PMID- 32459597 OWN - NLM STAT- MEDLINE DCOM- 20210215 LR - 20210802 IS - 1527-7755 (Electronic) IS - 0732-183X (Print) IS - 0732-183X (Linking) VI - 38 IP - 22 DP - 2020 Aug 1 TI - Safety and Patient-Reported Outcomes of Atezolizumab Plus Chemotherapy With or Without Bevacizumab Versus Bevacizumab Plus Chemotherapy in Non-Small-Cell Lung Cancer. PG - 2530-2542 LID - 10.1200/JCO.19.03158 [doi] AB - PURPOSE: Atezolizumab, bevacizumab, carboplatin, and paclitaxel (ABCP) demonstrated survival benefit versus bevacizumab, carboplatin, and paclitaxel (BCP) in chemotherapy-naive nonsquamous non-small-cell lung cancer (NSCLC). We present safety and patient-reported outcomes (PROs) to provide additional information on the relative impact of adding atezolizumab to chemotherapy with and without bevacizumab in nonsquamous NSCLC. METHODS: Patients were randomly assigned to receive atezolizumab, carboplatin, and paclitaxel (ACP), ABCP, or BCP. Coprimary end points were overall survival and investigator-assessed progression-free survival. The incidence, nature, and severity of adverse events (AEs) were assessed. PROs, a secondary end point, 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. RESULTS: Overall, 400 (ACP), 393 (ABCP), and 394 (BCP) patients were safety evaluable (ie, intention-to-treat population that received one or more doses of any study treatment). More patients had grade 3/4 treatment-related AEs during the induction versus maintenance phase (ACP, 40.5% v 8.2%; ABCP, 48.6% v 21.2%; BCP, 44.7% v 11.1%). During induction, the incidence of serious AEs (SAEs) was 28.3%, 28.5%, and 26.4% in the ACP, ABCP, and BCP arms, respectively. During maintenance, SAE incidences were 20.0%, 26.3%, and 13.0%, respectively. Completion rates of the PRO questionnaires were > 88% at baseline and remained >/= 70% throughout most study visits. Across arms, patients on average reported no clinically meaningful worsening of global health status or physical functioning scores through cycle 13. Patients across arms rated common symptoms with chemotherapy and immunotherapy similarly. CONCLUSION: ABCP seems tolerable and manageable versus ACP and BCP in first-line nonsquamous NSCLC. Treatment tolerability differed between induction and maintenance phases across treatment arms. PROs reflect a minimal treatment burden (eg, health-related quality of life, symptoms) with each regimen. FAU - Reck, Martin AU - Reck M AD - Lung Clinic Grosshansdorf, Airway Research Center North, German Center of Lung Research, Grosshansdorf, Germany. FAU - Wehler, Thomas AU - Wehler T AD - Evangelisches Krankenhaus Hamm gGmbH, Hamm, Germany. FAU - Orlandi, Francisco AU - Orlandi F AD - Instituto Nacional del Torax, Santiago, Chile. FAU - Nogami, Naoyuki AU - Nogami N AD - National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan. FAU - Barone, Carlo AU - Barone C AD - Universita Cattolica del Sacro Cuore, Rome, Italy. FAU - Moro-Sibilot, Denis AU - Moro-Sibilot D AD - Centre Hospitalier Universitaire de Grenoble Alpes, Grenoble, France. FAU - Shtivelband, Mikhail AU - Shtivelband M AD - Ironwood Cancer & Research Center, Chandler, AZ. FAU - Gonzalez Larriba, Jose Luis AU - Gonzalez Larriba JL AD - Hospital Clinico San Carlos, Madrid, Spain. FAU - Rothenstein, Jeffrey AU - Rothenstein J AD - Durham Regional Cancer Center, Lakeridge Health, Oshawa, Ontario, Canada. FAU - Fruh, Martin AU - Fruh M AD - Cantonal Hospital of St Gallen, St Gallen, Switzerland. AD - University of Bern, Bern, Switzerland. FAU - Yu, Wei AU - Yu W AD - Genentech, South San Francisco, CA. FAU - Deng, Yu AU - Deng Y AD - Genentech, South San Francisco, CA. FAU - Coleman, Shelley AU - Coleman S AD - Genentech, South San Francisco, CA. FAU - Shankar, Geetha AU - Shankar G AD - Genentech, South San Francisco, CA. FAU - Patel, Hina AU - Patel H AD - Genentech, South San Francisco, CA. FAU - Kelsch, Claudia AU - Kelsch C AD - Genentech, South San Francisco, CA. FAU - Lee, Anthony AU - Lee A AD - Genentech, South San Francisco, CA. FAU - Piault, Elisabeth AU - Piault E AD - Genentech, South San Francisco, CA. FAU - Socinski, Mark A AU - Socinski MA AD - AdventHealth Cancer Institute, Orlando, FL. LA - eng SI - ClinicalTrials.gov/NCT02366143 PT - Clinical Trial, Phase III PT - Comparative Study PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20200527 PL - United States TA - J Clin Oncol JT - Journal of clinical oncology : official journal of the American Society of Clinical Oncology JID - 8309333 RN - 0 (Antibodies, Monoclonal, Humanized) RN - 2S9ZZM9Q9V (Bevacizumab) RN - 52CMI0WC3Y (atezolizumab) RN - BG3F62OND5 (Carboplatin) SB - IM MH - Adult MH - Aged MH - Aged, 80 and over MH - Antibodies, Monoclonal, Humanized/administration & dosage MH - Antineoplastic Combined Chemotherapy Protocols/*therapeutic use MH - Bevacizumab/administration & dosage MH - Carboplatin/administration & dosage MH - Carcinoma, Non-Small-Cell Lung/*drug therapy/pathology MH - Female MH - Follow-Up Studies MH - Humans MH - Lung Neoplasms/*drug therapy/pathology MH - Male MH - Middle Aged MH - *Patient Reported Outcome Measures MH - Prognosis MH - *Quality of Life PMC - PMC7392741 EDAT- 2020/05/28 06:00 MHDA- 2021/02/16 06:00 PMCR- 2021/08/01 CRDT- 2020/05/28 06:00 PHST- 2020/05/28 06:00 [pubmed] PHST- 2021/02/16 06:00 [medline] PHST- 2020/05/28 06:00 [entrez] PHST- 2021/08/01 00:00 [pmc-release] AID - 1903158 [pii] AID - 10.1200/JCO.19.03158 [doi] PST - ppublish SO - J Clin Oncol. 2020 Aug 1;38(22):2530-2542. doi: 10.1200/JCO.19.03158. Epub 2020 May 27.