ASCO2013:一线治疗之索拉非尼+卡培他滨+奥沙利铂(SECOX)
单臂、多中心的2期,香港和新加坡的联合研究。
51名晚期肝癌患者参与该研究,90%的患者为BCLCC期,80%有肝外转移。肿瘤反应率为16%(均为部分缓解),62%的患者肿瘤稳定超过8周,中位肿瘤进展时间为5.29月,中位无进展生存期为5.26月,中位生存率为11.73月。作者对总体结果表示满意,期待SECOX方案与索拉非尼单用的随机对照试验。
摘要详情:
Abstract:
Background: This is a single arm, multi-center, phase II study to assess the efficacy and tolerability of sorafenib, oxaliplatin and capecitabine combination for the treatment of advanced hepatocellular carcinoma (HCC) patients.
Methods: Eligible patients received SECOX regime—sorafenib 400 mg bid (Day one-fourteen), oxaliplatin 85 mg/m2 (Day one) and capecitabine 1700 mg/m2(Day one-seven) every two weeks. Response assessment was based on RECIST 1.0 criteria. The primary endpoint was time-to-progression (TTP) and the secondary endpoints were tumor response rate (RR), progression-free survival (PFS), overall survival (OS) and tolerability.
Results: A total of 51 patients were enrolled in the trial.The median age was 58 years (range, 28-81) and 84% of patients were chronic hepatitis B carriers. Ninety percent of recruited patients belonged to BCLC stage C disease and 41 (80%) patients had extra-hepatic metastasis. The best RR was 16% and they were all partial response. Another 62% of patients achieved stable disease for at least eight weeks. The median TTP was 5.29 months (95% CI 3.81-5.88 months), PFS 5.26 months (95% CI 3.75-5.88 months) and OS was 11.73 months (95% CI 8.87- 15.38 months). Diarrhea (75%), Hand-foot-skin reaction (73%) and transient liver function derangement were the most commonly encountered adverse events, with the majority of patients having grade one or two. No treatment-related death was reported. Conclusions: The SECOX regime indicates preliminary promising activity and safety in Asian population with advanced HCC. Our data support a randomized trial comparing SECOX versus sorafenib alone for treatment of advanced HCC.
Clinical trial information: NCT00752063.
- ASCO2013:复旦大学附属肿瘤医院杜祥教授发现新型生物标记物可用于弥漫大B细胞淋巴瘤分子分型及预后
- ASCO2013:一线治疗之Nintedanib对索拉非尼的头对头临床试验
- ASCO2013:二线治疗之Regorafenib的三期临床试验
- ASCO2013:一线治疗之索拉非尼上市后的临床监测
- ASCO2013:流行病学之性别对肝癌患者生存的关系
- ASCO2013:流行病学之糖尿病是罹患肝癌的独立危险因素
- ASCO2013:观察性研究之乙肝相关肝癌和丙肝相关肝癌的VEGF通路相关分子的表达对比
- ASCO2013:标志物之VEGF及VEGFR的基因多态性与索拉非尼治疗毒性及疗效的相关
- ASCO2013:二线治疗之PF-03446962 (ALK-1单抗)的1期临床研究
- ASCO2013:一线/二线治疗之TGF-β抑制剂(LY2157299)