NICE Guidelines Back Preventive Therapy

The National Institute for Health and Clinical Excellence (NICE), which advises the United Kingdom's National Health Service on providing medical services, published draft guidelines in January recommending that women with a high risk of familial breast cancer be given the option of taking the estrogen receptor modulators tamoxifen or raloxifene as preventive drug treatments.

The draft guidelines represent the first time in the UK that a nonsurgical treatment approach has been recommended for prevention of breast cancer, and this change was hailed by patient advocate groups.

The guidelines propose that pre- and postmenopausal women at high risk for breast cancer but without a personal history of breast cancer, blood clots, or uterine cancer be offered the estrogen receptor modulators as preventive therapy. Specifically, the recommendations suggest that tamoxifen should be offered for 5 years to premenopausal women at high risk and that both tamoxifen and raloxifene should be offered for 5 years to postmenopausal women at high risk. The guidelines also recommend that women with a moderate level of risk factors should be considered for preventive therapy.

“Up to 3% of women over 30 years of age are at a high or moderate risk of developing familial breast cancer and would therefore be eligible to receive tamoxifen or raloxifene as a preventive treatment for breast cancer if the draft recommendations become a final guidance,” says Mark Baker, MD, FRCP, director of the Centre for Clinical Practice at NICE. “Although neither treatment currently has a UK marketing authorization for chemoprevention in women who do not have a diagnosis of breast cancer, it was felt that the evidence of benefit was sufficiently strong to outweigh the potential harms of side effects.”

The new draft guidelines, which include recommendations on genetic testing and monitoring of familial breast cancer, update the 2006 NICE guidelines. NICE's Guideline Development Group says that the guidelines are revised regularly to ensure that they are up-to-date and based on the best available published evidence.

The group believed the timing was right, noting that “high-quality” long-term follow-up data from 2 randomized trials (Fisher et al. 2005 and Cuzick et al. 2007) suggest the incidence of breast cancer is lower in patients given tamoxifen than in those given a placebo.

Due to risks associated with tamoxifen and raloxifene, including endometrial cancer and thromboembolic events, the draft guidelines recommend that patients receive written information about the absolute risks and benefits of all options for preventive treatment.

“Although the recommendations relating to chemoprevention may be a significant change in clinical practice that would incur some additional costs, there could be potential cost savings associated with the recommendations by reducing the incidence of breast cancer in this population of patients,” adds Baker.

A comment period on the draft guidelines continues until February 25. Publication of the final guidelines is scheduled for June 2013.