Jakesz R, Samonigg H, Gnant M, Kubista E, Steindorfer P, Hausmaninger H, Sevelda P, Tschurtschenthaler B, Fridrik M, Stierer M, Kolb R, Steger G
Eur J Cancer. 1998 Jan;34(1):66-70. doi: 10.1016/s0959-8049(97)10010-7.
A randomised clinical trial was performed to test whether or not low-dose chemotherapy lasting only 35 days improves the outcome of breast cancer patients with stage I disease and negative oestrogen and progesterone receptors (ER-, PgR-). Between 1984 and 1990, 277 stage I breast cancer patients with tumours negative for both oestrogen and progesterone receptors were randomised to receive either low-dose short-term chemotherapy or no chemotherapy. Chemotherapy consisted of one cycle of doxorubicin, vincristin (AV) and one cycle of cyclophosphamide, methotrexate, fluorouracil (CMF). Patients were stratified for tumour stage, type of surgery, menopausal status and participating centre. Results were analysed both by univariate and multivariate statistical. After a median length of follow-up of 84 months, disease-free (DFS) and overall survival (OS) did not differ significantly between patients having received adjuvant chemotherapy and the control group. Uni- and multivariate analysis did not show any significant prognostic or therapy related factor. A low-dose short-term adjuvant chemotherapy is insufficient to improve the prognosis of patients with breast cancer stage I with ER-, PgR-tumours.
开展了一项随机临床试验，以检验仅持续35天的低剂量化疗是否能改善I期疾病且雌激素和孕激素受体均为阴性（ER-、PgR-）的乳腺癌患者的预后。1984年至1990年间，277例雌激素和孕激素受体均为阴性的I期乳腺癌患者被随机分配接受低剂量短期化疗或不接受化疗。化疗包括一个阿霉素、长春新碱（AV）周期和一个环磷酰胺、甲氨蝶呤、氟尿嘧啶（CMF）周期。患者按肿瘤分期、手术类型、绝经状态和参与中心进行分层。结果采用单变量和多变量统计分析。中位随访84个月后，接受辅助化疗的患者与对照组之间的无病生存期（DFS）和总生存期（OS）无显著差异。单变量和多变量分析均未显示任何显著的预后或治疗相关因素。低剂量短期辅助化疗不足以改善ER-、PgR-肿瘤的I期乳腺癌患者的预后。
