Effects of biologic and targeted therapies for rheumatoid arthritis on cancer outcomes

类风湿关节炎的生物疗法和靶向疗法对癌症结果的影响

• 批准号: 10654754
• 负责人: SHARON Hermes GIORDANO
• 金额: $ 21.38万
• 依托单位: UNIVERSITY OF TX MD ANDERSON CAN CTR
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-07-23 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10654754
• 关键词: Acceleration; Address; Adverse event; Antitumor Response; Area; Arthritis; Attitude; Belief; Benefits and Risks; Big Data; Biological; Biological Response Modifier Therapy; Cancer Center; Cancer Patient; Clinical; Clinical Research; Comparative Effectiveness Research; Complex; Computerized Medical Record; Data; Data Analyses; Data Mart; Data Set; Data Sources; Databases; Decision Making; Development; Disease; Disease-Free Survival; Disease-Modifying Second-Line Drugs; Down-Regulation; Electronic Health Record; Face; Future; Goals; Hospitalization; Immune; Immune system; Impairment; Infection; Interview; Knowledge; Link; Malignant Neoplasms; Medicare; Methods; Methotrexate; Modeling; Observational Study; Oncologist; Outcome; Pathogenicity; Pathway interactions; Patient Preferences; Patients; Persons; Physicians; Provider; Quality of life; Recording of previous events; Recurrence; Recurrent Malignant Neoplasm; Research; Research Personnel; Rheumatism; Rheumatoid Arthritis; Risk; Risk Adjustment; Risk Assessment; Risk Estimate; SEER Program; Safety; Statistical Methods; Subgroup; Texas; Therapeutic; Therapy trial; Uncertainty; United States; University of Texas M D Anderson Cancer Center; Woman; arthritis therapy; cancer diagnosis; cancer recurrence; cancer risk; cancer survival; cancer therapy; cancer type; cognitive interview; comparative; design; disorder control; experience; immunomodulatory therapies; immunoregulation; improved; men; neoplasm registry; patient subsets; preference; programs; rheumatologist; risk prediction model; safety outcomes; targeted treatment; therapeutic evaluation; tool; trial design; tumor progression

PROJECT SUMMARY The treatment of rheumatoid arthritis (RA) has changed substantially in the last two decades with the development of new biologic and targeted therapies which modulate the immune system. It is well accepted that these agents do not increase risk of developing new cancers, however, their safety in patients with RA who have concomitant cancer is controversial given their immunomodulatory potential which could increase the risk of cancer progression or recurrence, and result in the development of other adverse events such as infections. Decision making in complex situations, as is the case for patients with RA and cancer who need treatment for their arthritis, can be challenging in the face of uncertainty. The potential effects of biologic and targeted RA therapies on cancer progression and survival in patients with cancer are largely unknown, precluding development of risk models and tools that can aid in these complex decisions. We are proposing this study to fill current gaps in knowledge in several areas. First, we will perform secondary data analyses of the Surveillance, Epidemiology and End Results (SEER), Texas Cancer Registry (TCR) Medicare linked files, Optum Clinformatics Data Mart, and The University of Texas MD Anderson Cancer Center electronic health records. We will examine the association of use of biologic and targeted therapies in patients with RA and concomitant cancer, with survival across various cancer types. Second, using the same datasets, we will evaluate other safety outcomes including serious infections, unplanned hospitalizations and new primary malignancies. Third, in order to understand the informational needs of patients with RA and concomitant cancer, we will conduct cognitive interviews of patients with both diseases to assess their beliefs with respect to the potential harms and benefits of biologic and targeted therapies for RA, and their preferences. Lastly, we will conduct interviews with rheumatologists and oncologists to ascertain their beliefs and decision-making data needs for choosing RA therapies in patients with concomitant cancer. Our ultimate goal is to use the information gained with this study to develop a risk prediction model and decision tool that can assist patients with RA and cancer, and their physicians, in making informed choices about RA treatment. Results of this study will have a great impact as approximately 1.5 million people in the United States have RA, and one in three men and one in two women will develop cancer over their lifetime, facing complex therapeutic decisions about their treatments. Investigators in this proposal have an excellent track record of successful observational studies and our preliminary data demonstrates the feasibility of the proposed study objectives. The knowledge gained from this clinical observational study will lay the groundwork needed to design a future clinical study evaluating a treatment decision-making aid.

项目摘要 在过去的二十年中，类风湿关节炎（RA）的治疗发生了很大变化 开发调节免疫系统的新生物学和靶向疗法。很公认 这些药物不会增加开发新癌症的风险，但是，它们在RA患者中的安全性 鉴于其免疫调节潜力可能会增加风险 癌症的进展或复发，并导致其他不良事件（例如感染）的发展。 在复杂情况下进行决策，就像需要治疗的RA和癌症患者一样 面对不确定性，它们的关节炎可能具有挑战性。生物学和靶向RA的潜在影响 癌症患者的癌症进展和存活的疗法在很大程度上是未知的，排除了 开发可以帮助这些复杂决策的风险模型和工具。我们建议这项研究以填补 当前的知识差距在几个领域。首先，我们将执行监视的辅助数据分析， 流行病学和最终结果（SEER），德克萨斯州癌症注册中心（TCR）Medicare链接文件，optum Clinformatics 数据集市和德克萨斯大学医学博士安德森癌症中心电子健康记录。我们将检查 在RA和伴随癌症患者中使用生物学和靶向疗法的使用，生存 在各种癌症类型中。其次，使用相同的数据集，我们将评估其他安全结果 严重的感染，计划外的住院和新的主要恶性肿瘤。第三，为了了解 RA和伴随癌症患者的信息需求，我们将对患者进行认知访谈 两种疾病都可以评估他们对生物学的潜在危害和益处的信念 RA的疗法及其偏好。最后，我们将对风湿病学家和肿瘤学家进行采访 确定他们的信念和决策数据需求，以选择伴随的患者RA疗法 癌症。我们的最终目标是利用本研究中获得的信息来开发风险预测模型和 可以帮助RA和癌症患者及其医生做出明智的选择的决策工具 RA处理。这项研究的结果将产生很大的影响，因为美国大约有150万人 各州有RA，三分之一的男人和二分之一的女人将在一生中发展癌症，面对 关于其治疗的复杂治疗决定。该提案中的调查人员有一个很好的轨道 成功的观察性研究记录和我们的初步数据证明了所提出的可行性 研究目标。从这项临床观察性研究中获得的知识将奠定所需的基础 设计一项评估治疗决策辅助的未来临床研究。