CALGB LABORATORY STUDIES IN THE ELDERLY

本研究是CALGB 9343：肿块切除术评价的实验室伴侣。 他莫昔芬和乳腺照射与肿块切除术加他莫昔芬治疗70岁或以上雌激素受体阳性乳腺癌小于2 cm的女性的比较。临床阴性腋窝淋巴结：一项III期研究。 我们假设，原发性肿瘤患者的分子标志物谱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。 使用本研究中每位患者所需的一部分石蜡块，我们将通过执行下面列出的具体目标来测试这一假设。CALGB 9343关注一组70岁或以上的女性，她们正在接受肿块切除术和他莫昔芬（有或没有辅助放疗）治疗浸润性乳腺癌。本试验的基本假设是，老年女性的乳腺癌生物学侵袭性低于年轻女性，因此适合于侵袭性较低的治疗（老年女性具有较高的高分化和中等分化肿瘤的频率，更可能是雌激素和孕激素受体阳性，并且更可能具有较低的肿瘤增殖率。 临床试验的资格是临床阴性腋窝淋巴结，然而，由于大多数或所有这些患者将不接受腋窝淋巴结清扫术，我们将没有一个最重要的分期参数来预测患者的局部和远处复发的风险。 因此，识别替代肿瘤标志物来预测疾病的侵袭性将是重要的。 此外，在美国，老年人乳腺癌占新诊断乳腺癌的50%，然而，关于该年龄组肿瘤生物学特征的信息以及使用这些标志物来预测结果的信息很少。

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.