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Multicenter prospective study of interferon-alpha versus bone marrow transplantation for newly diagnosed patients with chronic myelogenous leukemia An interim analysis of the Kouseisho leukemia study group



Multicenter prospective study of interferon-alpha versus bone marrow transplantation for newly diagnosed patients with chronic myelogenous leukemia An interim analysis of the Kouseisho leukemia study group



Blood 98(11 Part 1): 348a, November 16



Interferon-alpha (IFN) therapy was compared with bone marrow transplantation (BMT) in patients with chronic myelogenous leukemia (CML) in a multicenter, prospective study. The objective of this study was to determine the optimal indications for and timing of unrelated-donor BMT, which remain controversial. This study was conducted based on genetic randomization, i.e. patients were allocated according to eligibility for transplant and then received BMT if available. Of 257 evaluable patients, 174 received IFN and 83 received allogeneic BMT, 52 of whom received transplants from HLA-identical related donors (R-BMT) and 31 from HLA-matched unrelated donors (U-BMT). Complete hematologic response was achieved by 148 patients (89%) in the IFN group and 54 (75%) before BMT in the BMT group. In the IFN group, a complete cytogenetic response was induced in 26 patients (16%), a partial cytogenetic response in 38 (23%) and a minor cytogenetic response in 39 (24%). At a median follow-up of 38 months, in the IFN group the predicted 5-year survival rate was 78%, and the predicted 5-year rate of remaining in chronic phase was 66%. In the BMT group the predicted 5-year survival rate was 77% for R-BMT and 69% for U-BMT. Overall survival did not differ significantly among the R-BMT, U-BMT, and IFN group. In the IFN group, overall survival in the low-risk group was better than that in the intermediate- and high-risk group according to the Sokal relative risk-classification (5-year survival: 87% vs 70%, P=0.07 by log-rank test). However, in the R-BMT and U-BMT groups there was no significant correlation between survival and Sokal risk. Regarding age, the cut-off value of 36 years was selected because it was the median age of the BMT group. Survival in the BMT group was approximately the same as in the IFN group in patients aged ltoreq36 years. However, survival in the U-BMT group was worse than that in the IFN group in patients aged >36 years (5-year survival: 37% vs 77%, p=0.03). Among the low-risk patients, there was no significant difference in 5-year survival rate by age, whereas in higher-risk patients, 5-year survival after R-BMT or U-BMT tended to be better that with IFN therapy in patients aged ltoreq36 years (74% vs 83% vs 64%, p>0.8). Conversely, 4-year survival after U-BMT was worse than with IFN therapy in higher-risk patients aged >36 years (33% vs 71%, p=0.09). There was no significant difference in survival in patients who underwent BMT within 1 year of registration or after 1 year. Based on the results of the present study at a median follow-up 38 months, U-BMT may be recommended for higher-risk, younger patients. However, other treatment options should be considered carefully for higher-risk, older patients. Longer follow-up is needed to reach definitive conclusions with regard to the indications for and timing of U-BMT.

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Accession: 035349886

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