Bendamustine/Rituximab May Be Important Alternative Treatment Option for Indolent Non-Hodgkin Lymphoma or Mantle Cell Lymphoma
Results from the BRIGHT study combined with long-term safety data from other studies suggest that bendamustine (Treanda) plus rituximab (Rituxan) “may be an important alternative treatment option” for the initial therapy of patients with low-grade non-Hodgkin lymphoma (NHL) and mantle cell lymphoma, Flinn et al reported in Blood.
Study Details
This randomized, noninferiority, phase III study evaluated the efficacy and safety of bendamustine plus rituximab vs a standard rituximab-chemotherapy regimen (R-CHOP [rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone] or R-CVP [rituximab plus cyclophosphamide, vincristine, and prednisone]) for treatment-naive patients with indolent NHL or mantle cell lymphoma. Participating centers were located in the United States, Canada, Brazil, Peru, Mexico, Australia, and New Zealand.
Eligible patients were at least 18 years of age and had CD20-positive indolent NHL or mantle cell lymphoma. They needed to be treatment-naive and required treatment as indicated by at least one of the following findings: B symptoms, large tumor mass (lymph nodes > 3 cm in three or more regions or > 7 cm in one region), lymphoma-related complications, or hyperviscosity syndrome attributed to monoclonal gammopathy.
Patients were assigned to either R-CHOP or R-CVP during screening based on their performance status, comorbidities, and general health. After eligibility criteria were confirmed, the preassigned patients were randomly assigned to open-label treatment with either bendamustine/rituximab or standard therapy at a 1:1 ratio.
Six cycles were planned, and two additional cycles were permitted at investigator discretion. Among those treated with standard therapy, 104 patients received R-CHOP and 119 got R-CVP.
Results
Assessed by the primary endpoint of complete response rate, bendamustine/rituximab was noninferior to R-CHOP/R-CVP (31% vs 25%, P = .0225 for noninferiority). The complete response rate for bendamustine/rituximab was greater than the 22% threshold for noniferiority, an 88% margin.
The higher complete response rate with bendamustine/rituximab treatment was not statistically superior to standard therapy (P = .1269), the researchers noted. “Overall response rates were 97% for the [bendamustine/rituximab] treatment group and 91% for the standard-therapy treatment group, which was statistically superior for the [bendamustine/rituximab] treatment group [complete response rate ratio = 1.04, 95% confidence interval = 0.99–1.09, P = .0102].”
The safety profiles of the regimens differed. “Incidences of vomiting and drug-hypersensitivity reactions were significantly higher in patients treated with [bendamustine/rituximab] (P < .05), and incidences of peripheral neuropathy/paresthesia and alopecia were significantly higher in patients treated with standard-therapy regimens (P < .05),” the investigators reported.
By the data cutoff point in March 2012, 21 patients had died—12 in the bendamustine/rituximab treatment group and 9 in the standard therapy group. The deaths of three patients in the bendamustine/rituximab treatment group “were possibly related to treatment (pneumonia, chronic obstructive pulmonary disease, and sepsis),” the authors wrote. “Follow-up is continuing for [progression-free survival and overall survival], and a new study will provide further data on long-term toxicities,” the researchers added.
Ian W. Flinn, MD, of the Sarah Cannon Research Institute in Nashville, is the corresponding author for the Blood article.
The study was sponsored by Teva Pharmaceuticals. For full disclosures of the study authors, visit bloodjournal.hematologylibrary.org.
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