Breast Cancer Res Treat. 1995 Apr;34(1):1-13. doi: 10.1007/BF00666486.
In the early 1980s breast preservation was a rarely applied therapeutic modality in the primary treatment of breast cancer in the Federal Republic of Germany. Reports coming from retrospective studies as well as preliminary results from randomized trials made it desirable to introduce breast preservation in the form of a controlled clinical trial.
In stage pT1 N0 M0 breast cancer, mastectomy as the standard treatment was to be compared with radiotherapy of the remaining breast tissue. The study design originally planned as a randomized trial had to be changed into a prospective observation study due to the low randomization rate. Univeriate analysis of prognostic variables was the first step to a valid treatment comparison. Those factors determined as being significant were included together with the treatment effects in a multivariate analysis. A high therapeutic standard was guaranteed by quality control.
1036 out of 1119 recruited patients are evaluable. After a median follow-up of 48 months the following preliminary results can be reported. With the exception of death without recurrence from breast cancer, the 143 events are evenly distributed among the two treatment groups. Locoregional recurrence of the whole patient population was 5%. Out of all prognostic factors examined only tumor size and grading are significant in regard to recurrent disease. Recurrence-free survival decreased in cases with 'uncertain' tumor margins, whereas the width of the margin had no influence on recurrent disease. There was no significant difference in quality of life between the two treatment groups.
The four-year results of this study are in accordance with those of other breast preservation trials: There is no significant difference between the two treatment groups in the occurrence of locoregional failure. Incomplete tumorectomy has a negative influence on recurrence. Quality of life seems more dependent on the acceptance of the therapy by the patient than on the therapeutic modality itself. Breast preservation can also be performed appropriately in smaller institutions if the therapeutic standard is guaranteed by quality control.
20世纪80年代初，在德意志联邦共和国，保乳术在乳腺癌的初始治疗中是一种很少应用的治疗方式。回顾性研究报告以及随机试验的初步结果使得开展一项对照临床试验形式的保乳术成为必要。
在pT1 N0 M0期乳腺癌中，将乳房切除术作为标准治疗与对剩余乳腺组织进行放疗相比较。由于随机化率低，原本计划为随机试验的研究设计不得不改为前瞻性观察研究。对预后变量进行单因素分析是进行有效治疗比较的第一步。那些被确定为有显著意义的因素与治疗效果一起纳入多因素分析。通过质量控制确保了较高的治疗标准。
1119名招募患者中有1036名可进行评估。在中位随访48个月后，可报告以下初步结果。除了无乳腺癌复发死亡外，143例事件在两个治疗组中分布均匀。整个患者群体的局部区域复发率为5%。在所有检查的预后因素中，只有肿瘤大小和分级与复发性疾病显著相关。切缘“不确定”的病例无复发生存率降低，而切缘宽度对复发性疾病没有影响。两个治疗组在生活质量方面没有显著差异。
本研究的四年结果与其他保乳试验的结果一致：两个治疗组在局部区域失败的发生率方面没有显著差异。肿瘤切除不完全对复发有负面影响。生活质量似乎更多地取决于患者对治疗的接受程度，而不是治疗方式本身。如果通过质量控制保证治疗标准，较小的机构也可以适当地进行保乳术。
