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St. Louis Post-Dispatch Editorial

Commentary:
Support clinical trials to improve cancer treatment
By Gerard Doherty, M.D.
Sunday, October 15, 2000

BREAST CANCER
If I have seen further it is by standing on the shoulders of Giants.
-- Sir Isaac Newton 1675

Diagnosed with a small breast cancer in 1960, a woman was offered only one treatment, radical mastectomy. This operation involved the removal of the entire breast and lymph nodes from under the arm, as well as the chest wall skin and muscles, creating a wound that required a skin graft to cover the ribs. The same diagnosis today is often addressed by breast conservation therapy, removing only the part of the breast containing the tumor (lumpectomy), separately removing the one or two lymph nodes that drain the involved part of the breast (sentinel lymph node biopsy), and treating the breast tissue with radiation therapy. Why the change?

There are less disfiguring treatment options for women in 2000 than in 1960 because thousands of women have participated in clinical trials to prove that the newer approach is better. The women who participated in these trials are the giants on whose shoulders we now stand. Clinical trials are tests set up by physicians to determine which one of two or more strategies works best. In the most dramatic set of breast cancer trials, more than 4,000 extraordinary women allowed themselves to be randomly assigned to either mastectomy or lumpectomy, when no one knew if either was more effective than the other. Because of these studies in the 1970s and 1980s, women can now confidently choose breast conservation therapy.

Sentinel lymph node biopsy is the most recent example of a dramatic improvement in the way small breast cancers are treated. During this procedure, dye is injected near the site of the tumor, and followed to the lymph node draining that part of the breast. Until recently, the only way to determine whether cancer had spread to the lymph nodes under the arm was to remove about one half of them (typically 10 to 20 nodes) during an operation called axillary dissection. About 80 percent of women had no spread of cancer to the nodes, and thus no benefit from the procedure, but all patients suffered the discomfort, and a few developed complications. Between 5 percent and 25 percent of women developed degrees of permanent arm swelling called lymphedema.

Since 1993, women in St. Louis and from around the country have participated in clinical trials to prove the reliability of sentinel lymph node biopsy.

These women have proved that this more precise procedure is as reliable as axillary dissection for identifying breast cancer spread to the lymph nodes. With sentinel lymph node biopsy, there is little pain and virtually no risk of lymphedema. This is a clear advantage over the previous approach.

There have been other recent improvements in breast care. Image-guided biopsy techniques have largely eliminated the need for surgical biopsy. Mastectomy with breast reconstruction during the same operation is available for women who choose or require mastectomy to treat their cancer. Chemotherapy treatment is now shorter for many with breast cancer. These advances are due to the participation of thousands of women in clinical trials.

Other potential improvements are under investigation. Bone marrow testing in women with small breast cancers may better define prognosis. Radiofrequency destruction of the breast tumor might someday eliminate the need for surgical lumpectomy. Women with breast cancer today who participate in these studies will improve future treatment options for their sisters, friends and daughters.

What can we do to improve breast cancer treatment? First, we should encourage health insurers to pay for care provided during clinical trials. Most insurers pay only for treatment options that are already proven effective by clinical trials. Taxpayer-supported federal agencies, such as the National Cancer Institute, fund most of the clinical trials available to patients today. Second, each woman with breast cancer should be offered the opportunity to participate in clinical trials.

Currently, 5 percent or less of the eligible cancer patients in the United States are offered the chance to participate. We could greatly speed the rate of improvements in treating breast cancer by enrolling more women in clinical trials each year. Finally, each woman should emphasize early detection of breast cancer in her personal health care. Early detection allows a woman to take advantage of the advances made in the management of early breast cancer. October is National Breast Cancer Awareness Month, and we should take this opportunity to remember those heroes on whose shoulders we now stand, and ensure that those who follow us see further than we do.

Gerard Doherty is associate professor of surgery at Washington University School of Medicine, and director of the Breast Surgery Service of the Siteman Cancer Center at Barnes-Jewish Hospital and Washington University.