As reported in the Journal of Clinical Oncology by Cortes et al, the final 5-year results of the DASISION trial support the safety and efficacy of dasatinib (Sprycel) as first-line treatment in patients with chronic myeloid leukemia (CML) in chronic phase. Initial results in the trial led to approval of dasatinib in this setting.
In the trial, 519 patients were randomized to receive dasatinib at 100 mg once daily (n = 259) or imatinib at 400 mg once daily (n = 260). At study closure, 61% of dasatinib and 63% of imatinib patients remained on initial therapy.
Response and Survival
Cumulative 5-year rates of major molecular response (76% vs 64%, P = .0022) and molecular response with a 4.0- or 4.5-log reduction in BCR-ABL1 transcripts (42% vs 33%, P = .0251) were higher in the dasatinib group. Estimated 5-year overall survival was 91% vs 90% (hazard ratio [HR] = 1.01, 95% confidence interval [CI] = 0.58–1.73), and estimated 5-year progression-free survival was 85% vs 86% (HR = 1.06, 95% CI = 0.68–1.66). Overall and progression-free survival were greater among the 84% of dasatinib patients and 64% of imatinib patients who achieved BCR-ABL1 < 10% at 3 months compared with those who did not. Transformation to accelerated/blast phase occurred in 5% vs 7% of patients. BCR-ABL1 mutations were identified at treatment discontinuation in 15 dasatinib patients and 19 imatinib patients.
No unexpected adverse reactions were observed during follow-up. Drug-related pleural effusion was more common with dasatinib (28% vs 0.8%; 3% grade 3 or 4 in dasatinib group). Pleural effusion occurred in approximately 8% of at-risk dasatinib patients in year 1, with a comparable incidence in subsequent years; risk was higher among patients aged ≥ 65 years. Adverse events led to discontinuation of treatment in 16% vs 7% of patients. Arterial ischemic events were uncommon in both groups.
The investigators concluded: “These final results from the DASISION trial continue to support dasatinib [at] 100 mg once daily as a safe and effective first-line therapy for the long-term treatment of CML [chronic phase].”
The study was supported by Bristol-Myers Squibb.
Jorge E. Cortes, MD, of The University of Texas MD Anderson Cancer Center, is the corresponding author of the Journal of Clinical Oncology article.
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