Trial Update on Lower-Dose Dasatinib in Newly Diagnosed CML
Posted: Wednesday, July 24, 2019
Updated efficacy and toxicity trial results continue to support the 50-mg versus 100-mg daily dose of dasatinib for treating chronic phase chronic myeloid leukemia (CML-CP) in the front-line and salvage settings. Kiran Naqvi, MD, of The University of Texas MD Anderson Cancer Center, Houston, and colleagues noted that 81 patients with early CML-CP were enrolled between March 2016 and March 2018. With a median follow-up of 18 months, “none of the patients have transformed or died.”
Presenting these data at the 2019 American Society for Clinical Oncology (ASCO) Annual Meeting (Abstract 7052), the investigators explained that the study patients ran the gamut of Sokal risk: low (53), intermediate (22), and high (6). At 3 months, almost all patients (96%) had achieved early molecular response. With time, their response rates were calculated for a median time to complete cytogenetic response (4.6 months), major molecular response (6.0 months), molecular response 4.0 (11.4 months), and molecular response 4.5 (12.2 months).
Eighteen patients had treatment interruption due to factors including pregnancy, renal dysfunction, and, in four cases, pleural effusion (three possibly related to treatment). Pleural effusion was responsible for three of the four dose reductions. Four patients increased their dasatinib dose to 100 mg daily, three because of a lack of complete cytogenetic response at 6 months and one due to lack of major molecular response at 12 months. Finally, four patients are off study because of no response (two), pneumonitis (one), and insurance (one). In addition to pleural effusions, myelosuppression is another potential dasatinib-associated adverse event, the investigators noted.
Disclosure: The study authors’ disclosure information may be found at coi.asco.org.