Department of Medical Oncology, Fundeni Clinical Institute Bucharest, Romania.
J Gastrointestin Liver Dis. 2012 Sep;21(3):277-84.
This is a retrospective study of patients with advanced biliary tract carcinoma (BTC), who were treated with different regimens of chemotherapy.
We studied patients with advanced BTC registered at the Department of Oncology at the Fundeni Clinical Institute between 2004 and 2008. The following data were analyzed: rate of response, progression free survival (PFS) to first and second line of chemotherapy, overall survival (OS) and drug toxicity. Ninety-six patients were eligible having either advanced intra or extrahepatic cholangiocarcinoma, or gallbladder cancer with no prior chemotherapy.
Out of 96 patients, 57 (59.4%) received fluoropyrimidines (FP)+cisplatin and 39 (40.6%) gemcitabine (Gem)+/-cisplatin. The median PFS for FP+cisplatin was 5.9 months (95%CI 5-6.9) and for Gem+/-cisplatin 6.3 months (95%CI 5.4-7.1), p=0.661. Median OS for FP+cisplatin was 10.3 months (95%CI 7.5-13.1) and for Gem+/-cisplatin 9.1 months (95%CI 7.0-11.2), p=0.098. On disease progression, 46 patients received second line CT (Gem or FP+/-platinum compounds). Median OS for patients with FP based first line and Gem+/-cisplatin in second line was 19 months (95%CI 8.9-29) higher than for the reverse sequence: 13.2 months (95%CI 12-14.4), but not statistically significant (p=0.830). All patients were evaluated for toxicities. Most patients (75.5%) reported at least one adverse event.
Our results through direct comparison of FP+cisplatin with Gem+/-cisplatin as first line treatment did not show any statistical differences in terms of rate of response, PFS and OS. However, our study showed that FP+cisplatin as first line and Gem based second line therapy gave a better OS rate.
本研究回顾性分析了采用不同化疗方案治疗的晚期胆道癌(BTC)患者。
我们研究了 2004 年至 2008 年期间在 Fundeni 临床研究所肿瘤科登记的晚期 BTC 患者。分析了以下数据:缓解率、一线和二线化疗的无进展生存期(PFS)、总生存期(OS)和药物毒性。96 例患者符合条件,包括晚期肝内或肝外胆管癌或无化疗史的胆囊癌。
96 例患者中,57 例(59.4%)接受氟嘧啶(FP)+顺铂治疗,39 例(40.6%)接受吉西他滨(Gem)+/-顺铂治疗。FP+顺铂的中位 PFS 为 5.9 个月(95%CI 5-6.9),Gem+/-顺铂为 6.3 个月(95%CI 5.4-7.1),p=0.661。FP+顺铂的中位 OS 为 10.3 个月(95%CI 7.5-13.1),Gem+/-顺铂为 9.1 个月(95%CI 7.0-11.2),p=0.098。疾病进展后,46 例患者接受二线 CT(Gem 或 FP+/-铂类化合物)。以 FP 为一线、Gem+/-顺铂为二线的患者中位 OS 为 19 个月(95%CI 8.9-29),高于相反序列的 13.2 个月(95%CI 12-14.4),但无统计学意义(p=0.830)。所有患者均进行了毒性评估。大多数患者(75.5%)至少报告了一次不良事件。
通过直接比较 FP+顺铂与 Gem+/-顺铂作为一线治疗,我们的结果在缓解率、PFS 和 OS 方面没有显示出任何统计学差异。然而,我们的研究表明,FP+顺铂作为一线治疗、Gem 作为二线治疗的方案可获得更好的 OS 率。