Rituximab, bendamustine and lenalidomide in patients with aggressive B‐cell lymphoma not eligible for anthracycline‐based therapy or intensive salvage chemotherapy – SAKK 38/08

Abstract

An increasing number of older patients are suffering from aggressive lymphoma. Effective and more tolerable treatment regimens are urgently needed for this growing patient population. Patients with aggressive lymphoma not eligible for anthracycline-based first-line therapy or intensive salvage regimens were treated with the rituximab-bendamustine-lenalidomide (R-BL) regimen (rituximab 375 mg/m(2) day 1, bendamustine 70 mg/m(2) d 1, 2, lenalidomide 10 mg d 1-21) for six cycles every 4 weeks. Forty-one patients with a median age of 75 (range 40-94) years were enrolled: 33 patients had substantial co-morbidities. 13 patients were not eligible for anthracycline-based first-line chemotherapy, 28 patients had relapsed/refractory disease. The primary endpoint, overall response, was achieved by 25 (61%) patients (95% confidence interval 45-76%). Grade ≥ 3 toxicity comprised haematological (59%), skin (15%), constitutional (15%) and neurological (12%) events. 9 patients died during trial treatment: 5 from lymphoma progression, 2 from toxicity, 2 with sudden death. After a median follow-up of 25·9 (interquartile range 20·4-31·6) months, 13 patients were still alive. Median overall survival was 14·5 months. In conclusion, R-BL can be considered a treatment option for elderly patients with treatment naïve or relapsed/refractory aggressive lymphoma not eligible for standard aggressive regimens.

Rituximab plus bendamustine as front-line treatment in frail elderly (>70 years) patients with diffuse large B-cell non-Hodgkin lymphoma: a phase II multicenter study of the Fondazione Italiana Linfomi

“…In order to further improve these results, additional efforts should be made to attempt to increase the response rate and to prolong the short duration of response. New drugs such as lenalidomide and ibrutinib have shown activity against DLBCL, are both associated with an excellent safety profile, 16 , 17 and could be used to improve the results with an acceptable toxicity. A phase II trial of rituximab in association with a lenalidomide combination in elderly frail patients is currently being conducted by our group and actively recruiting patients ( clinicaltrials.gov identifier: 02955823 ).…”

Cancer-specific geriatric assessment and quality of life: important factors in caring for older patients with aggressive B-cell lymphoma

“…Patients with histologically confirmed aggressive non-Hodgkin lymphoma including DLBCL, transformed follicular lymphoma (FL), or FL grade 3b according to the WHO classification were enrolled in 12 Swiss centers from August 2011 to January 2014. Details on eligibility criteria are described elsewhere [17]. For response assessment, criteria of the International Working Group for evaluation of response in non-Hodgkin's Lymphoma were used.…”

“…The study was conducted in compliance with the Declaration of Helsinki and the International Conference on Harmonization Good Clinical Practices. Ethical approval was obtained from the ethics committee and institutional review board for each site and patients provided separate written informed consent for C-SGA and QoL assessments [17]. The study was registered with ClinicalTrials.gov, number NCT00987493.…”

“…In settings where so-called standard treatment therapy is not feasible, and the proportion of older patients is increasing, meaningful outcomes as represented by the different dimensions of a CGA and QoL should be mandatory [48]. We aimed to characterize and compare patients with aggressive B-cell lymphoma receiving a rituximab, bendamustine and lenalidomide (R-BL) regimen [17] by response and survival status based on pre-treatment cancer-specific geriatric (C-SGA) and QoL assessments. We also report on changes in C-SGA and QoL from pre-to post-treatment and characterize and compare patients registered vs. those not registered to the phase II trial based on C-SGA and QoL.…”

Efficacy of bendamustine on thrombocytopenia and hemolytic anemia secondary to CD5-positive B-cell lymphoma with massive splenomegaly in a patient with rheumatoid arthritis

“…Furthermore, anemia, although transiently aggravated, ultimately disappeared. Bendamustine is effective for indolent and mantle cell lymphoma (5) and even aggressive lymphoma (10,11). Bendamustine plus rituximab was better tolerated than R-CHOP with lower rates of myelotoxicity while higher frequency of grade 3-4 lymphocytopenia was seen in the bendamustine plus rituximab group (5).…”