A safety and patient-reported outcome analysis from the IMpower150 trial, reported in the Journal of Clinical Oncology by Martin Reck, PhD, and colleagues, indicated that atezolizumab plus bevacizumab and chemotherapy appeared to be a manageable and tolerable regimen when compared with atezolizumab or bevacizumab plus chemotherapy in chemotherapy-naive patients with metastatic nonsquamous non–small cell lung cancer (NSCLC).
“Atezolizumab/bevacizumab/carboplatin/paclitaxel seems tolerable and manageable vs atezolizumab/carboplatin/paclitaxel and bevacizumab/carboplatin/paclitaxel in first-line nonsquamous NSCLC. Treatment tolerability differed between induction and maintenance phases across treatment arms. Patient-reported outcomes reflect a minimal treatment burden (eg, health-related quality of life, symptoms) with each regimen.”— Martin Reck, PhD, and colleagues
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The trial showed significantly improved progression-free and overall survival with atezolizumab/bevacizumab/carboplatin/paclitaxel vs bevacizumab/carboplatin/paclitaxel in the subpopulation of patients without EGFR or ALK genetic alterations, supporting the December 2018 U.S. Food and Drug Administration approval of atezolizumab plus bevacizumab/carboplatin/paclitaxel in this setting.
Study Details
In the total population of the trial, patients were randomly assigned to receive atezolizumab/carboplatin/paclitaxel, atezolizumab/bevacizumab/carboplatin/paclitaxel, or bevacizumab/carboplatin/paclitaxel, with 400, 393, and 394 patients, respectively, constituting the safety evaluable population. Severe and serious adverse event rates among the three regimens were compared, and patient-reported outcomes were assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-Core 30 and EORTC QLQ-Lung Cancer 13.
Key Findings
During the induction phase (four or six 21-day cycles including all components of treatment), grade 3 or 4 treatment-related adverse events occurred in 48.6% of patients in the atezolizumab/bevacizumab/carboplatin/paclitaxel group, 40.5% of the atezolizumab/carboplatin/paclitaxel group, and 21.2% of the bevacizumab/carboplatin/paclitaxel group.
During the maintenance phase with continued atezolizumab, bevacizumab, or both, treatment-related grade 3 or 4 adverse events occurred in 21.2% of patients in the atezolizumab/bevacizumab/carboplatin/paclitaxel group, 8.2% of the atezolizumab/carboplatin/paclitaxel group, and 11.1% of the bevacizumab/carboplatin/paclitaxel group.
During induction, serious adverse events occurred in 28.5%, 28.3%, and 26.4% of the three groups, respectively. During maintenance, serious adverse events occurred in 26.3%, 20.0%, and 13.0%, respectively.
The overall incidence of discontinuation of any study treatment due to adverse events was 33.8%, 13.3%, and 24.9%.
For patient-reported outcomes, patients on average did not report clinically meaningful worsening of global health status or physical functioning scores at any point through cycle 13 in any treatment group. Average global health status and physical functioning scores remained generally similar during induction, with physical functioning showing a trend toward improvement during maintenance. Mean global health status and physical functioning scores were generally similar in the atezolizumab/bevacizumab/carboplatin/paclitaxel and bevacizumab/carboplatin/paclitaxel groups across all time points. Among all treatment groups, patients reported similar ratings for common symptoms with chemotherapy and immunotherapy.
The investigators concluded, “Atezolizumab/bevacizumab/carboplatin/paclitaxel seems tolerable and manageable vs atezolizumab/carboplatin/paclitaxel and bevacizumab/carboplatin/paclitaxel in first-line nonsquamous NSCLC. Treatment tolerability differed between induction and maintenance phases across treatment arms. Patient-reported outcomes reflect a minimal treatment burden (eg, health-related quality of life, symptoms) with each regimen.”
Dr. Reck, of LungenClinic Grosshansdorf, German Centre for Lung Research, Grosshansdorf, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: The study was supported by F. Hoffmann-La Roche and Genentech. For full disclosures of the study authors, visit ascopubs.org.
