Posted: Sunday, March 1, 2020
According to findings from the phase II VITAL trial presented at the 2019 American Society of Hematology (ASH) Annual Meeting & Exposition (Abstract 180) and published in the journal Blood, the combination of the anticancer quinolone derivative vosaroxin with infusional cytarabine “appears to be safe” in patients with newly diagnosed acute myeloid leukemia (AML). The combination treatment may prove to be tolerable, with an adverse-event profile similar to that of conventional induction regimens, concluded Stephen A. Strickland, MD, of the Vanderbilt-Ingram Cancer Center, Nashville, and colleagues.
“Vosaroxin and infusional cytarabine is a clinically active induction regimen that warrants further investigation based on response rates and toxicity profile at least similar to current anthracycline-based induction strategies with an apparent absence of cardiac toxicity,” the authors noted.
The investigators enrolled 42 patients with newly diagnosed AML in this study. Nearly all the patients (95%) had intermediate- or poor-risk AML. Patients received 90 mg/m2 of vosaroxin on days 1 and 4 of treatment and 100 mg/m2 of infusional cytarabine on days 1 through 7.
Oral mucositis was reported in 38% of patients, with 12 cases being grade 1 or 2 and 4 cases being grade 3. There were three grade 5 events reported: two were infection/sepsis and one was neutropenic colitis. Complete remission occurred in 20 patients (48%), and 3 patients reached complete remission with incomplete blood cell count recovery.
In the 10 patients with TP53 mutations, the investigators observed a complete response/complete response incomplete blood cell count recovery rate of 40%. Allogeneic hematopoietic stem cell transplantation was performed in 45% of patients (19 patients). The progression-free survival rate among all patients was 43%, with an overall survival rate of 48% at a 1-year follow-up.
Disclosure: For full disclosures of the study authors, visit ashpublications.org.