Sauer R, Schauer A, Rauschecker H F, Schumacher M, Gatzemeier W, Sauerbrei W, Dunst J, Seegenschmiedt M H, Marx D
Universitäts-Strahlenklinik, Erlangen.
Strahlenther Onkol. 1992 Apr;168(4):191-202.
In 1983, the German Breast Cancer Study Group (GBSG), sponsored by the Federal Ministry of Research and Technology, started a prospective multicenter trial on the treatment of early breast cancer (pT1 pN0 M0). This was preceded by a three-year reviewing period because of some novelties of medical, juristical and ethical problems in the FRG. University and, in the majority, community hospitals participated, combining all together 69 different institutions. From 11/1983 to 12/1989, 1112 patients were recruited. From 1036 patients, 733 underwent breast preservation (71%) and 303 mastectomy (29%). The randomization rate was only 6%. In 268 patients (26%) the tumor size was less than or equal to 10 mm, in 765 patients (74%) 11 to 22 mm. In 129 cases, we subdivided the tumor grading II[3] into IIa and IIb. Moreover, the immunohistochemical detection of the transmembrane proteins EGFR, p-185 and p-148 by oncogene overexpression and c-myc oncogene were undertaken in 425 breast cancers. After tumorectomy (or wide excision) and a lower axillary dissection (at least eight lymph nodes) the breast was irradiated up to 50 Gy in 25 fractions. A boost of 12 Gy was given to the tumor bed. The medial located lymph nodes were also irradiated in case of medially or centrally tumors. Quality control was performed by pathological, radiotherapeutic and methodical reference centers. Significant correlations could be demonstrated between receptor status and tumor grading, patient age and grading, and tumor size and grading. The results emphasize the central role of tumor grading among the prognostic factors. Especially the differentiation of the Bloom and Richardson score II into IIa and IIb seems to play an important role. After a median follow-up of 41 months, the frequency of local recurrences (4.4%), regional recurrences (1%) and distant metastases (4.6%) was exactly the same in both treatment groups. In multivariate analysis, only tumor size and tumor grading had a significant impact on disease-free survival. 23 patients with tumor-involved margins had a higher recurrence rate (DFS 62% versus 85% after five years). Without any impact on DFS were the other conventionally evaluated prognostic factors: age, menopausal status, hormone receptor status, histological tumor type, tumor localisation, degree of differentiation, pleomorphism, mitotic index and degree of dissociation. Among the transmembrane proteins EGFR, p-185, p-148 and c-myc, only the impact of p-185 and EGRF positivity on DSF is significant.(ABSTRACT TRUNCATED AT 400 WORDS)
1983年，由联邦研究与技术部赞助的德国乳腺癌研究组（GBSG）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。由于联邦德国在医学、法律和伦理问题上存在一些新情况，在此之前有一个为期三年的审查期。大学医院以及大多数社区医院参与其中，共有69个不同机构。从1983年11月至1989年12月，招募了1112名患者。1036名患者中，733例行保乳手术（71%），303例行乳房切除术（29%）。随机分组率仅为6%。268例患者（26%）肿瘤大小小于或等于10毫米，765例患者（74%）肿瘤大小为11至22毫米。在129例病例中，我们将肿瘤分级II[3]细分为IIa和IIb。此外，对425例乳腺癌进行了跨膜蛋白EGFR、p - 185和p - 148的免疫组化检测，检测癌基因过表达和c - myc癌基因情况。肿瘤切除（或广泛切除）及低位腋窝淋巴结清扫（至少8个淋巴结）后，乳房接受25次分割共50 Gy的照射。对瘤床追加12 Gy的照射。对于位于内侧或中央的肿瘤，内侧淋巴结也进行照射。由病理、放疗和方法学参考中心进行质量控制。受体状态与肿瘤分级、患者年龄与分级、肿瘤大小与分级之间存在显著相关性。结果强调了肿瘤分级在预后因素中的核心作用。尤其是将布鲁姆和理查森评分II细分为IIa和IIb似乎发挥了重要作用。中位随访41个月后，两个治疗组的局部复发率（4.4%）、区域复发率（1%）和远处转移率（4.6%）完全相同。在多变量分析中，只有肿瘤大小和肿瘤分级对无病生存期有显著影响。23例切缘有肿瘤累及的患者复发率较高（五年后无病生存率分别为62%和85%）。其他常规评估的预后因素，如年龄、绝经状态、激素受体状态、组织学肿瘤类型、肿瘤定位、分化程度、多形性、有丝分裂指数和解离程度，对无病生存期没有影响。在跨膜蛋白EGFR、p - 185、p - 148和c - myc中，只有p - 185和EGRF阳性对无病生存期有显著影响。（摘要截选至400字）
