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.
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Matono Tomomitsu, Tada Toshifumi, Hiraoka Atsushi, Hirooka Masashi, Nakamura Yoshiko, Yoshida Osamu, Kariyama Kazuya, Nouso Kazuhiro, Tani Joji, Morishita Asahiro, Atsukawa Masanori, Itokawa Norio, Okubo Tomomi, Arai Taeang, Takaguchi Koichi, Tsutsui Akemi, Nagano Takuya, Itobayashi Ei, Nishimura Takashi, Fukunishi Shinya, Enomoto Hirayuki, Tsuji Kunihiko, Tanaka Kazunari, Ishikawa Toru, Tajiri Kazuto, Tanaka Hironori, Toyoda Hidenori, Koshiyama Yuichi, Ogawa Chikara, Hatanaka Takeshi, Kanayama Yuki, Kakizaki Satoru, Kawata Kazuhito, Noritake Hidenao, Naganuma Atsushi, Kosaka Hisashi, Matsui Kosuke, Kaibori Masaki, Kuroda Hidekatsu, Yata Yutaka, Nishikawa Hiroki, Imai Michitaka, Aoki Tomoko, Ochi Hironori, Tamai Hideyuki, Okamura Jumpei, Komatsu Shohei, Matsuura Takanori, Nakamura Shinichiro, Ueda Yoshihide, Kim Soo Ki, Ohama Hideko, Tada Fujimasa, Fukumoto Takumi, Hiasa Yoichi, Kudo Masatoshi, Kumada Takashi
Аннотация
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.