一线吉西他滨/帕唑帕尼治疗局部晚期和/或转移性胆道癌。一项希腊肿瘤协作组的 II 期研究。
First Line Gemcitabine/Pazopanib in Locally Advanced and/or Metastatic Biliary Tract Carcinoma. A Hellenic Cooperative Oncology Group Phase II Study.
机构信息
Third Department of Medical Oncology, Agii Anargiri Cancer Hospital, Athens, Greece
Second Department of Medical Oncology, Agii Anargiri Cancer Hospital, Athens, Greece.
出版信息
Anticancer Res. 2020 Feb;40(2):929-938. doi: 10.21873/anticanres.14026.
BACKGROUND/AIM: The efficacy of gemcitabine-based chemotherapy in locally advanced/metastatic biliary tract carcinoma is limited. The aim of this trial was to assess the activity of a novel gemcitabine-pazopanib combination in such patients.
PATIENTS AND METHODS
In this phase II, multicenter trial, patients with histologically/cytologically confirmed biliary tract carcinoma, previously untreated for advanced disease, received 1000 mg/m of gemcitabine on days 1 and 8 every 21 days and 800 mg of pazopanib once daily continuously for 8 cycles, followed by pazopanib maintenance. The primary endpoint was objective response rate (ORR).
RESULTS
A total of 29 patients (median age; 69 years) were enrolled between June 2013 and March 2018. The ORR was 13.8% in the intent-to-treat and 19.1% in the per protocol population. The median progression-free and overall survival were 6.3 and 10.4 months, respectively.
CONCLUSION
The low response rate precludes further testing of the combination in patients with biliary tract carcinoma.
背景/目的：吉西他滨为基础的化疗在局部晚期/转移性胆道癌中的疗效有限。本试验旨在评估新型吉西他滨-帕唑帕尼联合治疗此类患者的疗效。
患者和方法
在这项 II 期、多中心试验中，组织学/细胞学证实的胆道癌患者，既往未接受过晚期疾病的治疗，接受吉西他滨 1000 mg/m2 于第 1 天和第 8 天每 21 天一次，帕唑帕尼 800 mg 每日一次连续 8 个周期，随后进行帕唑帕尼维持治疗。主要终点为客观缓解率（ORR）。
结果
2013 年 6 月至 2018 年 3 月期间共纳入 29 例患者（中位年龄 69 岁）。意向治疗人群的 ORR 为 13.8%，方案人群的 ORR 为 19.1%。中位无进展生存期和总生存期分别为 6.3 个月和 10.4 个月。
结论
低缓解率排除了进一步在胆道癌患者中测试该联合方案的可能性。
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