J Clin Oncol. 1985 Aug;3(8):1059-67. doi: 10.1200/JCO.1985.3.8.1059.
A prospective randomized trial to assess the impact of adding oophorectomy to adjuvant chemotherapy has been conducted in premenopausal patients with operable breast cancer and with metastases in four or more axillary lymph nodes. Following at least total mastectomy and axillary clearance, 327 evaluable patients were randomized to adjuvant oophorectomy followed by chemotherapy with cyclophosphamide (C), methotrexate (M), 5-fluorouracil (F), and prednisone (p) or to CMFp alone. At 48 months of median follow-up, no statistically significant differences between regimens in terms of disease-free survival or overall survival were demonstrated, even for patients with steroid hormone receptor-containing tumors. A high incidence of amenorrhea (89%) due to ovarian function suppression was observed for the group receiving CMFp alone. Supplementation of the adjuvant therapy regimen by surgical oophorectomy is rendered superfluous by this effect of cytotoxic treatment. The addition of oophorectomy to combination chemotherapy with CMFp cannot be recommended as adjuvant treatment for high-risk (four or more axillary lymph nodes involved) premenopausal patients with operable breast cancer.
一项前瞻性随机试验在绝经前可手术乳腺癌且腋窝淋巴结转移四个或更多的患者中开展，以评估在辅助化疗中加用卵巢切除术的影响。在至少行全乳切除术和腋窝清扫术后，327例可评估患者被随机分为两组，一组先行辅助性卵巢切除术，随后接受环磷酰胺（C）、甲氨蝶呤（M）、5-氟尿嘧啶（F）和泼尼松（p）化疗，另一组仅接受CMFp化疗。在中位随访48个月时，即使对于含类固醇激素受体肿瘤的患者，两种治疗方案在无病生存率或总生存率方面均未显示出统计学上的显著差异。单独接受CMFp治疗的组中观察到因卵巢功能抑制导致闭经的发生率很高（89%）。细胞毒性治疗的这种效果使得通过手术卵巢切除术补充辅助治疗方案变得多余。不推荐将卵巢切除术加至CMFp联合化疗中作为高危（腋窝淋巴结转移四个或更多）绝经前可手术乳腺癌患者的辅助治疗。
