Sauer R, Schauer A, Rauschecker H F, Schumacher M, Gatzemeier W, Schmoor C, Dunst J, Seegenschmiedt M H, Marx D
Department of Radiation Therapy, University of Erlangen, Germany.
Int J Radiat Oncol Biol Phys. 1992;23(5):907-14. doi: 10.1016/0360-3016(92)90894-n.
In 1983, The German Breast Cancer Study Group, sponsored by the Federal Ministry of Research and Technology, started a prospective multicenter trial on the treatment of early breast cancer pT1 pN0 M0. Treatment consisted of initial tumorectomy with microscopically free margins and lower axillary dissection. After conformation of a pT1 pN0-stage, additional treatment was either mastectomy or adjuvant radiotherapy (50 Gy in 25 fractions to the entire breast plus 12 Gy electron boost). In medially located tumors, the parasternal and supraclavicular area was also irradiated with 50 Gy. A randomization between both treatment modalities was initially planned but was not feasible and abandoned. Nearly all patients were treated according to their own choice. From November 1983 through December 1989, 1119 patients were recruited. Eighty-three were excluded from the protocol. Out of the remaining 1036 patients, 733 (71%) underwent breast preservation and 303 (29%) mastectomy. A detailed pathohistological examination of all tumorectomy specimens was performed in a pathologic reference center. Oncogen overexpression was evaluated by immunohistological detection of the transmembrane protein p-185 (corresponding to c-erb-B2) in 425 cases. After a median follow-up of 48 months, the frequency of local recurrences (4.7%), regional recurrences (1%), and distant metastases (5.4%) was the same in the breast preservation group and the mastectomy group. The 3-year disease-free survival was 90% after breast preservation and 88% after mastectomy (p = 0.21). In the breast preserving group, 24 patients with microscopically involved margins had a poorer disease-free survival than the study group (75% vs 90% after 3 years). The width of the margins had no impact on prognosis. Other prognostic factors in an univariate and multivariate analysis were tumor size and tumor grade. Age, menopausal status, hormone receptor status, histological tumor type, and treatment (mastectomy vs breast preservation) were not significant. P-185-expression was dependent on tumor grade and was the strongest prognostic factor in an univariate and multivariate analysis (p less than 0.001). The results emphasize the central role of tumor grade for prognosis and suggest the independent prognostic significance of the c-erb-B2 oncogen (corresponding to p-185) in pN0-patients.
1983年，由联邦研究与技术部资助的德国乳腺癌研究小组启动了一项关于早期乳腺癌pT1 pN0 M0治疗的前瞻性多中心试验。治疗包括初始肿瘤切除术，切缘在显微镜下无肿瘤残留，并进行腋窝下低位淋巴结清扫。在确定为pT1 pN0期后，进一步治疗要么是乳房切除术，要么是辅助放疗（全乳25次分割照射50 Gy，加电子线补量照射12 Gy）。对于位于内侧的肿瘤，胸骨旁和锁骨上区域也接受50 Gy的照射。最初计划在两种治疗方式之间进行随机分组，但不可行，于是放弃了。几乎所有患者都是根据自己的选择接受治疗。从1983年11月到1989年12月，共招募了1119例患者。83例被排除在方案之外。在其余1036例患者中，733例（71%）接受了保乳治疗，303例（29%）接受了乳房切除术。在一个病理参考中心对所有肿瘤切除标本进行了详细的病理组织学检查。对425例患者通过免疫组织化学检测跨膜蛋白p - 185（对应于c - erb - B2）评估癌基因过表达情况。中位随访48个月后，保乳组和乳房切除组的局部复发率（4.7%）、区域复发率（1%）和远处转移率（5.4%）相同。保乳后3年无病生存率为90%，乳房切除后为88%（p = 0.21）。在保乳组中，切缘显微镜下有肿瘤累及的24例患者的无病生存率低于研究组（3年后分别为75%和90%）。切缘宽度对预后无影响。单因素和多因素分析中的其他预后因素是肿瘤大小和肿瘤分级。年龄、绝经状态、激素受体状态、组织学肿瘤类型和治疗方式（乳房切除术与保乳术）均无显著意义。P - 185表达取决于肿瘤分级，在单因素和多因素分析中是最强的预后因素（p小于0.001）。结果强调了肿瘤分级对预后的核心作用，并提示c - erb - B2癌基因（对应于p - 185）在pN0患者中有独立的预后意义。
