Favorable long-term follow-up results over 6 years for response, survival, and safety with imatinib mesylate therapy in chronic-phase chronic myeloid leukemia after failure of interferon-α treatment Journal Article
| Authors: | Hochhaus, A.; Druker, B.; Sawyers, C.; Guilhot, F.; Schiffer, C. A.; Cortes, J.; Niederwieser, D. W.; Gambacorti, C.; Stone, R. M.; Goldman, J.; Fischer, T.; O'Brien, S. G.; Reiffers, J. J.; Mone, M.; Krahnke, T.; Talpaz, M.; Kantarjian, H. M. |
| Article Title: | Favorable long-term follow-up results over 6 years for response, survival, and safety with imatinib mesylate therapy in chronic-phase chronic myeloid leukemia after failure of interferon-α treatment |
| Abstract: | Imatinib mesylate, a targeted inhibitor of BCR-ABL tyrosine kinase, is the standard of care for chronic myeloid leukemia (CML). A phase 2 trial of imatinib in late chronic-phase (CP) CML after interferon-α (IFNα) failure enrolled 532 patients, 454 with a confirmed diagnosis of CP CML. Median time from diagnosis was 34 months; median duration of imatinib treatment was 65 months. Cumulative best rates of major cytogenetic response (MCyR) and complete cytogenetic response (CCyR) were 67% and 57%, respectively. At the 5-year landmark, 184 (41%) of the 454 patients are in CCyR. At more than 6 years, 199 (44%) of the 454 patients remain on imatinib. Most responses occurred within 12 months of starting imatinib; however, some patients achieved initial MCyR and CCyR more than 5 years after imatinib initiation. Estimated rates of freedom from progression to accelerated phase (AP) and blastic phase (BP) and overall survival at 6 years were 61% and 76%, respectively. Both freedom from progression to AP/BP and overall survival (OS) were associated with cytogenetic response level at 12 months. No increase in rates of serious adverse events was observed with continuous use of imatinib for up to 6.5 years, compared with earlier time points. Imatinib continues to be an effective and safe therapy for patients with CP CML after failure of IFN. © 2008 by The American Society of Hematology. |
| Keywords: | survival; adolescent; adult; controlled study; treatment outcome; aged; aged, 80 and over; middle aged; survival rate; treatment failure; major clinical study; clinical trial; drug tolerability; fatigue; neutropenia; salvage therapy; diarrhea; side effect; alpha interferon; follow up; follow-up studies; imatinib; edema; controlled clinical trial; enzyme inhibition; phase 2 clinical trial; anemia; bone marrow suppression; bleeding; nausea; randomized controlled trial; thrombocytopenia; vomiting; cytogenetics; protein tyrosine kinase; chronic myeloid leukemia; pyrimidines; time factors; abdominal pain; alanine aminotransferase blood level; arthralgia; aspartate aminotransferase blood level; drug dose escalation; rash; chromosome aberration; disease progression; drug response; patient safety; drug toxicity; headache; bcr abl protein; piperazines; fluid retention; interferon-alpha; muscle cramp; weight gain; musculoskeletal pain; leukemia, myeloid, chronic-phase |
| Journal Title: | Blood |
| Volume: | 111 |
| Issue: | 3 |
| ISSN: | 0006-4971 |
| Publisher: | American Society of Hematology |
| Date Published: | 2008-01-01 |
| Start Page: | 1039 |
| End Page: | 1043 |
| Language: | English |
| DOI: | 10.1182/blood-2007-07-103523 |
| PUBMED: | 17932248 |
| PROVIDER: | scopus |
| DOI/URL: | |
| Notes: | --- - "Cited By (since 1996): 98" - "Export Date: 17 November 2011" - "CODEN: BLOOA" - "Source: Scopus" |
