Morrison J M, Howell A, Kelly K A, Grieve R J, Monypenny I J, Walker R A, Waterhouse J A
Selly Oak Hospital, Birmingham, UK.
Br J Cancer. 1989 Dec;60(6):919-24. doi: 10.1038/bjc.1989.390.
The aim of this study was to test the effectiveness of a regimen of combination chemotherapy when given as an adjuvant treatment after mastectomy to patients with histologically negative axillary lymph nodes. A total of 574 patients with cancer of the breast and no involvement of axillary lymph nodes were randomised, after simple mastectomy with axillary sampling, to receive either no adjuvant treatment or oral fluorouracil 500 mg, methotrexate 25 mg and chlorambucil 10 mg p.o. on day 1 and fluorouracil 500 mg and chlorambucil 10 mg p.o. on day 2 (LMF) every 21 days for eight cycles. Randomisation was stratified according to menopausal status and tumour size. Treatment was started within 14 days of surgery in 97% of patients. Ninety per cent of patients received eight cycles of chemotherapy with no dose reduction. At a median follow-up of 7 years, there was no evidence that relapse-free or overall survival time were influenced by treatment.
本研究的目的是测试一种联合化疗方案作为辅助治疗给予组织学检查腋窝淋巴结阴性的乳房切除术后患者的有效性。共有574例乳腺癌且腋窝淋巴结未受累的患者，在进行单纯乳房切除术及腋窝取样后，被随机分配接受无辅助治疗，或在第1天口服氟尿嘧啶500mg、甲氨蝶呤25mg和苯丁酸氮芥10mg，在第2天口服氟尿嘧啶500mg和苯丁酸氮芥10mg（LMF方案），每21天为一个周期，共八个周期。随机分组根据绝经状态和肿瘤大小进行分层。97%的患者在手术后14天内开始治疗。90%的患者接受了八个周期的化疗且未减少剂量。在中位随访7年时，没有证据表明无复发生存期或总生存期受治疗影响。
