¹Gilbert J, ¹Dang T, ²Cmelak A, ³Shyr Y, ⁴Netterville J, ⁴Burkey B, ¹Chung CH, ⁵Ikpeazu E and ¹Murphy BA

¹Department of Internal Medicine, Division of Hematology and Medical Oncology, Vanderbilt University Medical Center, Nashville, TN. ²Department of Radiation Oncology, Vanderbilt University Medical Center, Nashville, TN. ³Division of Biostatistics, Vanderbilt University Medical Center, Nashville. ⁴Department of Otolaryngology, Vanderbilt University Medical Center, Nashville, TN. ⁵Meharry Medical College, Nashville, TN.

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/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.