A Combination of Cisplatin and 5-Fluorouracil With a Taxane in Patients Who Underwent Lymph Node Dissection for Nodal Metastases From Squamous Cell Carcinoma of the Penis: Treatment Outcome and Survival Analyses in Neoadjuvant and Adjuvant Settings

We addressed the use of perioperative chemotherapy in nodal metastates from penile cancer. Forty-seven N2 to 3M0 patients received perioperative taxane, cisplatin and 5-fluorouracil (T-PF) and 38.3% are disease-free at 22 months. Neoadjuvant T-PF allowed 12 (43%) clinical responsesand4 (14%) complete pathologic remissions among 28 patients, and the 2-year disease-free survival (DFS) was 7.1%. The 2-year DFS was 36.8% after adjuvant T-PF. T-PF is active and is associated with long-term survival after surgery. Chemotherapy must be offered with caution in patients with resectable nodal metastases. Background: The role of chemotherapy in nodal metastases from penile squamous cell carcinoma is not defined. We evaluated the efficacy of a combination of T-PF(a taxane, cisplatin, and 5-fluorouracil) in neoadjuvant and adjuvant settings. Patients and Methods: Since June of 2004, T-PF was administered to stage N2 to 3 patients. With time, neoadjuvant chemotherapy administration prevailed with respect to use in the adjuvant setting. Primary end points were progression-free (PFS) and overall (OS) survival. Secondary objectives were tolerability and activity in the neoadjuvant setting. Nonparametric tests, Kaplan-Meier, and regression analyses were performed. Results: As of October of 2012, 47 consecutive N2 to 3 M0 patients had undergone neoadjuvant (n = 28) or adjuvant (n = 19) T-PF: 18 patients (38.3%) remain disease-free after a median follow-up of 22 months (interquartile range, 17-42 months). The 2-year disease- free survivals were 36.8% (95% confidence interval [CI], 15.2-58.5) versus 7.1% ( 95% CI, 0-16.7) after adjuvant and neoadjuvant therapy, respectively. N3 metastases were associated with a poorer PFS, and bilateral metastases and mutated p53 were associated with a poorer OS. After neoadjuvant treatment, 43% clinical responses and 14% complete pathologic remissions were recorded, but responses were not associated with survival. Neutropenia (25.5%) was the most frequent Grade >= 2 toxicity. Conclusion: The T-PF regimen is well tolerated and compares with other regimens in terms of activity and efficacy in the neoadjuvant setting, and very long survivals have been recorded after adjuvant administration. The role of perioperative treatment in these patients remains controversial. Some caution in administering preemptive treatment in patients with resectable disease is needed. (C) 2015 Elsevier Inc. All rights reserved.