A phase II trial of gemcitabine plus carboplatin in advanced transitional cell carcinoma of the urotheliumReport as inadecuate




A phase II trial of gemcitabine plus carboplatin in advanced transitional cell carcinoma of the urothelium - Download this document for free, or read online. Document in PDF available to download.

BMC Cancer

, 7:98

First Online: 09 June 2007Received: 11 February 2007Accepted: 09 June 2007DOI: 10.1186-1471-2407-7-98

Cite this article as: Xu, N., Zhang, X.C., Xiong, J.P. et al. BMC Cancer 2007 7: 98. doi:10.1186-1471-2407-7-98

Abstract

BackgroundRecent studies have demonstrated the effectiveness of cisplatin-based combinations in patients with advanced transitional cell carcinomaTCC 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.

MethodsPatients with advanced TCC were treated with gemcitabine 1200 mg-m on days 1 and 8 and carboplatin area under the concentration-time curveAUC 5 on day 1 every 21 days.

ResultsOut 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.

ConclusionThe 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 registrationISRCTN88259320

Electronic supplementary materialThe online version of this article doi:10.1186-1471-2407-7-98 contains supplementary material, which is available to authorized users.

Nong Xu, Jian Ping Xiong contributed equally to this work.

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Author: Nong Xu - Xiao Chen Zhang - Jian Ping Xiong - Wei Jia Fang - Lan Fang Yu - Jiong Qian - Ling Zhang

Source: https://link.springer.com/



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