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

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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/m 2 (day 1 & 8), vinblastine 4mg/m 2 (day 1 & 8) and cisplatin 100mg/m 2 (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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Griffiths, G. O., Cowan, R. A., Grigor, K. M., Uscinska, B. M., Sydes, M., & Russell, M. (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. PLoS ONE, 14(1). https://doi.org/10.1371/journal.pone.0210785

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