The Comprehensive Cancer Center at Wake Forest University has been approved to participate in a sentinel node biopsy clinical trial sponsored by the National Cancer Institute''s National Surgical Adjuvant Breast and Bowel Project (NSABP).
Wake Forest is the fourth site in the Southeast and one of 20 in the country currently participating in the trial. The study will compare the effects of removing the sentinel node or nodes to the standard practice of removing a much larger number of underarm lymph nodes, known as axillary dissection.
The sentinel node is the first lymph node to which cancer is likely to spread. Sentinel node biopsy is being evaluated by a growing number of specially trained surgeons as a technique to determine if cancer has spread beyond the breast.
Edward A. Levine, M.D., the lead investigator of the study here said, "Research suggests that the sentinel node can be used to determine whether cancer has spread to other lymph nodes, but we still don''t know what the impact of removing only the sentinel node will have on cancer control and survival. This trial should help fill in many of the gaps in our knowledge about this procedure." Levine is an associate professor in the Section of Surgical Oncology at Wake Forest University School of Medicine, and started the sentinel node mapping program for breast cancer at Wake Forest University Hospital Baptist Medical Center. The program is one of a handful of programs approved in North America for participation in the mapping trial.
The sentinel node may provide valuable information about the status of a woman''s cancer without the complications associated with axillary dissection. Preliminary studies suggest that if an analysis shows no cancer cells have spread to the sentinel node, the patient is unlikely to have tumor cells in the remaining axillary nodes. While several studies have examined the validity of the sentinel node procedure, this study is one of the first two randomized trials that will compare the long-term results of sentinel node dissection to full axillary dissection.
A total of 4,000 women across the country will participate in the trial. Patients will be divided into two groups. One group will undergo the current conventional surgery for breast cancer -- either a lumpectomy or mastectomy -- and a sentinel node biopsy followed by an axillary dissection. The second group will also undergo tumor removal and sentinel node biopsy. But if the sentinel node is negative for cancer, women in this group will receive no axillary dissection. If the sentinel node is positive, the other axillary nodes will be removed.
Following standard guidelines for cancer treatment, patients may receive chemotherapy, radiotherapy and/or hormonal therapy following mastectomy. Patients undergoing lumpectomy will also receive breast radiation treatments.
The primary goals of this study are to determine if 1) control of the spread of breast cancer is equivalent between the two procedures, 2) the overall survival and number of years without recurrence are comparable, and 3) the side effects associated with sentinel node removal (lymphedema or swelling caused by excess fluid buildup, a persistent burning sensation, infection and limitation of shoulder movement) are less severe than those from conventional axillary dissection.
Levine adds that the results of thus study will provide essential information about survival, cancer control, and surgical side effects so that patients and doctors can make informed decisions about treatment.
The eligibility criteria for women who want to participate in this trial include having been diagnosed with invasive carcinoma and an operable tumor, but have not yet had definitive surgery.
Physicians or patients interested in more information on the study can call Diane Garski at 336-716-6240.
Media Contact: Jonnie Rohrer, (336) 716-6972, Jim Steele or Mark Wright, (336) 716-4587.