التفاصيل البيبلوغرافية
| العنوان: |
Safety and efficacy of lenvatinib by starting dose based on body weight in patients with unresectable hepatocellular carcinoma in REFLECT. |
| المؤلفون: |
Okusaka, Takuji, Ikeda, Kenji, Kudo, Masatoshi, Finn, Richard, Qin, Shukui, Han, Kwang-Hyub, Cheng, Ann-Lii, Piscaglia, Fabio, Kobayashi, Masahiro, Sung, Max, Chen, Minshan, Wyrwicz, Lucjan, Yoon, Jung-Hwan, Ren, Zhenggang, Mody, Kalgi, Dutcus, Corina, Tamai, Toshiyuki, Ren, Min, Hayato, Seiichi, Kumada, Hiromitsu |
| المصدر: |
Journal of Gastroenterology; Jun2021, Vol. 56 Issue 6, p570-580, 11p |
| مصطلحات موضوعية: |
BODY weight, HEPATOCELLULAR carcinoma, OVERALL survival, SURVIVAL rate, PROGRESSION-free survival |
| مستخلص: |
Background: REFLECT was an open-label, phase 3 study comparing the efficacy and safety of lenvatinib versus sorafenib in patients with unresectable hepatocellular carcinoma (uHCC). Based on phase 2 study (Study 202) results, body weight-based dosing for lenvatinib was used in REFLECT to minimize dose disruptions and modifications needed to address dose-related adverse events. This post hoc analysis of REFLECT data assessed lenvatinib efficacy and safety by body weight group.Methods: The study randomly administered lenvatinib (n = 476) or sorafenib (n = 475) to patients with untreated (no prior systemic therapy) uHCC. Lenvatinib starting-dose data were stratified by body weight: patients weighing < 60 kg received 8 mg/day; patients weighing ≥ 60 kg received 12 mg/day. Overall survival (OS), progression-free survival (PFS), objective response rate, and safety were assessed.Results: Survival outcomes and safety profiles appeared similar between the two body-weight-based lenvatinib starting-dose groups. Median OS for patients in the < 60 kg body weight group (n = 153) was 13.4 months [95% confidence interval (CI) 10.5-15.7] compared to 13.7 months (95% CI 12.0-15.6) in the ≥ 60 kg body weight group (n = 325). In both lenvatinib groups, PFS was 7.4 months (< 60 kg group: 95% CI 5.4-9.2; ≥ 60 kg group: 95% CI 6.9-9.0). Treatment-emergent adverse events (TEAEs) required dose modifications in 43.0% in the < 60 kg body weight group and 57.5% in the ≥ 60 kg body weight group.Conclusions: This exploratory analysis of data from REFLECT indicated that body weight-based lenvatinib dosing in patients with uHCC was successful in maintaining efficacy, with comparable rates of TEAEs and dose modifications in the two body weight groups.Clinincal Trial: Trial registration ID: ClinicalTrials.gov # NCT01761266. [ABSTRACT FROM AUTHOR] |
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| قاعدة البيانات: |
Complementary Index |
