Department of Gastroenterology and Hepatology, Osaka Red Cross Hospital, Osaka, Japan.
Liver Int. 2015 May;35(5):1581-9. doi: 10.1111/liv.12591. Epub 2014 Jun 10.
BACKGROUND & AIMS: There have been no established predictive factors of responders to sorafenib in patients with unresectable hepatocellular carcinoma (HCC). This study aimed to investigate the factors predicting a good response to sorafenib in Japanese patients with HCC.
A total of 465 patients with unresectable HCC in the Japanese Red Cross Liver Study Group were treated with sorafenib between January 2008 and August 2013, and 316 patients with sufficient clinical data were analysed. To determine the factors predicting a good response, the relationships between radiological response and the following clinicopathological factors were analysed: age, gender, performance status, liver function, tumour status and decrease in serum alpha-foetoprotein (AFP) level after 1 month.
This study included 259 males and 57 females with a median age of 70 years (range, 37-90 years), of which 191 (60.4%) were classified as Barcelona Clinic Liver Cancer stage C, and 271 (85.8%) had Child-Pugh class A liver function. The median overall survival time was 307 days and progression-free survival time was 109 days. According to the modified Response Evaluation Criteria In Solid Tumours, four patients achieved a complete response, 51 achieved a partial response, 136 had stable disease and 125 had progressive disease. Multivariate analysis identified female gender (P = 0.003) and decreased serum AFP level after 1 month (P = 0.042) as independent predictors of a complete or partial response.
Our results suggest female gender and a decrease in serum AFP level are independent predictors of good response to sorafenib.
目前尚未确定不可切除肝细胞癌（HCC）患者对索拉非尼有反应的预测因素。本研究旨在探讨预测日本 HCC 患者对索拉非尼反应良好的因素。
2008 年 1 月至 2013 年 8 月，日本红十字会肝脏研究组对 465 例不可切除 HCC 患者进行了索拉非尼治疗，对 316 例有足够临床数据的患者进行了分析。为了确定预测良好反应的因素，分析了影像学反应与以下临床病理因素之间的关系：年龄、性别、体能状态、肝功能、肿瘤状态和血清甲胎蛋白（AFP）水平在 1 个月后的下降。
本研究包括 259 名男性和 57 名女性，中位年龄为 70 岁（范围为 37-90 岁），其中 191 名（60.4%）为巴塞罗那临床肝癌分期 C，271 名（85.8%）为 Child-Pugh 级 A 肝功能。中位总生存时间为 307 天，无进展生存时间为 109 天。根据实体瘤反应评估标准的改良版，4 例患者达到完全缓解，51 例患者达到部分缓解，136 例患者病情稳定，125 例患者病情进展。多变量分析确定女性性别（P = 0.003）和 1 个月后血清 AFP 水平下降（P = 0.042）是完全或部分缓解的独立预测因素。
我们的结果表明，女性性别和血清 AFP 水平下降是索拉非尼反应良好的独立预测因素。
