作者: Sante Tura , Michele Baccarani , Eliana Zuffa , Domenico Russo , Renato Fanin
DOI: 10.1056/NEJM199403243301204
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摘要: Background. In view of studies showing that interferon alfa was effective treatment for chronic myeloid leukemia and it prolonged survival, we organized a prospective, controlled comparative study this treatment. Methods. We compared recombinant alfa-2a with conventional chemotherapy (hydroxyurea or busulfan) in trial designed to have power 80 percent detect difference 20 median survival between the group given chemotherapy. Between 1986 1988, 322 patients previously untreated minimally treated Philadelphia chromosome-positive were randomly assigned either (218 patients) (104 patients). Results. The rate karyotypic response (defined as >33 metaphases negative chromosome) 30 groupand 5 conventional-chemotherapy (P 72 vs. 45 months; P<0.001), (median, 52 6-year 50 29 percent; P = 0.002 both comparisons). There one treatment-related death each group. Treatment discontinued because side effects (mainly influenza-like, gastrointestinal, neurologic symptoms) 35 (16 percent). cost 200 times Conclusions. During long-term leukemia, induced more responses than chemotherapy, delayed disease progression longer, overall more.