Initial treatment patterns and survival outcomes in patients with Mantle Cell Lymphoma in the era of BTK inhibitors: A multicenter real-world study

Abstract Objective: This study aimed to characterize the disease profile, initial treatment approaches, and survival outcomes of patients with mantle cell lymphoma (MCL) in real-world clinical practice. Methods: The data of 234 patients with MCL in four major hematology centers in China from 2017 to 2025 were retrospectively analyzed. Results: The median age was 61 years. 91.0% of patients had ECOG PS (Eastern Cooperative Oncology Group Performance Status) scored 0-1, and 73.9% had advanced-stage disease. Ki67 expression <30% was observed in 29.9% of patients, while 44.4% were classified as low-risk according to the Mantle Cell Lymphoma International Prognostic Index (MIPI). Collectively, 93.6% of patients received Rituximab as first-line therapy. The most commonly used chemotherapy regimen was CHOP-like(28.2%), followed by high-dose cytarabine-containing regimens (24.4%) and Bendamustine (6.8%). 45.3% of patients received BTK inhibitors in the first line of treatment. Of the patients, 18.8% (n=44) underwent consolidation autologous stem cell transplantation (ASCT). Patients who achieved remission with first-line therapy accounted for 76.9%, with a median follow-up of 27 months and 1-/2-year overall survival (OS) rates of 90.2% and 82.7%, respectively. Age ≤60 years, Ki67 <30%, and remission after first-line therapy were independent prognostic factors for OS. The inclusion of BTK inhibitors improved 2-year OS (77.8% vs. 89.4%, p=0.064). The use of CD20 monoclonal antibody (rituximab) significantly improved 2-year OS (58.2% vs. 84.4%, p<0.001). The clinical benefit of high-dose cytarabine-containing chemotherapy was not significant (79.7% vs. 91.9%, p=0.434). Patients undergoing ASCT showed superior outcomes, with 2-year OS rates of (94.7% vs. 80.1%, p=0.040). Conclusions: This large retrospective dataset definitively demonstrates that ​first-line use of BTK inhibitors​ provides ​borderline significance​ in improving outcomes for mantle cell lymphoma (MCL) patients, while ​rituximab-containing regimens​ and ​autologous stem cell transplantation (ASCT)​​ retain their ​survival advantage​ as frontline therapies. Keywords: Mantle cell lymphoma, Initial treatment, BTK inhibitors, Multicenter study