title: American society of clinical oncology clinical practice guideline update on the use of pharmacologic interventions including tamoxifen, raloxifene, and aromatase inhibition for breast cancer risk reduction.
abstract: PURPOSE To update the 2002 American Society of Clinical Oncology guideline on pharmacologic interventions for breast cancer (BC) risk reduction. METHODS A literature search identified relevant randomized trials published since 2002. Primary outcome of interest was BC incidence (invasive and noninvasive). Secondary outcomes included BC mortality, adverse events, and net health benefits. An expert panel reviewed the literature and developed updated consensus guidelines. Results Seventeen articles met inclusion criteria. In premenopausal women, tamoxifen for 5 years reduces the risk of BC for at least 10 years, particularly estrogen receptor (ER) -positive invasive tumors. Women < or = 50 years of age experience fewer serious side effects. Vascular and vasomotor events do not persist post-treatment across all ages. In postmenopausal women, raloxifene and tamoxifen reduce the risk of ER-positive invasive BC with equal efficacy. Raloxifene is associated with a lower risk of thromboembolic disease, benign uterine conditions, and cataracts than tamoxifen in postmenopausal women. No evidence exists establishing whether a reduction in BC risk from either agent translates into reduced BC mortality. Recommendations In women at increased risk for BC, tamoxifen (20 mg/d for 5 years) may be offered to reduce the risk of invasive ER-positive BC, with benefits for at least 10 years. In postmenopausal women, raloxifene (60 mg/d for 5 years) may also be considered. Use of aromatase inhibitors, fenretinide, or other selective estrogen receptor modulators to lower BC risk is not recommended outside of a clinical trial. Discussion of risks and benefits of preventive agents by health providers is critical to patient decision making.
authors.affiliation: Cancer Policy and Clinical Affairs, 2318 Mill Rd, Suite 800, Alexandria, VA 22314, USA.
authors.forename: Kala
authors.initials: K
authors.lastname: Visvanathan
authors.forename: Rowan T
authors.initials: RT
authors.lastname: Chlebowski
authors.forename: Patricia
authors.initials: P
authors.lastname: Hurley
authors.forename: Nananda F
authors.initials: NF
authors.lastname: Col
authors.forename: Mary
authors.initials: M
authors.lastname: Ropka
authors.forename: Deborah
authors.initials: D
authors.lastname: Collyar
authors.forename: Monica
authors.initials: M
authors.lastname: Morrow
authors.forename: Carolyn
authors.initials: C
authors.lastname: Runowicz
authors.forename: Kathleen I
authors.initials: KI
authors.lastname: Pritchard
authors.forename: Karen
authors.initials: K
authors.lastname: Hagerty
authors.forename: Banu
authors.initials: B
authors.lastname: Arun
authors.forename: Judy
authors.initials: J
authors.lastname: Garber
authors.forename: Victor G
authors.initials: VG
authors.lastname: Vogel
authors.forename: James L
authors.initials: JL
authors.lastname: Wade
authors.forename: Powel
authors.initials: P
authors.lastname: Brown
authors.forename: Jack
authors.initials: J
authors.lastname: Cuzick
authors.forename: Barnett S
authors.initials: BS
authors.lastname: Kramer
authors.forename: Scott M
authors.initials: SM
authors.lastname: Lippman
mesh_terms: D018931:Antineoplastic Agents, Hormonal / Q000627:therapeutic use*; D047072:Aromatase Inhibitors / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000517:prevention & control*; D005260:Female; D006801:Humans; D020849:Raloxifene Hydrochloride / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D012307:Risk Factors; D020845:Selective Estrogen Receptor Modulators / Q000627:therapeutic use*; D013629:Tamoxifen / Q000627:therapeutic use*
chemical_list: D018931:Antineoplastic Agents, Hormonal; D047072:Aromatase Inhibitors; D020845:Selective Estrogen Receptor Modulators; D013629:Tamoxifen; D020849:Raloxifene Hydrochloride