Pearce Alison, Haas Marion, Viney Rosalie, Pearson Sallie-Anne, Haywood Philip, Brown Chris, Ward Robyn
Centre for Health Economics Research and Evaluation, University of Technology Sydney, Sydney, New South Wales, Australia.
Medicines Policy Research Unit, University of New South Wales, Sydney, New South Wales, Australia.
PLoS One. 2017 Oct 10;12(10):e0184360. doi: 10.1371/journal.pone.0184360. eCollection 2017.
Chemotherapy 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.
We 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.
Side 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.
This 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.
化疗副作用在临床试验中经常被报告；然而，关于其在常规临床护理中的发生率的证据却很少。本研究的目的是描述澳大利亚各治疗中心在常规护理中患者报告的化疗副作用的频率和严重程度。
我们对接受化疗的乳腺癌、肺癌或结直肠癌患者进行了一项前瞻性队列研究。通过患者自我报告来确定副作用。按癌症类型和分级计算副作用的频率、患病率和发病率，并计算每种副作用的累积发病率曲线。使用卡方统计量比较不同人口亚组之间副作用的频率。
449名符合条件的个体的副作用数据可用，他们的中位随访时间为5.64个月。86%的参与者在研究期间报告了至少一种副作用，27%报告了IV级副作用，最常见的是疲劳或呼吸困难。疲劳是总体上最常见的副作用（85%），其次是腹泻（74%）和便秘（74%）。不同副作用和癌症类型的患病率和发病率相似。年龄是与副作用发生率相关的唯一人口统计学因素，老年人报告副作用的可能性较小。
本研究首次得出了澳大利亚常规临床护理中患者自我报告的化疗副作用发生率的估计值。常规护理中的化疗副作用很常见，在整个化疗过程中持续存在，且可能很严重。这项工作证实了观察性数据在为决策者提供与临床实践相关信息方面的重要性。
