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Volume 337:223-229 July 24, 1997 Number 4
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Interferon Alfa-2b Combined with Cytarabine versus Interferon Alone in Chronic Myelogenous Leukemia
François Guilhot, M.D., Claude Chastang, M.D., Ph.D., Mauricette Michallet, M.D., Agnès Guerci, M.D., Ph.D., Jean-Luc Harousseau, M.D., Frédéric Maloisel, M.D., Réda Bouabdallah, M.D., Ph.D., Denis Guyotat, M.D., Nathalie Cheron, M.D., Franck Nicolini, M.D., Jean-François Abgrall, M.D., Joseph Tanzer, M.D., Maurice Navarro, Dominique Bordessoule, Patrick Morice, Norbert Ifrah, Henri Rochant, Jean-Pierre Vilque, Martine Delain, Francis Bauters, Joëlle Guilhot, for The French Chronic Myeloid Leukemia Study Group

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ABSTRACT

Background Treatment with interferon prolongs survival in chronic myelogenous leukemia. We conducted a clinical trial to assess the efficacy of treatment with a combination of interferon and cytarabine.

Methods Previously untreated patients with chronic myelogenous leukemia 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 monthly courses of cytarabine (20 mg per square meter per day, for 10 days). The end points were overall survival, complete hematologic remission at 6 months, and major cytogenetic response (less than 35 percent Philadelphia chromosome–positive cells in the bone marrow) at 12 months.

Results The trial was stopped when a sequential analysis showed a benefit of interferon and cytarabine. A significant improvement in survival was observed in the interferon–cytarabine group (360 patients) as compared with the interferon group (361 patients) (P = 0.02; relative risk of death, 0.64; 95 percent confidence interval, 0.44 to 0.93). After three years, the survival rate was 85.7 percent with interferon and cytarabine and 79.1 percent with interferon alone. The rate of hematologic response was higher in the interferon–cytarabine group than in the interferon group (P = 0.003). Major cytogenetic responses were observed 12 months after randomization in 126 of 311 patients treated with interferon and cytarabine (41 percent) and in 75 of 314 patients treated with interferon only (24 percent, P<0.001).

Conclusions The combination of interferon and cytarabine, as compared with interferon alone, increases the rate of major cytogenetic response and prolongs survival in patients in the chronic phase of chronic myelogenous leukemia.


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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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Related Letters:

Interferon Alfa-2b and Cytarabine in Chronic Myelogenous Leukemia
Patel T., Roychowdhury D. F., Guilhot F., Guilhot J., Chastang C.
Extract | Full Text  
N Engl J Med 1997; 337:1634-1635, Nov 27, 1997. Correspondence

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