Liver cancer · 2026
Real-World Efficacy and Safety of TACE Combined with Lenvatinib and PD-1 Inhibitor in Conversion Therapy for Unresectable Hepatocellular Carcinoma (GUIDANCE007): A Multicenter Retrospective Study.
СтатьяНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Ye Lin, Liu Guo-Xing, Yang Da-Long, Zeng Fan-Jian, Liu Jie, Yao Hong-Bing, Nong Jun-Liang, Liu Shao-Ping, Peng Ning, Li Wen-Feng, Wu Pei-Sheng, Qin Chuang, Su Ze, Ou Jun-Jie, Dong Xiao-Feng, Yan Yi-He, Zhong Teng-Meng, Wu Ming-Song, Chen Yao-Zhi, Wang Guo-Dong, Li Mian-Jing, Wang Xue-Yao, Yang Fu-Quan, Chen Shu-Chang, Yang Yong-Yu, Chen Kang, Lai Yong-Cheng, Pang Qing-Qing, Liang Xiu-Mei, Mao Xian-Shuang, Liang Yong-Rong, Li Fu-Xin, Shi Hao, Li Ren-Jian, Xiang Bang-De, Ma Liang, Zhong Jian-Hong, Yu Ya-Qun, GUIDANCE investigators
Аннотация
INTRODUCTION: Transarterial chemoembolization (TACE) combined with lenvatinib has demonstrated efficacy for unresectable hepatocellular carcinoma (HCC). However, real-world evidence on the additional benefit of PD-1 inhibitors in conversion therapy remains limited. This study aimed to investigate the efficacy and safety of triple therapy (TACE, lenvatinib, and PD-1 inhibitors) versus dual therapy (TACE and lenvatinib) in conversion therapy for initially unresectable HCC.
METHODS: This multicenter study was conducted in 20 Chinese tertiary hospitals. Patients received either triple therapy (TLP group, n = 289) or dual therapy (TL group, n = 132). Inverse probability of treatment weighting (IPTW) was used to control for confounding. Multivariate models compared overall survival (OS) and progression-free survival (PFS).
RESULTS: From January 2019 to June 2023, 421 consecutive patients were enrolled. After IPTW adjustment, baseline characteristics were well balanced. The TLP group showed superior efficacy: objective response rate 55.1% versus 34.7% (p < 0.001), complete response rate 24.9% versus 14.9% (p = 0.010), and conversion surgery rate 35.5% versus 15.7% (p < 0.001). Median OS was prolonged (31.67 vs. 25.00 months; adjusted HR 0.60, 95% CI: 0.42-0.85, p = 0.001) and median PFS extended (16.47 vs. 12.00 months; adjusted HR 0.65, 95% CI: 0.47-0.93, p = 0.008). Sensitivity analyses including propensity score matching (HR 0.61), landmark analysis (HR 0.64), and time-varying covariate analysis (HR 0.58) confirmed the findings. E-value analysis (2.72) suggested unmeasured confounding alone is unlikely to explain the benefit. Treatment effects were consistent across subgroups. Grade 3-4 adverse events were similar (35.6% vs. 36.4%, p = 0.885), though immune-related adverse events were more frequent in the TLP group.
CONCLUSIONS: Adding PD-1 inhibitors to TACE plus lenvatinib was associated with improved tumor response, prolonged survival, and higher conversion surgery rates, with an acceptable safety profile. Given the heterogeneity of PD-1 inhibitors and inherent limitations of retrospective design, these findings should be considered hypothesis generating and require verification in prospective randomized controlled trials.
METHODS: This multicenter study was conducted in 20 Chinese tertiary hospitals. Patients received either triple therapy (TLP group, n = 289) or dual therapy (TL group, n = 132). Inverse probability of treatment weighting (IPTW) was used to control for confounding. Multivariate models compared overall survival (OS) and progression-free survival (PFS).
RESULTS: From January 2019 to June 2023, 421 consecutive patients were enrolled. After IPTW adjustment, baseline characteristics were well balanced. The TLP group showed superior efficacy: objective response rate 55.1% versus 34.7% (p < 0.001), complete response rate 24.9% versus 14.9% (p = 0.010), and conversion surgery rate 35.5% versus 15.7% (p < 0.001). Median OS was prolonged (31.67 vs. 25.00 months; adjusted HR 0.60, 95% CI: 0.42-0.85, p = 0.001) and median PFS extended (16.47 vs. 12.00 months; adjusted HR 0.65, 95% CI: 0.47-0.93, p = 0.008). Sensitivity analyses including propensity score matching (HR 0.61), landmark analysis (HR 0.64), and time-varying covariate analysis (HR 0.58) confirmed the findings. E-value analysis (2.72) suggested unmeasured confounding alone is unlikely to explain the benefit. Treatment effects were consistent across subgroups. Grade 3-4 adverse events were similar (35.6% vs. 36.4%, p = 0.885), though immune-related adverse events were more frequent in the TLP group.
CONCLUSIONS: Adding PD-1 inhibitors to TACE plus lenvatinib was associated with improved tumor response, prolonged survival, and higher conversion surgery rates, with an acceptable safety profile. Given the heterogeneity of PD-1 inhibitors and inherent limitations of retrospective design, these findings should be considered hypothesis generating and require verification in prospective randomized controlled trials.