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Under-reporting of subjective symptoms and its prognostic value: a pooled analysis of 12 cancer clinical trials
ESMO Open ( IF 7.3 ) Pub Date : 2024-03-06 , DOI: 10.1016/j.esmoop.2024.102941
L. Arenare , R. Di Liello , P. De Placido , C. Gridelli , A. Morabito , S. Pignata , F. Nuzzo , A. Avallone , E. Maiello , P. Gargiulo , C. Schettino , A. Gravina , C. Gallo , P. Chiodini , M. Di Maio , F. Perrone , M.C. Piccirillo

Oncologists tend to under-report subjective symptoms during cancer treatment. This study describes the under-reporting rate of selected symptoms and explores its association with overall survival (OS). A secondary aim is to test the association of patient-reported symptoms with OS. This is a analysis on data pooled from 12 randomized trials, promoted by the National Cancer Institute of Naples (Italy), enrolling patients between 2002 and 2019, with published primary analyses. Occurrence and grade of six side-effects (anorexia, nausea, vomiting, constipation, diarrhea and fatigue) reported by physicians were compared with corresponding symptoms reported by patients in quality-of-life (QoL) questionnaires. Under-reporting was defined as the rate of cases reported grade 0 by the physician while grade ≥1 by the patient. Prognostic value was tested in a multivariable model stratified by trial, including age, sex and performance status as confounders. A landmark threshold was defined for OS analyses. 3792 patients with advanced lung, ovarian, pancreatic, breast or colorectal cancer were pooled; 2603 (68.6%) were eligible having at least one toxicity assessment and one QoL questionnaire, before the first planned disease restaging. Concordance between physicians’ and patients’ reporting was low with Cohen’s k coefficients ranging from 0.03 (fatigue) to 0.33 (vomiting). Under-reporting ranged from 52.7% (nausea) to 80.5% (anorexia), and was not associated with OS. Patient-reported anorexia, vomiting and fatigue (‘a little’ or more) were significantly associated with shorter OS. Under-reporting of treatment side-effects is frequent, but it does not affect OS. Patients’ reported symptoms should be used for prognostic evaluation.

中文翻译:

主观症状的漏报及其预后价值:12项癌症临床试验的汇总分析

肿瘤学家在癌症治疗期间往往会低估主观症状。本研究描述了选定症状的漏报率,并探讨了其与总生存期 (OS) 的关联。第二个目的是测试患者报告的症状与 OS 的关联。这是对意大利那不勒斯国家癌症研究所发起的 12 项随机试验汇总数据的分析,该试验在 2002 年至 2019 年间招募了患者,并发表了初步分析。将医生报告的六种副作用(厌食、恶心、呕吐、便秘、腹泻和疲劳)的发生和程度与患者在生活质量(QoL)问卷中报告的相应症状进行比较。漏报定义为医生报告 0 级而患者报告 ≥ 1 级的病例比例。在通过试验分层的多变量模型中测试预后价值,包括年龄、性别和表现状态作为混杂因素。为 OS 分析定义了一个里程碑阈值。汇集了 3792 名晚期肺癌、卵巢癌、胰腺癌、乳腺癌或结直肠癌患者;在第一次计划的疾病重新分期之前,2603 名患者 (68.6%) 符合至少进行一次毒性评估和一份生活质量调查问卷的资格。医生和患者报告之间的一致性较低,Cohen's k 系数范围为 0.03(疲劳)到 0.33(呕吐)。漏报率从 52.7%(恶心)到 80.5%(厌食)不等,并且与 OS 无关。患者报告的厌食、呕吐和疲劳(“一点”或更多)与较短的 OS 显着相关。治疗副作用的漏报现象很常见,但这并不影响 OS。患者报告的症状应用于预后评估。
更新日期:2024-03-06
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