Francesco Facchinetti1, Giulia Mazzaschi2, Fausto Barbieri3, Francesco Passiglia4, Francesca Mazzoni5, Rossana Berardi6, Claudia Proto7, Fabiana Letizia Cecere8, Sara Pilotto9, Vieri Scotti10, Sabrina Rossi11, Alessandro Del Conte12, Emanuele Vita13, Chiara Bennati14, Andrea Ardizzoni15, Giulio Cerea16, Maria Rita Migliorino17, Elisa Sala18, Andrea Camerini19, Alessandra Bearz12, Elisa De Carlo12, Francesca Zanelli20, Giorgia Guaitoli3, Marina Chiara Garassino7, Lucia Pia Ciccone10, Giulia Sartori9, Luca Toschi11, Filippo Gustavo Dall'Olio15, Lorenza Landi14, Elio Gregory Pizzutilo21, Gabriele Bartoli17, Cinzia Baldessari3, Silvia Novello4, Emilio Bria13, Diego Luigi Cortinovis18, Giulio Rossi22, Antonio Rossi23, Giuseppe Luigi Banna24, Roberta Camisa2, Massimo Di Maio25, Marcello Tiseo26. 1. Medical Oncology Unit, University Hospital of Parma, Parma, Italy; Université Paris-Saclay, Institut Gustave Roussy, Inserm, Biomarqueurs Prédictifs et Nouvelles Stratégies Thérapeutiques en Oncologie, 94800, Villejuif, France. Electronic address: francescofacchietti2@gmail.com. 2. Medical Oncology Unit, University Hospital of Parma, Parma, Italy. 3. Division of Medical Oncology, Azienda Ospedaliero-Universitaria Policlinico, Modena, Italy. 4. Department of Oncology, University of Turin, San Luigi Hospital, Orbassano, Italy. 5. Medical Oncology Unit, Department of Oncology, Careggi University Hospital, Firenze, Italy. 6. Oncology Clinic, Università Politecnica Delle Marche, Ospedali Riuniti di Ancona, Ancona, Italy. 7. Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan, Italy. 8. IRCCS Regina Elena National Cancer Institute, Rome, Italy. 9. Section of Medical Oncology, Department of Medicine, University of Verona, Verona, Italy. 10. Radiation Therapy Unit, Department of Oncology, Careggi University Hospital, Firenze, Italy. 11. Department of Oncology & Hematology, Humanitas Clinical & Research Center, Rozzano, Milan, Italy. 12. Medical Oncology and Immuno-Related Tumors, Centro di Riferimento Oncologico di Aviano (CRO) IRCCS, Aviano, Italy. 13. Comprehensive Cancer Center, Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, Università Cattolica Del Sacro Cuore, Rome, Italy. 14. Onco-Hematology Department, S Maria Delle Croci Hospital Ravenna, Italy. 15. Department of Oncology, Policlinico S. Orsola-Malpighi, University of Bologna, Bologna, Italy. 16. Niguarda Cancer Center, Grande Ospedale Metropolitano Niguarda, Milano, Italy. 17. Pneumologia Oncologica, Azienda Ospedaliera San Camillo Forlanini, Rome, Italy. 18. Oncology Unit, Ospedale S. Gerardo, Monza, Italy. 19. Medical Oncology, Azienda USL Toscana Nord-ovest, Ospedale Versilia, Italy. 20. Oncology Unit, Azienda Unità Sanitaria Locale - IRCCS di Reggio Emilia, Reggio Emilia, Italy. 21. Niguarda Cancer Center, Grande Ospedale Metropolitano Niguarda, Milano, Italy; Department of Oncology and Hemato-Oncology, Università Degli Studi di Milano, Milan, Italy. 22. Pathology Unit, S. Maria Delle Croci Hospital, Ravenna, Italy. 23. Division of Medical Oncology, Fondazione IRCCS Casa Sollievo Della Sofferenza, San Giovanni Rotondo (FG), Italy. 24. United Lincolnshire Hospitals NHS Trust, Lincoln, UK. 25. Department of Oncology, University of Turin, Ordine Mauriziano Hospital, Torino, Italy. 26. Medical Oncology Unit, University Hospital of Parma, Parma, Italy; Department of Medicine and Surgery, University of Parma, Parma, Italy.
