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Phase II study of paclitaxel plus carboplatin in patients with advanced carcinoma of the urothelium and renal dysfunction (E2896)
Author(s) -
Vaughn David J.,
Manola Judith,
Dreicer Robert,
See William,
Levitt Ralph,
Wilding George
Publication year - 2002
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/cncr.10782
Subject(s) - medicine , carboplatin , urology , chemotherapy , oncology , paclitaxel , urothelium , hazard ratio , population , carcinoma , confidence interval , surgery , cisplatin , urinary bladder , environmental health
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 ≥ 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. Cancer 2002;95:1022–7. © 2002 American Cancer Society. DOI 10.1002/cncr.10782