15-ICML: ROBUST Trial Examines Efficacy of Lenalidomide/R-CHOP in Previously Untreated ABC-Type DLBCL
The ROBUST trial compared the addition of lenalidomide to R-CHOP (rituximab plus cyclophosphamide/doxorubicin/vincristine/prednisone) vs placebo/R-CHOP in previously untreated, prospectively selected, CD20-positive patients with activated B-cell–like (ABC)-type diffuse large B-cell lymphoma (DLBCL). Vitolo et al presented findings from the study at the 15th International Conference on Malignant Lymphoma (ICML; Abstract 005).
Methods
A total of 570 patients with Ann Arbor stage II to IV disease, International Prognostic Index (IPI) score ≥ 2, and ECOG performance score ≤ 2 were enrolled in ROBUST. Patients were stratified by IPI score (2 vs ≥ 3), bulky disease (< 7 vs ≥ 7 cm) and age (< 65 years vs ≥ 65 years), and then were randomly assigned 1:1 to 15 mg/day of lenalidomide for days 1–14 of a 21-day cycle plus standard RCHOP for 21 days or placebo/R-CHOP for 21 days for six cycles, plus two additional optional doses of rituximab per local practice.
The primary endpoint was progression-free survival defined as time from randomization until progressive disease or death from any cause.
Findings
Progression-free survival was not met (hazard ratio [HR] = 0.85, 95% confidence interval [CI] = 0.63–1.14, P = .29); median progression-free survival was not reached for either arm. However, positive progression-free survival trends were seen in patients treated with lenalidomide/R-CHOP vs placebo R-CHOP who also had disease stage III to IV and IPI score of ≥ 3. Median event-free survival was not reached for either arm (HR = 1.04, 95% CI = 0.80–1.34, P = .73).
At a median follow-up of 27.1 months, 2-year overall survival was 79% in the lenalidomide/R-CHOP arm vs 80% for placebo/R-CHOP; overall response rate was 91% for both arms; and complete response was seen in 69% of the lenalidomide/R-CHOP arm vs 65% in the placebo/R-CHOP arm.
Safety
The most common grade 3/4 adverse events reported were neutropenia (60% in the lenalidomide/R-CHOP arm vs 48% in the placebo/R-CHOP arm), anemia (22% vs 14%), thrombocytopenia (17% vs 11%), leukopenia (14% vs 15%), febrile neutropenia (14% vs 9%), and lymphopenia (11% vs 8%).
The investigators concluded, “Overall, the ROBUST study did not meet the primary endpoint of progression free survival for lenalidomide/R-CHOP vs placebo/R-CHOP in previously untreated patients with ABC-DLBCL, although a positive trend favoring lenalidomide/R-CHOP has been observed in advanced-stage and higher-risk patients. The safety profile of lenalidomide/R-CHOP was consistent with those of individual medicines, and no new safety signals were identified with the combination.”
Disclosure: For full disclosures of the study authors, visit lymphcon.ch.
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