November 04, 2015
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Lenalidomide plus rituximab shows promise as initial therapy for mantle cell lymphoma

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A combination of the immunomodulatory compound lenalidomide and the anti-CD20 antibody rituximab demonstrated activity as first-line treatment for patients with mantle cell lymphoma, according to results of a multicenter phase 2 study.

Mantle cell lymphoma — a type of B-cell non-Hodgkin’s lymphoma — is an incurable cancer of the white blood cells that mainly affects the elderly. Patients with mantle cell lymphoma usually receive chemotherapy; however, older patients often have comorbidities or other factors that make them unsuitable candidates for chemotherapy.

 “Conventional, intensive treatment may be out of reach or undesirable for many patients with mantle cell lymphoma who often receive less intensive or palliative care that is of limited benefit,” Jia Ruan, MD, associate professor of clinical medicine at Weill Cornell Medicine in New York, said in a press release. “This inspired us to look for a less toxic, biological option with novel drugs that could easily be administered and more widely applicable.”

Ruan and colleagues sought to evaluate the combination of lenalidomide (Revlimid; Celgene) and rituximab (Rituxan; Genentech, Biogen Idec) in induction and maintenance phases because previous data indicated each agent is active in patients with recurrent mantle cell lymphoma. However, their efficacy as initial therapy had been unknown.

The analysis included data from 38 patients (median age, 65 years; range, 42-86). Thirty-four percent of the patients had low-risk disease, 34% had intermediate-risk disease and 32% had high-risk disease.

During induction, patients received 20 mg daily lenalidomide (days 1-21 of 28-day cycle for 12 cycles) — which escalated to 25 mg if no dose-limiting toxicities occurred — and once-weekly rituximab for the first 4 weeks and then every other cycle until disease progression. Patients received 15 mg daily lenalidomide during the maintenance phase.

Overall response rate served as the primary endpoint. Secondary endpoints included safety and quality of life.
Median follow-up was 30 months (range, 10-42 months).

The overall response rate was 92% (95% CI, 78-98) and the complete response rate was 64% (95% CI, 46-79).

The median PFS had not been reached at the time of the analysis. However, researchers estimated a 2-year PFS rate of 85% (95% CI, 67-94) and 2-year OS rate of 97% (95% CI, 79-99).

Among the 36 evaluable patients, 28 (78%) were in remission without disease progression, 26 of whom had completed induction therapy and were receiving maintenance therapy.

Researchers also found that patients who responded tended to have improved quality of life.

John P. Leonard

John P. Leonard

“For patients, their quality of life was preserved or improved, and that’s a huge step up from regular chemotherapy,” Ruan said in the release. “With this frontline treatment, we were able to achieve a very high quality and durable response rate without needing to use chemotherapy. It is very meaningful for the patients who have always been told that their disease is without a cure.”

The most common grade 3 or grade 4 adverse events included neutropenia (50%), rash (29%), thrombocytopenia (13%), “tumor flare” (11%), anemia (11%), serum sickness (8%) and fatigue (8%).

 “I’m inspired by the fact that patients are enthusiastic about this approach,” John P. Leonard, MD, professor of medicine and the Richard T. Silver Distinguished Professor of Hematology and Medical Oncology at the Joan and Sanford I. Weill Department of Medicine and associate dean for clinical research at Weill Cornell Medicine said in a statement. “I’m also excited that lymphoma physicians are thinking out of the box, that many in the community now think that a non–chemotherapy-based paradigm with novel agents is something important to take forward and more broadly assess.” – by Anthony SanFilippo

Disclosure: This study was sponsored in part by Celgene. Ruan reports research funding from, and consultant/advisory and speakers bureau roles with Celgene. Please see the full study for a list of all other researchers’ relevant financial disclosures.