Huang Kuo-Wei, Lee Pei-Chang, Chao Yee, Su Chien-Wei, Lee I-Cheng, Lan Keng-Hsin, Chu Chi-Jen, Hung Yi-Ping, Chen San-Chi, Hou Ming-Chih, Huang Yi-Hsiang
Division of Gastroenterology and Hepatology, Department of Medicine, Taipei Veterans General Hospital, Taipei.
Department of Oncology, Taipei Veterans General Hospital, Taipei.
Ther Adv Med Oncol. 2022 May 22;14:17588359221099401. doi: 10.1177/17588359221099401. eCollection 2022.
The response rate to sorafenib is limited for unresectable hepatocellular carcinoma (HCC). Little is known about the long-term outcomes of objective responders. The role of second-line therapies on the survival of sorafenib-responders is unclear. We aimed to delineate the long-term outcomes and the role of subsequent treatment after responding to sorafenib.
From September 2012 to December 2019, 922 patients who received sorafenib treatment for unresectable HCC were retrospectively reviewed. Of these, 21 (2.3%) achieved a complete response (CR) and 54 (5.9%) had a partial response (PR) based on mRECIST criteria. Factors associated with survivals were analyzed.
During the median follow-up of 35.3 months, the median duration of response was 18.3 months (range: 2.3-45.5) for patients achieving CR and 10.0 months (range: 1.9-60.3) for PR. The median overall survival (OS) was 39.5 months [95% confidence interval (CI): 28.4-50.5] including values not yet estimable for CR and 25.8 months for PR. Patients who experienced treatment-related adverse events (TRAEs) had better median OS than those without (44.9 18.1 months, = 0.003). Eventually, 53 patients developed tumor progression; 30 patients received second-line systemic treatment including nivolumab ( = 8), regorafenib ( = 15), and chemotherapy ( = 7). Sorafenib-nivolumab sequential therapy provided the best median OS sorafenib-regorafenib and sorafenib-chemotherapy in these patients (55.8, 39.5, and 25.5 months), respectively.
The response is durable for advanced HCC patients with CR or PR to sorafenib. Subsequent immunotherapy seems to provide the best survival. This information is important for characterizing outcomes of sorafenib-responders and the choice of sequential treatment.
对于不可切除的肝细胞癌（HCC），索拉非尼的缓解率有限。关于客观缓解者的长期预后知之甚少。二线治疗对索拉非尼缓解者生存的作用尚不清楚。我们旨在描述索拉非尼治疗缓解后的长期预后及后续治疗的作用。
回顾性分析2012年9月至2019年12月期间922例接受索拉非尼治疗不可切除HCC的患者。其中，根据mRECIST标准，21例（2.3%）达到完全缓解（CR），54例（5.9%）达到部分缓解（PR）。分析与生存相关的因素。
在35.3个月的中位随访期内，达到CR的患者中位缓解持续时间为18.3个月（范围：2.3 - 45.5个月），达到PR的患者为10.0个月（范围：1.9 - 60.3个月）。中位总生存期（OS）为39.5个月[95%置信区间（CI）：28.4 - 50.5]，包括CR患者中尚未可评估的值，PR患者为25.8个月。经历治疗相关不良事件（TRAEs）的患者中位OS优于未经历者（44.9对18.1个月，P = 0.003）。最终，53例患者出现肿瘤进展；30例患者接受二线全身治疗，包括纳武利尤单抗（n = 8）、瑞戈非尼（n = 15）和化疗（n = 7）。在这些患者中，索拉非尼 - 纳武利尤单抗序贯治疗的中位OS分别优于索拉非尼 - 瑞戈非尼和索拉非尼 - 化疗（55.8、39.5和25.5个月）。
对于对索拉非尼达到CR或PR的晚期HCC患者，缓解是持久的。后续免疫治疗似乎能提供最佳生存。该信息对于描述索拉非尼缓解者的预后及序贯治疗的选择很重要。
