Randomized comparison of interferon α and hydroxyurea with hydroxyurea monotherapy in chronic myeloid leukemia (CML-study II): prolongation of survival by the combination of interferon α and hydroxyurea
| Autor: | Christoph Scheid, T. Schmeiser, Georgia Metzgeroth, W. Queißer, Carlo Aul, Andreas Tobler, Jörg Hasford, H. P. Lohrmann, Carl Richard Meier, Hartmut Eimermacher, O. Maywald, H. Pralle, Martin Wilhelm, Christoph Nerl, H. J. Kolb, R. Kuse, L. Labedzki, Martin Griesshammer, Markus Pfirrmann, Andreas Hochhaus, Andreas Reiter, Dieter K. Hossfeld, Ute Berger, J. Weiß, M. Perker, A. Tichelli, Michael Schenk, Helmut Löffler, S. Kremers, J.T. Fischer, Ruediger Hehlmann, Hermann Heimpel |
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| Rok vydání: | 2003 |
| Předmět: |
Adult
Male Cancer Research medicine.medical_specialty Adolescent Combination therapy Alpha interferon Risk Assessment Gastroenterology Hydroxycarbamide Cause of Death Leukemia Myelogenous Chronic BCR-ABL Positive Internal medicine Antineoplastic Combined Chemotherapy Protocols Humans Hydroxyurea Transplantation Homologous Medicine Child Interferon alfa Aged business.industry Remission Induction Hematopoietic Stem Cell Transplantation Interferon-alpha Hematology Middle Aged medicine.disease Survival Analysis Transplantation Oncology Cytogenetic Analysis Immunology Cytarabine Female business Busulfan medicine.drug Chronic myelogenous leukemia |
| Zdroj: | Leukemia. 17:1529-1537 |
| ISSN: | 1476-5551 0887-6924 |
| DOI: | 10.1038/sj.leu.2403006 |
| Popis: | The optimum treatment conditions of interferon (IFN) alpha therapy in chronic myeloid leukemia (CML) are still controversial. To evaluate the role of hydroxyurea (HU) for the outcome of IFN therapy, we conducted a randomized trial to compare the combination of IFN and HU vs HU monotherapy (CML-study II). From February 1991 to December 1994, 376 patients with newly diagnosed CML in chronic phase were randomized. In all, 340 patients were Ph/BCR-ABL positive and evaluable. Randomization was unbalanced 1:2 in favor of the combination therapy, since study conditions were identical to the previous CML-study I and it had been planned in advance to add the HU patients of study I (n=194) to the HU control group. Therefore, a total of 534 patients were evaluable (226 patients with IFN/HU and 308 patients with HU). Analyses were according to intention-to-treat. Median observation time of nontransplanted living patients was 7.6 years (7.9 years for IFN/HU and 7.3 years for HU). The risk profile (new CML score) was available for 532 patients: 200 patients (38%) were low, 239 patients (45%) intermediate, and 93 patients (17%) high risk. Complete hematologic response rates were higher in IFN/HU-treated patients (59 vs 32%). Of 169 evaluable IFN/HU-treated patients (75%), 104 patients (62%) achieved a cytogenetic response that was complete in 12% (n=21), major in 14% (n=24), and at least minimal in 35% (n=59). Of the 534 patients, 105 (20%) underwent allogeneic stem cell transplantation in first chronic phase. In the low-risk group, 65 of 200 patients were transplanted (33%), 30 (13%) in the intermediate-risk group, and nine (10%) in the high-risk group. Duration of chronic phase was 55 months for IFN/HU and 41 months for HU (P |
| Databáze: | OpenAIRE |
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