Semiglazov Vladimir F, Semiglazov Vladislav V, Dashyan Garik A, Ziltsova Elena K, Ivanov Vadim G, Bozhok Alla A, Melnikova Olga A, Paltuev Ruslan M, Kletzel Alexander, Berstein Lev M
N. N. Petrov Research Institute of Oncology, St. Petersburg, Russia.
Cancer. 2007 Jul 15;110(2):244-54. doi: 10.1002/cncr.22789.
Few studies have compared primary neoadjuvant endocrine therapy with neoadjuvant chemotherapy in breast cancer patients. The need for preoperative chemotherapy with doxorubicin or taxanes may be reduced in postmenopausal patients with estrogen receptor (ER)-positive and/or progesterone receptor (PgR)-positive tumors. This randomized, controlled, phase 2 study evaluated the efficacy of neoadjuvant chemotherapy compared with endocrine treatment with aromatase inhibitors in postmenopausal women with ER-positive and/or PgR-positive breast cancer.
Eligible patients were randomly assigned to receive neoadjuvant anastrozole 1 mg/day (n = 61) or exemestane 25 mg/day (n = 60) for 3 months or doxorubicin 60 mg/m(2) with paclitaxel 200 mg/m(2) (four 3-week cycles). Study end points included overall objective response determined by palpation, mammography, and ultrasound, and the number of patients who qualified for breast-conserving surgery and radiotherapy.
Clinical objective response was 64% in the endocrine therapy and chemotherapy treatment groups. Median time to clinical response was 57 and 51 days with aromatase inhibitors and chemotherapy, respectively (P > .05). Rates of pathological complete response (3% vs 6%) and disease progression (9% vs 9%) did not differ significantly in the endocrine therapy or chemotherapy group, respectively (P > .05). Rates of breast-conserving surgery were slightly higher in the endocrine group (33% vs 24%; P = .058). The most frequent toxicities from chemotherapy were alopecia (79%), grade 3/4 neutropenia (33%), and grade 2 neuropathy (30%). Endocrine treatment was well tolerated. No deaths occurred during the preoperative treatment.
Preoperative neoadjuvant endocrine therapy with aromatase inhibitors was well tolerated and resulted in rates similar to chemotherapy in overall objective response and breast-conserving surgery in postmenopausal women with ER-positive and/or PgR-positive tumors.
很少有研究比较乳腺癌患者的原发性新辅助内分泌治疗与新辅助化疗。对于雌激素受体（ER）阳性和/或孕激素受体（PgR）阳性肿瘤的绝经后患者，使用阿霉素或紫杉烷进行术前化疗的必要性可能会降低。这项随机、对照、2期研究评估了新辅助化疗与芳香化酶抑制剂内分泌治疗在ER阳性和/或PgR阳性绝经后乳腺癌女性中的疗效。
符合条件的患者被随机分配接受新辅助阿那曲唑1毫克/天（n = 61）或依西美坦25毫克/天（n = 60），为期3个月，或阿霉素60毫克/平方米加紫杉醇200毫克/平方米（四个3周周期）。研究终点包括通过触诊、乳房X光检查和超声确定的总体客观反应，以及符合保乳手术和放疗条件的患者数量。
内分泌治疗组和化疗治疗组的临床客观反应率均为64%。使用芳香化酶抑制剂和化疗时，临床反应的中位时间分别为57天和51天（P > .05）。内分泌治疗组和化疗组的病理完全缓解率（3%对6%）和疾病进展率（9%对9%）分别无显著差异（P > .05）。内分泌组的保乳手术率略高（33%对24%；P = .058）。化疗最常见的毒性反应是脱发（79%）、3/4级中性粒细胞减少（33%）和2级神经病变（30%）。内分泌治疗耐受性良好。术前治疗期间未发生死亡。
对于ER阳性和/或PgR阳性肿瘤的绝经后女性，术前使用芳香化酶抑制剂进行新辅助内分泌治疗耐受性良好，总体客观反应率和保乳手术率与化疗相似。
