Unità Sperimentazioni Cliniche, Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, Naples.
Oncologia Medica, P.O. Ospedale del Mare-ASL Napoli 1 Centro, Naples.
ESMO Open. 2024 Mar;9(3):102941. doi: 10.1016/j.esmoop.2024.102941. Epub 2024 Mar 6.
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 post hoc 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.
肿瘤学家在癌症治疗过程中往往会低估主观症状。本研究描述了选定症状的低估报告率，并探讨了其与总生存期（OS）的关系。次要目的是检验患者报告的症状与 OS 的相关性。
这是对来自 12 项随机试验的数据的事后分析，这些试验由那不勒斯（意大利）国家癌症研究所发起，招募了 2002 年至 2019 年期间发表过主要分析结果的患者。医生报告的六种副作用（厌食、恶心、呕吐、便秘、腹泻和疲劳）的发生和严重程度与患者在生活质量（QoL）问卷中报告的相应症状进行了比较。低估报告定义为医生报告的 0 级病例率而患者报告的 1 级及以上病例率。在包括年龄、性别和表现状态作为混杂因素的分层试验多变量模型中检验了预后价值。为 OS 分析定义了一个里程碑阈值。
共纳入 3792 例晚期肺癌、卵巢癌、胰腺癌、乳腺癌或结直肠癌患者；2603 例（68.6%）有至少一次毒性评估和一次 QoL 问卷，且在第一次计划疾病重新分期之前。医生和患者报告的一致性较低，Cohen's k 系数范围从 0.03（疲劳）到 0.33（呕吐）。低估报告率从 52.7%（恶心）到 80.5%（厌食）不等，与 OS 无关。患者报告的厌食、呕吐和疲劳（“有点”或更严重）与较短的 OS 显著相关。
治疗副作用的低估报告很常见，但不会影响 OS。应使用患者报告的症状进行预后评估。
