Activity and toxicity of paclitaxel in pretreated metastatic penile cancer patients

Anticancer Drugs. 2009 Apr;20(4):277-80. doi: 10.1097/CAD.0b013e328329a293.

Abstract

The objective of this study was to evaluate the use of paclitaxel in patients with advanced squamous cell penile cancer previously treated with neoadjuvant cisplatin-based chemotherapy. This was a single-arm, phase II, multicenter study. Patients were treated with 175 mg/m paclitaxel at a 3-week interval, until disease progression or irreversible toxicity. The primary end point was the objective response rate. Secondary end points were safety, progression-free survival, and overall survival. Twelve patients were enrolled. Partial responses were observed in 25% (3 of 12) of patients (95% confidence interval: 12-40%). Grade 3 neutropenia and oral mucositis were the most common side effects, each noted in three patients. Median progression-free survival was 4 months (range 2-6 months) and median overall survival was 6 months (range 3-10 months). Paclitaxel is well tolerated and associated with promising efficacy. Further trials, also in a neoadjuvant setting, are needed to corroborate our preliminary findings.

Publication types

  • Clinical Trial, Phase II
  • Multicenter Study

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Agents, Phytogenic / adverse effects
  • Antineoplastic Agents, Phytogenic / therapeutic use*
  • Carcinoma, Squamous Cell / drug therapy*
  • Carcinoma, Squamous Cell / physiopathology
  • Chemotherapy, Adjuvant
  • Cisplatin / therapeutic use
  • Disease-Free Survival
  • Follow-Up Studies
  • Humans
  • Male
  • Middle Aged
  • Neoplasm Metastasis
  • Neutropenia / chemically induced
  • Paclitaxel / adverse effects
  • Paclitaxel / therapeutic use*
  • Penile Neoplasms / drug therapy*
  • Penile Neoplasms / physiopathology
  • Stomatitis / chemically induced
  • Survival Rate
  • Treatment Outcome

Substances

  • Antineoplastic Agents, Phytogenic
  • Paclitaxel
  • Cisplatin