CALGB LABORATORY STUDIES IN THE ELDERLY

这项研究是CALGB 9343：肿块切除术的评价的实验室配套研究。三苯氧胺联合乳房放疗与肿瘤切除加三苯氧胺治疗70岁及以上雌激素受体阳性乳腺癌的疗效比较和临床阴性腋窝淋巴结：第三阶段研究。我们假设，患者的分子标志物图谱；原发肿瘤将有助于预测疾病的侵袭性、临床结果和对放射治疗的潜在反应。使用本研究中每个患者所需的石蜡块的一部分，我们将通过执行下面列出的特定目标来检验这一假设。CALGB 9343专注于一组70岁或70岁以上的女性，她们正在接受肿块切除术和他莫昔芬治疗浸润性乳腺癌，无论是否有辅助放射。这项试验的基本假设是，与年轻女性相比，老年女性在生物学上患有侵袭性较低的乳腺癌，因此更容易接受侵袭性较低的治疗(老年女性患上分化良好和中等分化的肿瘤的频率更高，雌激素和孕激素受体呈阳性的可能性更大，肿瘤增殖率更低。临床试验的资格是腋窝淋巴结临床阴性，然而，由于这些患者中的大多数或全部不会接受腋窝清扫，我们将没有最重要的分期参数之一来预测患者的局部和远处复发的风险。因此，确定替代肿瘤标志物以预测疾病侵袭性将是重要的。此外，老年乳腺癌占美国新诊断乳腺癌的50%，但关于这一年龄段肿瘤的生物学特征以及使用这些标记物预测预后的信息很少。

This study is a laboratory companion to CALGB 9343: Evaluation of Lumpectomy. Tamoxifen and Irradiation of the Breast Compared with Lumpectomy plus Tamoxifen in Women Seventy Years of Age or Older Who have Estrogen Receptor Positive Carcinoma of the Breast that is less than 2 cm. and Clinically Negative Axillary Nodes: A Phase III Study. We hypothesize that a profile of molecular markers in the patients; primary tumors will be useful in predicting disease aggressiveness, clinical outcome, and potential response to radiation therapy. Using a portion of the paraffin block required for each patient in this study, we will test this hypothesis by performing the specific aims listed below. CALGB 9343 focuses on a cohort of women, 70 years of age or older, who are being treated for invasive breast cancer with lumpectomy and tamoxifen, with or without adjuvant radiation. The underlying hypothesis in this trial is that elderly women have a biologically less aggressive breast cancer than younger women and thus are amenable to less aggressive therapy (older women have greater frequency of well and moderately differentiated tumors, are more likely to be estrogen and progesterone receptor positive, and are more likely to have lower tumor proliferative rates. Eligibility for the clinical trial is clinically negative axillary nodes, however, since most or all of these patients will not receive axillary dissection, we will not have one of the most important staging parameters to predict a patient's risk of local and distant recurrence. Thus the identification of surrogate tumor markers to predict disease aggressiveness will be important. In addition, breast cancer in the elderly comprise 50 percent of newly diagnosed breast cancers in the United States yet, there is a scarcity of information on biologic characteristics of tumors in this age group and the use of these markers to predict outcome.