Posted: Monday, October 5, 2020
According to findings from the QUAZAR AML-001 trial, presented during the 2020 Society of Hematologic Oncology (SOHO) Annual Meeting (Abstract AML-186), most patients with acute myeloid leukemia (AML) treated with the oral hypomethylating agent CC-486 experienced low-grade gastrointestinal (GI) treatment-emergent adverse events. Hervé Dombret, MD, of the Universite de Paris, France, and colleagues noted that the use of GI medication decreased with GI events, suggesting that continued CC-486 therapy may increase GI tolerance.
“Clinicians and patients should be aware of possible GI events during early CC-486 treatment,” the authors said. “Prophylaxis and symptomatic intervention may facilitate treatment adherence to promote better outcomes.”
In this phase III trial, the authors enrolled patients with AML who reached complete remission or complete remission with incomplete hematologic recovery. Patients who were candidates for hematopoietic stem cell transplantation were not included. The patients were given 300 mg of CC-486 once daily or a placebo. In total, 236 patients were treated with CC-486.
The authors found that 91% of those who received CC-486 experienced a GI treatment-emergent adverse event during treatment, the most common being nausea (65%), vomiting (60%), and diarrhea (50%). Most treatment-adverse events were low grade, with a small number of patients experiencing grade 3 nausea (3%), vomiting (3%), or diarrhea (5%). Only one patient experienced a grade 4 event.
Serious GI treatment-emergent adverse events were reported in 15 patients (6%). The most common GI medications used were odansetron (77%), metoclopramide (25%), pantoprazole (24%), omeprazole (21%), lactulose (17%), potassium chloride (16%), granisetron (14%), and loperamide (13%). Dose modifications because of adverse events were infrequent. The authors noted that adverse events were most common during early treatment cycles and decreased thereafter. For instance, during cycles 1–2, 3–4, and 5–6, any-grade treatment-emergent adverse events were reported in 92%, 78%, and 71% of patients, respectively.
Disclosure: Disclosure information was not collected for this poster submission.