Harold J Burstein1, Sarah Temin2, Holly Anderson2, Thomas A Buchholz2, Nancy E Davidson2, Karen E Gelmon2, Sharon H Giordano2, Clifford A Hudis2, Diana Rowden2, Alexander J Solky2, Vered Stearns2, Eric P Winer2, Jennifer J Griggs2. 1. Harold J. Burstein, Eric P. Winer, Dana-Farber Cancer Institute, Boston, MA; Sarah Temin, American Society of Clinical Oncology, Alexandria, VA; Holly Anderson, Breast Cancer Coalition of Rochester; Alexander J. Solky, Interlakes Onc and Hem PC, Rochester; Clifford A. Hudis, Memorial Sloan Kettering Cancer Center, New York, NY; Thomas A. Buchholz, Sharon H. Giordano, The University of Texas MD Anderson Cancer Center, Houston; Diana Rowden, Dallas, TX; Nancy E. Davidson, University of Pittsburgh Cancer Institute and UPMC Cancer Center, Pittsburgh, PA; Karen E. Gelmon, British Columbia Cancer Agency, Vancouver, British Columbia, Canada; Vered Stearns, Johns Hopkins School of Medicine, Baltimore, MD; and Jennifer J. Griggs, University of Michigan, Ann Arbor, MI. guidelines@asco.org. 2. Harold J. Burstein, Eric P. Winer, Dana-Farber Cancer Institute, Boston, MA; Sarah Temin, American Society of Clinical Oncology, Alexandria, VA; Holly Anderson, Breast Cancer Coalition of Rochester; Alexander J. Solky, Interlakes Onc and Hem PC, Rochester; Clifford A. Hudis, Memorial Sloan Kettering Cancer Center, New York, NY; Thomas A. Buchholz, Sharon H. Giordano, The University of Texas MD Anderson Cancer Center, Houston; Diana Rowden, Dallas, TX; Nancy E. Davidson, University of Pittsburgh Cancer Institute and UPMC Cancer Center, Pittsburgh, PA; Karen E. Gelmon, British Columbia Cancer Agency, Vancouver, British Columbia, Canada; Vered Stearns, Johns Hopkins School of Medicine, Baltimore, MD; and Jennifer J. Griggs, University of Michigan, Ann Arbor, MI.
Abstract
PURPOSE: To update the ASCO clinical practice guideline on adjuvant endocrine therapy on the basis of emerging data on the optimal duration of treatment, particularly adjuvant tamoxifen. METHODS: ASCO convened the Update Committee and conducted a systematic review of randomized clinical trials from January 2009 to June 2013 and analyzed three historical trials. Guideline recommendations were based on the Update Committee's review of the evidence. Outcomes of interest included survival, disease recurrence, and adverse events. RESULTS: This guideline update reflects emerging data on duration of tamoxifen treatment. There have been five studies of tamoxifen treatment beyond 5 years of therapy. The two largest studies with longest reported follow-up show a breast cancer survival advantage with 10-year durations of tamoxifen use. In addition to modest gains in survival, extended therapy with tamoxifen for 10 years compared with 5 years was associated with lower risks of breast cancer recurrence and contralateral breast cancer. RECOMMENDATIONS: Previous ASCO guidelines recommended treatment of women who have hormone receptor-positive breast cancer and are premenopausal with 5 years of tamoxifen, and those who are postmenopausal a minimum of 5 years of adjuvant therapy with an aromatase inhibitor or tamoxifen followed by an aromatase inhibitor (in sequence). If women are pre- or perimenopausal and have received 5 years of adjuvant tamoxifen, they should be offered 10 years total duration of tamoxifen. If women are postmenopausal and have received 5 years of adjuvant tamoxifen, they should be offered the choice of continuing tamoxifen or switching to an aromatase inhibitor for 10 years total adjuvant endocrine therapy.
PURPOSE: To update the ASCO clinical practice guideline on adjuvant endocrine therapy on the basis of emerging data on the optimal duration of treatment, particularly adjuvant tamoxifen. METHODS: ASCO convened the Update Committee and conducted a systematic review of randomized clinical trials from January 2009 to June 2013 and analyzed three historical trials. Guideline recommendations were based on the Update Committee's review of the evidence. Outcomes of interest included survival, disease recurrence, and adverse events. RESULTS: This guideline update reflects emerging data on duration of tamoxifen treatment. There have been five studies of tamoxifen treatment beyond 5 years of therapy. The two largest studies with longest reported follow-up show a breast cancer survival advantage with 10-year durations of tamoxifen use. In addition to modest gains in survival, extended therapy with tamoxifen for 10 years compared with 5 years was associated with lower risks of breast cancer recurrence and contralateral breast cancer. RECOMMENDATIONS: Previous ASCO guidelines recommended treatment of women who have hormone receptor-positive breast cancer and are premenopausal with 5 years of tamoxifen, and those who are postmenopausal a minimum of 5 years of adjuvant therapy with an aromatase inhibitor or tamoxifen followed by an aromatase inhibitor (in sequence). If women are pre- or perimenopausal and have received 5 years of adjuvant tamoxifen, they should be offered 10 years total duration of tamoxifen. If women are postmenopausal and have received 5 years of adjuvant tamoxifen, they should be offered the choice of continuing tamoxifen or switching to an aromatase inhibitor for 10 years total adjuvant endocrine therapy.
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