A randomized trial of dasatinib 100 mg versus imatinib 400 mg in newly diagnosed chronic-phase chronic myeloid leukemia Journal Article
| Authors: | Radich, J. P.; Kopecky, K. J.; Appelbaum, F. R.; Kamel-Reid, S.; Stock, W.; Malnassy, G.; Paietta, E.; Wadleigh, M.; Larson, R. A.; Emanuel, P.; Tallman, M.; Lipton, J.; Turner, A. R.; Deininger, M.; Druker, B. J. |
| Article Title: | A randomized trial of dasatinib 100 mg versus imatinib 400 mg in newly diagnosed chronic-phase chronic myeloid leukemia |
| Abstract: | Tyrosine kinase inhibitor therapy with imatinib (IM), dasatinib (DAS), or nilotinib is very effective in chronic-phase chronic myeloid leukemia. Two hundred fiftythree patients with newly diagnosed chronic-phase chronic myeloid leukemia were randomized to IM 400 mg/day or DAS 100 mg/day. The proportion of patients achieving a complete cytogenetic remission rate was superior with DAS (84% vs 69%), as was the 12-month molecular response by the proportions of patients achieving > 3-log, > 4-log, and > 4.5-log reduction in BCR-ABL transcript levels. Overall and progressionfree survival was similar in the 2 arms. Among patients who achieved hematologic CR, 3-year relapse-free survival was 91% with DAS and 88% with IM 400 mg. Grade 3 and 4 toxicities were most commonly hematologic, including thrombocytopenia in 18% and 8% of DAS and IM patients, respectively. DAS induced more complete cytogenetic response and deeper molecular responses after 12 months, compared with IM 400 mg, and with a median follow-up of 3.0 years there have been very few deaths, relapses, or progressions in the 2 arms. In summary, DAS compared with IM appeared to have more short-term cytogenetic and molecular response, more hematologic toxicity, and similar overall survival. This trial is registered at www. clinicaltrials.gov as NCT00070499. © 2012 by The American Society of Hematology. |
| Keywords: | adult; controlled study; treatment outcome; treatment response; aged; aged, 80 and over; middle aged; young adult; major clinical study; overall survival; mutation; fatigue; cancer growth; diarrhea; drug dose reduction; drug withdrawal; side effect; antineoplastic agents; cancer patient; follow up; anorexia; imatinib; edema; progression free survival; sensory neuropathy; thrombocyte; nausea; randomized controlled trial; thrombocytopenia; vomiting; qt prolongation; recurrence; cytogenetics; hemoglobin blood level; drug resistance, neoplasm; dasatinib; chronic myeloid leukemia; pyrimidines; drug dose escalation; febrile neutropenia; pruritus; rash; protein kinase inhibitors; oncogene; drug fatality; neutrophil; disease progression; cardiotoxicity; headache; piperazines; leukemia relapse; thiazoles; pericardial effusion; metabolic disorder; proteinuria; heart arrest; leukemia remission; recurrence free survival; musculoskeletal pain; leukemia, myeloid, chronic-phase |
| Journal Title: | Blood |
| Volume: | 120 |
| Issue: | 19 |
| ISSN: | 0006-4971 |
| Publisher: | American Society of Hematology |
| Date Published: | 2012-11-08 |
| Start Page: | 3898 |
| End Page: | 3905 |
| Language: | English |
| DOI: | 10.1182/blood-2012-02-410688 |
| PROVIDER: | scopus |
| PUBMED: | 22915637 |
| PMCID: | PMC3496952 |
| DOI/URL: | |
| Notes: | --- - "Cited By (since 1996): 1" - "Export Date: 3 December 2012" - "CODEN: BLOOA" - "Source: Scopus" |
