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)

Autor: Derek-Zhen Xu, Ann-Lii Cheng, Juan Liu, Masatoshi Kudo, Shukui Qin, Masafumi Ikeda, Philippe Merle, Richard S. Finn, Valeriy Breder, Wendy Verret, Ahmed Kaseb, Sohail Mulla, Michel Ducreux, Chen Huang, Daneng Li, Tae-You Kim, Peter R. Galle, Andrew X. Zhu, Sairy Hernandez, Ho Yeong Lim
Rok vydání: 2020
Předmět:
Zdroj: Journal of Clinical Oncology. 38:476-476
ISSN: 1527-7755
0732-183X
DOI: 10.1200/jco.2020.38.4_suppl.476
Popis: 476 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.
Databáze: OpenAIRE
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