Dreicer Robert, Li Hailun, Cooney Matthew M, Wilding George, Roth Bruce J
Department of Solid Tumor Oncology, Taussig Cancer Institute, Cleveland Clinic, Cleveland, Ohio 44195, USA.
Cancer. 2008 Jun 15;112(12):2671-5. doi: 10.1002/cncr.23503.
There is a need to identify active new regimens in patients with advanced urothelial cancer. Pemetrexed and gemcitabine are active agents in advanced urothelial cancer. A phase 2 trial of the combination of these 2 agents was performed in patients with advanced urothelial cancer who were previously untreated for metastatic disease.
Forty-six patients with advanced urothelial carcinoma received pemetrexed disodium 500 mg/m2 and gemcitabine 1000 mg/m2 intravenously on Day 1, with gemcitabine repeated on Day 8. Cycles were repeated every 3 weeks for a maximum of 6 cycles.
Two patients attained a complete response, and 12 patients attained a partial response for an overall response rate of 31.8% (90% confidence interval, 20.4%-45.2%). The median time to disease progression was 5.8 months, and the median overall survival was 13.4 months. Thirty-three patients (75%) experienced grade>or=3 neutropenia, and 5 patients (11%) had febrile neutropenia. There were 2 therapy-related deaths.
The combination of pemetrexed and gemcitabine had moderate antitumor activity in previously untreated patients with advanced urothelial cancer at the expense of significant myelosuppression.
需要在晚期尿路上皮癌患者中确定有效的新治疗方案。培美曲塞和吉西他滨是晚期尿路上皮癌的有效药物。对既往未接受过转移性疾病治疗的晚期尿路上皮癌患者进行了这两种药物联合应用的2期试验。
46例晚期尿路上皮癌患者在第1天静脉注射培美曲塞二钠500mg/m²和吉西他滨1000mg/m²，吉西他滨在第8天重复给药。每3周重复1个周期，最多6个周期。
2例患者达到完全缓解，12例患者达到部分缓解，总缓解率为31.8%（90%置信区间，20.4%-45.2%）。疾病进展的中位时间为5.8个月，总生存的中位时间为13.4个月。33例患者（75%）出现≥3级中性粒细胞减少，5例患者（11%）出现发热性中性粒细胞减少。有2例与治疗相关的死亡。
培美曲塞和吉西他滨联合应用在既往未治疗的晚期尿路上皮癌患者中具有中等抗肿瘤活性，但代价是显著的骨髓抑制。
