BA08: An open-label, single-arm, non-randomised, phase 2 trial of cisplatin, methotrexate and vinblastine (CMV) for pure squamous cell cancer of the urinary tract

PLoS One. 2019 Jan 16;14(1):e0210785. doi: 10.1371/journal.pone.0210785. eCollection 2019.

Abstract

Background: Pure squamous cell carcinoma (SCC) of the urinary tract is rare in the UK and has a poor prognosis compared with transitional cell carcinoma (TCC). Cisplatin based chemotherapy has been shown to be effective in TCC.

Methods: Patients with T3-T4, pelvic relapsed, nodal or metastatic SCC of the urinary tract were recruited into an open-label, single-arm, non-randomised, phase 2 trial evaluating the activity and safety of cisplatin, methotrexate and vinblastine (CMV) chemotherapy. CMV was given as three 21-day cycles of methotrexate 30mg/m2 (day 1 & 8), vinblastine 4mg/m2 (day 1 & 8) and cisplatin 100mg/m2 (day 2).

Results: 38 patients were recruited. Overall response was 39% (95% CI 24%, 55%)-13% CR and 26% PR. Median OS was 7.8 months (95% CI 3.4, 12.6) with 39% 1-year survival. Toxicity was acceptable.

Conclusion: CMV is well tolerated and active in patients with pure SCC of the urinary tract.

Publication types

  • Clinical Trial, Phase II
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Carcinoma, Squamous Cell / drug therapy*
  • Carcinoma, Squamous Cell / mortality
  • Cisplatin / administration & dosage
  • Female
  • Humans
  • Kaplan-Meier Estimate
  • Male
  • Methotrexate / administration & dosage
  • Middle Aged
  • Urinary Bladder Neoplasms / drug therapy
  • Urologic Neoplasms / drug therapy*
  • Urologic Neoplasms / mortality
  • Vinblastine / administration & dosage

Substances

  • Vinblastine
  • Cisplatin
  • Methotrexate