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

Giuseppe Di Lorenzo, Giacomo Cartenì, Riccardo Autorino, Antonio Gonnella, Sisto Perdonà, Matteo Ferro, Nicola Longo, Pasquale Rescigno, Francesca Doria, Adriana Faiella, Vincenzo Altieri, Giovannella Palmieri, Ciro Imbimbo, Vincenzo Mirone, Sabino De Placido

Journal: Anti-cancer drugs 2009;20(4):277-80

PMID: 19262371

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Abstract

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.

Address: University Federico II, Naples, Italy. [email protected]

DOI: 10.1097/CAD.0b013e328329a293

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MeSH Terms: Adult, Aged, Antineoplastic Agents, Phytogenic, Carcinoma, Squamous Cell, Chemotherapy, Adjuvant, Cisplatin, Disease-Free Survival, Follow-Up Studies, Humans, Male, Middle Aged, Neoplasm Metastasis, Neutropenia, Paclitaxel, Penile Neoplasms, Stomatitis, Survival Rate, Treatment Outcome