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Phase II study of paclitaxel plus carboplatin in patients with advanced carcinoma of the urothelium and renal dysfunction (E2896) : A trial of the Eastern Cooperative Oncology Group

✍ Scribed by David J. Vaughn; Judith Manola; Robert Dreicer; William See; Ralph Levitt; George Wilding


Publisher
John Wiley and Sons
Year
2002
Tongue
English
Weight
74 KB
Volume
95
Category
Article
ISSN
0008-543X

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✦ Synopsis


Background:

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.

Methods:

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.

Results:

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%).

Conclusions:

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.


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