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Lenalidomide plus rituximab safe, effective for mantle cell lymphoma
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Initial treatment with lenalidomide plus rituximab induced durable responses with a manageable safety profile among patients with mantle cell lymphoma, according to 5-year follow-up of a multicenter, single-arm phase 2 study.
“Mantle cell lymphoma is an uncommon subtype of non-Hodgkin lymphoma that primarily affects elderly populations,” Jia Ruan, MD, PhD, associate professor at Meyer Cancer Center and Weill Cornell Medicine, told HemOnc Today. “Conventional chemotherapy regimens are generally not curative, and may not be tolerated by many patients, underscoring the unmet need for effective treatment alternatives that are accessible by all patients. Previous experience with immunomodulatory compound lenalidomide [Revlimid, Celgene] has shown favorable activity and was well tolerated in patients with relapsed mantle cell lymphoma.”
Mantle cell lymphoma represents 5% to 8% of non-Hodgkin lymphomas, with reported median survival of approximately 5 years in population studies, researchers wrote.
Ruan and colleagues assessed 36 evaluable patients (median age, 65; 71% men) with mantle cell lymphoma treated with frontline lenalidomide plus rituximab (Rituxan; Genentech, Biogen).
The study included a balance of low- (34%), intermediate- (34%) and high-risk (32%) patients based on mantle cell lymphoma international prognostic index scores.
Treatment continued until progression or unacceptable toxicity, with the option to stop therapy after 3 years if in clinical remission.
Seventy-five percent of patients completed at least 3 years of treatment.
At a median follow-up of 64 months (range, 21 to 78), 21 (58%) evaluable patients remained in durable remission beyond 3 years, including five patients who discontinued treatment after 3 years.
Researchers observed 3-year PFS of 80.3% (95% CI, 63- 90.1) and 3-year OS of 89.5% (95% CI, 74.3-95.9). The estimated 5-year PFS was 63.9% (95% CI, 44.8-77.9) and OS was 77.4% (95% CI, 59.4-88.1).
Median PFS and duration of response had not been reached at data cutoff.
Among 10 patients who completed at least 3 years of treatment and underwent peripheral blood assay, eight had complete response and were minimal residual disease negative.
“The main findings of the study showed that the novel combination free of conventional chemotherapy was effective and well tolerated when given as induction and maintenance,” Ruan said. “The overall response rate was 92% with complete response rate of 64%. Importantly, this study provides evidence that lenalidomide plus rituximab combination was able to achieve minimal residual disease-negative complete remissions.
The most common hematologic adverse events during the maintenance phase of treatment included asymptomatic grade 3 or grade 4 neutropenia (42%), thrombocytopenia (5%) and anemia (3%), as well as grade 1 or grade 2 infections managed in the outpatient setting. The most common infections included upper respiratory infection (45%), urinary tract infection (21%), sinusitis (13%), cellulitis (11%) and pneumonia (8%).
“The introduction of novel agents is poised to transform mantle cell lymphoma management by making accessible effective and potentially less toxic ‘chemo-free’ treatment in relapsed/refractory setting, as well as challenging the conventional chemotherapy-based treatment paradigm in frontline setting,” the researchers wrote.
“Further studies are warranted to 1) evaluate lenalidomide plus rituximab activities among risk-stratified populations, including subsets who are ineligible for or with high-risk mutations resistant to intensive chemotherapy; 2) conduct a comparative efficacy study randomizing lenalidomide plus rituximab to conventional outpatient-based chemoimmunotherapy; and 3) develop real-time minimal residual disease-adapted strategy to guide treatment intensity and duration with novel agents combination,” Ruan said. – by Cassie Homer
For more information:
Jia Ruan, MD, PhD, can be reached at Meyer Cancer Center, 1305 York Ave., New York, NY; email: jruan@med.cornell.edu.
Disclosures: Celgene helped fund this study. Ruan reports research support from and consultant/advisory roles with Celgene. Please see the study for all other authors’ relevant financial disclosures.
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