Lenalidomide Plus Rituximab May Be As Effective As Standard of Care in Follicular Lymphoma
Previous studies have shown that rituximab plus lenalidomide may not only be as effective but also improve immune competence in this patient population.
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Lenalidomide plus rituximab may be as effective among patients with previously untreated symptomatic follicular lymphoma (FL) compared with standard immunochemotherapy, according to findings presented in an oral session at the American Society of Clinical Oncology 2018 Annual Meeting on Sunday, June 3.1
The current standard-of-care for FL is rituximab plus chemotherapy induction followed rituximab. Previous studies however, have shown that rituximab plus lenalidomide may not only be as effective but also may improve immune competence in this patient population.
In the phase 3 RELEVANCE study (ClinicalTrials.gov Identifier: NCT01650701), researchers randomly assigned 1030 previously untreated patients with grade 1 to 3a FL to receive lenalidomide plus rituximab (experimental arm) or rituximab plus investigator's choice-chemotherapy including CHOP, CVP, bendamustine (control arm); responding patients in both groups received rituximab maintenance therapy thereafter. Baseline characteristics were comparable between both study arms.
After a median follow-up of 37.9 months, the superiority of the experimental arm to the standard-of-care could not be established.
Independent review committee (IRC)-determined complete responses (CR/CRu) were 48% and 53% among patients in the experimental arm and control arm, respectively (P = .013), and investigator-assessed CR/CRu was 55% and 58%, respectively (P = .38).
IRC and investigator review showed that there were no significant differences in the risk of disease progression in both study arms. The 2-year PFS rate was approximately 84% and ranged between 83% and 87% for the experimental arm and control arm, respectively. The 3-year PFS rate was 77% and 78%, respectively.
The two study groups presented with different safety profiles; patients in the control arm reported higher rates of grade 3 to 4 lab and febrile neutropenia compared with higher grade 3 to 4 cutaneous adverse events (AE) in the experimental arm. Secondary primary malignancies occurred in 7% and 9% of patients in the experimental and control arms, respectively, and both groups reported a 1% rate of grade 5 AEs.
Sixty-nine percent of patients in the experimental group and 71% in the control group were able to complete treatment.
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- Fowler NH, Morschhauser F, Feugier P, et al. RELEVANCE: Phase III randomized study of lenalidomide plus rituximab (R2) versus chemotherapy plus rituximab, followed by rituximab maintenance, in patients with previously untreated follicular lymphoma. Oral presentation at: 2018 ASCO Annual Meeting; June 1-5, 2018; Chicago, IL.