Kaufman Donald S, Carducci Michael A, Kuzel Tim M, Todd Mary B, Oh William K, Smith Matthew R, Ye Zhishen, Nicol Steven J, Stadler Walter M
Massachusetts General Hospital, Boston, MA, USA.
Urol Oncol. 2004 Sep-Oct;22(5):393-7. doi: 10.1016/j.urolonc.2004.01.002.
The purpose of the study was to evaluate response and survival in patients with metastatic urothelial cancer treated with combination gemcitabine and paclitaxel administered on a biweekly schedule at doses of 3000 mg/m2 and 150 mg/m2, respectively. Patients with adequate organ function and performance status were accrued through 7 institutions, stratified by prior therapy status, and treated as noted. Response was evaluated by 1979 bi-dimensional World Health Organization (WHO) criteria. Of 55 eligible patients, 17 had a partial and 5 had a complete response rate for an overall response rate of 40% (27-54%). One complete response and one partial response were observed in the 6 previously treated patients. Overall median survival was 11.8 months (11.9 months in the chemonaive cohort). Grade 3 or 4 myelosuppression occurred in 56%, but only 4 serious infections were observed. We conclude that because of a lower than expected complete response rate, even when corrected for prognostic groupings, this regimen is not recommended for routine use in patients with metastatic urothelial cancer. Insufficient patients with poor renal function or prior therapy were accrued to reach conclusions regarding its utility in these subgroups.
本研究的目的是评估接受吉西他滨与紫杉醇联合治疗的转移性尿路上皮癌患者的反应和生存情况，该联合治疗方案按每两周一次的给药计划进行，剂量分别为3000mg/m²和150mg/m²。通过7家机构招募了器官功能和体能状态良好的患者，根据既往治疗状态进行分层，并按所述方法进行治疗。根据1979年世界卫生组织（WHO）二维标准评估反应。在55例符合条件的患者中，17例部分缓解，5例完全缓解，总缓解率为40%（27%-54%）。在6例既往接受过治疗的患者中观察到1例完全缓解和1例部分缓解。总体中位生存期为11.8个月（初治队列中为11.9个月）。3级或4级骨髓抑制发生率为56%，但仅观察到4例严重感染。我们得出结论，由于完全缓解率低于预期，即使对预后分组进行校正，该方案也不推荐用于转移性尿路上皮癌患者的常规治疗。肾功能差或既往接受过治疗的患者入组不足，无法得出该方案在这些亚组中的应用结论。
