Oral mucositis risk & multicycle chemotherapy: Do multiple cycles multiply risk?

描述（由申请人提供）：口腔黏膜炎（OM）是癌症治疗的一种痛苦和虚弱的后果，但在标准剂量、多周期化疗期间，其风险和结果描述很少。这些信息的缺乏损害了临床决策和临床试验的设计，以预防OM。本研究的目的是：1)描述化疗期间临床显著性骨肉瘤与其后续化疗周期风险之间的关系；2)建立后续周期风险的预测模型并评估该模型的预测价值；3)描述骨肉瘤与临床和患者报告结果之间的关系。将对177例结直肠癌、乳腺癌或非霍奇金淋巴瘤患者在1121个化疗周期中的OM风险和结果进行研究。化疗方案反映了目前世界范围内对这些癌症的护理标准（FolFOX, FolFIri， TAC， AC+T和CHOP）。数据将从现有的多中心、前瞻性、纵向研究癌症治疗诱导的OM的风险和结果数据库中获得。在最初的研究中没有提出这些目标。然而，这些数据非常适合回答这个问题，因为患者报告的OM和结果是在多个化疗周期中使用先前验证的工具每天收集的。每个周期估计临床显著性OM的风险（受影响的患者或周期的百分比），然后使用多变量技术建模。随后的周期风险将根据前一个周期的风险和严重程度进行估计，并以类似的方式建模。结果模式和资源利用将在多个化疗周期中进行检查。临床结果是体重减轻，需要阿片类药物，计划治疗延迟，剂量减少，发热性中性粒细胞减少或菌血症发作。患者报告的结果是日常生活活动的干扰，止痛药的使用，疲劳和生活质量评分。医疗资源包括计划外的门诊、急诊室和住院。这项研究的结果将有助于识别有临床显著性OM风险的实体瘤患者或其参与新预防药物临床试验的严重后果。

DESCRIPTION (provided by applicant): Oral mucositis (OM) is a painful and debilitating consequence of cancer therapy, but its risk and outcomes during standard dose, multi-cycle chemotherapy are poorly described. The lack of such information compromises clinical decision making and design of clinical trials addressing prevention of OM. The objectives of this study are to 1) characterize the relationship between clinically significant OM during chemotherapy and its risk during subsequent chemotherapy cycles, 2) develop a predictive model of subsequent cycle risk and to assess the model's predictive value, and 3) to describe associations between OM and clinical and patient-reported outcomes. OM risk and outcomes will be studied in 177 patients with colorectal or breast cancers or non-Hodgkins lymphoma during 1121 cycles of chemotherapy. The chemotherapy regimens reflect the current standard of care for these cancers, worldwide (FolFOX, FolFIri, TAC, AC+T, and CHOP). Data will be obtained from an existing database of OM risk and outcomes created during a multi-center, prospective, longitudinal study of cancer treatment-induced OM. These objectives were not posed during the original study. However, the data are ideally suited to answering this question because patient reported OM and outcomes were collected daily during multiple cycles of chemotherapy using previously validated tools. Risk of clinically significant OM (percentage of patients or cycles affected) will be estimated, per cycle, then modeled using multivariate techniques. Subsequent cycle risk will be estimated, conditioned on previous cycle risk and severity, and modeled in similar fashion. Patterns of outcomes and resource utilization will be examined over multiple chemotherapy cycles. The clinical outcomes are weight loss, requirement for opioids, delays in planned therapy, dose reductions, and episodes of febrile neutropenia or bacteremia. The patient- reported outcomes are interference with activities of daily living, pain medication usage, and fatigue and quality of life scores. The healthcare resources are unplanned outpatient office visits, emergency room visits, and hospitalizations. Information resulting from this study will be instrumental in identifying solid tumor patients at risk of clinically significant OM or its serious outcomes for participation in clinical trials of new preventive agents. PUBLIC HEALTH RELEVANCE: The goal of this study is to determine whether the risk or severity of chemotherapy-induced injury to the mouth and throat tissues is higher among patients who have experienced this injury during a previous cycle of chemotherapy. This information is critical to clinical decisions about use of high cost preventive agents and frequency of clinic visits for side effect monitoring; it is also critical to design of clinical trials of new therapeutics.