Posted on October 23rd, 2012 by
Induction therapy with R-CHOP followed by maintenance with Rituxan® (rituximab) nearly doubled the remission duration in older patients with mantle cell lymphoma, according to the results of a study published in the New England Journal of Medicine.
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. Mantle cell lymphoma is a subset of NHL that accounts for approximately 5%–10% of all lymphomas. Older patients with mantle cell lymphoma typically have a poor long-term prognosis, with relapse or disease progression occurring within two to three years.
One commonly used treatment approach for NHL is R-CHOP, which refers to the combination of treatment with the targeted agent Rituxan plus chemotherapy with CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone).
To evaluate whether a new induction regimen could improve remission rates among older patients with mantle cell lymphoma, researchers conducted a randomized clinical trial that included 560 patients age 60 or older with stage II to IV mantle cell lymphoma. None of the patients were eligible for high-dose therapy. The patients were randomly assigned to six cycles of Rituxan, fludarabine, and cyclophosphamide (R-FC) every 28 days or eight cycles of R-CHOP every 21 days. Patients who experienced a response then underwent a second randomization to maintenance therapy with Rituxan or interferon alfa, given until disease progression.
The primary analysis included 485 patients—246 who were assigned to R-FC and 239 who were assigned to R-CHOP. The median age of patients was 70 years. The results indicated that both groups had similar remission rates. More patients in the R-FC group demonstrated complete remission (40% vs. 34%); however, there was also a higher rate of progressive disease (14% vs. 5%) in the R-FC group. Four-year overall survival was significantly higher in the R-CHOP group—62 percent compared to 47 percent in the R-FC group.
Patients who responded to treatment underwent a second randomization and 143 patients received maintenance therapy with Rituxan while 131 received maintenance with interferon alfa. The results indicated that the remission duration was significantly longer in the Rituxan group compared to the interferon group. Rituxan reduced the risk of progression or death by 45 percent compared to interferon. What’s more—maintenance therapy with Rituxan significantly improved overall survival among patients who responded to R-CHOP. The four-year survival rate was 87 percent in the Rituxan group compared to 63 percent in the interferon group.
The researchers concluded that R-CHOP induction followed by maintenance therapy with Rituxan is effective for older patients with mantle-cell lymphoma.
Kluin-Nelemans HC, Hoster E, Hermine O, et al. Treatment of Older Patients with Mantle-Cell Lymphoma. New England Journal of Medicine. 2012; 367: 520-531.
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