A Phase II Trial of Gemcitabine Plus Carboplatin in Advanced Transitional Cell Carcinoma of the Urothelium

Overview

Journal BMC Cancer

Publisher Biomed Central

Specialty Oncology

Date 2007 Jun 15

PMID 17559681

Citations 4

Authors

Nong Xu

Xiao Chen Zhang

Jian Ping Xiong

Wei Jia Fang

Lan Fang Yu

Jiong Qian

Ling Zhang

Affiliations

Soon will be listed here.

Abstract

Background: Recent studies have demonstrated the effectiveness of cisplatin-based combinations in patients with advanced transitional cell carcinoma(TCC) of the urothelium. Concern over cisplatin toxicity instigated a search for alternative regimens. The aim of the study was to evaluate the activity and tolerability of gemcitabine plus carboplatin combination as first-line treatment in patients with advanced transitional cell carcinoma of the urothelium.

Methods: Patients with advanced TCC were treated with gemcitabine 1200 mg/m2 on days 1 and 8 and carboplatin area under the concentration-time curve(AUC) 5 on day 1 every 21 days.

Results: Out of 41 patients, thirty-nine were evaluable for efficacy and 41 for toxicity. A median of 5 cycles (range 1-6) was administered. Overall response rate was 46.2% (95% confidence interval: 32-65%) including 10.3% complete responses and 35.9% partial responses. The median time to progression and median overall survival were 7.5 months (95% confidence interval: 6.6-8.4 months) and 13.6 months (95% confidence interval: 10.2-17.0 months), respectively. Grade 3/4 neutropenia, anemia and thrombocytopenia were observed in 36.6%, 26.8, and 24.4% of patients, respectively. Non-hematological toxicity was generally mild. Grade 3 vomiting occurred in 1 (2.4%) patients.

Conclusion: The gemcitabine plus carboplatin combination is active in advanced TCC with acceptable toxicity and needs to be evaluated further and compared with other non-cisplatin-containing regimens.

Trial Registration: ISRCTN88259320.

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Sequential chemotherapy using gemcitabine + carboplatin followed by gemcitabine + carboplatin + docetaxel for advanced upper-tract urothelial cancer.

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