Morrison J M, Kelly K A, Howell A, Grieve R J, Monypenny I J, Walker R A, Waterhouse J A
Department of Surgery, Selly Oak Hospital, Birmingham, England.
J Natl Cancer Inst Monogr. 1992(11):85-8.
Between 1976 and 1984, 574 patients with operable breast cancer and histologically negative axillary lymph nodes were randomly assigned after mastectomy to receive either no further treatment or chemotherapy with oral LMF (fluorouracil, 500 mg, methotrexate, 25 mg, and chlorambucil, 10 mg, on day 1; fluorouracil, 500 mg, and chlorambucil, 10 mg, on day 2). There is no overall survival or relapse-free survival benefit at a median follow-up of 10 years and 8 years, respectively. There are significantly more local relapses in the control group (P less than .01), but an excess of distant relapses in the treated group is not statistically significant (P = .24). A positive treatment effect in small tumors (relapse-free survival, odds ratio = 0.55, P = .01) and a negative effect in progesterone receptor-positive tumors (survival, odds ratios = 2.04, P = .04) is probably ascribable to chance. Analysis of various prognostic factors shows that tumor size and histological grade have a clear effect on both relapse-free interval and survival.
1976年至1984年间，574例可手术切除的乳腺癌且腋窝淋巴结组织学检查阴性的患者在乳房切除术后被随机分配，分别接受不进一步治疗或口服LMF（氟尿嘧啶500毫克、甲氨蝶呤25毫克和苯丁酸氮芥10毫克，第1天服用；氟尿嘧啶500毫克和苯丁酸氮芥10毫克，第2天服用）化疗。在分别进行10年和8年的中位随访后，未观察到总生存期或无复发生存期方面的获益。对照组的局部复发明显更多（P<0.01），但治疗组远处复发增多在统计学上无显著意义（P=0.24）。小肿瘤的阳性治疗效果（无复发生存期，优势比=0.55，P=0.01）以及孕激素受体阳性肿瘤的阴性治疗效果（生存期，优势比=2.04，P=0.04）可能是偶然因素所致。对各种预后因素的分析表明，肿瘤大小和组织学分级对无复发间期和生存期均有明显影响。
