The results of the study (NCT01234467) were published by Park SI from the UNC Lineberger Comprehensive Cancer Centre in Chapel Hill, and colleagues in Br J Haematol. in July 2016. The results of this trial have demonstrated the high response rates in older patients’ ≥65 years when administered a combined therapy of bendamustine and rituximab (BR).
The primary objective of the study was to determine the safety and efficacy profile in older patients who were deemed as poor candidates for R-CHOP (rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone) in previously untreated stage II-IV Diffuse Large B- Cell Lymphoma (DLBCL).
The take home messages are:
- When administered in frail patients, the combined therapy shows a positive correlation with high response rates (overall response rate 78%, complete response rate 52%), although survival rates were low.
- Although the trial has demonstrated encouraging results with BR to be used as a front-line therapy in elderly DLBLC patients, use of BR in this population with poor functional status should be proceeded with caution in future trials.
A phase II trial of bendamustine in combination with rituximab in older patients with previously untreated diffuse large B-cell lymphoma
Bendamustine in combination with rituximab (BR) has been associated with high response rates and acceptable toxicity in older patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL). Evaluation of BR is warranted in the front-line setting for DLBCL patients not eligible for anthracyclines or for the elderly. In this phase II study, we enrolled DLBCL patients aged ≥65 years who were poor candidates for R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) to determine the efficacy and safety of BR in previously untreated stage II-IV DLBCL. Twenty-three patients were enrolled with a median age of 80 years. 52% of patients presented with poor functional status (Eastern Cooperative Oncology Group performance score of ≥2). The overall response rate was 78% with 12 complete responses (52%). At a median follow up of 29 months, the median overall survival was 10·2 months and the median progression-free survival was 5·4 months. The most common grade 3/4 adverse events were haematological. Combination therapy with BR demonstrates high response rates as front-line therapy in frail older patients with DLBCL, but survival rates were low. BR should be used with caution in future clinical trials involving older DLBCL patients with poor functional status.