(PQ3) Addressing Cancer Treatment Disparities for Persons with HIV

项目概要/摘要 联合抗逆转录病毒疗法 (ART) 的引入导致艾滋病相关病例急剧下降 死亡率。然而，随着艾滋病毒感染者 (PWH) 年龄的增长，非艾滋病定义癌症 (NADC) 的死亡率也会增加 持续增加，现已成为感染者死亡的主要原因。最近的研究表明 与对照组相比，PWH 和癌症患者在开始癌症治疗和生存方面持续存在差异 普通民众。这可能部分是由于医学和放射肿瘤学家对 PWH 癌症治疗的安全性和有效性。或者，化疗加放疗也是可能的 单独治疗 (CRT) 和放射治疗 (RT) 在 PWH 中可能效果较差，或者与更大的风险相关。 毒性。众所周知，积极的癌症结果取决于所有步骤的成功导航 在癌症护理提供过程中，包括：及时开始治疗、治疗完成和治疗 安全性，定义为避免严重不良事件 (SAE)。评估持续的健康状况也很重要 感染艾滋病毒的癌症幸存者的需求，包括长期慢性健康状况的风险（即晚期不良反应） 癌症治疗后的影响）。先前的研究已经评估了某些癌症治疗的起始率 然而，目前还没有发表的研究全面评估癌症之间的差异 与未感染艾滋病毒的人相比，感染者在癌症护理提供过程中其他关键步骤的结果 （HIV-），也没有研究评估可能导致艾滋病毒感染的患者和提供者因素 每一步的差距。我们提出以下具体目标来解决这些关键知识 接受 CRT/RT 治疗的 PWH 中四种最常见 NADC（肛门、头颈、肺或前列腺）的差距 癌症）：目标 1：评估 PWH 和匹配的癌症治疗开始时间的差异 HIV-与癌症，以及感染者延迟治疗的危险因素。目标 2：评估短期差异 PWH 与开始 CRT/RT 的匹配 HIV 患者之间的 SAE 和癌症治疗完成情况。目标 3：评估 PWH 与癌症以及匹配的患者相比的长期死亡风险和癌症复发风险 HIV-患者。目标 4：比较感染者慢性健康状况与癌症的风险，(a) HIV- 和 癌症和 (b) 未患癌症的产后卫生保健。除了评估 PWH 和 HIV 之间结果的差异外， 对于癌症患者，研究目标还将评估关键潜在风险因素的影响，包括： ART 治疗方案、免疫抑制、治疗剂量和完成情况，可能与 CRT/RT 相关 结果。这项观察性队列研究将确定超过 3,000 名被诊断患有癌症的 PWH，1:1 匹配的 HIV- 患有相同癌症的人，以及 4:1 匹配的未患癌症的、接受过医疗机构护理的 PWH 退伍军人管理局或凯撒医疗机构是美国两个最大的单一付款人综合医疗保健系统 美国。研究结果将为癌症护理提供和治疗提供目标数据 干预措施，并为艾滋病毒特异性癌症治疗指南提供信息，以提高感染者的癌症生存率。

PROJECT SUMMARY/ABSTRACT The introduction of combination antiretroviral therapy (ART) has led to a dramatic decline in AIDS-associated mortality. However, as persons with HIV (PWH) age, mortality from non-AIDS-defining cancer (NADC) continues to increase and is now the leading cause of death for PWH. Recent studies have demonstrated persistent disparities in both initiation of cancer therapy and survival among PWH and cancer compared with the general population. This may be due in part to medical and radiation oncologists' concerns regarding the safety and efficacy of cancer treatment for PWH. Alternatively, it is possible that chemotherapy with radiation therapy (CRT) and radiation therapy (RT) alone may be less effective in PWH or associated with greater toxicity. It is well established that positive cancer outcomes are dependent on successful navigation of all steps in the cancer care delivery process, including: timely treatment initiation, treatment completion, and treatment safety, defined by avoidance of serious adverse events (SAEs). It is also critical to evaluate the ongoing health needs of cancer survivors with HIV, including the risk of long-term chronic health conditions (i.e., late adverse effects) after cancer treatment. Prior studies have evaluated cancer treatment initiation rates for certain cancers, however, there have been no published studies that have comprehensively evaluated differences in outcomes at other key steps in the cancer care delivery process for PWH compared with people without HIV (HIV-), nor have there been studies that have evaluated patient- and provider-factors that might contribute to disparities at each step. We propose the following Specific Aims which will address these critical knowledge gaps for the four most common NADCs in PWH treated with CRT/RT (anal, head and neck, lung, or prostate cancer): Aim 1: To evaluate differences in the timing of cancer treatment initiation between PWH and matched HIV- with cancer, and risk factors for delayed treatment in PWH. Aim 2: To evaluate disparities in short-term SAEs and cancer treatment completions between PWH and matched HIV- patients who initiated CRT/RT. Aim 3: To evaluate the long-term risk of mortality and cancer recurrence comparing PWH with cancer and matched HIV- patients. Aim 4: To compare risk of chronic health conditions among PWH with cancer, with (a) HIV- with cancer and (b) PWH without cancer. In addition to evaluating differences in outcomes between PWH and HIV- patients with cancer, study aims will also evaluate the impacts of key potential risk factors, including: ART regimens, immunosuppression, and treatment dosage and completion, which may be associated with CRT/RT outcomes. This observational cohort study will identify >3,000 PWH diagnosed with cancer, 1:1 matched HIV- persons with the same cancers, and 4:1 matched PWH without cancer who have received care from the Veteran's Administration or Kaiser Permanente, the two largest single-payer integrated healthcare systems in the United States. Study findings will provide data to provide targets for cancer care delivery and treatment interventions, and inform HIV-specific cancer treatment guidelines to improve cancer survival among PWH.