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. Copyright
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. Copyright
Authors: Suzanne Richter; J Dean Ruether; Lori Wood; Christina Canil; Patricia Moretto; Peter Venner; Joel Gingerich; Urban Emmenegger; Andrea Eisen; Pawel Zalewski; Anthony Joshua; Som Dave Mukherjee; Daniel Heng; Piotr Czaykowski; Denis Soulieres; Norman Blais; Ricardo Rendon; Neil Fleshner; Juanita M Crook; Srikala S Sridhar Journal: Can Urol Assoc J Date: 2013 Nov-Dec Impact factor: 1.862
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Authors: Carlo Buonerba; Giuseppe Di Lorenzo; Giuseppe Calderoni; Matteo Ferro; Francesco Perri; Lucia Lombardi; Raffaele Ardito; Piera Federico; Sabino De Placido; Michele Aieta Journal: Future Sci OA Date: 2015-11-01
Authors: Carlo Buonerba; Luca Scafuri; Ferdinando Costabile; Bruno D'Ambrosio; Simona Gatani; Pasquale Verolino; Rossella Di Trolio; Vincenzo Cosimato; Antonio Verde; Giuseppe Di Lorenzo Journal: Future Sci OA Date: 2021-05-21