PHASE-II STUDY OF AMONAFIDE IN THE TREATMENT OF PATIENTS WITH ADVANCED SQUAMOUS-CELL CARCINOMA OF THE HEAD AND THE NECK - AN ILLINOIS-CANCER-CENTER STUDY

Amonafide (nafidimide), a synthetic organic compound with an inhibitor y effect on cellular replication, was used in a phase II study conduct ed by the Illinois Cancer Center in order to assess its efficacy and t oxicity in advanced or recurrent squamous cell cancer of the head and neck. Eligible patients had received no more than one prior adjuvant o r neoadjuvant chemotherapy, had normal bone marrow, renal and hepatic function, ECOG performance status of 0-2, and bidimensionally measurab le disease. Eligible patients were administered amonafide at a startin g dose of 300 mg/m(2) for five consecutive days every 3 weeks with dos e escalation or de-escalation according to established hematologic cri teria in the absence of disease progression. Nineteen of 22 entered pa tients were evaluable for response and all patients were evaluable for toxicity. Eleven of 19 patients achieved stable disease. Median time to progression after start of treatment was 57 days, for the 18 patien ts for whom the date of progression is known. There were no partial or complete responses. Hematologic toxicity was dose limiting with grade 3-4 neutropenia in 50 percent of patients and 4 deaths associated wit h neutropenic sepsis. Non-hematologic toxicity was mild to moderate wi th nausea and vomiting predominating. In this study, amonafide was a m yelotoxic, inactive treatment in advanced/recurrent head and neck canc er. Further use in head and neck cancer appears unwarranted.