Clinical Research Papers:
Phase II study of docetaxel, cisplatin, and fluorouracil in patients with distantly metastatic penile cancer as first-line chemotherapy
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Sheng Zhang1,2,*, Yao Zhu2,3,*, Dingwei Ye2,3
1Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai 200032, China
2Department of Oncology, Shanghai Medical College, Fudan University, Shanghai 200032, China
3Department of Urology, Fudan University Shanghai Cancer Center, Shanghai 200032, China
*These authors have contributed equally to this work
Dingwei Ye, e-mail: firstname.lastname@example.org
Keywords: penile cancer, docetaxel, fluorouracil, metastases
Received: June 21, 2015 Accepted: July 17, 2015 Published: July 30, 2015
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/m2 (day1), cisplatin 70 mg/m2 (day1), and fluorouracil 500 mg/m2/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.
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