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

Nicola Nicolai, Laura Maria Sangalli, Andrea Necchi, Patrizia Giannatempo, Anna Maria Paganoni, Maurizio Colecchia, Luigi Piva, Mario Achille Catanzaro, Davide Biasoni, Silvia Stagni, Tullio Torelli, Daniele Raggi, Elena Faré, Giorgio Pizzocaro, Roberto Salvioni

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish
JournalClinical Genitourinary Cancer
DOIs
Publication statusAccepted/In press - Apr 3 2015

Keywords

  • Adjuvant chemotherapy
  • Drug therapy
  • Lymph node excision
  • Neoadjuvant chemotherapy
  • Penile neoplasms

ASJC Scopus subject areas

  • Oncology
  • Urology

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