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USPSTF Outlines Use of Breast Cancer Prevention Drugs - recommends primary prevention drugs should be offered to high-risk women at low risk for side effects
  pdf of Annals article attached
Published: Sep 23, 2013
Breast cancer primary prevention drugs should be offered to higher-risk women at low risk of side effects, the U.S. Preventive Services Task Force again recommended.
Risk-reducing drugs, such as tamoxifen and raloxifene (Evista) got a grade B endorsement for such women, ages 35 and older, with no prior breast cancer, ductal carcinoma in situ (DCIS), or lobular carcinoma in situ (LCIS).
That group would include many with a 5-year breast cancer risk of 3% or greater as estimated by the Gail model, "although the balance depends on age, race/ethnicity, the medication used, and whether or not the patient has a uterus."
But chemoprophylaxis got a grade D recommendation against use in low or average breast cancer risk among asymptomatic women, according to the update released online in the Annals of Internal Medicine.
Those recommendations remained the same as in the last iteration in 2002, task force chair Virginia A. Moyer, MD, MPH, of the American Board of Pediatrics in Chapel Hill, N.C., and colleagues noted.
Uptake by eligible high-risk women has stayed low, though, noted Clifford A. Hudis, MD, chief of breast cancer medicine at Memorial Sloan-Kettering Cancer Center in New York City, and president of the American Society of Clinical Oncology.
"In the clinic, if we focus on the group of people most likely to benefit, where the risk-to-benefit ratio is greatest, maybe the uptake will actually go up because the people taking it will get a definable, measurable, meaningful benefit," he told MedPage Today.
The systematic review upon which the recommendations were based acknowledged that adverse effects appear to be a driving factor in low uptake.
The reiteration of a recommendation to offer chemoprevention to higher-risk women "can only help," Hudis suggested. "The more that people promulgate clear guidance for how these drugs should be used and the more people are aware of the potential to really prevent cancer, it should really be useful."
Other organizations have come to largely similar conclusions on who should be offered a selective estrogen receptor modulator for chemoprophylaxis:
· ASCO suggested tamoxifen as an option for elevated-risk women ages 35 years or older, with raloxifene and exemestane (Aromasin) as options for breast cancer risk reduction in postmenopausal women.
· The Canadian counterpart to the USPSTF has recommended counseling high-risk women on the risks and benefits of tamoxifen for cancer prevention and recommended against tamoxifen for low- or normal-risk women.
· The British National Institute for Health and Care Excellence (NICE) recommended tamoxifen or raloxifene for 5 years for high-risk postmenopausal women with a uterus, except those with a past history or at increased risk for thromboembolic disease or endometrial cancer.
"Only a small fraction of women are at increased risk for breast cancer; moreover, only a subset of those women will derive benefit from risk-reducing medications," the task force emphasized.
It cited a systematic review indicating tamoxifen and raloxifene cut incidence of invasive breast cancer by seven to nine events per 1,000 women over 5 years, with tamoxifen being more effective in that regard than raloxifene.
Both drugs also had "adequate" evidence for a reduction in risk of nonvertebral or vertebral fractures in postmenopausal women.
Raloxifene is only approved for breast cancer prevention in postmenopausal women; tamoxifen has an indication for women 35 and older regardless of menopausal status.
However, there was also "adequate" evidence that both drugs increase venous thromboembolic event risk by four to seven events per 1,000 women over 5 years, with tamoxifen raising that risk more than raloxifene. Tamoxifen also raises endometrial cancer risk by four cases per 1,000 women and may contribute to cataracts.
Both drugs commonly cause hot flushes that can impact quality of life and willingness to use or adhere to their use, the task force pointed out.
The guidelines didn't address women with BRCA gene mutations.
Annals of Internal Medicine 24 September 2013
Medications for Risk Reduction of Primary Breast Cancer in Women: U.S. Preventive Services Task Force Recommendation Statement FREE ONLINE FIRST
Virginia A. Moyer, MD, MPH, on behalf of the U.S. Preventive Services Task Force*
Update of the 2002 U.S. Preventive Services Task Force (USPSTF) recommendation on the use of medications for breast cancer risk reduction. Methods: The USPSTF reviewed evidence on the effectiveness, adverse effects, and subgroup variations of medications to reduce the risk for breast cancer-specifically, the selective estrogen receptor modulators tamoxifen and raloxifene. The USPSTF also reviewed a meta-analysis of placebo-controlled trials to understand the relative benefits and harms of tamoxifen and raloxifene.
Population: This recommendation applies to asymptomatic women aged 35 years or older without a prior diagnosis of breast cancer, ductal carcinoma in situ, or lobular carcinoma in situ.
Recommendation: The USPSTF recommends that clinicians engage in shared, informed decision making with women who are at increased risk for breast cancer about medications to reduce their risk. For women who are at increased risk for breast cancer and at low risk for adverse medication effects, clinicians should offer to prescribe risk-reducing medications, such as tamoxifen or raloxifene. (B recommendation) The USPSTF recommends against the routine use of medications, such as tamoxifen or raloxifene, for risk reduction of primary breast cancer in women who are not at increased risk for breast cancer. (D recommendation)
The U.S. Preventive Services Task Force (USPSTF) makes recommendations about the effectiveness of specific preventive care services for patients without related signs or symptoms.
It bases its recommendations on the evidence of both the benefits and harms of the service and an assessment of the balance. The USPSTF does not consider the costs of providing a service in this assessment.
The USPSTF recognizes that clinical decisions involve more considerations than evidence alone. Clinicians should understand the evidence but individualize decision making to the specific patient or situation. Similarly, the USPSTF notes that policy and coverage decisions involve considerations in addition to the evidence of clinical benefits and harms.
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