Long-Term Survival Outcomes With Front-Line Dasatinib in CML
Posted: Monday, May 4, 2020
According to follow-up research published in the journal Cancer, dasatinib continues to be efficacious and maintains a strong safety profile despite long-term use by patients with chronic myeloid leukemia (CML). The follow-up sought to determine whether the tyrosine kinase inhibitor retained its superior response rate over time.
“After this long‐term follow‐up, dasatinib continues to show an excellent safety profile and produces rapid cytogenetic responses and [major molecular responses], durable deep [major molecular responses], and excellent long‐term survival outcomes in patients with chronic phase chronic myeloid leukemia,” concluded Hagop M. Kantarjian, MD, of the MD Anderson Cancer Center in Houston, and colleagues.
Between November 2005 and August 2014, 149 patients were initially enrolled in the study. Until June 2009, patients were randomly assigned to receive daily dasatinib in either a single 100-mg dose or two 50-mg doses; after June 2009, all patients received 100 mg daily. At a median follow-up of 6.5 years, 63% of patients (n = 94) remained on dasatinib.
At 11 years, the cumulative complete cytogenetic response rate was 92.6%, and the major molecular response rate was 88.2%. The rate of patients achieving at least a 4.5-log reduction in BCR-ABL1 transcripts during a molecular response was 79.5%, and 55% of patients (n = 82) sustained that achievement for at least 2 years. The median time to major molecular response was 6 months, whereas the median time to 4.5-log reduction was 23 months.
An association was noted between improved overall survival and the achievement of complete molecular response. At 10 years, the rate was 89% for overall survival, 95% for transformation-free survival, 86% for event-free survival, and 65% for failure-free survival. Treatment discontinuation was most commonly attributed to toxicity and elective discontinuation. Fatigue, thrombocytopenia, and infections were the most common grade 3 or 4 adverse events.
Disclosure: For full disclosures of the study authors, please visit acsjournals.onlinelibrary.wiley.com.