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Early response and safety of atezolizumab plus bevacizumab for unresectable hepatocellular carcinoma in patients who do not meet IMbrave150 eligibility criteria
Author(s) -
Sho Takuya,
Suda Goki,
Ogawa Koji,
Kimura Megumi,
Kubo Akinori,
Tokuchi Yoshimasa,
Kitagataya Takashi,
Maehara Osamu,
Ohnishi Shunsuke,
Shigesawa Taku,
Nakamura Akihisa,
Yamada Ren,
Ohara Masatsugu,
Kawagishi Naoki,
Natsuizaka Mitsuteru,
Nakai Masato,
Morikawa Kenichi,
Furuya Ken,
Baba Masaru,
Yamamoto Yoshiya,
Suzuki Kazuharu,
Izumi Takaaki,
Meguro Takashi,
Terashita Katsumi,
Ito Jun,
Miyagishima Takuto,
Sakamoto Naoya
Publication year - 2021
Publication title -
hepatology research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.123
H-Index - 75
eISSN - 1872-034X
pISSN - 1386-6346
DOI - 10.1111/hepr.13693
Subject(s) - atezolizumab , medicine , bevacizumab , hepatocellular carcinoma , adverse effect , gastroenterology , oncology , surgery , cancer , chemotherapy , immunotherapy , pembrolizumab
Aim A clinical trial (IMbrave150) indicated the efficacy and safety of atezolizumab plus bevacizumab for patients with unresectable hepatocellular carcinoma (HCC). In this study, we evaluated this therapeutic combination in a real‐world setting, with a focus on patients who did not meet the IMbrave150 eligibility criteria. Methods In this multicenter study, patients with unresectable HCC treated with atezolizumab plus bevacizumab between October 2020 and May 2021 were screened. In patients who did not meet IMbrave150 eligibility criteria, treatment responses and safety at 6 and 12 weeks were evaluated. Results Atezolizumab plus bevacizumab was initiated in 64 patients, including 46 patients (71.9%) who did not meet IMbrave150 eligibility criteria. Most of these patients had a history of systemic therapy (44/46). The objective response rate and disease control rate observed using Response Evaluation Criteria in Solid Tumors 1.1 were 5.2% and 82.8% at 6 weeks and 10.0% and 84.0% at 12 weeks, respectively; these rates were similar between patients who met and did not meet the IMbrave150 criteria. Ten patients experienced progressive disease (PD) at 6 weeks. Portal vein tumor thrombosis was significantly associated with PD ( p = 0.039); none of the 15 patients with hepatitis B virus‐related HCC experienced PD ( p = 0.050). The most common adverse events of grade 3 or higher were aspartate aminotransferase elevation ( n = 8, 13.8%) and the safety profile was similar between patients who met and did not meet the IMbrave150 criteria. Conclusion Most patients treated with atezolizumab plus bevacizumab did not meet the IMbrave150 criteria; however, the combination therapy showed good safety and efficacy at the early treatment phase.