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 Ohama12, Kazuhiro Nouso7, Asahiro Morishita8, Akemi Tsutsui10, Takuya Nagano10, Norio Itokawa9, Tomomi Okubo9, Taeang Arai9, Michitaka Imai14, Atsushi Naganuma23, Yohei Koizumi6, Shinichiro Nakamura5, Kouji Joko16, Masaki Kaibori22, Hiroko Iijima19, Yoichi Hiasa6, Takashi Kumada24. 1. Department of Gastroenterology, Gunma Saiseikai Maebashi Hospital, Kamishindenmachi 564-1, Maebashi, Gunma, 371-0821, 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, Gunma, 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: This study aimed to investigate the utility of C-reactive protein (CRP) and alpha-fetoprotein (AFP) in immunotherapy (CRAFITY) score in hepatocellular carcinoma (HCC) patients receiving atezolizumab and bevacizumab (Atez/Bev). METHODS: This retrospective cohort study included a total of 297 patients receiving Atez/Bev from September 2020 to November 2021 at 21 different institutions and hospital groups in Japan. Patients with AFP ≥ 100 ng/mL and those with CRP ≥ 1 mg/dL were assigned a CRAFITY score of 1 point. RESULTS: The patients were assigned CRAFITY scores of 0 points (n = 147 [49.5%]), 1 point (n = 111 [37.4%]), and 2 points (n = 39 [13.1%]). AFP ≥ 100 ng/mL and CRP ≥ 1.0 mg/dL were significantly associated with progression-free survival (PFS) and overall survival (OS). The median PFS in the CRAFITY score 0, 1, and 2 groups was 11.8 months (95% confidence interval [CI] 6.4-not applicable [NA]), 6.5 months (95% CI 4.6-8.0), and 3.2 months (95% CI 1.9-5.0), respectively (p < 0.001). The median OS in patients with CRAFITY score 0, 1 and 2 was not reached, 14.3 months (95% CI 10.5-NA), and 11.6 months (95% CI 4.9-NA), respectively. The percentage of patients with grade ≥ 3 liver injury, any grade of decreased appetite, any grade of proteinuria, any grade of fever, and any grade of fatigue was lowest in patients with a CRAFITY score of 0, followed by patients with CRAFITY scores of 1 and 2. CONCLUSIONS: The CRAFITY score is simple and could be useful for predicting therapeutic outcomes and treatment-related adverse events.
AIM: This study aimed to investigate the utility of C-reactive protein (CRP) and alpha-fetoprotein (AFP) in immunotherapy (CRAFITY) score in hepatocellular carcinoma (HCC) patients receiving atezolizumab and bevacizumab (Atez/Bev). METHODS: This retrospective cohort study included a total of 297 patients receiving Atez/Bev from September 2020 to November 2021 at 21 different institutions and hospital groups in Japan. Patients with AFP ≥ 100 ng/mL and those with CRP ≥ 1 mg/dL were assigned a CRAFITY score of 1 point. RESULTS: The patients were assigned CRAFITY scores of 0 points (n = 147 [49.5%]), 1 point (n = 111 [37.4%]), and 2 points (n = 39 [13.1%]). AFP ≥ 100 ng/mL and CRP ≥ 1.0 mg/dL were significantly associated with progression-free survival (PFS) and overall survival (OS). The median PFS in the CRAFITY score 0, 1, and 2 groups was 11.8 months (95% confidence interval [CI] 6.4-not applicable [NA]), 6.5 months (95% CI 4.6-8.0), and 3.2 months (95% CI 1.9-5.0), respectively (p < 0.001). The median OS in patients with CRAFITY score 0, 1 and 2 was not reached, 14.3 months (95% CI 10.5-NA), and 11.6 months (95% CI 4.9-NA), respectively. The percentage of patients with grade ≥ 3 liver injury, any grade of decreased appetite, any grade of proteinuria, any grade of fever, and any grade of fatigue was lowest in patients with a CRAFITY score of 0, followed by patients with CRAFITY scores of 1 and 2. CONCLUSIONS: The CRAFITY score is simple and could be useful for predicting therapeutic outcomes and treatment-related adverse events.
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