Single Agent Irinotecan for the Treatment of Metastatic or Recurrent Squamous Carcinoma of the Head and Neck (SCCHN)

Abstract

Background Patients with recurrent or metastatic head and neck cancer (HNC) have a poor response and survival with currently available chemotherapy agents. Thus new agents are needed. We report the results of a phase II trial of irinotecan in patients with metastatic or recurrent HNC. Patients and Methods Chemonaive patients were treated with irinotecan 125 mg/m 2 on a weekly schedule for four weeks, followed by a two week rest. However, due to excessive toxicity, the dose and schedule of irinotecan was changed to 75 mg/m 2 on days 1 and 8 of a 21 day cycle. All previously treated patients received 75 mg/m 2 on days 1 and 8 of a 21 day cycle. Results Forty-nine patients were enrolled on study. The response rate was 20% in the chemonaive patients treated at the 125 mg/m 2 dose. The response rate decreased to 12.5% at the 75 mg/m 2 dose. In the previously treated cohort, the response rate was 20%. Median survival for the chemonaive and previously treated cohorts were 6.7 months and 5.0 months, respectively. Conclusions Irinotecan has modest activity in chemonaive and previously treated HNC, thus it merits further study in this advanced disease population.