Reducing the dose of lenalidomide and discontinuing dexamethasone offers similar outcomes to continuous lenalidomide-dexamethasone therapy in elderly patients with multiple myeloma, according to new research.
“Our study shows, for the first time, that reducing the dose or intensity of treatment is a feasible option and produces similar outcomes as standard dose treatments for intermediate-fit patients,” said lead author Dr Alessandra Larocca, of the University of Turin in Italy.
The new study, published in Blood, tested the treatment reduction in a total of 199 patients aged 66 to 80 who were defined as intermediate-fit based on a frailty score. Patients were randomised to receive either nine 28-day induction cycles of lenalidomide (25 mg/day) and dexamethasone followed by lenalidomide maintenance therapy (10 mg/day for 21 days), or ongoing cycles of the two agents until progression or intolerance.
After a median follow-up of 37 months, the median event-free survival was 10.4 months with the adjusted regimen compared with 6.9 months in the continuous therapy arm, for a hazard ratio of 0.70 (95% CI, 0.51-0.95; p = .02). The authors noted that the EFS advantage was maintained beyond treatment cycle nine.
The median progression-free survival in the two groups was 20.2 months and 18.3 months, respectively (p = .16). The median overall survival had not yet been reached, and the three-year OS rate was 74% with the adjusted regimen and 63% with continuous therapy. The overall response rate was not statistically different between the groups.
“Prolonged steroid use is scarcely tolerated in the long term, even in younger patients, and patients may often require dose reduction or interruption,” Dr Larocca said.
Lenalidomide discontinuation was required in 24% of the dose-adjusted group and in 30% of the continuous therapy group; dose reductions of lenalidomide were needed in 45% and 62%, respectively, and of dexamethasone in 17% and 31%, respectively.
“We expect the results of this study may help to improve and optimize the 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.