Department of Oncology, University of Turin, Candiolo Cancer Institute - FPO- IRCCS, Candiolo, TO, Italy.
Department of Oncology, University of Turin, Ordine Mauriziano Hospital, Torino, Italy.
Crit Rev Oncol Hematol. 2020 Feb;146:102877. doi: 10.1016/j.critrevonc.2020.102877. Epub 2020 Jan 18.
BACKGROUND: In this study, our aim was to describe quality of life (QoL) prevalence and heterogeneity in QoL reporting in colorectal cancer phase III trials. METHODS: We included all phase III trials evaluating anticancer drugs in colorectal cancer patients published between 2012 and 2018 by 11 major journals. RESULTS: Out of the 67 publications identified, in 41 (61.2 %) QoL was not listed among endpoints. Out of 26 primary publications of trials including QoL among endpoints, QoL results were not reported in 10 (38.5 %). Overall, no QoL data were available in 51/67 (76.1 %) primary publications. In particular, in the metastatic setting, QoL data were not available in 12/18 (66.7 %) trials with primary endpoint overall survival, and in 20/29 (69.0 %) trials with other primary endpoints. CONCLUSIONS: QoL was absent in a high proportion of recently published phase III trials in colorectal cancer, even in trials of second or further lines, where attention to QoL should be particularly high.
背景：在这项研究中，我们旨在描述结直肠癌 III 期临床试验中生活质量（QoL）的流行情况和报告中的异质性。
方法：我们纳入了 2012 年至 2018 年间 11 个主要期刊发表的所有评估结直肠癌患者抗癌药物的 III 期临床试验。
结果：在确定的 67 篇文献中，有 41 篇（61.2%）未将 QoL 列为终点。在 26 项将 QoL 作为终点的试验的主要出版物中，有 10 项（38.5%）未报告 QoL 结果。总体而言，51/67（76.1%）项主要出版物中没有 QoL 数据。特别是在转移性环境中，18 项以总生存期为主要终点的试验中有 12 项（66.7%）和 29 项以其他主要终点为试验中有 20 项（69.0%）没有 QoL 数据。
结论：在最近发表的结直肠癌 III 期临床试验中，很大一部分试验没有 QoL 数据，即使是二线或进一步治疗的试验，也应该特别关注 QoL。
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