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

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

Gareth O Griffiths  1 , Richard A Cowan  2 , Kenneth M Grigor  3 , Barbara M Uscinska  4 , Matthew Sydes  4 , Martin Russell  5
Affiliations
Clinical Trial

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

Gareth O Griffiths et al. PLoS One. .

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.

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Conflict of interest statement

The authors have declared that no competing interests exist.

Figures

Fig 1
Fig 1. CONSORT diagram.
Fig 2
Fig 2. Kaplan-Meier curve of overall survival.
See this image and copyright information in PMC

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