Frailty-Guided Treatment Strategy for Newly Diagnosed Patients With Myeloma
Posted: Tuesday, May 11, 2021
The results of a randomized phase III study published in Blood indicate that in 199 intermediate-fit patients between the ages of 66 and 80 with newly diagnosed multiple myeloma, all ineligible for autologous stem cell transplantation, similar outcomes were seen with standard continuous lenalidomide plus dexamethasone (n = 98) and with a regimen that included nine cycles of lenalidomide plus dexamethasone and then a switch to reduced-dose lenalidomide maintenance without dexamethasone (n = 101). Not only were progression-free and overall survival outcomes similar, noted Alessandra Larocca, MD, PhD, of the University of Torino, Italy, and colleagues, but event-free survival, the primary endpoint, was significantly longer in the experimental arm.
In the experimental group, event-free survival was 10.4 months versus 6.9 months with continuous lenalidomide plus dexamethasone (P = .02). Event-free survival, the team noted, was defined as disease progression or death from any cause, lenalidomide discontinuation, or any hematologic grade 4 or nonhematologic grade 3 or 4 adverse events. With a median follow-up of 37 months, median progression-free survival was 20.2 versus 18.3 months (P = .16), and 3-year overall survival was 74% versus 63% (P = .06) in the experimental and continuous lenalidomide/dexamethasone groups, respectively. Rates of best response (partial or better response) were comparable at 78% versus 68%, respectively (P = .15).
The results of the study, reportedly the first randomized phase III trial to compare a steroid-free, reduced-lenalidomide maintenance treatment schedule with standard continuous lenalidomide plus dexamethasone in this patient population, “may help improve treatment of elderly patients, who may be at greater risk of treatment toxicity and poor survival due to their age or comorbidities,” Dr. Larocca said in an American Society of Hematology press release. She added that ongoing and future trials should and will include “frailty-guided” strategies to optimize treatment.
Disclosure: The study authors’ disclosure information can be found at ashpublications.org.