Lack of efficacy of topotecan in the treatment of metastatic or recurrent squamous carcinoma of the head and neck - An Eastern Cooperative Oncology Group trial (E3393)

Recurrent or metastatic squamous carcinoma of the head and neck (RMSCHN) is a modestly chemoresponsive tumor; however. currently available agents have failed to improve survival. New active agents are needed for the treatment of this disease. Topotecan is a topoisomerase inhibitor that demonstrated initial promising activity in squamous carcinoma of the head and neck. The Eastern Cooperative Oncology Group conducted a phase II trial of topotecan to determine the efficacy and toxicity of a weekly treatment schedule in pa tients with RMSCHN. Patients with metastatic or locally recurrent squamous carcinoma of the head and neck were treated with topotecan 1.5 mg/m(2) X 24 hours by continuous infusion on days 1, 8, 15, and 22 of each 35-day cycle . Patients were stratified in two cohorts: chemonaive and previously treate d. Sixteen chemonaive and 16 previously treated patients were registered on study. Grade III/IV neutropenia and anemia occurred in 16% and 18% of pati ents, respectively. No responses were observed in either cohort. Median sur vival for previously untreated patients was 4.6 months and 3.2 months for p reviously treated patients. Topotecan failed to demonstrate efficacy in pat ients with RMSCHN. Further evaluation of this agent is not planned.