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Clinical Trial Results

Summaries of Newsworthy Clinical Trial Results

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    Posted: 06/16/2003    Reviewed: 12/06/2005
Related Pages
Search for Clinical Trials 1
NCI's PDQ® Cancer Clinical Trials Registry.

Hodgkin Lymphoma Home Page 2
NCI's gateway for information about Hodgkin lymphoma.
No Added Benefit from Radiation for Hodgkin's Patients in Complete Remission

Key words
Hodgkin lymphoma, lymphatic system, radiation therapy. (Definitions of many terms related to cancer can be found in the Cancer.gov Dictionary 3.)

Summary
Radiation therapy offered no added benefit for patients with advanced Hodgkin’s lymphoma whose disease was in complete remission after multidrug chemotherapy.

Source
New England Journal of Medicine, June 12, 2003 (see the journal abstract).

Background
Hodgkin’s lymphoma is a rare cancer of the lymphatic system – the tissues and organs that produce, store, and carry white blood cells. More than 70 percent of patients with advanced Hodgkin’s lymphoma can be cured by chemotherapy regimens involving four or more drugs.

Whether radiation therapy reduces the relapse rate and ultimately extends survival in patients with Hodgkin’s lymphoma who have a complete remission after chemotherapy is controversial. Previous studies have suggested that radiation increases these patients’ risk of developing a second cancer ― a risk that increases over time. This study was designed to try to resolve whether radiation offers any added benefit for patients who have a complete remission after chemotherapy.

The Study
Patients with advanced Hodgkin’s lymphoma were enrolled in the study between 1989 and 2000 at 42 cancer treatment centers in seven European countries. All of the patients had had a complete remission of their disease after undergoing multidrug chemotherapy. A total of 333 patients were assigned at random to receive either no further treatment or radiation treatment of the area where their cancer originally occurred (“involved-field” radiotherapy).

Results
After a median follow-up period of 6.6 years, survival rates were not significantly different in patients who received radiation treatment and those who did not. However, radiation treatment conferred an increased risk of getting a second cancer. Fifteen of 172 patients (8.7 percent) who were treated with radiation developed a second cancer, compared with six of 161 patients (3.7 percent) who had no further treatment.

“[We] found that there is no need for involved-field radiotherapy to maintain remission in patients with stage III or IV Hodgkin lymphoma who are in complete remission” after chemotherapy, concluded the study authors, who were led by Berthe M.P. Aleman, M.D., of the Netherlands Cancer Institute in Amsterdam.

Wyndham Wilson, M.D., Ph.D., chief of the lymphoma section at the National Cancer Institute’s Center for Cancer Research, agreed. “The results of this study confirm previous studies that have also found that radiation does not extend survival,” he said.

Limitations
These findings apply only to patients in whom all observable signs of disease disappear after chemotherapy. It is quite common for patients to have some remaining abnormalities on X-rays, and these patients are considered to be in a remission by newer definitions; some of these patients may still have active Hodgkin’s lymphoma and could potentially benefit from radiation. However, because these patients were not randomized, it remains unclear whether post-chemotherapy radiation could have benefited them, said Wilson.

In addition, Wilson added, the chemotherapy regimen used in this study differs from the standard multidrug chemotherapy regimen used in the United States.



Glossary Terms

chemotherapy (KEE-moh-THAYR-uh-pee)
Treatment with drugs that kill cancer cells.
lymphatic system (lim-FA-tik SIS-tem)
The tissues and organs that produce, store, and carry white blood cells that fight infections and other diseases. This system includes the bone marrow, spleen, thymus, lymph nodes, and lymphatic vessels (a network of thin tubes that carry lymph and white blood cells). Lymphatic vessels branch, like blood vessels, into all the tissues of the body.
radiation therapy (RAY-dee-AY-shun THAYR-uh-pee)
The use of high-energy radiation from x-rays, gamma rays, neutrons, protons, and other sources to kill cancer cells and shrink tumors. Radiation may come from a machine outside the body (external-beam radiation therapy), or it may come from radioactive material placed in the body near cancer cells (internal radiation therapy). Systemic radiation therapy uses a radioactive substance, such as a radiolabeled monoclonal antibody, that travels in the blood to tissues throughout the body. Also called irradiation and radiotherapy.
randomized clinical trial
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.
regimen
A treatment plan that specifies the dosage, the schedule, and the duration of treatment.
remission
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.
white blood cell
A type of immune cell. Most white blood cells are made in the bone marrow and are found in the blood and lymph tissue. White blood cells help the body fight infections and other diseases. Granulocytes, monocytes, and lymphocytes are white blood cells. Also called leukocyte and WBC.


Table of Links

1http://www.cancer.gov/clinicaltrials/search
2http://www.cancer.gov/cancertopics/types/hodgkin
3http://www.cancer.gov/dictionary