Related Pages Search for Clinical Trials 1 NCI's PDQ® Cancer Clinical Trials Registry. Non-Hodgkin Lymphoma Home Page 2 NCI's gateway for information about non-Hodgkin lymphoma. Highlights from ASCO 2004 3 (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 ⁴.)

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.

Glossary Terms

A statistics term. The middle value in a set of measurements.

A type of protein made in the laboratory that can locate and bind to substances in the body, including tumor cells. There are many kinds of monoclonal antibodies. Each monoclonal antibody is made to find one substance. Monoclonal antibodies are being used to treat some types of cancer and are being studied in the treatment of other types. They can be used alone or to carry drugs, toxins, or radioactive materials directly to a tumor.

A molecule made up of amino acids that are needed for the body to function properly. Proteins are the basis of body structures such as skin and hair and of substances such as enzymes, cytokines, and antibodies.

A study in which the participants are assigned by chance to separate groups that compare different treatments; neither the researchers nor the participants can choose which group. Using chance to assign people to groups means that the groups will be similar and that the treatments they receive can be compared objectively. At the time of the trial, it is not known which treatment is best. It is the patient's choice to be in a randomized trial.

A decrease in or disappearance of signs and symptoms of cancer. In partial remission, some, but not all, signs and symptoms of cancer have disappeared. In complete remission, all signs and symptoms of cancer have disappeared, although cancer still may be in the body.

In medicine, treatment that experts agree is appropriate, accepted, and widely used. Health care providers are obligated to provide patients with standard therapy. Also called best practice and standard of care.

Describes a mathematical measure of difference between groups. The difference is said to be statistically significant if it is greater than what might be expected to happen by chance alone. Also called significant.

A type of treatment that uses drugs or other substances, such as monoclonal antibodies, to identify and attack specific cancer cells. Targeted therapy may have fewer side effects than other types of cancer treatments.