As reported in the Journal of Clinical Oncology by Franck Morschhauser, MD, PhD, and colleagues, 6-year results from the second interim analysis of the phase III RELEVANCE trial show similar progression-free and overall survival with lenalidomide/rituximab (R2) vs rituximab/chemotherapy (R-chemo) followed by rituximab maintenance in previously untreated patients with advanced follicular lymphoma.
Study Details
In the international trial, 1,030 patients with grade 1–3a disease were randomly assigned between December 2011 and November 2014 to receive R2 (n = 513) or R-chemo (n = 517) followed by rituximab maintenance. Chemotherapy consisted of physician’s choice of either cyclophosphamide, vincristine, and prednisone (n = 28); bendamustine (n = 117); or cyclophosphamide, doxorubicin, vincristine, and prednisone (n = 372).
Co-primary endpoints were complete response (confirmed/unconfirmed) at week 120 and progression-free survival. At the previously reported first interim analysis, patients from the two groups had similar complete response rates and progression-free survival.
R2 continues to demonstrate comparable, durable efficacy and safety vs R-chemo in previously untreated patients with follicular lymphoma and provides an acceptable chemo-free alternative.— Franck Morschhauser, MD, PhD, and colleagues
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Key Findings
At second interim analysis, median follow-up was 72 months.
Progression-free survival at 6 years was 60% (95% confidence interval [CI] = 55%–64%) in the R2 group vs 59% (95% CI = 54%–64%) in the R-chemo group (hazard ratio [HR] = 1.03, 95% CI = 0.84–1.27, P = .78).
Estimated overall survival at 6 years was 89% in both groups.
After relapse, additional treatment was received by 107 patients in the R2 group vs 99 in the R-chemo group. Objective response was observed in 61% vs 59% of patients, with complete response (confirmed/unconfirmed) in 37% vs 45%. Estimated 5-year overall survival rates after progression were not significantly different (69% vs 74%).
The cumulative incidence of histologic transformation at 6 years was 4.4% in the R2 group vs 3.3% in the R-chemo group, with rates per year of 0.68% vs 0.45%. Second primary malignancies occurred in 11% vs 13% of patients (P = .34). No new safety signals were observed.
The investigators concluded, “R2 continues to demonstrate comparable, durable efficacy and safety vs R-chemo in previously untreated patients with follicular lymphoma and provides an acceptable chemo-free alternative.”
Dr. Morschhauser, of Centre Hospitalier Universitaire Régional de Lille, Lille, France, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: The study was supported by Celgene, a Bristol Myers Squibb Company, and the Lymphoma Academic Research Organisation (LYSARC). For full disclosures of the study authors, visit ascopubs.org.
