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Phase II trial of docetaxel, cisplatin and 5FU chemotherapy in locally advanced and metastatic penis cancer (CRUK/09/001)

Nicholson, S., Hall, E., Harland, S., Chester, John D ORCID:, Pickering, L., Barber, J., Elliott, T., Thomson, A., Burnett, S., Cruickshank, C., Carrington, B., Waters, R. and Bahl, A. 2013. Phase II trial of docetaxel, cisplatin and 5FU chemotherapy in locally advanced and metastatic penis cancer (CRUK/09/001). British Journal of Cancer 109 (10) , pp. 2554-2559. 10.1038/bjc.2013.620

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Background:Penis cancer is rare and clinical trial evidence on which to base treatment decisions is limited. Case reports suggest that the combination of docetaxel, cisplatin and 5-flurouracil (TPF) is highly active in this disease.Methods:Twenty-nine patients with locally advanced or metastatic squamous carcinoma of the penis were recruited into a single-arm phase II trial from nine UK centres. Up to three cycles of chemotherapy were received (docetaxel 75 mg m-2 day 1, cisplatin 60 mg m-2 day 1, 5-flurouracil 750 mg m-2 per day days 1-5, repeated every 3 weeks). Primary outcome was objective response (assessed by RECIST). Fourteen or more responses in 26 evaluable patients were required to confirm a response rate of 60% or higher (Fleming-A'Hern design), warranting further evaluation. Secondary endpoints included toxicity and survival.Results:10/26 evaluable patients (38.5%, 95% CI: 20.2-59.4) achieved an objective response. Two patients with locally advanced disease achieved radiological complete remission. 65.5% of patients experienced at least one grade 3/4 adverse event.Conclusion:Docetaxel, cisplatin and 5FU did not reach the pre-determined threshold for further research and caused significant toxicity. Our results do not support the routine use of TPF. The observed complete responses support further investigation of combination chemotherapy in the neoadjuvant setting.

Item Type: Article
Date Type: Publication
Status: Published
Schools: Medicine
Subjects: R Medicine > R Medicine (General)
R Medicine > RC Internal medicine
R Medicine > RC Internal medicine > RC0254 Neoplasms. Tumors. Oncology (including Cancer)
R Medicine > RZ Other systems of medicine
Uncontrolled Keywords: Aged; Antineoplastic Combined Chemotherapy Protocols; Carcinoma Squamous Cell; Cisplatin; Disease Progression; Fluorouracil; Great Britain; Humans; Male; Middle Aged; Neoplasm Metastasis; Penile Neoplasms; Survival Analysis; Taxoids;penis cancer; chemotherapy; metastatic; locally advanced
Publisher: Nature Publishing Group
ISSN: 0007-0920
Date of Acceptance: 15 September 2013
Last Modified: 28 Oct 2022 09:45

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