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    Posted: 07/10/2006
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Initial Treatment with Rituximab is a New Standard for Elderly Patients with B-Cell Lymphoma

Key Words

Non-Hodgkin's lymphoma, B-cell lymphoma, elderly, targeted therapy, rituximab (Rituxan®). (Definitions of many terms related to cancer can be found in the Cancer.gov Dictionary.)

Summary

Elderly patients with B-cell lymphoma stayed disease-free for significantly longer when they were treated with the drug rituximab. Patients benefited from rituximab whether they got it with their initial standard chemotherapy or as maintenance therapy afterward. These findings establish a new standard of care for the treatment of elderly patients with B-cell lymphoma.

Source

Journal of Clinical Oncology, published online June 5, 2006; in print July 1, 2006 (see the journal article).
(J Clin Oncol. 2006 Jul 1;24(19):3121-7. Epub 2006 Jun 5)

Background

B-cell lymphoma is a cancer of the B cells, a type of white blood cell. As part of the immune system, normal B cells make antibodies and help fight infections. B-cell lymphoma is the most common type of non-Hodgkin's lymphoma. More than 60 percent of patients are over age 60 when they are diagnosed with B-cell lymphoma.

For the past 30 years the chemotherapy regimen of cyclophosphamide, doxorubicin, vincristine, and prednisone, known as CHOP, has been the standard therapy for B-cell lymphoma. Younger patients may benefit from high doses of chemotherapy combined with a stem-cell transplant, but this approach is considered too toxic for older patients.

Rituximab is a monoclonal antibody that binds to a specific protein (CD20) on the surface of many B cells, tagging those cells for destruction by the patient’s own immune system. Targeted therapies such as rituximab tend to be less toxic than other kinds of systemic treatments that affect a variety of normal tissues. Preliminary studies suggested that patients with B-cell lymphoma might benefit from the addition of rituximab to standard treatment with CHOP.

The Study

This phase III study involved 1,047 patients with B-cell lymphoma whose median age was 69, and was conducted between February 1998 and July 2001. The patients were randomly assigned to initial (or induction) treatment with either CHOP plus rituximab (R-CHOP) or CHOP alone. After completing their assigned treatment, patients whose tumors had disappeared or shrank significantly were once more randomly assigned

The study was conducted by researchers with the Eastern Cooperative Oncology Group, the Cancer and Leukemia Group B, and the Southwest Oncology Group, three of nine research groups supported by the National Cancer Institute (NCI) to conduct large, multicenter cancer trials. The principal investigator was Thomas M. Habermann, M.D., of the Mayo Clinic in Rochester, Minnesota.

Results

At a median follow-up point of three and a half years, 53 percent of patients who received R-CHOP after the first randomization were alive without having had a relapse of their disease (called failure-free survival). By contrast, 46 percent of patients treated with CHOP alone remained alive without relapse. These results were statistically significant. Overall survival rates, however, were not significantly different. Side effects were similar between the two groups.

Among patients who were randomized a second time, 76 percent of those treated with maintenance rituximab were alive and disease-free after two years, compared with 61 percent of those in the observation group, findings that were statistically significant. Again, however, there was no difference in terms of overall survival.

In the group of patients who were initially treated with CHOP alone, 74 percent of those who went on to receive maintenance rituximab remained alive and free of disease after two years, compared with 49 percent of those who were merely observed. Notably, however, patients who received rituximab as part of both induction (R-CHOP) and maintenance therapy didn’t fare any better than those who were merely observed after their R-CHOP induction. In other words, for R-CHOP patients, maintenance rituximab provided no additional benefit.

Comments

“We recommend R-CHOP as the standard treatment for older [patients with B-cell lymphoma],” the study authors write.

Michael Bishop, M.D., of the National Cancer Institute’s Center for Cancer Research, agrees. “R-CHOP has become the standard of care for older patients with B-cell lymphoma,” he says. “Giving rituximab as maintenance therapy on the basis of the patient’s response to induction therapy with CHOP could deny a potentially effective therapy to patients whose disease does not respond to CHOP alone.”

Limitations

This study was conducted in older patients and the results may not apply to younger people with B-cell lymphoma, notes Bishop.

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