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

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/m² 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.