Gemcitabine and docetaxel as first-line treatment for advanced urothelial carcinoma: a phase II study
2005

Gemcitabine and Docetaxel for Advanced Bladder Cancer

Sample size: 31 publication Evidence: moderate

Author Information

Author(s): Ardavanis A, Tryfonopoulos D, Alexopoulos A, Kandylis C, Lainakis G, Rigatos G

Primary Institution: 1st Department of Medical Oncology, St Savas Anticancer Hospital, Athens, Greece

Hypothesis

The study investigates the toxicity and efficacy of gemcitabine and docetaxel in untreated advanced urothelial carcinoma.

Conclusion

The combination of gemcitabine and docetaxel is effective and well tolerated as a first-line treatment for advanced urothelial carcinoma.

Supporting Evidence

  • Overall response rate was 51.6%, including four complete responses and 12 partial responses.
  • The median time to progression was 8 months.
  • The median overall survival was 15 months with a 1-year survival rate of 60%.
  • Toxicity was primarily haematologic, with neutropenia being the most common severe side effect.

Takeaway

Doctors tested a new medicine for bladder cancer and found it works well and is safe for patients.

Methodology

This was a phase II study involving patients with untreated advanced urothelial carcinoma, treated with gemcitabine and docetaxel every 21 days for up to nine cycles.

Limitations

The study was nonrandomized and conducted at a single institution, which may limit the generalizability of the results.

Participant Demographics

The study included 31 patients, predominantly male (80.6%), with a median age of 64 years.

Statistical Information

Confidence Interval

{"time_to_progression":"5.1–9.2 months","overall_survival":"11.2–18.5 months"}

Digital Object Identifier (DOI)

10.1038/sj.bjc.6602378

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