Posted: Monday, May 11, 2020
The immunomodulatory agent lenalidomide appeared to lend no hand to intensive standard chemotherapy in improving therapeutic outcomes in 222 older patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndromes (MDS), according to the results of a randomized phase II study published in Leukemia. Treatment modalities with better effectiveness are urgently needed for this patient population, noted Gert J. Ossenkoppele, MD, PhD, of Amsterdam University Medical Center, the Netherlands, and colleagues.
The team had hoped lenalidomide would show promise in this setting. Instead, the rates of complete response and complete response with incomplete hematologic recovery in the chemotherapy-plus-lenalidomide and the chemotherapy-alone arms did not statistically differ (69% vs. 66%, respectively). “Event-free survival at 36 months was 19% for the standard arm versus 21% for the lenalidomide arm, and overall survival [was] 35% versus 30%, respectively,” they continued.
Patients’ median age was 69 years in both arms; about 90% and 10% in each arm had AML and MDS, respectively. All patients received standard remission-induction chemotherapy (“3 + 7”), but the experimental arm also received 20 mg daily of lenalidomide on days 1 to 21 of treatment cycle 1. In cycle 2, the experimental arm continued to take lenalidomide on the same schedule, and all patients also received cytarabine at 1,000 mg/m2 twice daily on days 1 to 6.
“Whether lenalidomide should be regarded as an inactive drug in the setting of AML cannot be entirely definitively concluded from the results of the current study,” noted the authors. “The schedule of only two short cycles of application of lenalidomide in the current study may have been inadequate.”
Disclosure: The study authors reported no conflicts of interest.