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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

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
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

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.

Journal Article
1932-6203
Griffiths, Gareth O.
7fd300c0-d279-4ff6-842d-aa1f2b9b864d
Cowan, Richard A.
04ae16a5-0513-4458-b7b6-4f3d03e6decb
Grigor, Kenneth M.
1c901a3c-7f5b-49fd-8c4d-52d5800ab79b
Uscinska, Barbara M.
d04a14ca-73c3-48fb-8406-5e14477580e4
Sydes, Matthew
b8217e31-fcaf-4d61-ab91-c3508f1cb16d
Russell, Martin
4829dd95-df9d-45f2-b2cb-7d881dc72048
Griffiths, Gareth O.
7fd300c0-d279-4ff6-842d-aa1f2b9b864d
Cowan, Richard A.
04ae16a5-0513-4458-b7b6-4f3d03e6decb
Grigor, Kenneth M.
1c901a3c-7f5b-49fd-8c4d-52d5800ab79b
Uscinska, Barbara M.
d04a14ca-73c3-48fb-8406-5e14477580e4
Sydes, Matthew
b8217e31-fcaf-4d61-ab91-c3508f1cb16d
Russell, Martin
4829dd95-df9d-45f2-b2cb-7d881dc72048

Griffiths, Gareth O., Cowan, Richard A., Grigor, Kenneth M., Uscinska, Barbara M., Sydes, Matthew and Russell, Martin (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). (doi:10.1371/journal.pone.0210785).

Record type: Article

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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Accepted/In Press date: 31 December 2018
e-pub ahead of print date: 16 January 2019
Published date: 2019
Keywords: Journal Article

Identifiers

Local EPrints ID: 427943
URI: https://eprints.soton.ac.uk/id/eprint/427943
ISSN: 1932-6203
PURE UUID: 9fbe87ad-def0-41b8-86c6-62c98caf33f3
ORCID for Gareth O. Griffiths: ORCID iD orcid.org/0000-0002-9579-8021

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Date deposited: 05 Feb 2019 17:30
Last modified: 20 Jul 2019 00:36

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Contributors

Author: Richard A. Cowan
Author: Kenneth M. Grigor
Author: Barbara M. Uscinska
Author: Matthew Sydes
Author: Martin Russell

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