Rauschecker H F, Sauerbrei W, Gatzemeier W, Sauer R, Schauer A, Schmoor C, Schumacher M
Department of Radiation Therapy, University of Erlangen, Germany.
Eur J Cancer. 1998 Feb;34(3):315-23. doi: 10.1016/s0959-8049(97)10035-1.
In this report, the results of the first controlled clinical trial on breast cancer in Germany, begun in 1983, are presented after a median follow-up of 8 years. Four-year results have been previously published. In pT1 N0 M0 breast cancer, mastectomy as the standard treatment was to be compared with tumorectomy plus radiotherapy to the remaining breast tissue. The study design, originally planned as a comprehensive cohort study including randomised and non-randomised patients, had to be changed into a prospective observation study due to the low randomisation rate. 1036 out of 1119 recruited patients were evaluable. After a median follow-up of 97 months, 237 events (local recurrence, regional recurrence, distant metastases, contralateral breast cancer or death of the patient without previous recurrence) occurred. With the exception of death without recurrence, the events were evenly distributed among the two treatment groups. The 8-year local recurrence rate of the whole patient population is 8.8%. Out of all prognostic factors examined, only tumour size and grade had a significant influence on recurrent disease. Event-free survival decreased in cases with 'uncertain' tumour margins, whereas the width of the margin has no influence on disease recurrence. Based on 151 deaths observed so far, there was no significant difference in overall survival between the two treatment groups. The 8-year results of this study are in accordance with the 4-year results reported previously and with those of other breast-conserving treatment trials. There was no significant difference between the two treatment groups with regard to event-free and overall survival. Incomplete tumorectomy had a negative influence on recurrence.
在本报告中，呈现了德国于1983年开始的首例乳腺癌对照临床试验的结果，中位随访时间为8年。四年期结果此前已发表。在pT1 N0 M0期乳腺癌中，将乳房切除术作为标准治疗方法与肿瘤切除术加对剩余乳腺组织进行放射治疗进行比较。该研究设计原本计划为一项包括随机和非随机患者的综合队列研究，但由于随机化率低，不得不改为前瞻性观察研究。在招募的1119名患者中，1036名患者可进行评估。中位随访97个月后，发生了237起事件（局部复发、区域复发、远处转移、对侧乳腺癌或患者在无先前复发情况下死亡）。除无复发死亡外，这些事件在两个治疗组中分布均匀。整个患者群体的8年局部复发率为8.8%。在所有检查的预后因素中，只有肿瘤大小和分级对复发性疾病有显著影响。“切缘不确定”的病例无病生存率降低，而切缘宽度对疾病复发没有影响。基于目前观察到的151例死亡病例，两个治疗组的总生存率没有显著差异。本研究的8年结果与先前报告的4年结果以及其他保乳治疗试验的结果一致。两个治疗组在无病生存率和总生存率方面没有显著差异。肿瘤切除不完全对复发有负面影响。
