Safety and Patient-Reported outcomes of atezolizumab plus chemotherapy with or without bevacizumab in stage IIIB/IV non-squamous non-small cell lung cancer with EGFR mutation, ALK rearrangement or ROS1 fusion progressing after targeted therapies (GFPC 06-2018 study).

BACKGROUND

In an open-label multicenter non-randomized non-comparative phase II study in patients with stage IIIB/IV non-squamous non-small cell lung cancer (NSCLC), oncogenic addiction (EGFR mutation or ALK/ROS1 fusion), with disease progression after tyrosine-kinase inhibitor and no prior chemotherapy (NCT04042558), atezolizumab, carboplatin, pemetrexed with or without bevacizumab showed some promising result. Beyond the clinical evaluation, we assessed safety and patient-reported outcomes (PROs) to provide additional information on the relative impact of adding atezolizumab to chemotherapy with and without bevacizumab in this population.

MATERIALS

Patients received platinum-pemetrexed-atezolizumab-bevacizumab (PPAB cohort) or, if not eligible, platinum-pemetrexed-atezolizumab (PPA cohort). The incidence, nature, and severity of adverse events (AEs) were assessed. PROs were evaluated using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-Core 30 and EORTC QLQ-Lung Cancer 13).

RESULT

Overall, 68 (PPAB) and 72 (PPA) patients were evaluable for safety. Grade 3-4 AEs occurred in 83.8% (PPAB) and 63.9% (PPA). Grade 3-4 atezolizumab-related AEs occurred in 29.4% and 19.4%, respectively. Grade 3-4 bevacizumab-related AEs occurred in 36.8% (PPAB). Most frequent grade 3-4 AEs were neutropenia (19.1% in PPAB; 23.6% in PPA) and asthenia (16.2% in PPAB; 9.7% in PPA). In PPAB, we observed a global stability in global health security (GHS) score, fatigue and dyspnea with a constant tendency of improvement, and a significant improvement in cough. In PPA, we observed a significant improvement in GHS score with a significant improvement in fatigue, dyspnea and cough. At week 54, we observed an improvement from baseline in GHS score for 49.2% of patients. In both cohorts, patients reported on average no clinically significant worsening in their overall health or physical functioning scores.

CONCLUSION

PPAB and PPA combinations seem tolerable and manageable in patients with stage IIIB/IV non-squamous NSCLC with oncogenic addiction (EGFR mutation or ALK/ROS1 fusion) after targeted therapies.

Informations de copyright

Copyright © 2024 The Author(s). Published by Elsevier B.V. All rights reserved.

Déclaration de conflit d'intérêts

Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: P.T report adviser and consultant for TAKEDA, BMS, ROCHE, JANSSENS, AMGEN and ASTRA ZENECA; support for attending meeting for TAKEDA, BMS, ASTRA ZENECA and JANSSENS. G.R-B report adviser and consultant for TAKEDA, ASTRA ZENECA,SANOFI, BMS ; support for attending meeting for LILLY, ASTRA ZENECA, PFIZER, SANOGI, TAKEDA, BOEHRINGER. L.B-G report adviser and consultant for BMS, MSD, ROCHE, JANSSEN, TAKEDA, VIATRIS, ASTRA-ZENECA, SANOFI and LEOPHARMA; support for attending meeting for JANSSEN, TAKEDA, ASTRA-ZENECA,MSD. D.A report support for attending meeting for MSD, TAKEDA, SANOFI. H.M report support for attending meeting for ARAIR, MSD, PFIZER, TAKEDA and BOEHRINGER. R.V report adviser and consultant for MSD, JANSSEN, ROCHE, BMS, PFIZER, SANOFI and TAKEDA; support for attending meeting for JANSSEN, TAKEDA and SANOFI. G.J report support for attending meeting for Sanofi. P.F report adviser and consultant for SANOFI, MSD and ASTRA ZENECA; support for attending meeting for TAKEDA. A.V report adviser and consultant for PIERRE FABRE, AMGEN and MSD; support for attending meeting for PIERRE FABRE, AMGEN; Participation on “Data Safety Monitoring Board or Advisory Board ” for MSD, ASTRAZENECA, SANOFI, AMGEN, PIERRE FABRE. A.B report support for attending meeting for Takeda, Sanofi and BMS. F.S report adviser and consultant for; support for attending meeting for report adviser and consultant for; support for attending meeting for C.D report adviser and consultant for BMS, MSD, TAKEDA, AMGEN, ROCHE, PFIZER, SANOFI, JANSSEN; support for attending meeting for ROCHE, AMGEN , MSD, TAKEDA. C.C reports research support from AstraZeneca, Boerhinger, GSK, Sanofi, BMS, MSD, Lilly, Novartis, Pfizer, Takeda, Bayer and Amgen; adviser and consultant for AstraZeneca, Boerhinger, GSK, Roche, Sanofi , BMS, MSD, Lilly, Novartis, Pfizer, Takeda, Bayer and Amgen ; support for attending meeting for AstraZeneca, Boerhinger, GSK, Roche, Sanofi , BMS, MSD, Lilly, Novartis, Pfizer, Takeda, Bayer and Amgen; L.G. reports research support from BMS, MSD, Amgen, Lilly, Novartis, Pfizer, Roche, Sanofi and Takeda, adviser and consultant for Amgen, Janssens, BMS, Lilly, MSD, Novartis, Pfizer, Roche, Sanofi and Takeda; support for attending meeting for AstraZeneca, Amgen, MSD, Pfizer and Takeda. Participation on “Data Safety Monitoring Board or Advisory Board ” for Inhatarget Therapeutics; O.B reports adviser and consultant for BMS, AstraZeneca, Roche, MSD, Takeda, Janssens, support for attending meeting for AstraZeneca and MSD. All other authors (L.A,E.D, C.R, E.H, F.S, B.C) have declared no conflicts of interest.