2014-05-26 00:00:00来源：医脉通阅读：22次
2014年美国临床肿瘤学会年会将于当地时间5月30日-6月3日在芝加哥召开，根据大会的会议日程，我国肿瘤专家秦叔逵教授在6月1日上午有一项研究在“Poster Highlights Session”中展出，下面和大家提前分享这项精彩研究。医脉通小编们今年也将继续奔赴ASCO年会现场，及时将各项最新研究进展整理、发布，欢迎大家保持关注！
晚期肝细胞癌（HCC）是全球癌症死亡的第三大常见原因。阿帕替尼是一种新型口服的血管内皮生长因子受体-2多激酶抑制剂。这里报告阿帕替尼一线治疗中国晚期HCC患者的Ⅱ期临床研究结果。
研究方法
这是一项多中心，随机，非盲，剂量探索的II期试验。Child-Pugh肝功能分级A级的初治型晚期肝癌患者随机接受阿帕替尼 850 mg/qd或750 mg/qd。在每8周的周期终点评估疗效。主要研究终点为疾病进展时间（TTP）。次要终点包括总生存期（OS），客观缓解率（ORR），疾病控制率（DCR），α-甲胎蛋白（AFP）水平和安全性。根据肿瘤临床试验西蒙两阶段设计，36例患者被纳入第1阶段，85例患者入组第2阶段（延伸期）。
研究结果
从2010年7月到2012年3月，共有121例患者入选。两治疗组患者的基线特征包括疾病状态，ECOG评分，转移部位数，病理分级及前期治疗情况相似（P>0.05）。疗效方面，850 mg组中位进展时间为4.2个月，750毫克组中位进展时间为3.3个月。两组的中位总生存期分别为9.7个月和9.8个月。850 mg组DCR为48.57％，750毫克组DCR为37.25％。患者对阿帕替尼耐受良好，大部分的不良事件在停药或者减量后缓解。两组均无显著良好的安全性，超过2％的患者出现转氨酶升高，血小板减少，胆红素升高，高血压，白细胞减少症，手足综合征，疲劳。
结论
这项无空白对照的II期研究结果表明，阿帕替尼在晚期肝癌患者中具有潜在的生存获益。对于进一步的临床试验，850 mg/qd 或750 mg/qd均是推荐研究剂量。临床试验信息：NCT01192971。
医脉通整理报道，转载请注明出处。
会议专题》》》2014年ASCO年会专题报道
阅读英文摘要
Apatinib in Chinese patients with advanced hepatocellular carcinoma: A phase II randomized, open-label trial.（Abstract No:4019）
Authors: Shukui Qin; Nanjing Bayi Hospital, Nanjing, China
Session Type: Poster Highlights Session
Background: Advanced hepatocellular carcinoma (HCC) is the third most common cause of cancer death in worldwide. Apatinib is a novel oral multi-kinase inhibitor of the vascular endothelial growth factor receptor-2 . Here report the results of phase II clinical study of apatinib as first- line treatment in chinese patients with advanced HCC.
Methods: This was a multicenter, randomized, open-label, dose-finding, phase II trial. Treatment naive Patients with advanced HCC had Child-Pugh liver function class A were randomized to receive apatinib 850 mg/qd or 750 mg/qd. The efficacy was assessed at the end of each 8 weeks period. Primary endpoint was time to progression (TTP). Secondary endpoint included overall survival (OS), objective response rate (ORR), disease control rate (DCR), the level of α-fetoprotein (AFP) and safety. According to oncology clinical trial Simon two-stage design, thirty-six patients were enrolled into stage 1 and 85 patients were enrolled into stage 2 (extension phase) of the trial. The trial was registered with ClinicalTrial.gov, NO. NCT01192971.
Results: From 2010.07-2012.03 Total 121 patients were enrolled. The patient baseline characteristics of two treatment groups were similar with regards to disease status, ECOG scores, number of metastatic sites, pathological grading and prior therapy (P>0.05). For efficacy, median time to progression of the 850 mg group and the 750 mg group was 4.2 months and 3.3 months respectively. The median overall survival of the two groups was 9.7 months and 9.8 months respectively. The DCR was 48.57% for 850 mg qd group and 37.25% for 750 mg qd, respectively. Apatinib has been well tolerable in patients, most of the adverse event could be managed by dose interruptions or reductions. There was no significant favorable safety profile between two groups, above 2% of patients were elevated aminotransferase, thrombocytopenia, elevated bilirubin, hypertension, leukocytopenia, hand-and-foot syndrome, fatigue.
Conclusions: Results of this uncontrolled phase II study indicated that apatinib has potential survival benefit in patients with advance HCC. 850 mg/qd or 750 mg/qd was recommended dose for further clinical study. Clinical trial information: NCT01192971.