We present long-term combined results of two clinical trials implementing R-MACLO-IVAM induction followed by thalidomide or rituximab maintenance in 44 patients with untreated mantle cell lymphoma (MCL). The first 22 patients (UM-MCL1 ClinicalTrials.gov identifier NCT00450801) received maintenance with thalidomide (200 mg daily until relapse/intolerable toxicity) and a subsequent cohort of 22 patients (UM-MCL2 ClinicalTrials.gov identifier NCT00878254) received rituximab (375mg/m2 IV weekly x 4, repeated every 6 months for 3 years). Considering all 44 patients, 41 (93.2%) achieved complete response (CR), 2 (4.5%) partial response (PR), and 1 (2.3%) was not evaluated for response. With a median follow up of 7.2 years (range < 1 month to 16 years), the 5 year progression-free survival (PFS) was 55.6% (95%CI: 38.9-69.4%) and median PFS 7.9 years (95%CI: 3.7-11 years). 5 year OS was 83.3% (95%CI: 68.1%-91.7%) and median OS was not reached. Patients with blastic variant (n=6) had a 5-year PFS and OS of 20.8% and 60%, respectively. Myelosuppression was the most common adverse event during immunochemotherapy. Long-term treatment-related mortality was 6.8%. R-MACLO-IVAM followed by maintenance therapy is an effective regimen to induce long-term remission in MCL without need for consolidation with ASCT. This article is protected by copyright. All rights reserved.
R-MACLO-IVAM regimen followed by maintenance therapy induces durable remissions in untreated mantle cell lymphoma - long term follow up results.