PHASE-II TRIAL OF 13-CIS-RETINOIC ACID PLUS INTERFERON-ALPHA IN RECURRENT HEAD AND NECK-CANCER

13-cis-retinoic acid (isotretinoin) and interferon-alpha have limited activity as single agents in advanced cancer. Preclinical data indicat e that these agents have different mechanisms of action and, in combin ation have greater activity (that is, the ability to modulate growth a nd differentiation) in a number of malignant cell types than either ag ent alone. In clinical trials, the new biological regimen of 13-cis-re tinoic acid and interferon-a was shown to have major activity in advan ced squamous cell carcinoma of the skin and cervix. We conducted a pha se II trial of this regimen in recurrent squamous cell carcinoma of th e head and neck. Of the 21 evaluable patients, none had a complete res ponse, and only one had a partial response (5%). Two patients had mino r responses, four had stable disease, and 14 experienced disease progr ession. Five patients developed grade 3 toxic effects, including skin toxicity, fatigue, headache, and anorexia/weight loss. The median surv ival duration was 25.5 weeks (range, 4-95). The combination of 13-cis- retinoic acid and interferon-alpha at this dose and schedule is ineffe ctive for the treatment of recurrent squamous cell carcinoma of the he ad and neck.