Abstract
This single-arm phase 3 study was conducted to confirm the results of our phase 2 study of bendamustine (B)-rituximab (R) in patients with relapsed/refractory diffuse large B cell lymphoma (rrDLBCL). The primary endpoint was overall response rate (ORR). Autologous stem cell transplantation-ineligible rrDLBCL patients with ≤ 2 prior chemotherapy regimens received R 375 mg/m2 IV on day 1 and B 120 mg/m2/day IV on days 2 and 3 every 21 days up to 6 cycles. Thirty-eight patients with a median age of 74 years (range, 43–86) received BR. The ORR and complete response rates were 76.3% and 47.4%, respectively. With a median follow-up of 19.5 months including long-term follow-up, median progression-free survival was 11.9 months. Median OS was 29.2 months. Discontinuation of treatment due to Gr3-5 TEAE was observed among 13 of 38 patients (34.2%). One patient with cytomegalovirus enterocolitis died during follow-up. This BR regimen was confirmed to be effective and tolerable in studied patients. ClinicalTrials.gov Identifier: NCT03372837 registered on 14 December 2017, NCT04354402 registered on 21 April, 2020.
Highlights
Diffuse large B cell lymphoma (DLBCL) is the most common subtype of non-Hodgkin lymphoma (NHL) in Western countries and Japan [1]
Despite improvements in the prognosis of patients with DLBCL in the R era, relapsed or refractory DLBCL developing in approximately one-third of patients with DLBCL remains a major cause of morbidity and mortality [4]
A number of novel immunotherapeutic modalities for refractory DLBCL (rrDLBCL) have been under investigation, some of which have been approved for the treatment of rrDLBCL when used alone or in combination with combined chemotherapies
Summary
Diffuse large B cell lymphoma (DLBCL) is the most common subtype of non-Hodgkin lymphoma (NHL) in Western countries and Japan [1]. Patients with rrDLBCL eligible for high-dose chemotherapy (HDC)/autologous stem cell transplantation (ASCT) are usually treated with intensive salvage regimens including R, dexamethasone, high-dose cytarabine, and cisplatin (R-DHAP); R, ifosfamide, carboplatin, and etoposide (R-ICE); R, gemcitabine, dexamethasone, and cisplatin (R-GDP); or R, cyclophosphamide, high-dose cytarabine, etoposide, and dexamethasone (CHASER) [5]. CAR-T therapy has shown efficacy for rrDLBCL, and 5 drugs including axicabtagene have received regulatory approval from the Food and Drug Administration. Those novel therapies still present challenges with respect to accessibility, patient’s functional status, disease burden, and price. An optimal salvage regimen for them remains as an unmet need
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