A PHASE-II TRIAL OF 10-ETHYL-10-DEAZA-AMINOPTERIN, A NOVEL ANTIFOLATE, IN PATIENTS WITH ADVANCED AND OR RECURRENT SQUAMOUS-CELL CARCINOMA OF THE HEAD AND NECK

Forty-seven patients with advanced and/or recurrent squamous cell carc inoma of the head and neck were treated with 10-ethyl-10-deaza-aminopt erin (10-EdAM), a new analogue of methotrexate. The drug was given as a weekly i.v. bolus injection, starting at 80 mg/m2 with two dose incr ements of 10% if no toxicity was observed after two weeks. Only patien ts with tumors of the larynx, oral cavity, oropharynx and hypopharynx were included in the trial. Eighty-two percent of the patients had had prior surgery and/or radiotherapy. Forty-four patients were evaluable for response and toxicity. Five CR (12%) and five PR were obtained, y ielding a response rate of 24% (CR + PR). The toxicity was similar to that usually seen with methotrexate; stomatitis and skin toxicity were rather pronounced. The data suggest that 10-EdAM has activity similar to that of methotrexate in patients with head and neck cancer.