Five-year follow-up of patients receiving imatinib for chronic myeloid leukemia.
Level 2 - randomized trial
Individual multicenter randomized controlled trial with 5-year follow-up
PubMed 17151364 · doi:10.1056/NEJMoa062867
What was done
In a multicenter randomized trial, 1,106 patients with newly diagnosed chronic-phase chronic myeloid leukemia (CML) were randomly assigned to receive initial therapy with either imatinib (n = 553) or interferon alfa plus cytarabine (n = 553). Patients were followed for a median of 60 months to evaluate overall and event-free survival, progression to accelerated-phase CML or blast crisis, cytogenetic and molecular responses, and adverse events.
What was found
Among patients assigned to initial imatinib, the estimated cumulative best rate of complete cytogenetic response was 69% at 12 months and 87% at 60 months. An estimated 7% progressed to accelerated-phase CML or blast crisis, and estimated overall survival at 60 months was 89%. Achieving a complete cytogenetic response or a reduction of BCR-ABL transcript levels by at least 3 log was associated with significantly reduced risk of disease progression (P < 0.001). Rates of grade 3 or 4 adverse events decreased over time.
Why it matters
This study established that front-line imatinib provides durable disease control and high 5-year survival with favorable long-term tolerability in chronic-phase CML.
Limits
The abstract reports detailed 5-year outcome figures solely for patients on initial imatinib and omits comparative long-term numerical outcomes for the control arm (interferon alfa plus cytarabine). Specific numbers and types of adverse events are not quantified in the abstract text.
Cited by
- supports Gleevec (imatinib) is an effective targeted therapy for leukemia.