Comparison of anastrozole versus tamoxifen as preoperative therapy in postmenopausal women with hormone receptor-positive breast cancer - The Pre-Operative "Arimidex" Compared to Tamoxilen (PROAC7) trial
Comparison of anastrozole versus tamoxifen as preoperative therapy in postmenopausal women with hormone receptor-positive breast cancer - The Pre-Operative "Arimidex" Compared to Tamoxilen (PROAC7) trial
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DOI：
10.1002/cncr.21872
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发表时间：
2006-05-15
期刊：
影响因子：
6.2
通讯作者：
de Oliveira, CT
中科院分区：
文献类型：
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作者：
Cataliotti, L;Buzdar, AU;de Oliveira, CT
背景。术前“瑞宁得”与他莫昔芬比较 (PROACT) 研究是一项随机、多中心研究，比较阿那曲唑与他莫昔芬作为绝经后女性患有大型、可手术（T2/3、N0-2、M0）或潜在可手术（T4b、N0-2、M0）乳腺癌的术前治疗。还研究了术前内分泌治疗对计划进行乳房切除术或基线时患有无法手术肿瘤的患者的影响。方法。激素受体阳性乳腺癌患者在初次手术前接受阿那曲唑 (n = 228) 或他莫昔芬 (n = 223) 联合或不联合化疗 12 周。 结果。阿那曲唑和他莫昔芬的客观缓解率分别为 39.5% 和 35.4% 的患者（超声测量）、50.0% 和 46.2% 的患者（卡尺测量）。在仅接受激素治疗的患者 (it = 314) 中，接受阿那曲唑治疗的患者 43.0% 接受他莫昔芬治疗的患者 30.8% 在 3 个月后基线可行手术得到改善 (P = 0.04)。在意向治疗人群中，与他莫昔芬组相比，阿那曲唑组从基线到 3 个月时实际手术的可行手术改善在数值上更高，但这种差异并未达到显着性。阿那曲唑组和他莫昔芬组分别有 20.2% 和 18.1% 的患者报告了药物相关不良事件。结论。阿那曲唑是一种有效且耐受性良好的术前治疗，可产生临床有益的肿瘤降期和肿瘤体积缩小。这些效果使得能够对计划进行乳房切除术的患者以及先前无法手术的肿瘤患者进行乳房切除术进行更小的手术干预。在这种情况下，阿那曲唑似乎至少与他莫昔芬一样有效，并且在某些临床相关亚组中比他莫昔芬更有效。
BACKGROUND. The Pre-Operative "Arimidex" Compared to Tamoxifen (PROACT) study was a randomized, multicenter study comparing anastrozole with tamoxifen as a preoperative treatment of postmenopausal women with large, operable (T2/3, N0-2, M0), or potentially operable (T4b, N0-2, M0) breast cancer. The effect of preoperative endocrine therapy in patients scheduled for mastectomy or with inoperable tumors at baseline was also investigated.METHODS. Patients with hormone receptor-positive breast cancer received anastrozole (n = 228) or tamoxifen (n = 223) with or without chemotherapy for 12 weeks before primary surgery.RESULTS. Objective responses for anastrozole and tamoxifen occurred in 39.5% and 35.4% of patients, respectively (ultrasound measurements), and 50.0% and 46.2% of patients, respectively (caliper measurements). In hormonal therapy-only patients (it = 314), feasible surgery at baseline improved after 3 months in 43.0% of patients receiving anastrozole and 30.8% receiving tamoxifen (P =.04). In the intent-to-treat population, improvement in feasible Surgery at baseline to actual surgery at 3 months was found to be numerically higher in the anastrozole group compared with the tamoxifen group, although this difference did not reach significance. Drug-related adverse events were reported in 20.2% and 18.1% of patients, respectively, in the anastrozole and tamoxifen groups.CONCLUSIONS. Anastrozole is an effective and well-tolerated preoperative therapy, producing clinically beneficial tumor downstaging and reductions in tumor volume. These effects enable more minimal Surgical interventions in patients scheduled for mastectomy, and mastectomy in patients with previously inoperable tumors. Anastrozole appears to be at least as effective as tamoxifen in this setting, and more effective than tamoxifen in certain clinically relevant subgroups.