Prolonged subcutaneous administration of recombinant α2b interferon in patients with previously untreated Philadelphia chromosome-positive chronic-phase chronic myelogenous leukemia: Effect on remission duration and survival: Cancer and leukemia group B study 8583

摘要: We investigated whether recombinant alpha 2b interferon (r 2bIFN) would reduce the proportion of bone marrow Philadelphia chromosome (Ph) cells in chronic-phase chronic myelogenous leukemia (CML) by treating 107 previously untreated patients daily with r 2bIFN at 5 x 10(6)IU/m2 subcutaneously. Patients complete remission, partial or hematologic remission received treatment until progression; those progressive disease were taken off study and observed for survival. Sixty-three (59%) achieved least a (24 remissions 39 remissions). The median time to response 63 responders was 3.4 months, duration 52 months 81% continuing beyond 12 months. survival 66 Of 78 cytogenetic follow-up data, 31 (40%) (n = 17) 14). percentage among all 29% (31 patients). first 9 A major dose reduction (> 50%) required some during 38% patients, 26% 10% 49% reductions, 36% had minor reductions < 10%. No association between attainment response. None usual prognostic factors (sex, race, performance status, weight loss, from diagnosis treatment, hepatosplenomegaly, age, symptoms, hemoglobin, platelet, blast, basophil, white blood cell count) significantly related These data provide confirmation that responses prolonged administration subcutaneous occur 20% (95% confidence interval) chronic- phase Ph-positive patients. Although it is hypothesized achieving should have compared nonresponders, analyses effect both “landmark” time-dependent covariate techniques fail statistically significant evidence an on This may be due part size insufficiently large detected number treated this study. Thus, benefit, if any, therapy CML must await outcome randomized trials comparing IFN conventional agents.