A phase II trial of gemcitabine plus carboplatin in advanced transitional cell carcinoma of the urothelium
2007

Gemcitabine and Carboplatin for Advanced Bladder Cancer

Sample size: 41 publication Evidence: moderate

Author Information

Author(s): Xu Nong, Zhang Xiao Chen, Xiong Jian Ping, Fang Wei Jia, Yu Lan Fang, Qian Jiong, Zhang Ling

Primary Institution: The First Affiliated Hospital, School of Medicine, Zhejiang University

Hypothesis

The study aims to evaluate the activity and tolerability of gemcitabine plus carboplatin as first-line treatment in patients with advanced transitional cell carcinoma of the urothelium.

Conclusion

The combination of gemcitabine plus carboplatin is effective in treating advanced transitional cell carcinoma with manageable toxicity.

Supporting Evidence

  • The overall response rate was 46.2%, with 10.3% complete responses and 35.9% partial responses.
  • Median progression-free survival was 7.5 months and median overall survival was 13.6 months.
  • Grade 3/4 neutropenia occurred in 36.6% of patients, indicating significant hematological toxicity.

Takeaway

This study tested a new medicine combination for bladder cancer and found it works well without causing too many side effects.

Methodology

Patients received gemcitabine and carboplatin in a specific schedule and were monitored for response and side effects.

Potential Biases

Potential bias due to the single-arm design and lack of a control group.

Limitations

The study was limited to a single-arm design and included only Chinese patients.

Participant Demographics

Median age was 64.5 years, with 75.6% male and 24.4% female participants.

Statistical Information

P-Value

p<0.0000

Confidence Interval

95% CI: 32–65%

Statistical Significance

p<0.0000

Digital Object Identifier (DOI)

10.1186/1471-2407-7-98

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