Prophylactic Mastectomy Associated with Reduced Breast Cancer Risk Among Mutation Carriers
Bilateral prophylactic mastectomy is associated with a 90% reduction in the risk of breast cancer in BRCA1 or BRCA2 mutation carriers, a new study has found.
In 1999, a group of researchers reported that bilateral prophylactic mastectomy was associated with a 90% reduction in breast cancer risk among moderate-risk and high-risk women. However, the BRCA1/2 mutation status of the 639 women studied was not known, and later the investigators found that only 18 of the women were BRCA1/2 mutation carriers.
Timothy R. Rebbeck, Ph.D., and Barbara L. Weber, M.D., of the University of Pennsylvania, and colleagues from the Prevention and Observation of Surgical End Points (PROSE) study group looked at information on 105 BRCA1/2 mutation carriers who had bilateral prophylactic mastectomy and 378 mutation carriers who had not had surgery. The study was published in the March 15 issue of the Journal of Clinical Oncology.
After 6.4 years of follow-up, there were two (1.9%) cases of breast cancer in the surgery group and 184 (48.7%) cases in the group that did not have surgery. For women who also had a concurrent or prior oophorectomy, bilateral prophylactic mastectomy was associated with a 95% reduction in risk of breast cancer. For women with intact ovaries, the calculated risk reduction associated with prophylactic mastectomy was 90%.
Monoclonal Antibody Approved for Colorectal Cancer
The U.S. Food and Drug Administration approved the monoclonal antibody Erbitux (cetuximab) for use in combination with irinotecan for patients with metastatic colorectal cancer or for use alone in patients who cannot tolerate irinotecan.
Erbitux made headlines in late 2001 when the original application for approval submitted by drug manufacturer ImClone Systems Inc. was turned down because of insufficient study data. The following June, the companys founder Samuel Waksal, Ph.D., was arrested on multiple charges of securities fraud, conspiracy, and perjury. He later pleaded guilty to six of those charges and is now serving a 7-year prison sentence.
The recent approvaldone under FDAs accelerated approval programwas based on data from 329 patients with refractory colorectal cancer were randomly assigned to receive either Erbitux and irinotecan or Erbitux alone. The combined treatment shrunk tumors by half in 22.9% of the patients, compared with 10.8% of patients treated with Erbitux alone.
The drug targets the epidermal growth factor receptor (EGFR) and is the first monoclonal antibody approved to treat colorectal cancer.
See also News, Vol. 94, No. 24, p. 1824Vol. 94, No. 24, p. 1824, "Erbitux Trial Flawed From the Beginning, Committee Finds," and Vol. 94, No. 5, p. 326, "Biotech Firm Faces Challenges from FDA, Falling Stock Prices."
![]() |
||||
|
Oxford University Press Privacy Policy and Legal Statement |