Posted on June 12th, 2012 by
The combination of Treanda® (bendamustine) and Rituxan® (rituximab) more than doubled progression-free survival compared with standard R-CHOP therapy among patients with indolent lymphoma and mantle cell lymphoma, according to the results of a multi-center, phase III study presented at the 2012 annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago, Illinois.
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.
One commonly used treatment approach for NHL is R-CHOP, which refers to the combination of treatment with Rituxan plus chemotherapy with CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone). 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.
This phase III clinical trial evaluated the use of Treanda in the initial treatment of NHL. The study included 514 patients with previously untreated follicular, indolent, or mantle cell lymphomas who were randomly assigned to receive treatment with R-CHOP or with Treanda plus Rituxan. Earlier data from this trial was presented at the annual meeting of the American Society of Hematology (ASH) in 2008 and indicated that Treanda plus Rituxan was as effective as R-CHOP and less toxic. Now long-term results indicate that the combination improves progression-free survival (PFS).
After a median follow-up of 45 months, the median PFS in the Treanda/Rituxan group was 69.5 months compared to 31.2 months in the R-CHOP group. Overall survival was similar between the two groups; however, nearly half of the R-CHOP patients whose disease continued to progress were allowed to cross over and receive the Treanda/Rituxan regimen. Because survival for indolent lymphomas tends to be very long, PFS is the most reliable measure of clinical benefit from therapies.
There were fewer serious adverse effects in the Treanda/Rituxan group. Patients in this group had no hair loss and a lower incidence of nerve toxicity and infection compared to the R-CHOP group. Furthermore, 69 percent of patients in the R-CHOP group experienced moderate to severe neutropenia (low white blood cells) compared to only 29 percent of patients in the Treanda/Rituxan group.
The researchers concluded that Treanda/Rituxan is more effective and less toxic than R-CHOP in the initial treatment of indolent and mantle cell lymphoma. The results of this study are expected to change standard clinical practice in the treatment of NHL.
 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.
 Rummel MJ, von Gruenhagen U, Niederle N et al. Bendamustine plus rituximab versus CHOP plus rituximab in the first-line treatment of patients with follicular, indolent and mantle cell lymphomas: results of a randomized phase III study of the Studygroup Indolent Lymphomas (StiL). Presented at the 50th Annual Meeting of the American Society of Hematology, December 6-9 2008, San Francisco, CA. Abstract 2596.
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