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Clinical Trial Results

Summaries of Newsworthy Clinical Trial Results

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    Posted: 05/10/2006
Related Pages
Search for Clinical Trials 1
NCI's PDQ® Cancer Clinical Trials Registry.

Breast Cancer Home Page 2
NCI's gateway for information about breast cancer.

Sentinel Lymph Node Biopsy: Q & A 3
A fact sheet that describes the sentinel lymph node biopsy procedure and details two clinical trials evaluating the effectiveness of this procedure.
Sentinel Node Biopsy Improves Quality of Life in Early-Stage Breast Cancer

Reprinted from the NCI Cancer Bulletin, vol. 3/no. 19, May 9, 2006 (see the current issue 4).

In the May 3, 2006, Journal of the National Cancer Institute (JNCI), investigators reported results from the first multicenter randomized trial to compare postoperative quality of life between patients with early-stage breast cancer who underwent sentinel node biopsy and those who underwent standard axillary lymph node clearance.

Standard axillary lymph node clearance involves removal of all the lymph nodes in the armpit region. The procedure can cause considerable morbidity, and most women with early-stage breast cancer do not have metastases to their lymph nodes. In sentinel lymph node biopsy, a single node that is directly connected to the tumor site by the lymphatic system is examined for metastases. If none are found, no further lymph nodes are removed.

The ALMANAC trial randomly assigned patients to two groups: 1) standard axillary clearance or 2) sentinel node biopsy with delayed axillary clearance (or axillary radiation therapy if metastases were found). Surgeons performing sentinel node biopsies received special training through the trial centers. Researchers evaluated patients in both groups for side effects and for perceived quality of life.

Patients in the standard axillary treatment group were significantly more likely to report moderate or severe lymphedema at one, three, six, and 12 months after surgery than were patients undergoing sentinel node biopsy. Patients in the standard axillary treatment group also had greater sensory loss and nerve damage up to 12 months after surgery. Self-reported quality of life was significantly higher at all time points for patients undergoing sentinel node biopsy than for the standard treatment group.

The authors conclude that sentinel node biopsy is a safe and effective alternative treatment for patients with early-stage breast cancer. However, they caution that data on "…relapse-free and overall survival following sentinel lymph node biopsy are required before this procedure can be accepted as the standard of care."



Glossary Terms

axillary lymph node (AK-sih-LAYR-ee limf ...)
A lymph node in the armpit region that drains lymph from the breast and nearby areas.
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.
lymphedema (LIM-fuh-DEE-muh)
A condition in which extra lymph fluid builds up in tissues and causes swelling. It may occur in an arm or leg if lymph vessels are blocked, damaged, or removed by surgery.
metastasis (meh-TAS-tuh-sis)
The spread of cancer from one part of the body to another. A tumor formed by cells that have spread is called a “metastatic tumor” or a “metastasis.” The metastatic tumor contains cells that are like those in the original (primary) tumor. The plural form of metastasis is metastases (meh-TAS-tuh-SEEZ).
morbidity
A disease or the incidence of disease within a population. Morbidity also refers to adverse effects caused by a treatment.
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.


Table of Links

1http://www.cancer.gov/clinicaltrials/search
2http://www.cancer.gov/cancertopics/types/breast
3http://www.cancer.gov/cancertopics/factsheet/therapy/sentinel-node-biopsy
4http://www.cancer.gov/ncicancerbulletin