Vaughn David J, Manola Judith, Dreicer Robert, See William, Levitt Ralph, Wilding George
Abramson Cancer Center, University of Pennsylvania, Philadelphia 19104, USA.
Cancer. 2002 Sep 1;95(5):1022-7. doi: 10.1002/cncr.10782.
Chemotherapy options for the patients with advanced urothelial carcinoma and renal dysfunction are limited. The authors performed a Phase II trial of paclitaxel plus carboplatin in patients with advanced carcinoma of the urothelium and renal dysfunction.
Forty-two patients were accrued; 37 eligible patients were treated. Patients received paclitaxel 225 mg/m(2) over three hours followed by carboplatin targeted area under the concentration-time curve = 6 mg/mL. minute every three weeks for up to six cycles.
The median number of cycles received was four (range, one to six). The objective response rate was 24.3% (95% confidence interval, 11.9-41.7%). The median progression free survival was 3 months and the median overall survival was 7.1 months. The number of poor prognostic risk factors (Eastern Cooperative Oncology Group performance status > 1 or lung, liver, or bone metastases) significantly predicted for survival. The most common > or = 1 Grade 3 toxicities included granulocytopenia (60%) and neurotoxicity (35%).
Paclitaxel/carboplatin is a chemotherapy option for patients with advanced urothelial carcinoma and renal dysfunction. Future trials in chemotherapy development for this patient population are warranted.
晚期尿路上皮癌合并肾功能不全患者的化疗选择有限。作者开展了一项针对晚期尿路上皮癌合并肾功能不全患者的紫杉醇联合卡铂的II期试验。
共纳入42例患者；37例符合条件的患者接受了治疗。患者接受3小时静脉滴注紫杉醇225mg/m²，随后给予卡铂，使浓度-时间曲线下面积（AUC）=6mg/mL·分钟，每3周1次，共6个周期。
接受治疗的周期数中位数为4个（范围1至6个）。客观缓解率为24.3%（95%置信区间，11.9 - 41.7%）。无进展生存期中位数为3个月，总生存期中位数为7.1个月。不良预后风险因素（东部肿瘤协作组体能状态>1或存在肺、肝或骨转移）的数量显著影响生存。最常见的≥3级毒性反应包括粒细胞减少（60%）和神经毒性（35%）。
紫杉醇/卡铂是晚期尿路上皮癌合并肾功能不全患者的一种化疗选择。有必要针对该患者群体开展未来的化疗研发试验。
