| 論文種別 | 原著(症例報告除く) |
| 言語種別 | 英語 |
| 査読の有無 | その他(不明) |
| 表題 | Outcomes of Patients With Hepatocellular Carcinoma Treated With Durvalumab Plus Tremelimumab in Real-World Clinical Practice Who Met or Did Not Meet the Inclusion Criteria for the Phase 3 HIMALAYA Trial. |
| 掲載誌名 | 正式名：Journal of gastroenterology and hepatology 略 称：J Gastroenterol Hepatol ISSNコード：14401746/08159319 |
| 掲載区分 | 国外 |
| 巻・号・頁 | pp.Online ahead of print |
| 著者・共著者 | Tomomitsu Matono, Toshifumi Tada, Atsushi Hiraoka, Masashi Hirooka, Yoshiko Nakamura, Osamu Yoshida, Kazuya Kariyama, Kazuhiro Nouso, Joji Tani, Asahiro Morishita, Masanori Atsukawa, Norio Itokawa, Tomomi Okubo, Taeang Arai, Koichi Takaguchi, Akemi Tsutsui, Takuya Nagano, Ei Itobayashi, Takashi Nishimura, Shinya Fukunishi, Hirayuki Enomoto, Kunihiko Tsuji, Kazunari Tanaka, Toru Ishikawa, Kazuto Tajiri, Hironori Tanaka, Hidenori Toyoda, Yuichi Koshiyama, Chikara Ogawa, Takeshi Hatanaka, Yuki Kanayama, Satoru Kakizaki, Kazuhito Kawata, Hidenao Noritake, Atsushi Naganuma, Hisashi Kosaka, Kosuke Matsui, Masaki Kaibori, Hidekatsu Kuroda, Yutaka Yata, Hiroki Nishikawa, Michitaka Imai, Tomoko Aoki, Hironori Ochi, Hideyuki Tamai, Jumpei Okamura, Shohei Komatsu, Takanori Matsuura, Shinichiro Nakamura, Yoshihide Ueda, Soo Ki Kim, Hideko Ohama, Fujimasa Tada, Takumi Fukumoto, Yoichi Hiasa, Masatoshi Kudo, Takashi Kumada |
| 発行年月 | 2026/05 |
| 概要 | BACKGROUND AND AIM:This study evaluated clinical outcomes in patients with hepatocellular carcinoma (HCC) treated with durvalumab plus tremelimumab (Dur/Tre) in routine practice, stratified by whether they fulfilled the eligibility criteria of the phase 3 HIMALAYA trial.METHODS:A total of 412 patients with unresectable HCC receiving Dur/Tre at 30 Japanese institutions were enrolled. Of these, 92 fulfilled the HIMALAYA trial eligibility criteria (HIMALAYA group) and 320 did not (non-HIMALAYA group).RESULTS:Median progression-free survival (PFS) was 5.4 months in the HIMALAYA group and 3.0 months in the non-HIMALAYA group (p = 0.012). Multivariable analysis identified body mass index ≥ 25 kg/m2 (hazard ratio [HR], 0.780; 95% confidence interval [CI], 0.612-0.993; p = 0.044) and portal vein invasion (HR, 1.509; 95% CI, 1.049-2.170; p = 0.027) as independent predictors of PFS. Median overall survival (OS) was 19.4 months in the HIMALAYA group versus 15.4 months in the non-HIMALAYA group (p = 0.014). Multivariable analysis showed Eastern Cooperative Oncology Group performance status ≥ 1 (HR, 1.878; 95% CI, 1.253-2.814; p = 0.002) and albumin-bilirubin grade ≥ 2 (HR, 2.032; 95% CI, 1.319-3.318; p = 0.001) as independent determinants of OS. Any-grade endocrine dysfunction occurred in 13 (14.1%) and 21 (6.6%) patients (p = 0.030), with grade ≥ 3 events in 5 (5.4%) and 2 (0.6%), respectively (p = 0.007). Subgroup analysis suggested that non-HIMALAYA patients with ALBI grade 1 may have OS comparable to the HIMALAYA group.CONCLUSIONS:Patients fulfilling the HIMALAYA trial eligibility criteria and those who did not but had preserved hepatic function demonstrated favorable survival outcomes with Dur/Tre. |
| DOI | 10.1111/jgh.70422 |
| PMID | 42175630 |