Burstein Harold J, Temin Sarah, Anderson Holly, Buchholz Thomas A, Davidson Nancy E, Gelmon Karen E, Giordano Sharon H, Hudis Clifford A, Rowden Diana, Solky Alexander J, Stearns Vered, Winer Eric P, Griggs Jennifer J
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.
J Clin Oncol. 2014 Jul 20;32(21):2255-69. doi: 10.1200/JCO.2013.54.2258. Epub 2014 May 27.
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.
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.
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.
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.
基于关于最佳治疗持续时间(尤其是辅助性他莫昔芬)的新数据,更新美国临床肿瘤学会(ASCO)关于辅助内分泌治疗的临床实践指南。
ASCO召集了更新委员会,对2009年1月至2013年6月期间的随机临床试验进行了系统评价,并分析了三项历史试验。指南建议基于更新委员会对证据的审查。感兴趣的结果包括生存、疾病复发和不良事件。
本指南更新反映了他莫昔芬治疗持续时间的新数据。有五项关于他莫昔芬治疗超过5年的研究。两项报告随访时间最长的最大规模研究表明,使用他莫昔芬10年对乳腺癌生存具有优势。除了生存方面的适度获益外,与5年相比,他莫昔芬延长治疗10年与乳腺癌复发和对侧乳腺癌风险降低相关。
ASCO之前的指南建议,对于激素受体阳性的绝经前乳腺癌女性,给予5年他莫昔芬治疗;对于绝经后女性,给予至少5年的芳香化酶抑制剂或他莫昔芬辅助治疗,随后序贯使用芳香化酶抑制剂。如果女性处于绝经前或围绝经期且已接受5年辅助性他莫昔芬治疗,则应给予总共10年的他莫昔芬治疗。如果女性处于绝经后且已接受5年辅助性他莫昔芬治疗,则应给予选择继续使用他莫昔芬或换用芳香化酶抑制剂进行总共10年的辅助内分泌治疗。