Bianco A R, De Placido S, Gallo C, Pagliarulo C, Marinelli A, Petrella G, D'Istria M, Delrio G
Division of Medical Oncology, University of Naples Medical School II, Italy.
Lancet. 1988 Nov 12;2(8620):1095-9.
Treatment with tamoxifen (TM), alone or in combination with cyclophosphamide, methotrexate, and fluorouracil (CMF), was used as an adjuvant to surgery in 433 patients with stage I, II, or III(T3a) breast cancer. Oestrogen receptors (ER) and progesterone (PgR) receptors were assayed in most cases. 308 premenopausal node-negative and postmenopausal node-negative or node-positive patients were randomised to receive TM, 30 mg daily for 2 years, or no further therapy. 125 premenopausal node-positive patients were randomised to receive either CMF for nine courses plus TM or CMF alone. After a median follow-up of 63 months TM significantly reduced the incidence of relapses and deaths compared with no therapy. A significant interaction between treatment effect and ER/PgR status was seen. Disease-free and overall survival were similar after treatment with CMF+ TM or CMF.
433例I期、II期或III期（T3a）乳腺癌患者在手术后使用他莫昔芬（TM）单独治疗或与环磷酰胺、甲氨蝶呤和氟尿嘧啶（CMF）联合治疗作为辅助治疗。大多数病例检测了雌激素受体（ER）和孕激素受体（PgR）。308例绝经前淋巴结阴性和绝经后淋巴结阴性或阳性的患者被随机分配接受TM治疗，每日30 mg，持续2年，或不再接受进一步治疗。125例绝经前淋巴结阳性患者被随机分配接受9个疗程的CMF加TM或单纯CMF治疗。中位随访63个月后，与不治疗相比，TM显著降低了复发和死亡的发生率。观察到治疗效果与ER/PgR状态之间存在显著交互作用。CMF+TM或CMF治疗后的无病生存期和总生存期相似。
