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.This analysis is based on interim data from the MAURIS study, an Italian multicenter, phase IIIb ongoing trial to evaluate treatment with atezolizumab plus carboplatin/etoposide in patients with newly diagnosed extensive-stage small-cell lung cancer.

Bria, E., Morgillo, F., Garassino, M. C., Ciardiello, F., Ardizzoni, A., Stefani, A., Verderame, F., Morabito, A., Chella, A., Tonini, G., Gilli, M., Del Signore, E., Berardi, R., Mencoboni, M., Bearz, A., Delmonte, A., Migliorino, M. R., Gridelli, C., Pazzola, A., Iero, M., De Marinis, F., Atezolizumab Plus Carboplatin and Etoposide in Patients with Untreated Extensive-Stage Small-Cell Lung Cancer: Interim Results of the MAURIS Phase IIIb Trial, <<THE ONCOLOGIST>>, 2024; (Feb): N/A-N/A. [doi:10.1093/oncolo/oyad342] [https://hdl.handle.net/10807/273486]

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

Bria, Emilio;Stefani, Alessio;
2024

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.This analysis is based on interim data from the MAURIS study, an Italian multicenter, phase IIIb ongoing trial to evaluate treatment with atezolizumab plus carboplatin/etoposide in patients with newly diagnosed extensive-stage small-cell lung cancer.
2024
Inglese
Bria, E., Morgillo, F., Garassino, M. C., Ciardiello, F., Ardizzoni, A., Stefani, A., Verderame, F., Morabito, A., Chella, A., Tonini, G., Gilli, M., Del Signore, E., Berardi, R., Mencoboni, M., Bearz, A., Delmonte, A., Migliorino, M. R., Gridelli, C., Pazzola, A., Iero, M., De Marinis, F., Atezolizumab Plus Carboplatin and Etoposide in Patients with Untreated Extensive-Stage Small-Cell Lung Cancer: Interim Results of the MAURIS Phase IIIb Trial, <<THE ONCOLOGIST>>, 2024; (Feb): N/A-N/A. [doi:10.1093/oncolo/oyad342] [https://hdl.handle.net/10807/273486]
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