13-CIS-RETINOIC ACID AND INTERFERON ALPHA-2A IN PATIENTS WITH ADVANCED ESOPHAGEAL CANCER - A PHASE-II TRIAL

The aim of this study was to investigate the possible therapeutic effe ct of 13-cis-retinoic acid plus interferon alpha-2a in patients with i noperable squamous cancer of the esophagus. Patients with advanced, me asurable, histologically confirmed squamous carcinoma of the esophagus with an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 who had adequate bone marrow, liver, and renal function w ere eligible for study. Patients were given cis-retinoic acid 1 mg/kg/ day per mouth continuously and interferon alpha-2a 3 Mu/day for 3 days followed by 6 Mu subcutaneously daily thereafter. Seventeen patients were entered on study. Fifteen patients were evaluable for toxicity. T he most common toxicities were grade 1 and 2 cheilitis, dry skin and f lu-like symptoms which occurred in all patients. Two patients had grad e 3 toxicity (1 anorexia and 1 fatigue). No grade 4 toxicity occurred. Fifteen patients were evaluable for response. No objective response w as documented. The median survival time was 15 weeks. With no response seen it is unlikely that the combination of treatment as used in this study will be of benefit in patients with advanced squamous cancer of the esophagus.