TY - JOUR
T1 - Development and validation of a modified albumin–bilirubin grade and α-fetoprotein score (mALF score) for hepatocellular carcinoma patients receiving atezolizumab and bevacizumab
AU - On behalf of the Real-life Practice Experts for HCC (RELPEC) Study Group, and HCC 48 Group (hepatocellular carcinoma experts from 48 clinics in Japan)
AU - Hatanaka, Takeshi
AU - Kakizaki, Satoru
AU - Hiraoka, Atsushi
AU - Tada, Toshifumi
AU - Hirooka, Masashi
AU - Kariyama, Kazuya
AU - Tani, Joji
AU - Atsukawa, Masanori
AU - Takaguchi, Koichi
AU - Itobayashi, Ei
AU - Fukunishi, Shinya
AU - Tsuji, Kunihiko
AU - Ishikawa, Toru
AU - Tajiri, Kazuto
AU - Ochi, Hironori
AU - Yasuda, Satoshi
AU - Toyoda, Hidenori
AU - Ogawa, Chikara
AU - Nishimura, Takashi
AU - Shimada, Noritomo
AU - Kawata, Kazuhito
AU - Kosaka, Hisashi
AU - Tanaka, Takaaki
AU - Ohama, Hideko
AU - Nouso, Kazuhiro
AU - Morishita, Asahiro
AU - Tsutsui, Akemi
AU - Nagano, Takuya
AU - Itokawa, Norio
AU - Okubo, Tomomi
AU - Arai, Taeang
AU - Imai, Michitaka
AU - Naganuma, Atsushi
AU - Koizumi, Yohei
AU - Nakamura, Shinichiro
AU - Kaibori, Masaki
AU - Iijima, Hiroko
AU - Hiasa, Yoichi
AU - Kumada, Takashi
N1 - Publisher Copyright:
© 2022, Asian Pacific Association for the Study of the Liver.
PY - 2023/2
Y1 - 2023/2
N2 - 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.
AB - 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.
KW - Atezolizumab
KW - Bevacizumab
KW - Child–Pugh class
KW - Immune checkpoint inhibitor
KW - Liver function
KW - Oncology
KW - Prognosis
KW - mALBI grade
KW - mALF score
KW - α-fetoprotein
UR - http://www.scopus.com/inward/record.url?scp=85137870012&partnerID=8YFLogxK
U2 - 10.1007/s12072-022-10406-8
DO - 10.1007/s12072-022-10406-8
M3 - 学術論文
C2 - 36076009
AN - SCOPUS:85137870012
SN - 1936-0533
VL - 17
SP - 86
EP - 96
JO - Hepatology International
JF - Hepatology International
IS - 1
ER -