American Society of Clinical Oncology clinical practice guideline: update on adjuvant endocrine therapy for women with hormone receptor-positive breast cancer

Abstract

Purpose: To develop evidence-based guidelines, based on a systematic review, for endocrine therapy for postmenopausal women with hormone receptor-positive breast cancer.

Methods: A literature search identified relevant randomized trials. Databases searched included MEDLINE, PREMEDLINE, the Cochrane Collaboration Library, and those for the Annual Meetings of the American Society of Clinical Oncology (ASCO) and the San Antonio Breast Cancer Symposium (SABCS). The primary outcomes of interest were disease-free survival, overall survival, and time to contralateral breast cancer. Secondary outcomes included adverse events and quality of life. An expert panel reviewed the literature, especially 12 major trials, and developed updated recommendations.

Results: An adjuvant treatment strategy incorporating an aromatase inhibitor (AI) as primary (initial endocrine therapy), sequential (using both tamoxifen and an AI in either order), or extended (AI after 5 years of tamoxifen) therapy reduces the risk of breast cancer recurrence compared with 5 years of tamoxifen alone. Data suggest that including an AI as primary monotherapy or as sequential treatment after 2 to 3 years of tamoxifen yields similar outcomes. Tamoxifen and AIs differ in their adverse effect profiles, and these differences may inform treatment preferences.

Conclusion: The Update Committee recommends that postmenopausal women with hormone receptor-positive breast cancer consider incorporating AI therapy at some point during adjuvant treatment, either as up-front therapy or as sequential treatment after tamoxifen. The optimal timing and duration of endocrine treatment remain unresolved. The Update Committee supports careful consideration of adverse effect profiles and patient preferences in deciding whether and when to incorporate AI therapy.

Fig 1.

Schema of included trials. ATAC, Arimidex, Tamoxifen, Alone or in Combination (trial); mos, months; HR (+), hormone receptor–positive; TAM, tamoxifen; ANA, anastrozole; BIG, Breast International Group; FU, follow-up; monotx, monotherapy; LET, letrozole; yrs, years; ABCSG, Austrian Breast and Colorectal Cancer Study Group; ER (+), estrogen receptor–positive; PR (+), progesterone receptor–positive; GOS, goserelin; ZOL, zoledronic acid; ABCSG, Austrian Breast and Colorectal Cancer Study Group; Chemo, chemotherapy; ITA, Italian Tamoxifen Anastrozole (trial); tx, therapy; TEAM, Tamoxifen Exemestane Adjuvant Multinational (trial); EXE, exemestane; IES, Intergroup Exemestane Study; Unk, unknown; N-SAS, National Surgical Adjuvant Study (Group); ARNO, Arimidex-Nolvadex (trial); NSABP, National Surgical Adjuvant Breast and Bowel Project.

Fig A1.

Quorum diagram. Inclusion and exclusion of publications identified for this systematic review.