PACLITAXEL FOR PENILE CANCER

Anticancer Drugs. 2009 Mar 3. [Epub ahead of print]

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Activity and toxicity of paclitaxel in pretreated metastatic penile cancer patients.

Di Lorenzo G, Cartenì G, Autorino R, Gonnella A, Perdonà S, Ferro M, Longo N, Rescigno P, Doria F, Faiella A, Altieri V, Palmieri G, Imbimbo C, Mirone V, De Placido S.

aOncology Division, University Federico II bOncology Division, Cardarelli Hospital cUrology Division, Second University dUrology Division, INT Fondazione 'G. Pascale' eUrology Division, University Federico II, Naples, Italy.

The objective of this study was to evaluate the use of paclitaxel in patients with advanced squamous cell penile cancer previously treated with neoadjuvant cisplatin-based chemotherapy. This was a single-arm, phase II, multicenter study. Patients were treated with 175 mg/m paclitaxel at a 3-week interval, until disease progression or irreversible toxicity. The primary end point was the objective response rate. Secondary end points were safety, progression-free survival, and overall survival. Twelve patients were enrolled. Partial responses were observed in 25% (3 of 12) of patients (95% confidence interval: 12-40%). Grade 3 neutropenia and oral mucositis were the most common side effects, each noted in three patients. Median progression-free survival was 4 months (range 2-6 months) and median overall survival was 6 months (range 3-10 months). Paclitaxel is well tolerated and associated with promising efficacy. Further trials, also in a neoadjuvant setting, are needed to corroborate our preliminary findings.