Background In view of studies showing that interferon alfa waseffective treatment for chronic myeloid leukemia and that itprolonged survival, we organized a prospective, controlled comparativestudy of this treatment.
Methods We compared recombinant interferon alfa-2a with conventionalchemotherapy (hydroxyurea or busulfan) in a trial designed tohave a power of 80 percent to detect a difference of 20 percentin median survival between the group given interferon and thegroup given conventional chemotherapy. Between 1986 and 1988,322 patients with previously untreated or minimally treatedPhiladelphia chromosome-positive chronic myeloid leukemia wererandomly assigned to treatment with either interferon alfa-2a(218 patients) or conventional chemotherapy (104 patients).
Results The rate of karyotypic response (defined as >33 percentof metaphases negative for the Philadelphia chromosome) was30 percent in the interferon group and 5 percent in the conventional-chemotherapygroup (P<0.001). The time to progression from the chronicphase of leukemia to an accelerated or a blastic phase was longerin the interferon group than in the conventional-chemotherapygroup (median, >72 vs. 45 months; P<0.001), as was survival(median, 72 vs. 52 months; 6-year survival, 50 percent vs. 29percent; P = 0.002 for both comparisons). There was one treatment-relateddeath in each group. Treatment was discontinued because of sideeffects (mainly influenza-like, gastrointestinal, or neurologicsymptoms) in 35 patients given interferon alfa-2a (16 percent).The cost of interferon treatment was 200 times that of the conventionaltreatment.
Conclusions During long-term treatment of Philadelphia chromosome-positivechronic myeloid leukemia, interferon alfa-2a induced more karyotypicresponses than conventional chemotherapy, delayed disease progressionlonger, and prolonged overall survival more.
Source Information
The Writing Committee of the Italian Cooperative Study on Chronic Myeloid Leukemia consisted of Sante Tura (Institute of Hematology "L. and A. Seragnoli," University of Bologna), Michele Baccarani (Chair of Hematology, University of Udine), Eliana Zuffa (Institute of Hematology "L. and A. Seragnoli," University of Bologna), Domenico Russo (Chair of Hematology, University of Udine), Renato Fanin (Chair of Hematology, University of Udine), Alfonso Zaccaria (Institute of Hematology "L. and A. Seragnoli," University of Bologna), and Mauro Fiacchini (Institute of Hematology "L. and A. Seragnoli," University of Bologna). Other members of the study group are listed in the Appendix.
Address reprint requests to Professor Michele Baccarani at the Division of Hematology, Udine University Hospital, 33100 Udine, Italy.
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