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.
Adult
Aged
Antineoplastic Combined Chemotherapy Protocols
/ therapeutic use
Carcinoma, Squamous Cell
/ drug therapy
Cisplatin
/ administration & dosage
Female
Humans
Kaplan-Meier Estimate
Male
Methotrexate
/ administration & dosage
Middle Aged
Urinary Bladder Neoplasms
/ drug therapy
Urologic Neoplasms
/ drug therapy
Vinblastine
/ administration & dosage
Journal
PloS one
ISSN: 1932-6203
Titre abrégé: PLoS One
Pays: United States
ID NLM: 101285081
Informations de publication
Date de publication:
2019
2019
Historique:
received:
03
04
2018
accepted:
31
12
2018
entrez:
17
1
2019
pubmed:
17
1
2019
medline:
2
11
2019
Statut:
epublish
Résumé
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. 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). 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. CMV is well tolerated and active in patients with pure SCC of the urinary tract.
Sections du résumé
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.
Identifiants
pubmed: 30650143
doi: 10.1371/journal.pone.0210785
pii: PONE-D-18-05564
pmc: PMC6334943
doi:
Substances chimiques
Vinblastine
5V9KLZ54CY
Cisplatin
Q20Q21Q62J
Methotrexate
YL5FZ2Y5U1
Types de publication
Clinical Trial, Phase II
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e0210785Subventions
Organisme : Medical Research Council
ID : MC_UU_12023/28
Pays : United Kingdom
Déclaration de conflit d'intérêts
The authors have declared that no competing interests exist.
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