TY - JOUR
T1 - Outcomes of patients with hepatocellular carcinoma treated with atezolizumab plus bevacizumab in real-world clinical practice who met or did not meet the inclusion criteria for the phase 3 IMbrave150 trial
AU - the Real-life Practice Experts for HCC (RELPEC) Study Group
AU - the Hepatocellular Carcinoma Experts from 48 clinics in Japan (HCC 48) Group
AU - Tada, Toshifumi
AU - Kumada, Takashi
AU - Hiraoka, Atsushi
AU - Hirooka, Masashi
AU - Kariyama, Kazuya
AU - Tani, Joji
AU - Atsukawa, Masanori
AU - Takaguchi, Koichi
AU - Itobayashi, Ei
AU - Fukunishi, Shinya
AU - Nishikawa, Hiroki
AU - Tsuji, Kunihiko
AU - Ishikawa, Toru
AU - Tajiri, Kazuto
AU - Koshiyama, Yuichi
AU - Toyoda, Hidenori
AU - Ogawa, Chikara
AU - Hatanaka, Takeshi
AU - Kakizaki, Satoru
AU - Kawata, Kazuhito
AU - Ohama, Hideko
AU - Tada, Fujimasa
AU - Nouso, Kazuhiro
AU - Morishita, Asahiro
AU - Tsutsui, Akemi
AU - Nagano, Takuya
AU - Itokawa, Norio
AU - Okubo, Tomomi
AU - Arai, Taeang
AU - Nishimura, Takashi
AU - Imai, Michitaka
AU - Kosaka, Hisashi
AU - Naganuma, Atsushi
AU - Matono, Tomomitsu
AU - Aoki, Tomoko
AU - Kuroda, Hidekatsu
AU - Yata, Yutaka
AU - Koizumi, Yohei
AU - Nakamura, Shinichiro
AU - Enomoto, Hirayuki
AU - Kaibori, Masaki
AU - Hiasa, Yoichi
AU - Kudo, Masatoshi
N1 - Publisher Copyright:
© 2024 John Wiley & Sons Ltd.
PY - 2024/7
Y1 - 2024/7
N2 - Background: Atezolizumab plus bevacizumab (Atezo/Bev) is frequently selected as the primary systemic therapy for hepatocellular carcinoma (HCC). Aims: To investigate the outcomes of patients with HCC treated with Atezo/Bev in a real-world setting based on whether they met the inclusion criteria for the phase 3 IMbrave150 trial. Methods: A total of 936 patients were enrolled. There were 404 patients who met the inclusion criteria of the phase 3 IMbrave150 trial (IMbrave150 group) and 532 who did not (non-IMbrave150 group). Results: Median progression-free survival (PFS) in the IMbrave150 and non-IMbrave150 groups was 7.4 months and 5.6 months (p = 0.002). Multivariable analysis revealed that non-B, non-C HCC aetiology (hazard ratio [HR], 1.173), α-fetoprotein ≥100 ng/mL (HR, 1.472), Barcelona Clinic Liver Cancer stage ≥ C (HR, 1.318), and modified albumin–bilirubin (mALBI) grade 2b or 3 (HR, 1.476) are independently associated with PFS. Median overall survival (OS) in the IMbrave150 and non-Imbrave150 groups was 26.5 and 18.8 months (p < 0.001). Multivariable analysis revealed that Eastern Cooperative Oncology Group performance status ≥2 (HR, 1.986), α-fetoprotein ≥100 ng/mL (HR, 1.481), and mALBI grade 2b or 3 (HR, 2.037) are independently associated with OS. In subgroup analysis, there were no significant differences in PFS or OS between these groups among patients with mALBI grade 1 or 2a. Conclusions: Patients who are treated with Atezo/Bev and meet the inclusion criteria for the phase 3 IMbrave150 trial, as well as those who do not meet the inclusion criteria but have good liver function, have a good prognosis for survival.
AB - Background: Atezolizumab plus bevacizumab (Atezo/Bev) is frequently selected as the primary systemic therapy for hepatocellular carcinoma (HCC). Aims: To investigate the outcomes of patients with HCC treated with Atezo/Bev in a real-world setting based on whether they met the inclusion criteria for the phase 3 IMbrave150 trial. Methods: A total of 936 patients were enrolled. There were 404 patients who met the inclusion criteria of the phase 3 IMbrave150 trial (IMbrave150 group) and 532 who did not (non-IMbrave150 group). Results: Median progression-free survival (PFS) in the IMbrave150 and non-IMbrave150 groups was 7.4 months and 5.6 months (p = 0.002). Multivariable analysis revealed that non-B, non-C HCC aetiology (hazard ratio [HR], 1.173), α-fetoprotein ≥100 ng/mL (HR, 1.472), Barcelona Clinic Liver Cancer stage ≥ C (HR, 1.318), and modified albumin–bilirubin (mALBI) grade 2b or 3 (HR, 1.476) are independently associated with PFS. Median overall survival (OS) in the IMbrave150 and non-Imbrave150 groups was 26.5 and 18.8 months (p < 0.001). Multivariable analysis revealed that Eastern Cooperative Oncology Group performance status ≥2 (HR, 1.986), α-fetoprotein ≥100 ng/mL (HR, 1.481), and mALBI grade 2b or 3 (HR, 2.037) are independently associated with OS. In subgroup analysis, there were no significant differences in PFS or OS between these groups among patients with mALBI grade 1 or 2a. Conclusions: Patients who are treated with Atezo/Bev and meet the inclusion criteria for the phase 3 IMbrave150 trial, as well as those who do not meet the inclusion criteria but have good liver function, have a good prognosis for survival.
UR - http://www.scopus.com/inward/record.url?scp=85192386789&partnerID=8YFLogxK
U2 - 10.1111/apt.18037
DO - 10.1111/apt.18037
M3 - 学術論文
C2 - 38716823
AN - SCOPUS:85192386789
SN - 0269-2813
VL - 60
SP - 233
EP - 245
JO - Alimentary Pharmacology and Therapeutics
JF - Alimentary Pharmacology and Therapeutics
IS - 2
ER -