A randomized trial of dasatinib 100 mg versus imatinib 400 mg in newly diagnosed chronic-phase chronic myeloid leukemia

作者：Radich Jerald P^*; Kopecky Kenneth J; Appelbaum Frederick R; Kamel Reid Suzanne; Stock Wendy; Malnassy Greg; Paietta Elisabeth; Wadleigh Martha; Larson Richard A; Emanuel Peter; Tallman Martin; Lipton Jeff; Turner A Robert; Deininger Michael; Druker Brian J

来源：Blood, 2012, 120(19): 3898-3905.

DOI：10.1182/blood-2012-02-410688

Tyrosine kinase inhibitor therapy with imatinib (IM), dasatinib (DAS), or nilotinib is very effective in chronic-phase chronic myeloid leukemia. Two hundred fifty-three 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 %26gt; 3-log, %26gt; 4-log, and %26gt; 4.5-log reduction in BCR-ABL transcript levels. Overall and progression-free 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. (Blood. 2012;120(19):3898-3905)

• 出版日期2012-11-8