R-CHOP Plus Revlimid Shows Tolerable Safety Profile, But Does Not Improve Progression-Free Survival

The addition of Revlimid (lenalidomide) to standard Rituxan (rituximab) plus cyclophosphamide, Lipodox (doxorubicin), Marqibo (vincristine) and Rayos (prednisone) (R-CHOP) did not meet its goal of improving progression-free survival in patients with B-cell like subtype of diffuse large B-cell lymphoma, although it was tolerable, according to data published in Journal of Clinical Oncology.

“Despite the lack of statistically significant efficacy benefit of (Revlimid) with R-CHOP, these study results provide support or ongoing and future analyses to further evaluate the potential effect of pharmacokinetics or dosing, molecular classification and mutational status in patients with diffuse large B-cell lymphoma,” the study authors wrote.

A total of 570 patients, with a median age of 65, were included in the study. Half (285 patients) received Revlimid at 15 mg daily on days one through 14 plus R-CHOP, and the other half (285 patients) received R-CHOP with placebo for six cycles. Two patients who received Revlimid plus R-CHOP and one patient who received the placebo with R-CHOP never received treatment. The most common reason for discontinuation of treatment were side effects (17% in Revlimid plus R-CHOP and 11% in placebo plus R-CHOP).

Treatment was completed by 74% of patients who received Revlimid plus R-CHOP and 84% of patients who received the placebo plus R-CHOP.

The primary endpoint of progression-free survival was not met in either treatment. At two years, progression-free survival was 67% for Revlimid plus R-CHOP and 64% for placebo plus R-CHOP.

Researchers also assessed a secondary endpoint of event-free survival, which is the time after primary treatment ends that a patient stays free of complication or events that the treatment was supposed to prevent or delay, which was also not met. Event-free survival was seen in 10 patients who received Revlimid plus R-CHOP and eight patients who received placebo plus R-CHOP. Although data on overall survival was not ready to assess, researchers estimated two-year overall survival to be 79% with Revlimid plus R-CHOP and 80% with placebo plus R-CHOP.

The most common severe or life-threatening side effects for those who received Revlimid versus placebo were abnormally low neutrophil count (60% vs. 48%), anemia (22% vs. 14%), low platelet levels (17% vs. 11%) and low white blood cell count (14% vs. 15%).

“These data will broaden our understanding to support future assessments of next-generation immune-modulatory agents (CELMoDs), which have displayed promising preclinical activity in B-cell lymphoma,” the authors concluded.

A limitation of this study was that the median time from initial diagnosis to start of treatment could have resulted in a selection bias for patients with a less high-risk disease.

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