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Phase III Trial of Interferon Alfa-2a With or Without 13-cis-Retinoic Acid for Patients With Advanced Renal Cell Carcinoma

2000; Lippincott Williams & Wilkins; Volume: 18; Issue: 16 Linguagem: Inglês

10.1200/jco.2000.18.16.2972

1527-7755

Robert J. Motzer, Barbara A. Murphy, Jennifer Bacik, Lawrence H. Schwartz, David M. Nanus, Tania Mariani, Patrick J. Loehrer, George Wilding, Diane L. Fairclough, David Cella, Madhu Mazumdar,

Ovarian cancer diagnosis and treatment

PURPOSE: A randomized phase III trial was conducted to determine whether combination therapy with 13-cis-retinoic acid (13-CRA) plus interferon alfa-2a (IFNα2a) is superior to IFNα2a alone in patients with advanced renal cell carcinoma (RCC). PATIENTS AND METHODS: Two hundred eighty-four patients were randomized to treatment with IFNα2a plus 13-CRA or treatment with IFNα2a alone. IFNα2a was given daily subcutaneously, starting at a dose of 3 million units (MU). The dose was escalated every 7 days from 3 to 9 MU (by increments of 3 MU), unless ≥ grade 2 toxicity occurred, in which case dose escalation was stopped. Patients randomized to combination therapy were given oral 13-CRA 1 mg/kg/d plus IFNα2a. Quality of life (QOL) was assessed. RESULTS: Complete or partial responses were achieved by 12% of patients treated with IFNα2a plus 13-CRA and 6% of patients treated with IFNα2a (P = .14). Median duration of response (complete and partial combined) in the group treated with the combination was 33 months (range, 9 to 50 months), versus 22 months (range, 5 to 38 months) for the second group (P = .03). Nineteen percent of patients treated with IFNα2a plus 13-CRA were progression-free at 24 months, compared with 10% of patients treated with IFNα2a alone (P = .05). Median survival time for all patients was 15 months, with no difference in survival between the two treatment arms (P = .26). QOL decreased during the first 8 weeks of treatment, and a partial recovery followed. Lower scores were associated with the combination therapy. CONCLUSION: Response proportion and survival did not improve significantly with the addition of 13-CRA to IFNα2a therapy in patients with advanced RCC. 13-CRA may lengthen response to IFNα2a therapy in patients with IFNα2a-sensitive tumors. Treatment, particularly the combination therapy, was associated with a decrease in QOL.