|The following article features coverage from the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting. Click here to read more of Hematology Advisor‘s conference coverage.|
According to results of the Eastern Cooperative Oncology Group (ECOG)-American College of Radiology Imaging Network (ACRIN) E1411 randomized phase 2 trial, the addition of bortezomib (V) to bendamustine-rituximab induction therapy did not significantly improve progression-free survival (PFS) in patients with mantle cell lymphoma (MCL).
ECOG-ACRIN E1411 (ClinicalTrials.gov Identifier: NCT01415752) assessed the efficacy and toxicity of initial induction therapy with BVR compared with BR and/or addition of lenalidomide (L) to rituximab (LR vs R) consolidation. The investigators presented the efficacy and toxicity findings of BVR vs BR induction during the ASCO21 Virtual Scientific Program.
Between 2012 and 2016, the study accrued 373 adult patients with untreated MCL, who were stratified by the Mantle Cell Lymphoma International Prognostic Index (MIPI) and age (≥60). Eligibility included ECOG performance status (PS) 0-2 and adequate hematologic and organ function. Each patient was assigned to 1 of 4 arms: BR induction followed by R; BVR followed by R; BR followed by LR; or BVR followed by LR. Following induction, patients without progressive disease could continue to consolidation.
Among eligible treated patients, the efficacy population comprised 179 patients in the BVR arm and 180 patients in the BR arm; progressive disease during induction occurred in 6 and 7 patients, respectively. Induction therapy was completed in 144 patients in the BVR arm and 153 patients in the BR arm, with 140 and 145 patients, respectively, continuing to consolidation therapy.
The median age of patients was 67 years (range 42-90 years), with 13% <60 years. Most patients were male (73%) and had ECOG PS 0-1 (97%). Among all patients, MIPI was low for 37%, medium for 29%, and high for 34%. Baseline demographics did not differ between the arms.
At 2 years, the estimated PFS was not significantly different between the BVR and BR arms (79.6% [95% CI, 73.8-85.9] vs 74.5% [95% CI, 68.2-81.4]; 1-sided stratified log-rank P =.268), and at a median follow-up of 51 months, the median estimated PFS was 64.1 months and 64.0 months, respectively. No difference in overall response rate was observed between the BVR and BR arms (88.9% [CR, 65.5%] vs 89.5% [CR, 60.5%]; 1-sided z-test P =.577).
Three treatment-related deaths occurred during induction (2 with BVR, cardiac arrest and hepatitis; 1 with BR, tumor lysis). Grade ≥3 toxicities occurred in 88.1% of the BVR arm and 77.5% of the BR arm, including neutropenia (52 vs 39 patients), febrile neutropenia (7 vs 6), anemia (7 vs 8), thrombocytopenia (18 vs 16), rash (9 vs 12), and peripheral neuropathy (6 sensory/1 motor vs 0).
“Bortezomib did not significantly improve the primary endpoint of PFS when added to BR as initial MCL therapy. ORR and CR rates at end of induction were also similar,” the authors concluded. “Follow-up continues to assess the entire treatment regimen, including consolidation R vs LR.”
Disclosure: Authors declared affiliations with industry. Please refer to the original abstract for a full list of disclosures.
Read more of Hematology Advisor’s coverage of the 2021 ASCO Annual Meeting by visiting the conference page.
Smith MR, Jegede O, Martin P, et al. ECOG-ACRIN E1411 randomized phase 2 trial of bendamustine-rituximab (BR)-based induction followed by rituximab (R) ± lenalidomide (L) consolidation for mantle cell lymphoma: effect of adding bortezomib to front-line BR induction on PFS. J Clin Oncol. 2021;39(suppl 15; abstr 7503). doi:10.1200/JCO.2021.39.15_suppl.7503