Meeting
2020 Gastrointestinal Cancers Symposium
Patient-reported outcomes (PROs) from the Phase III IMbrave150 trial of atezolizumab (atezo) + bevacizumab (bev) vs sorafenib (sor) as first-line treatment (tx) for patients (pts) with unresectable hepatocellular carcinoma (HCC).
Authors
Peter R. Galle
University Medical Center Mainz, Mainz, Germany
Peter R. Galle , Richard S. Finn , Shukui Qin , Masafumi Ikeda , Andrew X. Zhu , Tae-You Kim , Masatoshi Kudo , Valeriy Vladimirovich Breder , Philippe Merle , Ahmed Omar Kaseb , Daneng Li , Sohail Mulla , Wendy Verret , Derek-Zhen Xu , Sairy Hernandez , Juan Liu , Chen Huang , Ho Yeong Lim , Ann-Lii Cheng , Michel Ducreux
Organizations
University Medical Center Mainz, Mainz, Germany, University of California Los Angeles, Los Angeles, CA, People's Liberation Army Cancer Center, Nanjing, China, National Cancer Center Hospital East, Kashiwa, Japan, Massachusetts General Hospital, Boston, MA, Department of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, South Korea, Kindai University Faculty of Medicine, Osaka, Japan, Russian Oncological Research Center, N.N. Blokhin of Ministry of Health, Moscow, Russian Federation, Lyon University, Lyon, France, The University of Texas MD Anderson Cancer Center, Houston, TX, City of Hope National Medical Center, Duarte, CA, Genentech, Inc., South San Francisco, CA, Roche Product Development, Shanghai, China, Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Seoul, South Korea, National Taiwan University Hospital and National Taiwan University Cancer Center, Taipei, Taiwan, Gustave Roussy Cancer Campus Grand Paris, Villejuif, France
Research Funding
Pharmaceutical/Biotech Company
F. Hoffmann-La Roche, Ltd
Background: Atezo + bev in pts with unresectable HCC who had not received prior systemic therapy has shown statistically significant and clinically meaningful improvement in OS and PFS per independent review facility-assessed RECIST 1.1 vs sor in the Phase III IMbrave150 study (Cheng ESMO Asia 2019). Here, we report PRO data from this trial to show pt perspectives on the overall clinical benefit of atezo + bev. Methods: Pts were randomized 2:1 to receive either atezo 1200 mg IV q3w + bev 15 mg/kg IV q3w or sor 400 mg PO BID until loss of clinical benefit or unacceptable toxicity. Pts completed the EORTC QLQ-C30 and EORTC QLQ-HCC18 questionnaires before tx, every 3 wk on tx, and every 3 mo after tx discontinuation or disease progression. A pre-specified secondary endpoint was time to deterioration (TTD; first ≥ 10-point decrease from baseline held for 2 consecutive assessments or 1 assessment followed by death within 3 wk) of pt-reported quality of life (QOL), physical functioning, and role functioning. Pre-specified exploratory analyses included TTD of and proportion of pts with a clinically meaningful change (≥ 10 points from baseline) in key pt-reported symptoms. Results: Questionnaire completion rates were ≥ 92% in both arms from baseline through most of the tx period. Compared with sor, atezo + bev delayed TTD of pt-reported QOL (median TTD, 11.2 vs 3.6 mo; HR, 0.63 [95% CI: 0.46, 0.85]), physical functioning (median TTD, 13.1 vs 4.9 mo; HR, 0.53 [95% CI: 0.39, 0.73]), and role functioning (median TTD, 9.1 vs 3.6 mo; HR, 0.62 [95% CI: 0.46, 0.84]). Atezo + bev also delayed TTD in pt-reported appetite loss, fatigue, pain, and diarrhea vs sor; a lower proportion of pts on atezo + bev experienced clinically meaningful deterioration in each of these symptoms vs sor. Conclusions: High-quality PRO results from IMbrave150 showed large and consistent benefits in key aspects of the pt experience with atezo + bev, further supporting its overall clinical benefit in pts with unresectable HCC who have not received prior systemic therapy. Clinical trial information: NCT03434379
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Abstract Details
Session Type
Oral Abstract Session
Session Title
Oral Abstract Session B: Hepatobiliary Cancer, Neuroendocrine/Carcinoid, Pancreatic Cancer, and Small Bowel Cancer
Track
Hepatobiliary Cancer,Neuroendocrine/Carcinoid,Pancreatic Cancer,Small Bowel Cancer,Other GI Cancer
Sub Track
Patient-Reported Outcomes and Real-World Evidence
Clinical Trial Registration Number
NCT03434379
Citation
J Clin Oncol 38, 2020 (suppl 4; abstr 476)
Abstract #
476
Abstract Disclosures
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