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- Title
Atezolizumab Plus Carboplatin and Etoposide in Patients with Untreated Extensive-Stage Small-Cell Lung Cancer: Interim Results of the MAURIS Phase IIIb Trial.
- Authors
Bria, Emilio; Morgillo, Floriana; Garassino, Marina Chiara; Ciardiello, Fortunato; Ardizzoni, Andrea; Stefani, Alessio; Verderame, Francesco; Morabito, Alessandro; Chella, Antonio; Tonini, Giuseppe; Gilli, Marina; Signore, Ester Del; Berardi, Rossana; Mencoboni, Manlio; Bearz, Alessandra; Delmonte, Angelo; Migliorino, Marta Rita; Gridelli, Cesare; Pazzola, Antonio; Iero, Manuela
- Abstract
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.
- Subjects
THERAPEUTIC use of monoclonal antibodies; PATIENT safety; RESEARCH funding; TERMINATION of treatment; CARBOPLATIN; TREATMENT effectiveness; DESCRIPTIVE statistics; ETOPOSIDE; DRUG efficacy; RESEARCH; TUMOR classification; LUNG cancer; COMPARATIVE studies; PROGRESSION-free survival; OVERALL survival
- Publication
Oncologist, 2024, Vol 29, Issue 5, pe690
- ISSN
1083-7159
- Publication type
Article
- DOI
10.1093/oncolo/oyad342