Clinical Evidence on Apatinib in Treating Chemotherapy-Refractory Metastatic Esophageal Squamous Cell Carcinoma

Lei-ming Guo, Cheng-zhe Yang, Chun-yu He, Ke Li, L. Qiao, Shuning Xu, Xiaoyuan Wu, Y. Liu
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Abstract

Majority Chinese esophageal cancer patients have squamous cell carcinoma (ESCC) and with metastasis at initial diagnosis. Treatment for metastatic ESCC where first-line chemotherapy failed is an unmet medical need. Targeting human epidermal growth factor receptor 2 (HER2) and vascular endothelial growth factor receptor 2 (KDR) have been approved to be effective for esophageal adenocarcinoma (EAC). We explored the clinical relevance of these molecular signaling in ESCC cohorts and collected clinical evidence on applying apatinib, a Chinese FDA-approved KDR inhibitor for late-stage gastric carcinoma, in 26 patients with chemotherapy-refractory metastatic ESCC. The clinical response rate and disease control rate of these patients to apatinib 500mg once daily regimen was 12% and 60%, respectively. The patients’ median progression-free survival time (PFS) was 3.2 months (95% CI, 2.23-4.17 months) and overall survival time (OS) was 5.3 months (95% CI, 4.46-6.14 months). The most common grade 3-4 treatment-related adverse events included leukopenia (7.7%) and anemia (7.7%). No drug-related death occurred. In conclusion, apatinib has favorable activity and acceptable safety, and could be a new treatment option for patients with chemotherapy refractory metastatic ESCC.
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阿帕替尼治疗化疗难治性转移性食管鳞状细胞癌的临床研究
我国食管癌患者以鳞状细胞癌(ESCC)为主,初诊时有转移。对于一线化疗失败的转移性ESCC的治疗是一个未满足的医学需求。靶向人表皮生长因子受体2 (HER2)和血管内皮生长因子受体2 (KDR)已被批准对食管腺癌(EAC)有效。我们探讨了这些分子信号在ESCC队列中的临床相关性,并收集了26例化疗难治性转移性ESCC患者应用阿帕替尼(中国fda批准的KDR抑制剂)治疗晚期胃癌的临床证据。这些患者对阿帕替尼500mg每日1次的临床缓解率为12%,疾病控制率为60%。患者的中位无进展生存时间(PFS)为3.2个月(95% CI, 2.23-4.17个月),总生存时间(OS)为5.3个月(95% CI, 4.46-6.14个月)。最常见的3-4级治疗相关不良事件包括白细胞减少(7.7%)和贫血(7.7%)。没有发生与毒品有关的死亡。综上所述,阿帕替尼具有良好的活性和可接受的安全性,可能成为化疗难治性转移性ESCC患者的新治疗选择。
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