Costs and Complications of Radiotherapy Modalities

描述（由申请人提供）：本定量研究将比较用于早期浸润性乳腺癌和导管原位癌（DCIS）的两种放疗（RT）技术的成本和并发症。我们的目标是阐明全乳房放疗与基于近距离治疗的加速部分乳房放疗相比的风险、并发症率、放疗成本和后续并发症，加速部分乳房放疗是一种较新的放疗形式，可能与新的或增加的发病率风险相关；缺乏长期临床试验的有效性证据；到目前为止，由于后续行动有限，这可能有一些好处尚未得到证实。通过使用66岁以上诊断为乳腺癌并接受保乳手术和RT治疗的女性的医疗保险索赔数据，我们将评估这两种RT技术是否存在不同的并发症发生率和不同的成本负担。我们的具体目标是：1)识别和分类全乳放疗和基于近距离治疗的部分乳房加速放疗一年内相关和可能相关的并发症；2)在考虑患者和医疗系统因素的情况下，计算并比较不同放疗方式的放疗并发症的绝对数量和发生率；3)评估和比较RT模式的成本，考虑患者和医疗保健系统因素。这是已知的第一个在人群水平上评估基于近距离治疗的乳房RT与全乳房RT的成本和并发症发生率的研究。到目前为止，只有小的，选定的研究概述了基于近距离治疗的乳房放疗的并发症率。这样小的样本量可能会错过罕见的事件，并可能低估实际的并发症率。同样，费用的评估只基于预期的医疗保险对治疗本身的报销，而不是对与治疗相关的后续问题进行评估，如意外的球囊导管外植或重新植入术、问题性血清肿、脂肪坏死或感染。我们将评估一年内的治疗费用和并发症。我们的新方法将最大限度地减少RT类型的内生性偏差。这项研究将使我们能够在以人群为基础的水平上确定和量化保乳手术后接受RT的妇女的明确健康权衡和对医疗保健系统的成本影响。这对于这种新技术来说尤其重要，因为与标准护理相比，这种新技术的前期成本更高，而且没有已知的额外治疗益处。

DESCRIPTION (provided by applicant): This quantitative study will compare the costs and complications of two radiotherapy (RT) techniques used for early invasive breast cancer and ductal carcinoma in situ (DCIS). Our goals are to elucidate the risks, complication rates, and costs of RT and subsequent complications for whole breast RT compared to brachytherapy-based accelerated partial breast RT, a newer form of RT that may be associated with new or increased risks of morbidity; that lacks long-term clinical trial evidence of effectiveness; and that may have some advantages not borne out due to limited follow-up thus far. By using Medicare claims data for women ages 66+ with a breast cancer diagnosis and treated with breast- conserving surgery and RT, we will evaluate whether there are different rates of complications and differential cost burdens of these two RT techniques. Our specific aims are to: 1) Identify and classify related and possibly-related complications of whole breast RT and brachytherapy-based accelerated partial breast RT within one year of RT; 2) Calculate and compare absolute numbers and rates of RT complications by RT modality, accounting for patient and healthcare system factors; and 3) Assess and compare the costs of the RT modalities, accounting for patient and healthcare system factors. This is the first known study to evaluate costs and complication rates of brachytherapy-based breast RT compared to whole breast RT on a population level. Thus far, only small, selected studies have outlined complication rates of brachytherapy-based breast RT. Such small sample sizes are likely to miss rarer events and could underestimate actual complication rates. Likewise, costs have only been evaluated on the basis of expected Medicare reimbursement for treatment itself, but not for subsequent problems associated with treatment, such as unexpected explantation or reimplantation of a balloon catheter, problematic seromas, fat necrosis, or infection. We will assess costs for treatment and complications within one year of treatment. Our novel methods will minimize endogeneity bias by RT type. This study will allow us to identify and quantify the explicit health trade-offs and cost impact to the healthcare system for women undergoing RT following breast- conserving surgery on a population-based level. This is particularly important for this new technology that has higher up-front costs with no known additional therapeutic benefit compared to the standard of care.