Department of Surgery (Breast Surgery), Kyoto University, Kyoto, Japan.
Cancer Sci. 2011 Apr;102(4):858-65. doi: 10.1111/j.1349-7006.2011.01867.x. Epub 2011 Feb 10.
Aromatase inhibitor shows efficacy for hormone receptor positive postmenopausal breast cancer. We evaluated the activity of 24 weeks of aromatase inhibition with exemestane for primary breast cancer in a neoadjuvant setting. Patients with stage II/IIIA invasive breast cancer with estrogen receptor (ER) and/or progesterone receptor (PgR)-positive status were eligible. Primary endpoints were objective response rate (ORR) and safety. A steroidal aromatase inhibitor exemestane of 25 mg/day was administered for 16 weeks with an 8-week extension. Secondary endpoints were rates of breast-conserving surgery (BCS), and change of Ki67 index and ER/PgR expression in central laboratory analyses. Between March 2006 and December 2007, 116 patients were enrolled. Among those, 102 patients completed 24 weeks of administration. The ORR was 47% (55/116) at Week 16 and 51% (59/116) at Week 24, respectively. No serious toxicity was seen. ORR was associated with ER Allred scores but not with PgR scores. The significant reduction in Ki67 index was confirmed. No progression was experienced in tumors with less than 15% Ki67 index. Pathological response was observed in 28 (30%) of 94 evaluated cases. No statistical correlation between pre-treatment Ki67 index and pathological response was detected; however, a trend of correlation was found between the post-treatment preoperative endocrine prognostic index (PEPI), a prognostic score and the pathological response. At diagnosis, 59 patients (51%) would have required mastectomy but 40 patients were converted to BCS, showing an increase in the rate of BCS (77%). The 24-week aromatase inhibition provided preferable clinical benefits with significant reduction in Ki67 index. More precise mechanisms of the response need to be investigated.
芳香酶抑制剂对激素受体阳性绝经后乳腺癌有效。我们评估了在新辅助环境中使用来曲唑进行 24 周的芳香酶抑制治疗原发性乳腺癌的活性。符合条件的患者为 II 期/III 期浸润性乳腺癌，雌激素受体 (ER) 和/或孕激素受体 (PgR) 阳性。主要终点是客观缓解率 (ORR) 和安全性。每天 25 毫克的甾体芳香酶抑制剂来曲唑治疗 16 周，然后延长 8 周。次要终点为保乳手术 (BCS) 率以及中心实验室分析中 Ki67 指数和 ER/PgR 表达的变化。2006 年 3 月至 2007 年 12 月，共纳入 116 例患者。其中，102 例患者完成了 24 周的治疗。第 16 周的 ORR 为 47%（55/116），第 24 周的 ORR 为 51%（59/116）。未观察到严重毒性。ORR 与 ER Allred 评分相关，但与 PgR 评分无关。Ki67 指数的显著降低得到了证实。Ki67 指数小于 15%的肿瘤无进展。在 94 例可评估病例中，有 28 例（30%）观察到病理反应。未检测到治疗前 Ki67 指数与病理反应之间的统计学相关性；然而，在治疗前术前内分泌预后指数 (PEPI)、预后评分和病理反应之间发现了相关性的趋势。在诊断时，59 例患者（51%）需要行乳房切除术，但 40 例患者转为 BCS，BCS 率增加（77%）。24 周的芳香酶抑制治疗提供了更好的临床获益，Ki67 指数显著降低。需要进一步研究更精确的反应机制。
