Posted on April 2nd, 2013 by
The combination of Treanda® (bendamustine) and Rituxan® (rituximab) was found to be noninferior to the commonly used chemotherapy regimens R-CHOP (rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone) and R-CVP (rituximab plus cyclophosphamide, vincristine, and prednisone) in patients with previously untreated advanced indolent non-Hodgkin’s lymphoma (NHL) or mantle cell lymphoma (MCL), according to the results of a study presented at the 54th Annual Meeting of the American Society of Hematology in Atlanta, Georgia.
Non-Hodgkin’s lymphoma (NHL) is a form of cancer that begins in the cells of the lymph system. It is characterized by the excessive accumulation of atypical (cancerous) lymphocytes. These lymphocytes can crowd the lymph system and suppress the formation and function of other immune and blood cells.
R-CHOP and R-CVP are two commonly used treatment approaches for NHL. Research has been ongoing to evaluate other treatment approaches in an effort to improve effectiveness and reduce side effects. Treanda is a chemotherapy agent that combines the action of two types of agents, which attack cancerous cells through distinct pathways. It is approved for the treatment of recurrent NHL and chronic lymphocytic leukemia (CLL). Treanda has been widely used in Europe for decades, but only became available in the U.S. in 2008. It is currently being evaluated for use in other types of cancer as well as in the initial treatment of NHL.
Previous research has indicated that Treanda/Rituxan offers a significant improvement in progression-free survival over R-CHOP in follicular NHL and MCL and this treatment regimen has become the standard in Germany. Researchers conducted the BRIGHT study, which compared the safety and efficacy of Treanda/Rituxan with standard treatment regimens of R-CHOP and R-CVP as first-line treatment for indolent NHL or MCL in order to confirm the results of the earlier study.
The study included 419 evaluable patients, 213 who were randomly assigned to receive Treanda/Rituxan and 206 who were randomized to either R-CHOP or R-CVP. The study used complete response as the primary endpoint, and showed no difference between the two treatment arms. The complete response rate for Treanda/Rituxan was 31 percent compared with 25 percent in the control group. The complete response ratio of 1.26 met the definition of noninferiority, but was not statistically significant for superiority. Overall response rates were 97 percent for Treanda/Rituxan compared with 91 percent for R-CHOP/R-CVP.
The toxicity profiles for Treanda/Rituxan and R-CHOP/R-CVP are distinct and the researchers suggest that toxicity should be considered in treatment selection. Patients in the Treanda/Rituxan arm experienced a higher incidence of nausea/vomiting, pyrexia, chills, drug hypersensitivity reactions, decreased appetite, rash, and pruritus. These patients experienced increased grade 3 or higher adverse events that included hypersensitivity reactions, opportunistic infection, and respiratory/thoracic disorders. Patients in the R-CHOP/R-CVP arms experienced a higher incidence of constipation, paresthesia, peripheral neuropathy, and alopecia. These patients experienced more frequent febrile neutropenia, alopecia, and neuropathy. More deaths occurred in the Treanda/Rituxan group (six patients, due to pneumonia, respiratory failure, and sepsis; acute respiratory failure; cardiac arrest; pneumonia; chronic obstructive pulmonary disease; lung cancer) than in the R-CHOP/R-CVP group (one patient, due to sepsis).
The researchers concluded that in patients with advanced indolent NHL and MCL, Treanda/Rituxan produces a complete response rate that is noninferior to that of R-CHOP/R-CVP. In the subgroup of patients with MCL, Treanda/Rituxan produces a significantly higher complete response rate (51% vs 24%). High overall response rates were attained in both treatment groups.
 Flinn I, Van der Jagt R, Kahl B, et al: An open-label, randomized stdy of bendamustine and rituximab compared with rituximab, cyclophosphamide, vincristine, and prednisone (R-CVP) or rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone in first-line treatment of advanced indolent non-Hodgkin’s lymphoma or mantle cell lymphoma: The Bright study. 2012 ASH Annual Meeting. Blood (ASH Annual Meeting Abstracts) 2012 120: Abstract 902.
 Rummel MJ, Niederle N, Maschmeyer G, et al. Bendamustine plus rituximab (B-R) versus CHOP plus rituximab (CHOP-R) as first-line treatment in patients with indolent and mantle cell lymphomas (MCL): Updated results from the StiL NHL1 study. Presented at the 2012 annual meeting of the American Society of Clinical Oncology, June 1-5, 2012, Chicago, IL. Abstract 3.
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