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

Abstract

Background: Due to promising results in earlier clinical studies, a confirmatory phase II clinical trial of interferon alpha-2a (IF) and 13-cis-retinoic acid (RA) was conducted in patients with metastatic renal cell carcinoma (mRCC). Patients and Methods: 29 previously untreated patients with mRCC were treated. IF was given subcutaneously daily at 3 MU and escalated to 6 and 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 progressive disease was documented. Results:27 patients were eligible, 24 patients were evaluable for tumor response. 2/24 patients achieved a major response (2 partial responses), 9/24 had a treatment failure (9 progressive diseases), and 13/24 showed a status-idem situation (13 no-change cases). Myelotoxicity, nausea, epidermal toxicity, loss of appetite and weight loss were considerable and occurred inmost of the patients. Conclusions: IF and RA showed less anti-tumor activity than had been anticipated in advanced RCC. The proportion and the nature of response as well as the toxicity pattern suggest the deletion of this combination from the therapeutical repertoire of medical oncologists.

Randomized Phase II/III Trial of Interferon Alfa-2a With and Without 13-cis-Retinoic Acid in Patients With Progressive Metastatic Renal Cell Carcinoma: The European Organisation for Research and Treatment of Cancer Genito-Urinary Tract Cancer Group (EORTC 30951)

“…Another phase II study including 29 patients reported nausea, anorexia, weight loss, dermatologic toxicity, and myelotoxicity occurring in most of the patients. 26 In the phase III trial by Motzer et al, a lower overall incidence and grade of side effects were observed than in our study and with no difference between the treatment arms. 20 However, at all times of evaluation, patients in both treatment groups reported reduced quality of life compared with the pretreatment situation.…”