6/29/23, 11:57 PM StiL Pathway Feedback Search Clinical Topics Home Studies StiL StiL Disease Mantle cell lymphoma Trial question Is bendamustine plus rituximab noninferior to CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) plus rituximab as first-line treatment for patients with indolent and mantle cell lymphomas? Study design Multi-center Open label RCT Population 549 patients Inclusion criteria: patients with advanced indolent and mantle cell lymphomas Key exclusion criteria: severe cardiac disease or previous malignancy; in adequate hepatic, renal, or cardiac function; or infection with human immunodeficiency virus or hepatitis B Interventions N=274 bendamustine plus rituximab (intravenous bendamustine 90 mg/m on days 1 and 2 of a 4- week cycle for a maximum of six cycles plus rituximab 375 mg/m on day 1 of each cycle) N=275 R-CHOP (cycles every 3 weeks of cyclophosphamide 750 mg/m , doxorubicin 50 mg/m , and vincristine 1.4 mg/m on day 1, and prednisone 100 mg/day for 5 days for a maximum of six cycles plus rituximab 375 mg/m on day 1 of each cycle) Primary outcome Median progression-free survival 69.5 months 69.5 52.1 months https://web.pathway.md/studies/rec1lPD5QONFM3uOu 1/2 6/29/23, 11:57 PM StiL Pathway 34.8 months 31.2 17.4 months Significant increase 0.0 months Bendamustine plus rituximab R-CHOP Significant increase in median progression-free survival (69.5 months vs. 31.2 months; HR 1.72, 95% CI 1.35 to 2.27) Secondary outcomes Significant increase in complete response (40% vs. 30%; RR 1.33, 95% CI 0.2 to 2.46) Safety outcomes Significant differences in alopecia (0 vs. 100%), hematological toxicity (30% vs. 68%), infections (37% vs. 50%), peripheral neuropathy (7% vs. 29%), stomatitis (6% vs. 19%), and erythematous skin reactions (16% vs. 9%). Conclusion In patients with advanced indolent and mantle cell lymphomas, bendamustine plus rituximab was superior to R-CHOP with respect to median progression-free survival. Reference Rummel MJ, Niederle N, Maschmeyer G et al. Bendamustine plus rituximab versus CHOP plus rituximab as first-line treatment for patients with indolent and mantle-cell lymphomas: an open-label, multicentre, randomised, phase 3 non-inferiority trial. Lancet. 2013 Apr 6;381(9873):1203-10. Open reference URL https://web.pathway.md/studies/rec1lPD5QONFM3uOu 2/2