Takeshi Hatanaka1, Satoru Kakizaki2,3, Atsushi Hiraoka4, Toshifumi Tada5, Masashi Hirooka6, Kazuya Kariyama7, Joji Tani8, Masanori Atsukawa9, Koichi Takaguchi10, Ei Itobayashi11, Shinya Fukunishi12, Kunihiko Tsuji13, Toru Ishikawa14, Kazuto Tajiri15, Hironori Ochi16, Satoshi Yasuda17, Hidenori Toyoda17, Chikara Ogawa18, Takashi Nishimura19, Noritomo Shimada20, Kazuhito Kawata21, Hisashi Kosaka22, Takaaki Tanaka4, Hideko Ohama4, Kazuhiro Nouso7, Asahiro Morishita8, Akemi Tsutsui10, Takuya Nagano10, Norio Itokawa9, Tomomi Okubo9, Taeang Arai9, Michitaka Imai14, Atsushi Naganuma23, Yohei Koizumi6, Shinichiro Nakamura5, Masaki Kaibori22, Hiroko Iijima19, Yoichi Hiasa6, Takashi Kumada24. 1. Department of Gastroenterology, Gunma Saiseikai Maebashi Hospital, Kamishindenmachi, Maebashi, Gunma, 564-1, Japan. hatanaka@qk9.so-net.ne.jp. 2. Department of Clinical Research, National Hospital Organization Takasaki General Medical Center, Takasaki, Japan. 3. Department of Gastroenterology and Hepatology, Gunma University Graduate School of Medicine, Maebashi, Japan. 4. Gastroenterology Center, Ehime Prefectural Central Hospital, Matsuyama, Japan. 5. Department of Internal Medicine, Japanese Red Cross Himeji Hospital, Himeji, Japan. 6. Department of Gastroenterology and Metabology, Ehime University Graduate School of Medicine, Ehime, Japan. 7. Department of Gastroenterology, Okayama City Hospital, Okayama, Japan. 8. Department of Gastroenterology and Hepatology, Kagawa University, Kagawa, Japan. 9. Division of Gastroenterology and Hepatology, Department of Internal Medicine, Nippon Medical School, Tokyo, Japan. 10. Department of Hepatology, Kagawa Prefectural Central Hospital, Takamatsu, Japan. 11. Department of Gastroenterology, Asahi General Hospital, Asahi, Japan. 12. Premier Departmental Research of Medicine, Osaka Medical and Pharmaceutical University, Osaka, Japan. 13. Center of Gastroenterology, Teine Keijinkai Hospital, Sapporo, Japan. 14. Department of Gastroenterology, Saiseikai Niigata Hospital, Niigata, Japan. 15. Department of Gastroenterology, Toyama University Hospital, Toyama, Japan. 16. Center for Liver-Biliary-Pancreatic Disease, Matsuyama Red Cross Hospital, Matsuyama, Japan. 17. Department of Gastroenterology and Hepatology, Ogaki Municipal Hospital, Ogaki, Japan. 18. Department of Gastroenterology, Japanese Red Cross Takamatsu Hospital, Takamatsu, Japan. 19. Department of Internal Medicine, Division of Gastroenterology and Hepatology, Hyogo College of Medicine, Nishinomiya, Japan. 20. Division of Gastroenterology and Hepatology, Otakanomori Hospital, Kashiwa, Japan. 21. Hepatology Division, Department of Internal Medicine II, Hamamatsu University School of Medicine, Hamamatsu, Japan. 22. Department of Surgery, Kansai Medical University, Hirakata, Japan. 23. Department of Gastroenterology, National Hospital Organization Takasaki General Medical Center, Takasaki, Japan. 24. Department of Nursing, Gifu Kyoritsu University, Ogaki, Japan.
Abstract
AIM: Predicting the survival of hepatocellular carcinoma (HCC) patients receiving atezolizumab and bevacizumab (Atez/bev) remains a challenge. This study aims to validate the modified albumin-bilirubin grade and α-fetoprotein score (mALF score). METHODS: This retrospective, multicenter study included 426 HCC patients receiving Atez/Bev. Each patient was randomized 3:2 to a training set (n = 255) and a validation set (n = 171). We investigated prognostic factors in the training set and developed an easily applicable mALF score, which was evaluated in the validation set. RESULTS: We built the mALF score using baseline mALBI grade 2b or 3 (HR 2.36, 95% CI 1.37-4.05, p = 0.002) and α-fetoprotein ≥ 100 ng/ml (HR 2.61, 95% CI 1.49-4.55, p < 0.001), which were identified as unfavorable prognostic factors in a multivariate analysis. The 1-year OS rates were 82.7% (95% CI 68.9-90.8) in patients who meet neither of the criteria (mALF 0 points, n = 101), 61.7% (95% CI 44.5-74.9) in patients who meet either of the two criteria (mALF 1 point, n = 109), and 24.6% (95% CI 9.0-44.3) in patients who meet both criteria (mALF 2 points, n = 45); the difference was statistically significant (p < 0.001). The median PFS in patients with mALF 0, 1, and 2 points was 9.5 months (95% CI 4.3-NA), 6.6 months (95% CI 6.0-8.0), and 3.8 months (95% CI 3.0-5.2), respectively, which amounted to a significant difference (p < 0.001). These results were confirmed in the validation set (1-year OS rates, 0/1/2 points = 94.2%/62.1%/46.3%, p < 0.001; median PFS, 0/1/2 points = 9.3/6.7/4.7 months, p = 0.018). CONCLUSION: The mALF score can reliably predict the prognosis of HCC patients receiving Atez/Bev.
AIM: Predicting the survival of hepatocellular carcinoma (HCC) patients receiving atezolizumab and bevacizumab (Atez/bev) remains a challenge. This study aims to validate the modified albumin-bilirubin grade and α-fetoprotein score (mALF score). METHODS: This retrospective, multicenter study included 426 HCC patients receiving Atez/Bev. Each patient was randomized 3:2 to a training set (n = 255) and a validation set (n = 171). We investigated prognostic factors in the training set and developed an easily applicable mALF score, which was evaluated in the validation set. RESULTS: We built the mALF score using baseline mALBI grade 2b or 3 (HR 2.36, 95% CI 1.37-4.05, p = 0.002) and α-fetoprotein ≥ 100 ng/ml (HR 2.61, 95% CI 1.49-4.55, p < 0.001), which were identified as unfavorable prognostic factors in a multivariate analysis. The 1-year OS rates were 82.7% (95% CI 68.9-90.8) in patients who meet neither of the criteria (mALF 0 points, n = 101), 61.7% (95% CI 44.5-74.9) in patients who meet either of the two criteria (mALF 1 point, n = 109), and 24.6% (95% CI 9.0-44.3) in patients who meet both criteria (mALF 2 points, n = 45); the difference was statistically significant (p < 0.001). The median PFS in patients with mALF 0, 1, and 2 points was 9.5 months (95% CI 4.3-NA), 6.6 months (95% CI 6.0-8.0), and 3.8 months (95% CI 3.0-5.2), respectively, which amounted to a significant difference (p < 0.001). These results were confirmed in the validation set (1-year OS rates, 0/1/2 points = 94.2%/62.1%/46.3%, p < 0.001; median PFS, 0/1/2 points = 9.3/6.7/4.7 months, p = 0.018). CONCLUSION: The mALF score can reliably predict the prognosis of HCC patients receiving Atez/Bev.