniele, Moretti, Daniele, Monzani, Emiliano, Porcellana, Matteo, Prestia, Davide, Ostuzzi, Giovanni, Barbui, C, Bertolini, F, Bartoli, F, Calandra, C, Callegari, C, Carrà, G, D'Agostino, A, Lucii, C, Martinotti, G, Mastromo, D, Moretti, D, Monzani, E, Porcellana, M, Prestia, D, Ostuzzi, G, Barbui, Corrado, Bertolini, Federico, Bartoli, Francesco, Calandra, Carmela, Callegari, Camilla, Carrà, Giuseppe, D'Agostino, Armando, Lucii, Claudio, Martinotti, Giovanni, Mastromo, Daniele, Moretti, Daniele, Monzani, Emiliano, Porcellana, Matteo, Prestia, Davide, and Ostuzzi, Giovanni

Abstract

Background: Long acting injectable (LAI) antipsychotics have been claimed to ensure treatment adherence and possibly reduce the daily burden of oral formulations. So far, only surveys investigating the theoretical prescribing attitudes of clinicians have been employed. On this basis, we aimed to investigate reasons for prescribing LAIs in a real-world, unselected sample of patients. Methods: The STAR Network Depot Study is an observational, multicentre study consecutively enrolling adults initiating a LAI over a 12-months period. Clinical severity was assessed with the Brief Psychiatric Rating Scale, and patient’s attitude toward medications with the Drug Attitude Inventory 10 items. Psychiatrists recorded reasons for LAI prescribing for each study participant. Responses were grouped into six non-mutually exclusive categories: aggressiveness, patient engagement, ease of drug taking, side-effects, stigma, adherence. Results: Of the 451 patients included, two-thirds suffered from chronic psychoses. Improving patient engagement with the outpatient psychiatric service was the most common reason for prescribing LAIs (almost 80% of participants), followed by increasing treatment adherence (57%), decreasing aggressiveness (54%), and improving ease of drug taking (52%). After adjusting for confounders, logistic regression analyses showed that reasons for LAI use were associated with LAI choice (e.g. first-generation LAIs for reducing aggressiveness). Conclusion: Despite the wide availability of novel LAI formulation and the emphasis on their wider use, our data suggest that the main reasons for LAI use have remained substantially unchanged over the years, focusing mostly on improving patient’s engagement. Further, clinicians follow implicit prescribing patterns when choosing LAIs, and this may generate hypotheses for future experimental studies.

Published
2020

49. Natural history of bone metastasis in colorectal cancer: final results of a large Italian bone metastases study

Author

Santini, D., Tampellini, M., Vincenzi, B., Ibrahim, T., Ortega, C., Virzi, V., Silvestris, N., Berardi, R., Masini, C., Calipari, N., Ottaviani, D., Catalano, V., Badalamenti, G., Giannicola, R., Fabbri, F., Venditti, O., Fratto, M. E., Mazzara, C., Latiano, T. P., Bertolini, F., Petrelli, F., Ottone, A., Caroti, C., Salvatore, L., Falcone, A., Giordani, P., Addeo, R., Aglietta, M., Cascinu, S., Barni, S., Maiello, E., and Tonini, G.

Published
2012
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