• J. Clin. Oncol. · Nov 2003

    Multicenter Study Clinical Trial

    Subcutaneous interleukin-2 and interferon alfa administration in patients with metastatic renal cell carcinoma: final results of SCAPP III, a large, multicenter, phase II, nonrandomized study with sequential analysis design--the Subcutaneous Administration Propeukin Program Cooperative Group.

    • Jean-Marc Tourani, Christian Pfister, Nicole Tubiana, Mahmoud Ouldkaci, Gilles Prevot, Virginie Lucas, Stéphane Oudard, Maxime Malet, Paul Cottu, Jean-Marc Ferrero, Didier Mayeur, Olivier Rixe, Xu-Shan Sun, Olivier Bernard, Thierry Andre, Christophe Tournigand, Xavier Muracciole, Joelle Guilhot, and Subcutaneous Administration Propeukin Program Cooperative Group.
    • Service d'Oncologie Médicale and Unité de Biostatistique, Fédération de Cancérologie et d'Hématologie, Hôpital J Bernard, Poitiers, France. jm.tourani@chu-poitiers.fr
    • J. Clin. Oncol. 2003 Nov 1; 21 (21): 3987-94.

    PurposeThis outpatient multicenter trial tested the hypothesis that subcutaneous administration of an interleukin-2 (IL-2)/interferon alfa (IFN alpha) combination produces a response rate greater than 20% in patients with renal cell carcinoma (RCC).Patients And MethodsPatients with metastatic RCC received a 12-week induction treatment with subcutaneous IL-2 (5 days/wk, 9 and 18 million U/d)/IFN alpha (3 days/wk, 6 million U/d). After evaluation, patients with objective response or stable disease were randomly assigned to maintenance treatment or short consolidation treatment.ResultsLack of benefit was shown at the 12th sequential analysis, and the trial was closed. At the end of the induction period, 26 (21%) of 122 patients had objective responses (including six complete responses). Thirty-three patients (27%) developed severe toxicity requiring dose reductions, delayed treatment, or treatment termination. Survival rates at one, two, and four years were 63%, 38%, and 17%, respectively. Three-year survival was 20% in patients with two poor prognosis factors and 37% in patients with one or no poor prognosis factors (P =.016). Three-year survival was significantly better (P < 10-3) in patients with erythrocyte sedimentation rate less than 35 mm (43%) compared with those with 1-hour sedimentation rate greater than 35 mm (19%).ConclusionThis study confirms the importance of prognostic factors when initiating cytokine immunotherapy in patients with metastatic RCC and underlines the prognostic value of erythrocyte sedimentation rate before treatment initiation. Nonetheless, this subcutaneous IL-2/IFN alpha combination does not improve response rate or survival compared with subcutaneous IL-2 alone, although a definitive conclusion cannot be drawn in the absence of a randomized study comparing the two treatments.

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