medwireNews: Treatment-naïve follicular lymphoma patients have similar outcomes regardless of whether they receive lenalidomide or chemotherapy in combination with rituximab, suggest phase III trial findings published in The New England Journal of Medicine.
“Overall, both treatment groups showed good outcomes, and a median has not yet been reached for either progression-free survival or overall survival,” say the RELEVANCE investigators who were unable to demonstrate the superiority of either regimen.
The co-primary endpoint of complete response (confirmed or unconfirmed) at 120 weeks as assessed by independent review was achieved by 48% of the 513 participants who were randomly allocated to receive up to 18 cycles of the immunomodulatory regimen of rituximab plus lenalidomide, followed by maintenance therapy with rituximab alone, given every 8 weeks for 12 cycles.
This was comparable to the 53% rate for the 517 patients who received the current standard of care of rituximab and chemotherapy. Participants could receive the investigator’s choice of one of three rituximab-based regimens (rituximab given alongside cyclophosphamide, vincristine, and prednisone either with or without doxorubicin or rituximab plus bendamustine), after which they received maintenance rituximab on the same schedule as the lenalidomide group.
Progression-free survival, which was the other primary endpoint, was likewise similar between study arms, with 3-year rates of 77% among participants given rituximab–lenalidomide and 78% among those given rituximab plus chemotherapy.
And the overall survival rates at 3 years were identical for the treatment groups, at 94%, report Franck Morschhauser, from the University of Lille in France, and co-researchers.
During a median follow-up of 37.9 months, adverse events (AEs) of grade 3 or 4 occurred in a comparable 65% and 68% of patients given rituximab alongside lenalidomide or chemotherapy, respectively. Neutropenia was the most common AE of these grades in both groups, but the incidence was lower among lenalidomide- than chemotherapy-treated patients, at 32% versus 50%.
In terms of other grade 3 or 4 AEs, the incidence of febrile neutropenia (2 vs 7%) and leukopenia (2 vs 6%) was also lower with lenalidomide than chemotherapy, but cutaneous reactions were more common (7 vs 1%).
Morschhauser et al also point out that patients in the chemotherapy group were more likely to experience infections as a result of grade 3 or 4 neutropenia, despite a greater concomitant use of antimicrobial drugs.
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