Pooled analysis of phase II trials evaluating weekly or conventional cisplatin as first-line therapy for advanced urothelial carcinoma

Benjamin L. Maughan, Neeraj Agarwal, Syed A. Hussain, Kenneth M. Boucher, Hans Von Der Maase, Donald S. Kaufman, Vito Lorusso, Malcolm J. Moore, Matthew D. Galsky, Guru Sonpavde

Research output: Contribution to journalArticle

Abstract

Background: Weekly gemcitabine with GC every 3-4 weeks is considered conventional first-line chemotherapy for advanced urothelial carcinoma (UC). Weekly split-dose cisplatin with wGC might be less toxic and have similar activity, but has not been compared with GC. We pooled published phase II trials of GC and wGC to compare efficacy and safety. Patients and Methods: Two trials of wGC and 3 trials of GC were identified. Because the data were not derived from randomized trials, GC and wGC were not formally compared, and exact 95% quasi-binomial confidence intervals (CI), for response rates and grade ≥ 3 toxicities were calculated. Results: The 95% CI overlapped, suggesting agreement between wGC and GC. No clear difference in response rates and grade ≥ 3 toxicities between GC and wGC were observed. Conclusion: Gemcitabine combined with day 1 cisplatin and wGC yielded similar responses and grade ≥ 3 toxicities in advanced UC in a hypothesis-generating pooled analysis of phase II trials. Considering the probable lower nephrotoxicity of fractionated cisplatin, prospective evaluation of wGC might be warranted across cisplatin-eligible and -ineligible patients to develop a single chemotherapy template for the development of combinations with biological agents in a broad population of patients.

Original languageEnglish
Pages (from-to)316-320
Number of pages5
JournalClinical Genitourinary Cancer
Volume11
Issue number3
DOIs
Publication statusPublished - Sep 2013

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Keywords

  • Advanced urothelial carcinoma
  • Cisplatin
  • Conventional
  • Fractionated
  • Response rate
  • Toxicities
  • Weekly

ASJC Scopus subject areas

  • Oncology
  • Urology

Cite this

Maughan, B. L., Agarwal, N., Hussain, S. A., Boucher, K. M., Von Der Maase, H., Kaufman, D. S., Lorusso, V., Moore, M. J., Galsky, M. D., & Sonpavde, G. (2013). Pooled analysis of phase II trials evaluating weekly or conventional cisplatin as first-line therapy for advanced urothelial carcinoma. Clinical Genitourinary Cancer, 11(3), 316-320. https://doi.org/10.1016/j.clgc.2012.12.007