Hubay C A, Pearson O H, Marshall J S, Rhodes R S, Debanne S M, Mansour E G, Hermann R E, Jones J C, Flynn W J, Eckert C, McGuire W L
Surgery. 1980 May;87(5):494-501.
A prospective, randomized clinical trial of three treatment regimens: (1) Cytoxan, methotrexate, and 5-fluorouracil (CMF), (2) CMF plus the antiestrogen drug, tamoxifen (CMFT), and (3) CMFT plus bacillus Calmette-Guerin (BCG) vaccinations in women with stage 22 breast cancer is reported. All patients underwent mastectomy and estrogen receptor (ER) analysis was performed. The results of this study show that patients with ER- tumors have recurrences more rapidly and have a higher mortality rate than patients with ER+ tumors (P less than 0.0001). In ER+ patients CMFT treatment is more effective in delaying recurrence than CMF alone at 33 months (P = 0.0176). This effect appears to be occurring in both premenopausal and postmenopausal women. In ER- patients the recurrence rate is high, and there is no significant difference among the three treatment groups. In premenopausal patients treated with CMF alone, however, ER- patients recur more rapidly than ER+ patients (P = 0.0313) and suggests that the effect of CMF may be related to the suppression of ovarian function. These findings have demonstrated a significant role for the use of antiestrogen therapy in patients with state II, ER+ breast cancer.
报道了一项针对22期乳腺癌女性患者的三种治疗方案的前瞻性随机临床试验：（1）环磷酰胺、甲氨蝶呤和5-氟尿嘧啶（CMF）；（2）CMF加抗雌激素药物他莫昔芬（CMFT）；（3）CMFT加卡介苗（BCG）疫苗接种。所有患者均接受了乳房切除术，并进行了雌激素受体（ER）分析。该研究结果表明，ER阴性肿瘤患者比ER阳性肿瘤患者复发更快，死亡率更高（P小于0.0001）。在ER阳性患者中，CMFT治疗在33个月时比单独使用CMF更有效地延迟复发（P = 0.0176）。这种效果在绝经前和绝经后女性中均有出现。在ER阴性患者中，复发率很高，三个治疗组之间没有显著差异。然而，在单独接受CMF治疗的绝经前患者中，ER阴性患者比ER阳性患者复发更快（P = 0.0313），这表明CMF的作用可能与抑制卵巢功能有关。这些发现证明了抗雌激素疗法在II期、ER阳性乳腺癌患者中的重要作用。
