Sorafenib-Related Adverse Events in Predicting the Early Radiologic Responses of Hepatocellular Carcinoma
Sorafenib-Related Adverse Events in Predicting the Early Radiologic Responses of Hepatocellular Carcinoma
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DOI：
10.14740/gr1109
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发表时间：
2019-02-01
影响因子：
1.5
通讯作者：
Chang, Chi-Sen
中科院分区：
文献类型：
--
作者：
Lee, Shou-Wu;Lee, Teng-Yu;Chang, Chi-Sen
背景：肝细胞癌（HCC）预后不良，除索拉非尼外其他药物化疗效果均较低。既往研究表明，索拉非尼的不良事件（AE）可以预测 HCC 的治疗效果。本研究的目的是评估索拉非尼治疗的早期疗效和AE。方法：对2012年6月至2016年10月期间在台中荣总医院接受索拉非尼治疗的HCC患者数据库进行分析。所有HCC病例均为巴塞罗那临床肝癌（BCLC）分类C期。索拉非尼的早期疗效根据mRECIST标准分为部分缓解（PR）、疾病稳定（SD）或疾病进展（PD）。索拉非尼治疗开始后 6 周内记录疗效。 AE被定义为出现手足皮肤反应（HFSR）、高血压（HTN）和腹泻。排除标准为体能状态不佳、药物依从性差、中断随访或用药后 1 天内发生死亡。 结果：在总共 222 名受试者中，8 例（3.6%）被分类为 PR，82 例（36.9%）为 SD，132 例（59.5%）为 PD。 PR组HFSR（62.4%）和高血压（37.5%）比例最高。将 PR 和 SD 病例合并在一起，HFSR 调整奇数比 (aOR) 2.80，95% 置信区间 (CI) 1.52 - 5.16）和腹泻（aOR 3.42，95% CI 1.67 -7.01）的存在是索拉非尼治疗良好反应的良好预测因子。 结论：HFSR 和腹泻是索拉非尼治疗早期疗效的良好预测因子。
Background: Hepatocellular carcinoma (HCC) has a poor prognosis with low chemotherapeutic efficiency to medications except to sorafenib. Previous studies showed that adverse events (AEs) of sorafenib can predict therapy efficacy to HCC. The aim of the study is to evaluate the early efficacy and AEs of sorafenib therapy.Methods: The database of HCC patients receiving sorafenib at Taichung Veterans General Hospital during the period from June 2012 to October 2016 was analyzed. All HCC cases were Barcelona Clinic Liver Cancer (BCLC) classification stage C. The early efficacy of sorafenib was classified according to the mRECIST criteria as either partial response (PR), stable disease (SD) or progressive disease (PD). Responses were recorded within 6 weeks after the start of sorafenib treatment. AEs were defined as the appearance of hand-foot skin reaction (HFSR), hypertension (HTN) and diarrhea. Exclusion criteria were poor performance status, poor drug compliance, discontinued follow-up or mortality occurring within 1 day after medication.Results: From a total of 222 subjects, eight cases (3.6%) were classified as PR, 82 cases (36.9%) SD, and 132 cases (59.5%) PD. The PR group had the highest ratio of HFSR (62.4%) and hypertension (37.5%). Pooling cases of PR and SD together, the presence of HFSR adjusted odd ratio (aOR) 2.80, 95% confidence interval (CI) 1.52 - 5.16) and diarrhea (aOR 3.42, 95% CI 1.67 -7.01) were good predictors of favorable responses to sorafenib therapy.Conclusions: HFSR and diarrhea are good predictors of early therapy efficacy to the sorafenib treatment.