“The efficacy of first-line (lenalidomide plus rituximab), demonstrated by high response rates and durable remissions, as well as long-term safety and convenience of an outpatient treatment regimen, support the broad applicability of this regimen as a new approach said the authors of the phase 2 study (NCT01472562).
Lenalidomide (Revlimid), combined with rituximab (Rituxan), produced an anti-inflammatory drug in a small number of patients with untreated mantle cell lymphoma (MCL), according to results from a phase 2 trial (NCT01472562) with 9 years of follow-up. demonstrated long-term, durable responses and manageable toxicity published in Blood progress.
Median progression-free survival (PFS) with lenalidomide plus rituximab was 9 years. In addition, the estimated 7-year progression-free survival rate was 61.0% (95% CI, 41.8%-75.2%) and the 9-year progression-free survival rate was 51.0% (95% CI, 31.5%-68.0%). The estimated 7- and 9-year overall survival (OS) rates were 76.0% (95% CI, 58.7%-86.7%) and 66.0% (95% CI, 47.3%-79.2%), respectively. High-risk MCL International Prognostic Index (MIPI) score confers less favorable OS outcomes (ask = .03).
The researchers reported that 17 of 36 evaluable patients had ongoing responses; 17 responses lasted more than 6 years, 15 responses lasted more than 7 years, and 11 responses lasted more than 8 years. , with 6 replies being more than 9 years old. Additionally, 12 patients who achieved complete remission (CR) during maintenance therapy were able to discontinue treatment, and 10 patients maintained durable remission.
“The (lenalidomide/rituximab) study is the first chemotherapy-free first-line treatment for MCL, and our report provides long-term data on the use of a chemotherapy-free approach to treat MCL,” the study authors wrote. “First-line (lenalidomide plus rituximab), demonstrated by high response rates and durable remissions, as well as long-term safety and convenience of an outpatient treatment regimen, support the broad applicability of this regimen as a novel approach that has not previously been Treating MCL.”
Patients enrolled in this multicenter Phase 2 study received 20 mg of lenalidomide daily for the first 21 days of a 28-day cycle for 12 cycles, 25 mg daily during the induction period, and 25 mg daily after the first cycle. , and maintain 15 mg per day. The patient also received 375 mg/m22 Rituximab was administered weekly for 4 weeks in Cycle 1 and then every other cycle, including maintenance therapy.
The primary endpoint of the study is overall response rate (ORR). Secondary endpoints include PFS and OS.
Patients with measurable, histologically confirmed untreated MCL and a low-to-intermediate risk MIPI score or a high-risk MIPI score with contraindications to chemotherapy were able to participate in the study. Other eligibility criteria include ECOG performance status of 0 to 2 and a creatine clearance rate of 30 mL per minute or greater.
There were 38 patients in the study, with a mean age of 65 years (range, 42-86 years). Additionally, 87% of the population had evaluable Ki67 markers, with 21% having Ki67 higher than 30%. Among those evaluable for response (n = 36), the majority were able to complete induction therapy and continue on lenalidomide/rituximab maintenance therapy (n = 33).
Researchers reported that 70% of patients required a 15 mg lenalidomide dose reduction during maintenance therapy; the median maintenance dose was 10 mg. In addition, 5 patients remained on rituximab monotherapy, 1 patient remained on lenalidomide monotherapy, and 1 patient remained on rituximab/lenalidomide therapy.
Overall, 8 patients (21%) developed secondary primary malignancies. In addition, 2 patients (5%) had aggressive systemic malignancies, one with Merkel cell carcinoma and the other with pancreatic cancer. Both patients died after developing these systemic malignancies.
Common grade 3 or higher hematologic adverse reactions (AEs) included neutropenia (42%), thrombocytopenia (5%), and anemia (3%), which were reported to occur during maintenance therapy Less frequent and severe. In addition, infections were mainly grade 1/2, mainly including upper respiratory tract infection (50%), urinary tract infection (21%), sinusitis (16%), and cellulitis (16%). Investigators highlighted that four patients developed COVID-19, one of whom was hospitalized and subsequently died, and three patients did not require hospitalization.
refer to
Yamshon S, Chen GZ, Gribbin C, et al. Nine-year follow-up of lenalidomide plus rituximab as initial treatment for mantle cell lymphoma. blood upgrade 2023;7(21):6579-6588. doi:10.1182/bloodadvances.2023010606