Abstract
BACKGROUND: Pembrolizumab is the first-line standard of care for advanced non-small cell lung cancer (NSCLC) with a PD-L1 tumour proportion score (TPS) ≥ 50%. Eastern Cooperative Oncology Group performance status (PS) 2 patients may receive pembrolizumab, despite the absence of sustaining evidence. PATIENTS AND METHODS: GOIRC-2018-01 is a multicentre, retrospective, observational study. PS 2 NSCLC patients with a PD-L1 TPS ≥50% receiving first-line pembrolizumab from June 2017 to December 2018 at 21 Italian institutions were included. Clinical-pathological characteristics were correlated with disease response and survival outcomes; adverse events were recorded. The primary objective was 6-months progression-free rate (6-months PFR). RESULTS: One hundred fifty-three patients (median age 70 years) were enrolled. At a median follow-up of 18.2 months, median progression-free survival (PFS) and overall survival (OS) were 2.4 (95% confidence interval, 95% CI, 1.6-2.5) and 3.0 months (95% CI 2.4-3.5), respectively. 6-months PFR was 27% (95% CI 21-35%). Patients with a PS 2 determined by comorbidities (n = 41) had significantly better outcomes compared with disease burden-induced PS 2 (n = 112). Indeed, 6-months PFR was 49% versus 19%, median PFS 5.6 versus 1.8 months and OS 11.8 versus 2.8 months, respectively. Additional potential prognostic factors (radiotherapy, antibiotics, steroids received before pembrolizumab) correlated with clinical outcomes. The determinant of PS 2 resulted the only factor independently impacting on both PFS and OS. No toxicity issues emerged. CONCLUSIONS: Outcomes of PS 2 NSCLC patients with PD-L1 TPS ≥50% receiving first-line pembrolizumab were globally dismal but strongly dependent on the reason conditioning the poor PS itself.
BACKGROUND:Pembrolizumab is the first-line standard of care for advanced non-small cell lung cancer (NSCLC) with a PD-L1 tumour proportion score (TPS) ≥ 50%. Eastern Cooperative Oncology Group performance status (PS) 2 patients may receive pembrolizumab, despite the absence of sustaining evidence. PATIENTS AND METHODS: GOIRC-2018-01 is a multicentre, retrospective, observational study. PS 2NSCLCpatients with a PD-L1 TPS ≥50% receiving first-line pembrolizumab from June 2017 to December 2018 at 21 Italian institutions were included. Clinical-pathological characteristics were correlated with disease response and survival outcomes; adverse events were recorded. The primary objective was 6-months progression-free rate (6-months PFR). RESULTS: One hundred fifty-three patients (median age 70 years) were enrolled. At a median follow-up of 18.2 months, median progression-free survival (PFS) and overall survival (OS) were 2.4 (95% confidence interval, 95% CI, 1.6-2.5) and 3.0 months (95% CI 2.4-3.5), respectively. 6-months PFR was 27% (95% CI 21-35%). Patients with a PS 2 determined by comorbidities (n = 41) had significantly better outcomes compared with disease burden-induced PS 2 (n = 112). Indeed, 6-months PFR was 49% versus 19%, median PFS 5.6 versus 1.8 months and OS 11.8 versus 2.8 months, respectively. Additional potential prognostic factors (radiotherapy, antibiotics, steroids received before pembrolizumab) correlated with clinical outcomes. The determinant of PS 2 resulted the only factor independently impacting on both PFS and OS. No toxicity issues emerged. CONCLUSIONS: Outcomes of PS 2NSCLCpatients with PD-L1 TPS ≥50% receiving first-line pembrolizumab were globally dismal but strongly dependent on the reason conditioning the poor PS itself.
Authors: Diego L Kaen; Nicolas Minatta; Alessandro Russo; Umberto Malapelle; Diego de Miguel-Pérez; Christian Rolfo Journal: Adv Exp Med Biol Date: 2021 Impact factor: 2.622
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