EHA25 Virtual: Extended Follow-up on Early Switch From Imatinib to Dasatinib in CML
Posted: Monday, June 29, 2020
Switching patients with chronic myeloid leukemia (CML) who had high levels of BCR-ABL from imatinib to dasatinib after 3 months of treatment led to an increased response rate, with more patients achieving major molecular response (MR). These results of the 3-year extended follow-up of the phase IIb DASCERN study were presented during the virtual edition of the 25th European Hematology Association Annual Congress (EHA25 Virtual) by Jorge E. Cortes, MD, of Augusta University, Georgia, and colleagues (Abstract EP756).
This open-label, multinational, randomized trial recruited 260 adults with chronic phase CML. These patients had achieved a complete hematologic response to imatinib but still had more than 10% BCR-ABL transcripts 3 months after beginning therapy. Participants were then randomly assigned 2:1 to receive either 100 mg of dasatinib or continue on imatinib. A total of 45 patients in the imatinib arm who met the criteria for treatment failure and did not have dasatinib-resistant mutations crossed over to dasatinib after a median of 9 months.
At a minimum follow-up of 3 years, 73% of patients in each arm remained on the study. In total, 75% of patients receiving dasatinib and 43% of patients receiving imatinib achieved a major molecular response at any time. MR4 was attained by 42% of patients in the dasatinib group and 26% of the imatinib group, whereas MR4.5 was achieved by 27% and 20% of patients in each group.
The progression-free survival after 3 years was 95% in each group per intent to treat. Patients who crossed over from imatinib to dasatinib had a progression-free survival of 93%. Overall survival rates in the dasatinib and imatinib arms were 96% and 95%, and in the patients who crossed over, 93%.
Adverse events of any grade occurred in 84% of patients in the dasatinib group and 79% of patients in the imatinib group. Within the dasatinib group, 12% of patients experienced pleural effusions, whereas 6% of the imatinib group developed this complication (all of whom crossed over to dasatinib).
Disclosure: The study authors’ disclosures can be found at library.ehaweb.org.