Mlineritsch Brigitte, Tausch Christoph, Singer Christian, Luschin-Ebengreuth Gero, Jakesz Raimund, Ploner Ferdinand, Stierer Michael, Melbinger Elisabeth, Menzel Christian, Urbania Andrea, Fridrik Michael, Steger Günther, Wohlmuth Peter, Gnant Michael, Greil Richard
IIIrd Medical Department with Hematology, Medical Oncology, Hemostaseology, Rheumatology and Infectious Disease, Laboratory of Immunological and Molecular Cancer Research, Paracelsus Medical University Salzburg, Salzburg, Austria.
Breast Cancer Res Treat. 2008 Nov;112(1):203-13. doi: 10.1007/s10549-007-9843-x. Epub 2007 Dec 22.
A multicenter phase II study was conducted to analyze the clinical activity of the steroidal aromatase inhibitor exemestane in the neoadjuvant treatment of post-menopausal women with strongly ER- and/or PgR- positive operable breast cancer.
From September 2000 to December 2003, 80 women were recruited for treatment with exemestane 25 mg once daily for 4 months. The primary end-point was the clinical response rate according the WHO criteria; the secondary end-points included toxicity and the number of patients who qualified for breast conserving surgery at the end of treatment, comparability of evaluation methods for response, potential alterations of hormone receptor and Her2/neu status during treatment.
On an intention to evaluate analysis, according to the prespecified criteria the overall clinical objective response rate was 34%, the pCR rate was 3% and the rate of breast conserving surgery was 76%. When sonographic and mammographic longitudinal measurements were included in patients with missing palpation data, response rates were 38% and 41%, respectively. The tumor response was independent of the Her2/neu status which remained unchanged during treatment. In contrast, while the ER expression remained unaltered, downregulation of the PgR was observed. The treatment was well tolerated with no grade 3 and 4 toxicities except gastrointestinal (one grade 3 case) and hot flushes (two grade 3 cases).
This study shows that exemestane is effective and safe as a preoperative therapy in post-menopausal patients with strongly hormone receptor-positive breast cancer.
开展了一项多中心II期研究，以分析甾体类芳香化酶抑制剂依西美坦在新辅助治疗绝经后雌激素受体（ER）和/或孕激素受体（PgR）强阳性可手术乳腺癌患者中的临床活性。
2000年9月至2003年12月，招募了80名女性患者，接受依西美坦治疗，剂量为每日25mg，持续4个月。主要终点是根据世界卫生组织（WHO）标准得出的临床缓解率；次要终点包括毒性、治疗结束时符合保乳手术条件的患者数量、缓解评估方法的可比性、治疗期间激素受体和人表皮生长因子受体2/神经（Her2/neu）状态的潜在改变。
在意向性评估分析中，根据预先设定的标准，总体临床客观缓解率为34%，病理完全缓解（pCR）率为3%，保乳手术率为76%。对于触诊数据缺失的患者，纳入超声和乳腺钼靶纵向测量时，缓解率分别为38%和41%。肿瘤缓解与Her2/neu状态无关，其在治疗期间保持不变。相比之下，虽然ER表达未改变，但观察到PgR下调。该治疗耐受性良好，除了胃肠道反应（1例3级病例）和潮热（2例3级病例）外，无3级和4级毒性反应。
本研究表明，依西美坦作为绝经后激素受体强阳性乳腺癌患者的术前治疗有效且安全。
