BREAST CANCER PREVENTION IN HODGKINS DISEASE

描述：(申请人描述) 霍奇金氏病预后良好，大多数 治愈了原发肿瘤的患者。然而，治疗的晚期并发症 对这些患者的影响日益受到关注，特别是新的原发癌症 在这一群体中特别重要的是乳腺癌风险的增加 接受披风或胸部移植的女性霍奇金病幸存者 放射治疗(治疗后相对危险度约为20~15年)。他莫昔芬已经被 显示可将女性患乳腺癌的风险降低近50% Gail模型中考虑的基本因素的风险增加，DCIS或 先前的乳腺癌II.它还没有在放射源乳房中得到评估 癌症。HD幸存者如果接受HD治疗，也可能经历提前绝经 包括化疗12，和早期动脉粥样硬化性心脏病13，14和 辐射或综合治疗方式I引起的其他第二种癌症风险。 在这种情况下，人们的担忧可能会影响他莫昔芬的风险/收益考虑 风险人群，其风险在年轻时就显现出来。正因为如此 问题，重要的似乎是证明而不是假设他莫昔芬 I降低了这一人群患乳腺癌的风险。然而，由于有一个 可用于足够规模的研究的妇女人数有限 有足够的力量，证明可行性的问题似乎 危急时刻。在拟议的研究中，我们将讨论可行性方面的问题， 包括招募/接受、遵守、毒性和生活质量， 以及生殖荷尔蒙状况。我们建议招募50名女性霍奇金 接受放射治疗的疾病幸存者(外衣或其他 胸部)，在30岁之前确诊，当前年龄大于30岁，大于 参与一项先导研究，在这项研究中，他们将 他莫昔芬治疗2年，共治疗5年。我们会 估计招聘率，评估遵从性，评估生活质量和 《全面禁止核试验条约》所用措施的毒性，以及产生的问题 对这群人来说。我们的顾问委员会将考虑一年的数据和 协助我们决定是否继续进行更大规模的研究。一个 在以下情况下，对可用的HD幸存者进行决定性的随机试验是可行的 基于8%的估计绝对风险，坚守的比例为90% 未服用他莫昔芬的妇女在5年内的百分比。这是一个很大的风险 高于BCPT队列中的平均风险，允许较小 样本大小。我们还将评估乳房X光检查密度作为潜在的 中间端点可能允许更快地完成随机化 学习。

DESCRIPTION: (Applicant's Description) Hodgkin's Disease carries an excellent prognosis, with the majority of patients cured of their primary tumor. However, late complications of therapy in these patients are of increasing concern, especially new primary cancers of particular importance in this group is the increased risk of breast cancer among female Hodgkin's disease survivors who received mantle or chest radiation (RR approximate 20 by 15 yrs after treatment). Tamoxifen has been shown to reduce the risk of breast cancer by nearly 50percents in women at increased risk on the basis factors considered in the Gail model, DCIS or prior breast cancer II. It has not yet been evaluated in radiogenic breast cancer. HD survivors may also experience early menopause if their HD treatment included chemotherapy 12, and early atherosclerotic heart disease l3,14 and other second cancer risk from radiation or combined modalities I. These concerns may affect the risk/benefit considerations of tamoxifen in this high risk population whose risk becomes manifest at young ages. Because of these issues, it seems important to prove, rather than assume, that tamoxifen ireduces breast cancer risk in this population. However, since there are a limited number of women available for a study of sufficient size to address the question with sufficient power, demonstration of feasibility seems critical. In the proposed study, we will address aspects of feasibility , including recruitment/acceptance, adherence, toxicities and quality of life, and reproductive hormone status. We propose to recruit 50 female Hodgkin's Disease survivors whose treatment included radiation therapy (mantle or other chest), diagnosed before age 30, current age greater than 30 years, greater than 8 years from radiation to participate in a pilot study in which they will receive tamoxifen for 2 years on study, and 5 years in total. We will estimate recruitment rates, evaluate adherence, and assess quality of life and toxicities using measures employed in the BCPT, as well as questions developed for this population. Our advisory board will consider the one year data and assist us in deciding whether or not to proceed to attempt the larger study. A definitive randomized trial would be feasible with available HD survivors if adherence were 90 percents, based upon an estimated absolute risk of 8 percents over a 5 year period in women without tamoxifen. This is a risk much greater than the average risk in the BCPT cohort, permitting the smaller sample size. We will also evaluate mammographic density as a potential intermediate endpoint that might permit more rapid completion of a randomized study.