By David Douglas
NEW YORK (Reuters Health) - 3/4/2019
In patients with relapsed or refractory indolent non-Hodgkin lymphoma, adding lenalidomide to rituximab improves response, according to a placebo-controlled trial.
"The significantly greater efficacy of lenalidomide plus rituximab, versus rituximab alone, seems to be clinically meaningful in the context of the side effect profile," Dr. John P. Leonard of Weill Cornell Medicine and New York Presbyterian Hospital, in New York City, told Reuters Health by email.
He and his colleagues randomized 358 patients to oral lenalidomide plus IV rituximab or IV rituximab and placebo for 12 treatment cycles. All patients had relapsed or refractory follicular or marginal-zone lymphoma, and 24% had had three or more prior systemic treatments.
In the initial safety-analysis population, the full treatment course was completed in 71% of patients with lenalidomide plus rituximab and 61% with placebo plus rituximab, the team reports in the Journal of Clinical Oncology, online March 22.
Adverse events leading to dose interruptions were more common in the combination group (64%) than in the placebo group (26%). This was also the case for dose reduction (26% vs. 3%) and grade 3 or 4 neutropenia (50% vs. 13%).
However, disease progression led to discontinuation in only 12% of the combination group versus 30% of placebo patients, and 124 patients on lenalidomide entered follow-up compared to 107 on rituximab alone.
After a median of 28.3 months of follow-up, lenalidomide significantly boosted progression-free survival (PFS), with a hazard ratio of 0.46. Median PFS was 39.4 months in the combination group compared to 14.1 months in the placebo patients.
The combination of lenalidomide and rituximab "represents an important new option that patients and physicians can consider as they choose therapy for indolent lymphoma," Dr. Leonard said.
The study was supported by Celgene, developer of lenalidomide (Revlimib). Dr. Leonard has served as consultant to the company and three of his co-authors are Celgene employees.
J Clin Oncol 2019.