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

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