Clinical Research, François Baclesse Center, Caen, France.
Anticipe (Interdisciplinary Research Unit for the Prevention and Treatment of Cancer), INSERM Unit 1086, Caen, France.
J Natl Compr Canc Netw. 2023 May;21(5):473-479.e4. doi: 10.6004/jnccn.2022.7101.
Current standards for toxicity reporting do not fully capture the impact of adverse events (AEs) on patients' quality of life (QoL). This study aimed to evaluate the association between toxicity and QoL by using toxicity scores that take into account CTCAE grade grouping and AE duration and cumulation.
Analyses were performed on the AURELIA trial dataset, including 361 patients with platinum-resistant ovarian cancer treated with chemotherapy alone or with bevacizumab. Global and physical functioning QoL were issued from the EORTC QoL Questionnaire-Core 30 (QLQ-C30), collected at baseline and 8/9 and 16/18 weeks after treatment initiation. Four toxicity scores were computed: the total number of AEs, multiplied by their grade and not, and the cumulative duration of AEs, weighted by their grade and not. Each score included all AEs or only grade 3/4 nonlaboratory or treatment-related AEs. The relationship between toxicity scores and QoL was assessed through linear mixed regression.
We found that 171 (47.5%) and 43 (11.9%) patients experienced at least one grade 3 or 4 AE, respectively, whereas 113 (31.4%) experienced grade 2 AEs only. Physical QoL was negatively associated with all toxicity scores when computed with all grades of AEs (all P<.01), with a weaker association when treatment-related AEs were considered. Global QoL was negatively associated with toxicity scores computed with nonlaboratory all-grade AEs only (β, -3.42 to -3.13; all P<.01). Degrees of association were lower when considering the AE duration.
In this analysis of patients with platinum-resistant ovarian cancer, toxicity scores based on the cumulative number of AEs, modulated or not by grade, were more effective at predicting QoL changes than those based on AE duration. Toxicity impact on QoL was better reflected when grade 2 AEs were taken into account together with grade 3/4 AEs, whatever their treatment imputability, and when laboratory AEs were excluded.
目前的毒性报告标准并未充分捕捉不良反应（AE）对患者生活质量（QoL）的影响。本研究旨在通过使用考虑 CTCAE 分级分组以及 AE 持续时间和累积的毒性评分来评估毒性与 QoL 之间的关系。
对 AURELIA 试验数据集进行了分析，纳入了 361 例铂耐药卵巢癌患者，他们单独接受化疗或联合贝伐珠单抗治疗。全球和躯体功能 QoL 由 EORTC QoL 问卷核心 30 项（QLQ-C30）评估，在治疗开始时以及 8/9 和 16/18 周后采集。计算了 4 个毒性评分：AE 的总数，乘以其等级和不乘以其等级，以及 AE 的累积持续时间，乘以其等级和不乘以其等级。每个评分均包含所有 AE 或仅 3/4 级非实验室或与治疗相关的 AE。通过线性混合回归评估毒性评分与 QoL 之间的关系。
我们发现，分别有 171（47.5%）和 43（11.9%）例患者经历了至少 1 次 3/4 级 AE，而 113（31.4%）例患者仅经历了 2 级 AE。当计算所有等级的 AE 时，躯体 QoL 与所有毒性评分均呈负相关（均 P<.01），当考虑与治疗相关的 AE 时，相关性较弱。当仅考虑非实验室所有等级 AE 时，全球 QoL 与毒性评分呈负相关（β，-3.42 至-3.13；均 P<.01）。当考虑 AE 持续时间时，相关性程度较低。
在这项铂耐药卵巢癌患者的分析中，基于累积 AE 数量的毒性评分（无论是否调节等级），比基于 AE 持续时间的评分更能有效预测 QoL 变化。当将 2 级 AE 与 3/4 级 AE 一起考虑，无论其治疗归因如何，并且当排除实验室 AE 时，毒性对 QoL 的影响能更好地反映出来。
