Background Recombinant human interleukin-2 (aldesleukin) andrecombinant human interferon alfa can induce notable tumor regressionin a limited number of patients with metastatic renal-cell carcinoma.We conducted a multicenter, randomized trial to determine theeffect of each cytokine independently and in combination, andto identify patients who are best suited for this treatment.
Methods Four hundred twenty-five patients with metastatic renal-cellcarcinoma were randomly assigned to receive either a continuousintravenous infusion of interleukin-2, subcutaneous injectionsof interferon alfa-2a, or both. The main outcome measure wasthe response rate; secondary outcomes were the rates of event-freeand overall survival. Predictive factors for response and rapidprogression were identified by multivariate analysis.
Results Response rates were 6.5 percent, 7.5 percent, and 18.6percent (P<0.01) for the groups receiving interleukin-2,interferon alfa-2a, and interleukin-2 plus interferon alfa-2a,respectively. At one year, the event-free survival rates were15 percent, 12 percent, and 20 percent, respectively (P = 0.01).There was no significant difference in overall survival amongthe three groups. Toxic effects of therapy were more commonin patients receiving interleukin-2 than in those receivinginterferon alfa-2a. Response to treatment was associated withhaving metastasis to a single organ and with receiving the combinedtreatment. The probability of rapid progression of disease wasat least 70 percent for patients with at least two metastaticsites, liver metastases, and a period of less than one yearbetween the diagnosis of the primary tumor and the appearanceof metastases.
Conclusions Cytokines are active in a few patients with metastaticrenal-cell carcinoma. The higher response rate and longer event-freesurvival obtained with a combination of cytokines must be balancedagainst the toxicity of such treatment.
Source Information
From the Departments of Medical Oncology (S.N., T.P.) and Biostatistics (C.L., J.S.), Centre Léon Bérard, Lyons; Institut Gustave Roussy, Villejuif (B.E., T.T.); Centre René Gauducheau, Nantes (J.-Y.D.); Centre Claudius Régaud, Toulouse (C.C.); Institut Bergonié, Bordeaux (A.R.); Hôpital Edouard Herriot, Lyons (A.M.); Centre François Baclesse, Caen (J.P.); and Hôpital Michalon, Grenoble (M.M.) — all in France.
Address reprint requests to Dr. Negrier at the Centre Léon Bérard, 69373 Lyons CEDEX 08, France.
Cytokine Therapy in Metastatic Renal Cancer
Stadler W. M., Vogelzang N. J., Jerian S., Keegan P., Siegel J., Davis I. D., Gleave M., Elhilali M., Negrier S., Lasset C., Escudier B., The Groupe Français d'Immunothérapie
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Full Text
N Engl J Med 1998;
339:849-851, Sep 17, 1998.
Correspondence
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