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

描述（由申请人提供）：口腔粘膜炎（OM）是癌症治疗的一种疼痛和衰弱的后果，但其在标准剂量、多周期化疗期间的风险和结局描述不多。缺乏此类信息会影响临床决策和预防OM的临床试验设计。 本研究的目的是：1）描述化疗期间临床显著OM与后续化疗周期风险之间的关系，2）开发后续周期风险的预测模型并评估模型的预测价值，3）描述OM与临床和患者报告结局之间的相关性。 OM风险和结果将在177例结直肠癌或乳腺癌或非霍奇金淋巴瘤患者中进行研究，共1121个化疗周期。化疗方案反映了全球范围内这些癌症的当前标准治疗（FolFOX、FolFIri、TAC、AC+T和CHOP）。将从一项癌症治疗诱导OM的多中心、前瞻性、纵向研究期间创建的OM风险和结局的现有数据库中获取数据。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和结局是使用先前验证的工具在多个化疗周期期间每天收集的。 将估计每个周期的临床显著OM风险（受影响的患者或周期百分比），然后使用多变量技术建模。将估计后续周期风险，以先前周期风险和严重性为条件，并以类似方式建模。将检查多个化疗周期的结局和资源利用模式。临床结局为体重减轻、需要阿片类药物、计划治疗延迟、剂量减少和发热性中性粒细胞减少症或菌血症发作。患者报告的结局是对日常生活活动的干扰、止痛药的使用以及疲劳和生活质量评分。医疗保健资源是计划外的门诊就诊、急诊室就诊和住院。 本研究获得的信息将有助于识别有临床显著OM风险或严重结局的实体瘤患者，以参与新预防药物的临床试验。 公共卫生相关性：本研究的目的是确定在前一个化疗周期中经历过这种损伤的患者中，化疗诱导的口腔和咽喉组织损伤的风险或严重程度是否更高。这些信息对于使用高成本预防剂和进行副作用监测的临床访视频率的临床决策至关重要;对于设计新疗法的临床试验也至关重要。

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.