Neoadjuvant treatment of postmenopausal breast cancer with anastrozole, tamoxifen, or both in combination: The Immediate Preoperative Anastrozole, Tamoxifen, or Combined with Tamoxifen (IMPACT) multicenter double-blind randomized trial
Neoadjuvant treatment of postmenopausal breast cancer with anastrozole, tamoxifen, or both in combination: The Immediate Preoperative Anastrozole, Tamoxifen, or Combined with Tamoxifen (IMPACT) multicenter double-blind randomized trial
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DOI：
10.1200/jco.2005.04.005
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发表时间：
2005-08-01
影响因子：
45.3
通讯作者：
Walsh, G
中科院分区：
文献类型：
--
作者：
Smith, IE;Dowsett, M;Walsh, G
目的：即刻术前阿那曲唑、他莫昔芬或联合他莫昔芬（IMPACT）试验旨在验证新辅助他莫昔芬与阿那曲唑及术前他莫昔芬联合阿那曲唑对绝经后雌激素受体（ER）阳性、侵袭性、非转移性乳腺癌患者的临床和/或生物学效应的比较，以预测Arimidex的预后。他莫昔芬单独或联合（ATAC）辅助治疗试验。绝经后er阳性、侵袭性、非转移性、可手术或局部晚期可能手术的乳腺癌妇女随机分配到新辅助治疗他莫昔芬（20mg /天）、阿那曲唑（1mg /天）或他莫昔芬和阿那曲唑联合治疗3个月。用卡尺和超声评估肿瘤客观反应（OR）。还比较了临床反应与超声反应、实际可行手术与基线可行手术、人表皮生长因子受体2 （HER2）阳性癌症的OR和耐受性。结果在接受他莫昔芬、阿那曲唑或联合用药的意向治疗人群中，OR无显著差异。在基线评估为需要乳房切除术的患者（n = 124）中，44%的患者在阿那曲唑后接受了保乳手术（BCS），而在他莫昔芬后接受保乳手术的患者为31% (P = 0.23)；对于外科医生认为可行BCS的患者，这一差异变得显著（分别为46%和22%；P = 0.03）。her2阳性癌症患者（n = 34）的OR为阿那曲唑为58%，而他莫昔芬为22% （P = 0.18）。所有治疗均耐受良好。结论新辅助阿那曲唑对绝经后er阳性可手术乳腺癌患者的疗效和耐受性与他莫西芬相同，但临床预后可预测长期预后的假设尚不成立。
Purpose The Immediate Preoperative Anastrozole, Tamoxifen, or Combined With Tamoxifen (IMPACT) trial was designed to test the hypothesis that the clinical and/or biologic effects of neoadjuvant tamoxifen compared with anastrozole and with the combination of tamoxifen and anastrozole before surgery in postmenopausal women with estrogen receptor (ER)-positive, invasive, nonmetastatic breast cancer might predict for outcome in the Arimidex, Tamoxifen Alone or in Combination (ATAC) adjuvant therapy trial.Patients and Methods Postmenopausal women with ER-positive, invasive, nonmetastatic, and operable or locally advanced potentially operable breast cancer were randomly assigned to neoadjuvant tamoxifen (20 mg daily), anastrozole (1 mg daily), or a combination of tamoxifen and anastrozole for 3 months. The tumor objective response (OR) was assessed by both caliper and ultrasound. Comparisons were also made of clinical response with ultrasound response, actual and feasible surgery with feasible surgery at baseline, OR in human epidermal growth factor receptor 2 (HER2)-positive cancers, and tolerability.Results There were no significant differences in OR in the intent-to-treat population between patients receiving tamoxifen, anastrozole, or the combination. In patients who were assessed as requiring mastectomy at baseline (n = 124), 44% of patients received breast-conserving surgery (BCS) after anastrozole compared with 31% of patients after tamoxifen (P = .23); this difference became significant for patients who were deemed feasible for BCS by their surgeon (46% v 22%, respectively; P = .03). The OR for patients with HER2-positive cancer (n = 34) was 58% for anastrozole compared with 22% for tamoxifen (P = .18). All treatments were well tolerated.Conclusion Neoadjuvant anastrozole is as effective and well tolerated as tamoxifen in ER-positive operable breast cancer in postmenopausal women, but the hypothesis that clinical outcome might predict for long-term outcome in adjuvant therapy was not fulfilled.