Related Pages Search for Clinical Trials NCI's PDQ® registry of cancer clinical trials. Non-Hodgkin Lymphoma Home Page NCI's gateway for information about non-Hodgkin lymphoma. Highlights from ASCO 2004 (Posted: 06/05/2004, Reviewed: 12/06/2005) - A collection of links to material summarizing some of the important clinical trial results announced at the 2004 annual meeting of the American Society of Clinical Oncology (ASCO).

Keywords

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

Summary

Rituximab, when added to standard chemotherapy for initial treatment of mantle cell lymphoma, shrank or eliminated tumors in a significantly higher percentage of patients than the standard chemotherapy (CHOP) alone. Further follow-up is needed to show whether this approach also increases overall survival time.

Source

American Society of Clinical Oncology (ASCO) annual meeting, New Orleans, June 5, 2004. Final results subsequently published in the March 20, 2005, Journal of Clinical Oncology (see the journal abstract).

Background

Rituximab is now widely used in the treatment of various kinds of non-Hodgkin’s B-cell lymphoma. It is known to be effective as the initial treatment of diffuse large B-cell lymphoma, the most common form of the disease, and in other types it has proved effective as second-line treatment (that is, treatment given when the first treatment doesn’t work or stops working). But the drug’s use as initial, or front-line, therapy is still under study in many forms of lymphoma, including mantle cell lymphoma. Mantle cell lymphoma is an aggressive form of the disease and is often resistant to chemotherapy; median survival from time of diagnosis is only three to four years.

Ritiuximab, the first monoclonal antibody to be approved by the U.S. Food and Drug Administration, works by targeting the CD-20 protein often found on the surface of B-cell lymphomas. The antibody binds to the protein, leading to destruction of the cancerous cell.

The Study

The 122 patients in the study were divided randomly into two groups. One received the standard therapy known as CHOP, a combination of cytoxan, adriamycin, vincristine, and prednisone. The other group received CHOP plus rituximab.

The study’s research team was lead by Wolfgang Hiddemann, M.D.,Ph.D., of Ludwig-Maximilians University in Munich, Germany.

Results

About 34 percent of the patients receiving CHOP plus rituximab had a complete remission compared to just 7 percent of those receiving CHOP alone. The majority of patients in the rituximab group--94 percent--had either a complete or partial remission compared to 74 percent of those receiving CHOP alone.

Side effects were somewhat more severe in the rituximab group, with more frequent suppression of cells important in the immune system. However, rates of severe infection were only slightly greater among those taking rituximab (7 percent) compared to those taking CHOP alone (5 percent).

“We can really say this benefit had no costs in terms of side effects,” said Hiddeman.

Limitations

The study does not show whether patients treated with rituximab plus CHOP will survive any longer than those in the CHOP-alone group. Also, the results apply only to patients with mantle cell lymphoma, which is one of the less common forms of non-Hodgkin’s lymphoma.

Comments

These findings, added to those of other recent studies with rituximab, suggest that it will be used increasingly as a first-line therapy, said Howard S. Hochster, M.D., a lymphoma researcher at the New York University School of Medicine in New York City. “I think this is strategy you’ll be seeing more and more,” he said.

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