Advanced hepatocellular carcinoma: Impact of systemic treatments on health-related quality of life and patient-reported outcomes

Giacomo Aimar, Donatella Marino, Clizia Zichi, Teresa Gamba, Andrea Caglio, Francesca De Vita, Elisa Sperti, Massimo Di Maio
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Abstract

In the past years, treatment options for advanced hepatocellular carcinoma (HCC) have thriven. Although globally recognised, the patient-reported outcomes (PROs) are often underused and quality of life (QoL) results are underreported in many phase III trials. We performed a systematic review to describe the prevalence of QoL inclusion and heterogeneity in QoL reporting in published phase III trials of systemic treatment in advanced HCC. Twenty-one publications were identified: 12 (57.1%) in first line setting, eight (38.1%) in second line and only one (4.7%) in second and further lines. In 14 trials (66.6%), Qol was included in the analysis as a secondary or tertiary endpoint but only in nine (47.4%) cases Qol results were published in the main paper. QoL data are lacking in a significant proportion of published phase III trials in advanced HCC. The methodology of QoL analysis is heterogeneous for type of instruments, analysis and presentation of results.

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晚期肝细胞癌:系统治疗对健康相关生活质量和患者报告结果的影响
在过去的几年中,晚期肝细胞癌(HCC)的治疗选择已经蓬勃发展。尽管全球公认,但在许多III期试验中,患者报告的结果(PROs)往往未得到充分利用,生活质量(QoL)结果也未得到充分报告。我们进行了一项系统综述,以描述已发表的晚期HCC全身治疗III期试验中生活质量报告中生活质量纳入的普遍性和异质性。21篇出版物被确定:12篇(57.1%)发表在一线,8篇(38.1%)发表在二线,只有1篇(4.7%)发表在二线及以后的一线。在14项试验(66.6%)中,生活质量作为第二或第三终点纳入分析,但只有9例(47.4%)病例的生活质量结果发表在主论文中。在已发表的晚期HCC III期临床试验中,有很大一部分缺乏生活质量数据。生活质量分析的方法在仪器类型、分析和结果呈现方面存在差异。
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