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Lenalidomide maintenance extends PFS in elderly patients with diffuse large B-cell lymphoma
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Lenalidomide maintenance prolonged PFS among elderly patients with diffuse large B-cell lymphoma who had achieved partial or complete response to standard therapy, according to results of the phase 3 REMARC trial.
However, OS rates appeared similar between the two groups.
Diffuse large B-cell lymphoma (DLBCL) is the most common lymphoma diagnosed in adults and is standardly treated with R-CHOP (rituximab [Rituxan; Genentech, Biogen], cyclophosphamide, doxorubicin, vincristine and prednisone). Still, approximately 30% to 40% of patients experience disease progression and relapse, and 3-year PFS remains at 60% and OS at 70%.
Previous research showed lenalidomide (Revlimid, Celgene) alone or in combination with had significant effect on patients who have relapsed.
Therefore, Catherine Thieblemont, MD, PhD, from the department of hemato-oncology at Hôpital Saint-Louis in France, and colleagues conducted an analysis to compare maintenance lenalidomide with placebo in elderly patients with DLBCL.
The analysis included 650 elderly patients aged 60 to 80 years with previously untreated DLBCL or other aggressive B-cell lymphoma with complete (n = 495) or partial (n = 152) response after six or eight cycles of R-CHOP. Researchers randomly assigned patients to oral lenalidomide (25 mg/day for 21 of 28 days for 24 months) or placebo.
PFS served as the primary endpoint.
Among patients treated with lenalidomide, 111 completed maintenance therapy and 16 remained on therapy at the time of analysis. Among patients who received placebo, 169 completed treatment and 24 remained on therapy at the time of analysis.
Over a median follow-up of 39 months, median PFS was not reached for lenalidomide maintenance compared with 58.9 months for placebo (HR favoring lenalidomide = 0.7; 95% CI, 0.53-0.93). Two-year PFS improved to 80% (95% CI, 75-84) from 75% (95% CI, 70-80) among patients in the lenalidomide group. PFS benefit with lenalidomide remained consistent across all subgroups.
“None of the previously reported trials adding a novel drug to R-CHOP, either in combination during induction or after R-CHOP as maintenance, have achieved such a benefit,” Thieblemont and colleagues wrote.
Over a longer median follow-up of 52 months, neither group met the median OS, and rates of 2-year OS appeared comparable between patients who received lenalidomide (87%; 95% CI, 82-90) and placebo (89%; 95% CI, 85-92).
“At the time of this analysis, we do not yet fully understand the basis for lack of OS benefit despite the positive PFS data, other than this is not due to the excessive toxicity in the experimental arm,” the researchers wrote. “We speculate the reason may be differences in the outcomes after progression or some other recognized reason.”
The most common grade 3 or grade 4 adverse events included neutropenia (lenalidomide, 56% vs. placebo, 22%) and cutaneous reactions (5% vs. 1%).
Although the researchers expected toxicities to lenalidomide — which resulted in more premature discontinuation of therapy — patients with very little exposure to the drug still experienced PFS benefit. – by Melinda Stevens
Disclosures: Thieblemont reports a consultant or advisory role and honoraria from AbbVie, Bayer Healthcare Pharmaceuticals, Celgene and Janssen; research funding from Roche and travel, accommodations and expenses from Celgene. Please see the full study for a list of all other researchers’ relevant financial disclosures.
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