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

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/m2 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/m2 on days 1 and 8 of a 21 day cycle. All previously treated patients received 75 mg/m2 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/m2 dose. The response rate decreased to 12.5% at the 75 mg/m2 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.