Paclitaxel in pretreated metastatic penile cancer: Final results of a phase 2 study

Giuseppe Di Lorenzo, Piera Federico, Carlo Buonerba, Nicola Longo, Giacomo Carten, Riccardo Autorino, Sisto Perdon, Matteo Ferro, Pasquale Rescigno, Carmine D'Aniello, Elide Matano, Vincenzo Altieri, Giovannella Palmieri, Ciro Imbimbo, Sabino De Placido, Vincenzo Mirone

Research output: Contribution to journalArticle


Background: Previously published preliminary findings showed promising activity of paclitaxel in chemotherapy-pretreated metastatic penile cancer. Objective: To evaluate the activity and safety of paclitaxel in pretreated metastatic penile cancer. Design, setting, and participants: Twenty-five patients were enrolled in a single-arm phase 2 multicentre study and treated with 175 mg/m 2 paclitaxel at 3-wk intervals until disease progression or irreversible toxicity. Measurements: The objective response rate was the primary end point. Safety, progression-free survival (PFS), and overall survival (OS) were secondary end points. Results and limitations: Partial responses were observed in 20% (5 of 25 patients). Grade 1-2 neutropenia, nausea, and oral mucositis were the most common side effects, noted in 13, 9, and 8 patients, respectively. Grade 3-4 neutropenia was reported in seven patients (28%). Median PFS was 11 wk (95% confidence interval [CI], 7-30); median OS was 23 wk (95% CI, 13-48). Median survival in responders was 32 wk (95% CI, 20-48). One limitation of our study was the limited accrual, which did not reach the target of 27 patients, due to the typical slow enrolment of a rare disease. Conclusions: Final results of this study demonstrate that paclitaxel is moderately active and well tolerated. Further trials, which may also explore the combination of paclitaxel with other agents, are required to confirm our findings.

Original languageEnglish
Pages (from-to)1280-1284
Number of pages5
JournalEuropean Urology
Issue number6
Publication statusPublished - Dec 2011



  • Activity and toxicity
  • Metastatic penile cancer
  • Paclitaxel

ASJC Scopus subject areas

  • Urology

Cite this

Di Lorenzo, G., Federico, P., Buonerba, C., Longo, N., Carten, G., Autorino, R., Perdon, S., Ferro, M., Rescigno, P., D'Aniello, C., Matano, E., Altieri, V., Palmieri, G., Imbimbo, C., De Placido, S., & Mirone, V. (2011). Paclitaxel in pretreated metastatic penile cancer: Final results of a phase 2 study. European Urology, 60(6), 1280-1284.