Breast and Endocrine Section, Department of Surgery P, Aarhus Sygehus, Aarhus University Hospital, Tage-Hansens Gade 2, DK-8000, Aarhus C, Denmark.
J Natl Cancer Inst. 2011 Sep 21;103(18):1363-72. doi: 10.1093/jnci/djr299. Epub 2011 Aug 31.
Indications for adjuvant endocrine treatment of breast cancer have gradually increased over the past several years. We aimed to define subgroups of patients who may or may not benefit from adjuvant endocrine therapy.
A population-based cohort of systemically untreated breast cancer patients (N = 3197) were identified within the registry of the Danish Breast Cancer Cooperative Group (DBCG). The patients were node negative and had estrogen receptor-positive and/or progesterone receptor-positive tumors (except medullary tumors) and were further characterized by the following risk factors: aged 35-74 years (grouped into 5-year categories) at surgery, tumor size (≤20 mm), and histopathology (grade 1 ductal carcinoma, grade 1 or 2 invasive lobular carcinoma, other or unknown histopathology). Standardized mortality ratios (SMRs) were calculated based on the mortality rate (observed number of deaths per 100,000 person-years) among patients relative to the mortality rate in the general population of women (expected number of deaths per 100,000 person-years). The association between standardized mortality ratio and risk factors were analyzed in univariate and multivariable Poisson regression models. All findings were validated in a subsequent DBCG cohort of breast cancer patients (N = 2710).
The median follow-up after surgery was 14.8 years. In the study population there were 970 deaths compared with expected death of 737 women, which was an excess mortality of 233 deaths (SMR = 1.32, 95% CI = 1.24 to 1.40). Mortality rates were 2356 per 100,000 person-years in the study population and 1790 per 100,000 person-years in the general population of women. The mortality rate was associated with larger tumor size (11-20 mm tumors vs 1-10 mm tumors, SMR = 1.42, 95% confidence interval [CI] = 1.31 to 1.53 vs. SMR = 1.12, 95% CI = 1.00 to 1.26). The mortality rate was also associated with age (35-59 years, SMR > 1) compared with that in the general population of age-matched women, except for a small subgroup of patients (aged 60-74 years, tumors ≤10 mm, grade 1 ductal carcinoma, and grade 1 or 2 lobular carcinoma: adjusted relative risk = 1.02, 95% CI = 0.89 to 1.16.).
A small subgroup of breast cancer patients who were 60 years or older and had hormone-responsive early-stage tumors up to 10 mm, and received no systemic adjuvant therapy, were not at increased risk of mortality compared with women in this age-group in the general population.
近年来,乳腺癌辅助内分泌治疗的适应证逐渐增加。我们旨在确定可能受益或可能不受辅助内分泌治疗的亚组患者。
在丹麦乳腺癌合作组(DBCG)的登记处中,确定了 3197 例系统治疗前的乳腺癌患者的基于人群的队列。这些患者淋巴结阴性,雌激素受体阳性和/或孕激素受体阳性肿瘤(除了髓样肿瘤),并进一步根据以下风险因素进行特征描述:手术时年龄 35-74 岁(分为 5 岁一组),肿瘤大小(≤20mm)和组织病理学(1 级导管癌,1 级或 2 级浸润性小叶癌,其他或未知组织病理学)。标准化死亡率比(SMR)是根据患者死亡率(每 100000 人年观察到的死亡人数)相对于女性普通人群死亡率(每 100000 人年预期死亡人数)计算得出的。在单变量和多变量泊松回归模型中分析了标准化死亡率比与危险因素之间的关系。所有发现均在随后的 DBCG 乳腺癌患者队列(n=2710)中进行了验证。
手术后的中位随访时间为 14.8 年。在研究人群中,有 970 人死亡,而预期死亡人数为 737 人,这意味着超额死亡人数为 233 人(SMR=1.32,95%置信区间[CI]为 1.24-1.40)。研究人群的死亡率为每 100000 人年 2356 人,而女性普通人群的死亡率为每 100000 人年 1790 人。死亡率与肿瘤较大(11-20mm 肿瘤与 1-10mm 肿瘤相比,SMR=1.42,95%CI=1.31-1.53 vs. SMR=1.12,95%CI=1.00-1.26)相关。死亡率还与年龄(35-59 岁)相关,与年龄匹配的女性普通人群相比,死亡率高于人群(除了一小部分患者(60-74 岁,肿瘤≤10mm,1 级导管癌和 1 级或 2 级小叶癌):调整后的相对风险=1.02,95%CI=0.89-1.16)。
在年龄为 60 岁或以上、接受过无系统辅助治疗、激素反应性早期肿瘤直径达 10mm 及以下的乳腺癌患者亚组中,与普通人群中该年龄组的女性相比,死亡率没有增加的风险。