Atezolizumab Plus Carboplatin and Etoposide in Patients with Untreated Extensive-Stage Small-Cell Lung Cancer: Interim Results of the MAURIS Phase IIIb Trial.

Autor:	Bria E; Comprehensive Cancer Center, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy., Morgillo F; Medical Oncology and Haematology, Department of Precision Medicine, University of Campania 'Luigi Vanvitelli,' Naples, Italy., Garassino MC; Department of Hematology/Oncology, The University of Chicago, Chicago, IL, USA., Ciardiello F; Medical Oncology, Department of Precision Medicine, University of Campania Luigi Vanvitelli, Naples, Italy., Ardizzoni A; Division of Medical Oncology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy., Stefani A; Medical Oncology, Università Cattolica del Sacro Cuore, Rome, Italy., Verderame F; Medical Oncology Unit, Ospedale Cervello Villa Sofia, Palermo, Italy., Morabito A; Thoracic Medical Oncology, National Tumor Institute 'Fondazione G Pascale,' IRCCS, Naples, Italy., Chella A; Pneumology Unit, Azienda Ospedaliero Universitaria Pisana, Pisa, Italy., Tonini G; Department of Oncology, Campus Bio-Medico University, Rome, Italy., Gilli M; Unit of Pulmonary Oncology, University of Campania 'L. Vanvitelli,' Monaldi Hospital, Naples, Italy., Del Signore E; Division of Thoracic Oncology, European Institute of Oncology, IRCCS, Milan, Italy., Berardi R; Department of Medical Oncology, Università Politecnica delle Marche, Ancona, Italy., Mencoboni M; Oncology Unit, Villa Scassi Hospital, ASL3-Genovese, Genoa, Italy., Bearz A; Department of Medical Oncology, Centro di Riferimento Oncologico di Aviano (CRO), IRCCS, Aviano, Italy., Delmonte A; IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) 'Dino Amadori,' Meldola, Italy., Migliorino MR; Pulmonary Oncology Unit, Azienda Ospedaliera San Camillo Forlanini Hospital, Rome, Italy., Gridelli C; Division of Medical Oncology, A.O.S.G. Moscati, Avellino, Italy., Pazzola A; Medical Oncology Unit, University Hospital (AOU) of Sassari, Sassari, Italy., Iero M; Medical Dep-Oncology, Roche S.p.A., Monza, Italy., De Marinis F; Thoracic Oncology Division, European Institute of Oncology (IEO), IRCCS, Milan, Italy.
Jazyk:	angličtina
Zdroj:	The oncologist [Oncologist] 2024 May 03; Vol. 29 (5), pp. e690-e698.
DOI:	10.1093/oncolo/oyad342
Abstrakt:	Background: MAURIS is an Italian multicenter, open-label, phase IIIb ongoing trial, aiming at evaluating the safety and effectiveness of atezolizumab + carboplatin/etoposide in patients with newly diagnosed, extensive-stage small-cell lung cancer (ES-SCLC). The primary objective is the safety evaluation. Materials and Methods: Patients received atezolizumab + carboplatin/etoposide Q3W for 4-6 cycles in the induction phase, followed by atezolizumab maintenance Q3W. We presented the interim analysis on safety (referring to the induction phase) and clinical effectiveness, in all patients (N = 154) and in subgroups that received ≤3 (N = 23), 4 (N = 43), and 5-6 cycles (N = 89) of induction. Results: At a median follow-up of 10.5 months, 139 patients (90.3%) discontinued treatment. Serious adverse events occurred in 29.9% of patients overall, and the rate was lower in patients with 5-6 cycles (19.1%) than in those with 4 (34.9%) or ≤3 (63.6%) cycles. Immune-mediated adverse events were reported in 14.9%, 15.7%, 11.6%, and 18.2% of patients, overall and by subgroup, respectively. The median overall survival and progression-free survival were 10.7 and 5.5 months, respectively. Overall, 111 patients (71.6%) had a tumor response. Conclusions: Interim results provide further evidences about safety and efficacy profile of atezolizumab + carboplatin/etoposide treatment in a ES-SCLC patient population closer to that observed in clinical practice. Clinical Trial Registration: Eudract No. 2019-001146-17, NCT04028050. (© The Author(s) 2024. Published by Oxford University Press.)
Databáze:	MEDLINE
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