Background Treatment with interferon prolongs survival in chronicmyelogenous leukemia. We conducted a clinical trial to assessthe efficacy of treatment with a combination of interferon andcytarabine.
Methods Previously untreated patients with chronic myelogenousleukemia were randomly assigned to receive either hydroxyurea(50 mg per kilogram of body weight per day) and interferon alfa-2b(5 million units per square meter of body-surface area per day),or hydroxyurea and interferon in the same dosages plus monthlycourses of cytarabine (20 mg per square meter per day, for 10days). The end points were overall survival, complete hematologicremission at 6 months, and major cytogenetic response (lessthan 35 percent Philadelphia chromosome–positive cellsin the bone marrow) at 12 months.
Results The trial was stopped when a sequential analysis showeda benefit of interferon and cytarabine. A significant improvementin survival was observed in the interferon–cytarabinegroup (360 patients) as compared with the interferon group (361patients) (P = 0.02; relative risk of death, 0.64; 95 percentconfidence interval, 0.44 to 0.93). After three years, the survivalrate was 85.7 percent with interferon and cytarabine and 79.1percent with interferon alone. The rate of hematologic responsewas higher in the interferon–cytarabine group than inthe interferon group (P = 0.003). Major cytogenetic responseswere observed 12 months after randomization in 126 of 311 patientstreated with interferon and cytarabine (41 percent) and in 75of 314 patients treated with interferon only (24 percent, P<0.001).
Conclusions The combination of interferon and cytarabine, ascompared with interferon alone, increases the rate of majorcytogenetic response and prolongs survival in patients in thechronic phase of chronic myelogenous leukemia.
Source Information
From Hôpital Jean Bernard, Poitiers (F.G., J.T.); Hôpital Saint-Louis, Paris (C.C.); Hôpital Edouard Herriot, Lyons (M.M.); Hôpital Brabois, Vandoeuvre-Les-Nancy (A.G.); Hôtel Dieu, Nantes (J.-L.H.); Hôpital de Hautepierre, Strasbourg (F.M.); Institut Paoli Calmette, Marseilles (R.B.); Hôpital Nord, Saint-Etienne (D.G.); Hôpital Saint-Antoine, Paris (N.C.); Hôpital Michalon, Grenoble (F.N.); and Hôpital Morvan, Brest (J.-F.A.) — all in France. Other authors were Maurice Navarro, M.D. (Hôpital Lapeyronie, Montpellier), Dominique Bordessoule, M.D. (Hôpital Dupuytren, Limoges), Patrick Morice, M.D. (Hôpital La Bauchée, Saint-Brieuc), Norbert Ifrah, M.D. (Hôpital Régional, Angers), Henri Rochant, M.D. (Hôpital Henri Mondor, Créteil), Jean-Pierre Vilque, M.D. (Hôpital Robert Debré, Reims), Martine Delain, M.D. (Hôpital Bretonneau, Tours), Francis Bauters, M.D. (Hôpital Claude Huriez, Lille), and Joëlle Guilhot, B.S. (Hôpital Jean Bernard, Poitiers).
Address reprint requests to Dr. Guilhot at the Department of Hematology and Medical Oncology, Hôpital Jean Bernard, 86021 Poitiers CEDEX, France.
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