Tumori. 1988 Aug 31;74(4):377-86. doi: 10.1177/030089168807400402.
Indications for and modes of delivery of adjuvant chemotherapy in early breast cancer were assessed in a group of 353 patients followed within a cohort of 1110 newly diagnosed cases in 54 Italian general hospitals. Among node-positive patients 79% pre- and 44% post-menopausal women had the treatment. Only a few node-negative women (10% pre- and 5% post-menopausal) were treated. The multidrug combination CMF was by far the most commonly employed (89%) in its two types: cCMF (the classic combination where cyclophosphamide is given orally on days 1-14 and the two other drugs i.v. on days 1 and 8 every 28 days for either 6 or 12 cycles) to 33% women and nCMF (the more recent combination where all three drugs are given i.v. on day 1 every 21 days for 12 cycles) to 63%. The mode of delivery of treatment was consistent with the Italian National Breast Cancer Task Force (F.O.N.Ca.M.) recommendations for the cCMF combination, but the lack of clear guidelines on the use of nCMF led to wide variations in the total number of cycles administered. At present, however, it is hard to establish whether this will have any impact on patients' outcome. Overall the study suggests that adjuvant chemotherapy for breast cancer has entered general practice and can be satisfactorily delivered at the community level. However, better guidelines need to specify more precisely the treatment indications (i.e. subgroups with greater expected benefits), regimen type (is nCMF still experimental or already standard?) and treatment duration, in view of the present uncertainty about what should be the standard for general practice. The paper finally discusses the feasibility of the treatment comparing general hospitals' performance with that achieved in controlled clinical trials of adjuvant chemotherapy.
在意大利54家综合医院的1110例新诊断乳腺癌病例队列中,对353例患者进行了随访,评估早期乳腺癌辅助化疗的适应证和给药方式。在淋巴结阳性患者中,79%的绝经前和44%的绝经后女性接受了治疗。只有少数淋巴结阴性女性(绝经前10%,绝经后5%)接受了治疗。多药联合方案CMF是目前使用最为广泛的(89%),包括两种类型:经典CMF方案(cCMF),即环磷酰胺在第1 - 14天口服,另外两种药物在第1天和第8天静脉注射,每28天重复一次,共6或12个周期,占33%;新CMF方案(nCMF),即三种药物均在第1天静脉注射,每21天重复一次,共12个周期,占63%。cCMF方案的给药方式符合意大利国家乳腺癌特别工作组(F.O.N.Ca.M.)的建议,但由于缺乏nCMF方案的明确指南,导致给药总周期数差异很大。然而,目前很难确定这是否会对患者的治疗结果产生影响。总体而言,该研究表明乳腺癌辅助化疗已进入常规医疗实践,并且在社区层面可以得到满意的实施。然而,鉴于目前对于常规医疗实践的标准尚不明确,需要更好的指南更精确地明确治疗适应证(即预期获益更大的亚组)、方案类型(nCMF方案仍属于试验性还是已成为标准方案?)和治疗持续时间。本文最后比较了综合医院与辅助化疗对照临床试验的实施情况,讨论了该治疗方案的可行性。