Incidence and severity of self-reported chemotherapy side effects in routine care: A prospective cohort study

Alison Pearce,Robyn Ward,Sallie-Anne Pearson,Chris Brown,Philip Haywood,Marion Haas,Rosalie Viney,Apar Kishor Ganti

doi:10.1371/journal.pone.0184360

Abstract

AimChemotherapy side effects are often reported in clinical trials; however, there is little evidence about their incidence in routine clinical care. The objective of this study was to describe the frequency and severity of patient-reported chemotherapy side effects in routine care across treatment centres in Australia.MethodsWe conducted a prospective cohort study of individuals with breast, lung or colorectal cancer undergoing chemotherapy. Side effects were identified by patient self-report. The frequency, prevalence and incidence rates of side effects were calculated by cancer type and grade, and cumulative incidence curves for each side effect computed. Frequencies of side effects were compared between demographic subgroups using chi-squared statistics.ResultsSide effect data were available for 449 eligible individuals, who had a median follow-up of 5.64 months. 86% of participants reported at least one side effect during the study period and 27% reported a grade IV side effect, most commonly fatigue or dyspnoea. Fatigue was the most common side effect overall (85%), followed by diarrhoea (74%) and constipation (74%). Prevalence and incidence rates were similar across side effects and cancer types. Age was the only demographic factor associated with the incidence of side effects, with older people less likely to report side effects.ConclusionThis research has produced the first Australian estimates of self-reported incidence of chemotherapy side effects in routine clinical care. Chemotherapy side effects in routine care are common, continue throughout chemotherapy and can be serious. This work confirms the importance of observational data in providing clinical practice-relevant information to decision-makers.

Highlights

Chemotherapy is an important component of treatment for many cancers, and new anti-cancer drugs represent one of the largest areas of pharmaceutical development [1, 2]
Our understanding about side effects and their frequency comes primarily from clinical trials [12]. This may not reflect the reality of chemotherapy side effects in routine clinical practice
Patients who are at risk of complications are often excluded from clinical trials, and safety monitoring may be more intensive in trials than in routine care [12]

Summary

Introduction

Chemotherapy is an important component of treatment for many cancers, and new anti-cancer drugs represent one of the largest areas of pharmaceutical development [1, 2]. The management of a side effect can include a reduction in the dose intensity of chemotherapy [7] and there is evidence that patients who receive low dose chemotherapy have reduced survival rates [8,9,10,11]. Our understanding about side effects and their frequency comes primarily from clinical trials [12]. This may not reflect the reality of chemotherapy side effects in routine clinical practice. Side effects in clinical trials are typically clinician reported and there is evidence that clinicians often under report the number and severity of toxicities experienced by patients [15, 16]

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Conclusion