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Title: Phase II Trial of Sorafenib in Combination with Capecitabine in Patients with Hepatocellular Carcinoma: INST 08-20.
Author: Patt Y, Rojas-Hernandez C, Fekrazad HM, Bansal P, Lee FC.
Journal: Oncologist; 2017 Oct; 22(10):1158-e116. PubMed ID: 28687627.
Abstract:
LESSONS LEARNED: There continues to be a lack of systemic options for advanced hepatocellular carcinoma (HCC); sorafenib and, very recently, regorafenib are the only approved options. There exists a potential to combine sorafenib with chemotherapeutic agents shown to be active in HCC, such as capecitabine, safely.Good tumor response was observed, with objective improvement in a few patients seldom seen by single agent sorafenib; however, because of the limited number of patients, meaningful conclusions on survival cannot be drawn. BACKGROUND: Sorafenib is the currently approved first-line treatment for hepatocellular carcinoma (HCC). Capecitabine has antitumor activity in hepatobiliary cancers. The combination of the two, if tolerated, could possibly improve antitumor response, and survival. METHODS: Patients with advanced HCC ineligible for locoregional therapy, Eastern Cooperative Oncology Group performance status of ≤2, Child-Pugh class A or B-7 cirrhosis, hemoglobin ≥8.5 g/dL, platelets ≥50,000/μL, absolute neutrophil count (ANC) ≥1,500 cells/μL, and serum creatinine of ≤2.0 mg/dL were recruited. All subjects received a combination of sorafenib and capecitabine, on a 14-day 7-days on 7-days off schedule. The primary end point was safety and secondary end points were overall survival (OS) and disease control rate. RESULTS: A total of 15 out of 47 patients met inclusion criteria. Median age was 64 years (56-79) and 77% were male. With a median follow-up of 12 months, median OS was 12.7 months (95% confidence interval [CI], 8.5-23.4). Disease control rate was 77% (complete response 8%, partial response 8%, and stable disease 61%). Common adverse events were as follows: (a) thrombocytopenia (64%); (b) anemia (14%); (c) hypophosphatemia (21%); (d) hypomagnesemia (14%); (e) hyperbilirubinemia (21%); (f) increased aspartate transaminase (AST) (14%); (g) hand-foot syndrome (21%); and (h) deep vein thrombosis (21%). CONCLUSION: At tolerable doses, the combination of sorafenib and capecitabine seems an active and safe palliative treatment for HCC in class A and B-7 patients with cirrhosis. The small sample size does not allow comparison with single-agent sorafenib. 经验总结 • 晚期肝细胞癌（HCC）的系统选择仍然不足；最近获批准的药物仅有索拉非尼和瑞戈非尼。可能可以安全地联用索拉非尼与对HCC有效的化疗药物（如, 卡培他滨）。 • 在一些接受索拉非尼单药的少数患者中观察到了少见的良好肿瘤缓解效果和客观改善；然而, 由于患者数量有限, 无法得出有关生存期的有意义的结论。摘要 背景. 索拉菲尼是目前获批准的治疗肝细胞癌（HCC）的一线药物。卡培他滨在肝胆癌中具有抗肿瘤活性。联用这两种药物, 如果可耐受, 可能会改善抗肿瘤反应和存活率。 方法. 研究招募了不适合使用局部治疗, 美国东部肿瘤协作组的体能状态评分≤2, Child‐Pugh A级或B‐7级肝硬化, 血红蛋白≥8.5 g/dL, 血小板≥50 000/μL, 绝对中性粒细胞计数（ANC）≥1 500个细胞/μL, 血清肌酐≤2.0 mg/dL的晚期HCC患者。所有受试者均在计划的14天内（7天给药期, 7天停药期）接受了索拉菲尼和卡培他滨联合给药。主要终点是安全性和次要终点是总生存期（OS）和疾病控制率。 结果. 47名患者中共有15名患者符合入选标准。中位年龄为64岁（56‐79岁）, 77％为男性。中位随访时间为12个月, 中位OS为12.7个月[95％置信区间（CI）, 8.5‐23.4]。疾病控制率为77％（完全缓解率8％, 部分缓解率8％, 疾病稳定率61％）。常见不良事件如下：（a）血小板减少症（64％）；（b）贫血（14％）；（c）低磷血症（21％）；（d）低镁血症（14％）；（e）高胆红素血症（21％）；（f）天门冬氨酸氨基转移酶升高（AST）（14％）；（g）手足综合征（21％）和（h）深静脉血栓（21％）。 结论. 在可耐受剂量下, 索拉非尼和卡培他滨联合给药对于患有A级和B‐7级肝硬化的HCC患者是一种有效且安全的姑息治疗。由于样本量小, 研究结果与索拉非尼单药的结果没有可比性。

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