Atsushi Hiraoka1, Takashi Kumada2, Toshifumi Tada3, Masashi Hirooka4, Kazuya Kariyama5, Joji Tani6, Masanori Atsukawa7, Koichi Takaguchi8, Ei Itobayashi9, Shinya Fukunishi10, Kunihiko Tsuji11, Toru Ishikawa12, Kazuto Tajiri13, Hironori Ochi14, Satoshi Yasuda15, Hidenori Toyoda15, Chikara Ogawa16, Takashi Nishimura17, Takeshi Hatanaka18, Satoru Kakizaki19, Noritomo Shimada20, Kazuhito Kawata21, Atsushi Naganuma22, Takaaki Tanaka1, Hideko Ohama10, Kazuhiro Nouso5, Asahiro Morishita6, Akemi Tsutsui8, Takuya Nagano8, Norio Itokawa7, Tomomi Okubo7, Taeang Arai7, Michitaka Imai12, Yohei Koizumi4, Shinichiro Nakamura3, Kouji Joko14, Hiroko Iijima17, Yoichi Hiasa4, Masatoshi Kudo23. 1. Gastroenterology Center, Ehime Prefectural Central Hospital, Matsuyama, Japan. 2. Department of Nursing, Gifu Kyoritsu University, Ogaki, Japan. 3. Department of Internal Medicine, Japanese Red Cross Himeji Hospital, Himeji, Japan. 4. Department of Gastroenterology and Metabology, Ehime University Graduate School of Medicine, Ehime, Japan. 5. Department of Gastroenterology, Okayama City Hospital, Okayama, Japan. 6. Department of Gastroenterology and Hepatology, Kagawa University, Kagawa, Japan. 7. Division of Gastroenterology and Hepatology, Department of Internal Medicine, Nippon Medical School, Tokyo, Japan. 8. Department of Hepatology, Kagawa Prefectural Central Hospital, Takamatsu, Japan. 9. Department of Gastroenterology, Asahi General Hospital, Asahi, Japan. 10. Department of Gastroenterology, Osaka Medical College, Osaka, Japan. 11. Center of Gastroenterology, Teine Keijinkai Hospital, Sapporo, Japan. 12. Department of Gastroenterology, Saiseikai Niigata Hospital, Niigata, Japan. 13. Department of Gastroenterology, Toyama University Hospital, Toyama, Japan. 14. Hepato-Biliary Center, Japanese Red Cross Matsuyama Hospital, Matsuyama, Japan. 15. Department of Gastroenterology and Hepatology, Ogaki Municipal Hospital, Ogaki, Japan. 16. Department of Gastroenterology, Japanese Red Cross Takamatsu Hospital, Takamatsu, Japan. 17. Department of Internal Medicine, Division of Gastroenterology and Hepatology, Hyogo College of Medicine, Nishinomiya, Japan. 18. Department of Gastroenterology, Saiseikai Maebashi Hospital, Gunma, Japan. 19. Department of Clinical Research, National Hospital Organization Takasaki General Medical Center, Takasaki, Japan. 20. Division of Gastroenterology and Hepatology, Otakanomori Hospital, Kashiwa, Japan. 21. Department of Hepatology, Hamamatsu University School of Medicine, Hamamatsu, Japan. 22. Department of Gastroenterology, National Hospital Organization Takasaki General Medical Center, Takasaki, Japan. 23. Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka, Japan.
Abstract
BACKGROUND/AIM: Although systemic therapy is recommended for patients with multiple intermediate stage unresectable hepatocellular carcinoma (u-HCC) classified as beyond the up-to-7 criteria (UT-7 out/multiple) as a transcatheter arterial chemoembolization (TACE) unsuitable condition, few reports have examined the therapeutic efficacy of atezolizumab plus bevacizumab combination therapy (Atez/Bev) in such cases. This study aimed to elucidate the therapeutic response of Atez/Bev in u-HCC patients classified as UT-7 out/multiple. MATERIAL/ METHODS: From September 2020 to September 2021, 95 u-HCC Japanese patients classified as UT-7 out/multiple/Child-Pugh A were enrolled from 21 institutions (median age 76 years, males 73, Child-Pugh 5:6 = 68:27, TNM stage II:III = 17:78). Therapeutic response was retrospectively evaluated using Response Evaluation Criteria in Solid Tumors (RECIST), ver. 1.1 and modified RECIST (mRECIST). RESULTS: Atez/Bev was given as first-line treatment to 52 (54.7%). Objective response rate (ORR)/disease control rate (DCR) at six weeks of RECIST and mRECIST were 17.7%/84.7% and 42.5%/86.2%, respectively. Median PFS was 8.0 months (median observation period: 6.0 months). Child-Pugh A/modified Albumin-bilirubin grade (mALBI) 1 and 2a at baseline, 3, 6, and 9 weeks, were 100%/69.4%, 89.8%/57.3%, 94.8%/65.3%, and 91.4%/60.0%, respectively. Among adverse events (any-grade, >10%) during the present observation period, general fatigue was most frequent (23.2%), followed by urine protein (21.1%), appetite loss (20.0%), and hypertension (13.7%). CONCLUSION: Atez/Bev treatment showed favorable therapeutic response with less influence on hepatic function, suggesting it as a useful therapeutic option for patients with such condition.
BACKGROUND/AIM: Although systemic therapy is recommended for patients with multiple intermediate stage unresectable hepatocellular carcinoma (u-HCC) classified as beyond the up-to-7 criteria (UT-7 out/multiple) as a transcatheter arterial chemoembolization (TACE) unsuitable condition, few reports have examined the therapeutic efficacy of atezolizumab plus bevacizumab combination therapy (Atez/Bev) in such cases. This study aimed to elucidate the therapeutic response of Atez/Bev in u-HCC patients classified as UT-7 out/multiple. MATERIAL/ METHODS: From September 2020 to September 2021, 95 u-HCC Japanese patients classified as UT-7 out/multiple/Child-Pugh A were enrolled from 21 institutions (median age 76 years, males 73, Child-Pugh 5:6 = 68:27, TNM stage II:III = 17:78). Therapeutic response was retrospectively evaluated using Response Evaluation Criteria in Solid Tumors (RECIST), ver. 1.1 and modified RECIST (mRECIST). RESULTS: Atez/Bev was given as first-line treatment to 52 (54.7%). Objective response rate (ORR)/disease control rate (DCR) at six weeks of RECIST and mRECIST were 17.7%/84.7% and 42.5%/86.2%, respectively. Median PFS was 8.0 months (median observation period: 6.0 months). Child-Pugh A/modified Albumin-bilirubin grade (mALBI) 1 and 2a at baseline, 3, 6, and 9 weeks, were 100%/69.4%, 89.8%/57.3%, 94.8%/65.3%, and 91.4%/60.0%, respectively. Among adverse events (any-grade, >10%) during the present observation period, general fatigue was most frequent (23.2%), followed by urine protein (21.1%), appetite loss (20.0%), and hypertension (13.7%). CONCLUSION: Atez/Bev treatment showed favorable therapeutic response with less influence on hepatic function, suggesting it as a useful therapeutic option for patients with such condition.