Phase II study with interferon alpha-2a and 13-cis-retinoic acid in patients with metastatic renal cell carcinoma - A trial of the phase II study group of the Association for Medical Oncology of the German Cancer Society

Background: Due to promising results in earlier clinical studies, a confirm atory phase II clinical trial of interferon alpha-2a (IF) and 13-cis-retino ic acid (RA) was conducted in patients with metastatic renal cell carcinoma (mRCC). Patients and Methods: 29 previously untreated patients with mRCC w ere treated. IF was given subcutaneously daily at 3 MU and escalated to 6 a nd 9 MU if tolerated. The RA dose was 1 mg/kg/day. The treatment was given over a period of 12 weeks, a staging procedure was performed every 6 weeks within the first half year and, thereafter, in 3-month intervals until prog ressive disease was documented. Results: 27 patients were eligible, 24 pati ents were evaluable for tumor response. 2/24 patients achieved a major resp onse (2 partial responses), 9/24 had a treatment failure (9 progressive dis eases), and 13/24 showed a status-idem situation (13 no-change cases). Myel otoxicity, nausea, epidermal toxicity, loss of appetite and weight loss wer e considerable and occurred inmost of the patients. Conclusions: IF and RA showed less antitumor activity than had been anticipated in advanced RCC. T he proportion and the nature of response as well as the toxicity pattern su ggest the deletion of this combination from the therapeutical repertoire of medical oncologists.