Under-reporting of subjective symptoms and its prognostic value: a pooled analysis of 12 cancer clinical trials.

BACKGROUND

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.

PATIENTS AND METHODS

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.

RESULTS

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.

CONCLUSIONS

Under-reporting of treatment side-effects is frequent, but it does not affect OS. Patients' reported symptoms should be used for prognostic evaluation.

Informations de copyright

Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.

Déclaration de conflit d'intérêts

Disclosure LA: honoraria from Pfizer, EliLilly. RDL: honoraria from Astellas, Pfizer, Janssen. PDP: Honoraria from Lilly, Gilead, MSD, Roche, Exact Sciences, Novartis; support for attending meetings from Gilead, Lilly, Istituto Gentili, MSD. CG: honoraria as speaker bureau or advisory board member or consultant from MSD, BMS, AstraZeneca, Roche, Eli Lilly, Pfizer, Amgen, Novartis, GSK, Takeda, Boehringer, Menarini, Karyopharm, Sanofi. AM: honoraria for speaker’s bureau or advisory board from Roche, AstraZeneca, BMS, Pfizer, MSD, Boehringer, Takeda, Novartis, Lilly, Sanofi. SP: honoraria from AstraZeneca, MSD, Roche, GSK, Pharmamar; research funding from Roche, AstraZeneca, MSD, Pfizer, GSK. FN: honoraria from Seagen. AA: honoraria from Amgen, MSD, Eisai, Bristol-Meyers; consulting or advisory role: Amgen, AstraZeneca, MSD, Eisai, Bayer. AG: honoraria from Janssen. MDM: honoraria from AstraZeneca, Boehringer Ingelheim, Janssen, Merck Sharp & Dohme (MSD), Novartis, Pfizer, Roche, Takeda, Amgen, Merck for consultancy or participation to advisory boards; direct research funding from Tesaro/GlaxoSmithKline; institutional funding for work in clinical trials/contracted research from Beigene, Exelixis, MSD, Pfizer and Roche. FP: institutional support or grants for clinical trials from Roche, Bayer, AstraZeneca, Pfizer, Incyte, Tesaro/GSK, Merck; honoraria for participation on advisory boards from Bayer, Pierre Fabre, AstraZeneca, Incyte, Ipsen, Clovis, Astellas, Sanofi, Roche, Pfizer. MCP: institutional funding for clinical research from Roche, AstraZeneca, Bayer; honoraria for educational activities from Astellas, Pfizer, Ipsen, AstraZeneca; support for attending meetings from Menarini. All other authors have declared no conflicts of interest.