Phase II study of docetaxel, cisplatin, and fluorouracil in patients with distantly metastatic penile cancer as first-line chemotherapy

// Sheng Zhang 1, 2, * , Yao Zhu 2, 3, * , Dingwei Ye 2, 3 1 Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai 200032, China 2 Department of Oncology, Shanghai Medical College, Fudan University, Shanghai 200032, China 3 Department of Urology, Fudan University Shanghai Cancer Center, Shanghai 200032, China * These authors have contributed equally to this work Corresponence to: Dingwei Ye, e-mail: 568841700@qq.com Keywords: penile cancer, docetaxel, fluorouracil, metastases Received: June 21, 2015      Accepted: July 17, 2015      Published: July 30, 2015 ABSTRACT Purpose: Patients with distantly metastatic (M1) penile squamous carcinoma have extremely poor prognosis and few prospective clinical trials evaluating systemic treatment have ever been performed for this population. Methods: Patients (aged ≥ 18 years) with histologically confirmed, distantly metastatic, measurable penile squamous carcinoma were enrolled. They were treated with docetaxel 75 mg/m 2 (day1), cisplatin 70 mg/m 2 (day1), and fluorouracil 500 mg/m 2 /d (days 1 to 5) every 3 weeks as first line chemotherapy. The primary endpoint was objective response rate (ORR). Results: 39 patients received chemotherapy with a median of four cycles (range two to six). The median follow-up time was 11 months. 15 patients had a confirmed objective response (38.5%, 95% CI 23.36–55.38), all of which were partial responses. The median progression-free survival (PFS) was 3 months (95% CI 2.92–3.09), and the median overall survival (OS) was 7 months (95% CI 5.99–8.03). Toxicity was manageable and the most frequently recorded adverse events of grade 3 or higher were neutropenia (13 of 39; 33%), nausea/vomiting (7 of 39;18%). There was no treatment-related death. Conclusion: The palliative regimen of docetaxel, fluorouracil, and cisplatin induced moderate responses and can be used as a choice for the treatment of patients with distantly metastatic penile cancer. However, efforts to improve efficacy and minimize toxicity for this regimen should be made in the future.