Massimo Di Maio, Maria Carmela Piccirillo, Gennaro Daniele, Francesco Nuzzo, Andrea de Matteis, Jane Bryce, Alessandro Morabito, Gaetano Rocco, and Francesco Perrone, Istituto Nazionale Tumori-Fondazione "G. Pascale" Istituto di Ricovero e Cura a Carattere Scientifico; Ciro Gallo, Fortunato Ciardiello, and Simona Signoriello, Second University; Sabino De Placido, Federico II University, Napoli; Cesare Gridelli, S.G. Moscati Hospital, Avellino; Vittorio Gebbia, Istituto La Maddalena, Palermo; Anna Ceribelli, Regina Elena National Cancer Institute, Roma; Adolfo G. Favaretto, Istituto Oncologico Veneto, Padova, Italy; Natasha B. Leighl and Ronald Feld, Princess Margaret Hospital/University Health Network, Toronto; and Charles Butts, Cross Cancer Institute, Edmonton, Alberta, Canada.
J Clin Oncol. 2015 Mar 10;33(8):910-5. doi: 10.1200/JCO.2014.57.9334. Epub 2015 Jan 26.
Information about symptomatic toxicities of anticancer treatments is not based on direct report by patients, but rather on reports by clinicians in trials. Given the potential for under-reporting, our aim was to compare reporting by patients and physicians of six toxicities (anorexia, nausea, vomiting, constipation, diarrhea, and hair loss) within three randomized trials.
In one trial, elderly patients with breast cancer received adjuvant chemotherapy; in two trials, patients with advanced non-small-cell lung cancer received first-line treatment. Toxicity was prospectively collected by investigators (graded by National Cancer Institute Common Toxicity Criteria [version 2.0] or Common Terminology Criteria for Adverse Events [version 3]). At the end of each cycle, patients completed the European Organisation for Research and Treatment of Cancer quality-of-life questionnaires, including toxicity-related symptom items. Possible answers were "not at all," "a little," "quite a bit," and "very much." Analysis was limited to the first three cycles. For each toxicity, agreement between patients and physicians and under-reporting by physicians (ie, toxicity reported by patients but not reported by physicians) were calculated.
Overall, 1,090 patients (2,482 cycles) were included. Agreement between patients and physicians was low for all toxicities. Toxicity rates reported by physicians were always lower than those reported by patients. For patients who reported toxicity (any severity), under-reporting by physicians ranged from 40.7% to 74.4%. Examining only patients who reported "very much" toxicity, under-reporting by physicians ranged from 13.0% to 50.0%.
Subjective toxicities are at high risk of under-reporting by physicians, even when prospectively collected within randomized trials. This strongly supports the incorporation of patient-reported outcomes into toxicity reporting in clinical trials.
有关抗癌治疗的症状性毒性的信息并非基于患者的直接报告，而是基于临床试验中临床医生的报告。鉴于潜在的报告不足，我们的目的是比较三项随机试验中患者和医生报告的六种毒性（厌食，恶心，呕吐，便秘，腹泻和脱发）。
在一项试验中，老年乳腺癌患者接受辅助化疗；在两项试验中，晚期非小细胞肺癌患者接受一线治疗。毒性由研究者前瞻性收集（按国家癌症研究所通用毒性标准[版本 2.0]或常见不良事件术语标准[版本 3]分级）。在每个周期结束时，患者完成欧洲癌症研究与治疗组织的生活质量问卷，包括与毒性相关的症状项目。可能的答案是“一点也不”，“有点”，“相当多”和“非常多”。分析仅限于前三个周期。对于每种毒性，计算患者与医生之间的一致性以及医生的报告不足（即，患者报告但医生未报告的毒性）。
总体而言，共纳入 1090 例患者（2482 个周期）。所有毒性的患者与医生之间的一致性均较低。医生报告的毒性发生率始终低于患者报告的毒性发生率。对于报告毒性（任何严重程度）的患者，医生的报告不足率为 40.7％至 74.4％。仅检查报告“非常严重”毒性的患者，医生的报告不足率为 13.0％至 50.0％。
即使在随机试验中前瞻性收集，主观毒性也存在报告不足的高风险。这强烈支持将患者报告的结果纳入临床试验中的毒性报告。
