Department of Gynecology with Center for Oncological Surgery, Virchow Campus Clinic, Charité Medical University, Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Berlin, Germany.
Department of Gynecology, Krankenhaus Jerusalem Hamburg, Hamburg, Germany.
ESMO Open. 2021 Apr;6(2):100081. doi: 10.1016/j.esmoop.2021.100081. Epub 2021 Mar 18.
Recurrent ovarian cancer is an incurable disease with variable but poor prognosis. Health-related quality of life (HRQoL) is a patient-reported outcome measure generally applied to measure effects of therapies. Our aim was the development and validation of a risk score for the prediction of short-term mortality using the combination of sociodemographic and clinical factors and HRQoL.
For exploratory and validation analysis, the North-Eastern German Society of Gynecological Oncology (NOGGO) and Working Group Gynecological Oncology (AGO) study databases were screened for trials. Only trials which obtained defined HRQoL measurements were included in the final analysis. Multivariable logistic regression analyses were used to identify risk factors and their weighting for the risk score. Modulation with cubic regression analyses revealed median survival and short-term mortality defined as 1-year mortality for each value.
For exploration, 974 patients from three clinical studies of the NOGGO and for validation, 1235 patients from several clinical studies of the AGO were eligible. The risk score included platinum-free interval, performance status, age, global QoL and nausea/vomiting. Receiver operating characteristic analysis showed a good predictive value with an area under the curve of 0.81 for model 1 in the exploration and 0.74 in the validation. Short-term mortality in model 1 was 8.2%, 23.5% and 58.4% in the exploration sample, and 19.7%, 38.1% and 63.4% in the validation sample for patients under low, medium and high risk, respectively.
This risk score discriminates well between recurrent ovarian cancer patients under low, medium and high risk of short-term mortality. It may help to identify a risk group under high risk for short-term mortality that can be used for randomization in clinical trials and may support decision making for palliative chemotherapy.
复发性卵巢癌是一种无法治愈的疾病，预后不定且较差。健康相关生活质量（HRQoL）是一种患者报告的结果测量方法，通常用于衡量治疗效果。我们的目的是开发和验证一种使用社会人口统计学和临床因素与 HRQoL 相结合的短期死亡率预测风险评分。
为了进行探索性和验证性分析，筛选了东北德国妇科肿瘤学会（NOGGO）和妇科肿瘤工作组（AGO）研究数据库中的试验。只有获得明确 HRQoL 测量的试验才包括在最终分析中。使用多变量逻辑回归分析来确定风险因素及其对风险评分的权重。使用三次回归分析进行调节，以揭示每个值的中位生存时间和短期死亡率（定义为 1 年死亡率）。
在探索性研究中，有 974 名来自三个 NOGGO 临床研究的患者符合条件，在验证性研究中，有 1235 名来自多个 AGO 临床研究的患者符合条件。风险评分包括无铂间隔、表现状态、年龄、总体 QoL 和恶心/呕吐。在探索性研究中，模型 1 的曲线下面积为 0.81，验证性研究中为 0.74，ROC 分析显示出良好的预测价值。在模型 1 中，探索性样本中低、中、高风险组的短期死亡率分别为 8.2%、23.5%和 58.4%，验证性样本中分别为 19.7%、38.1%和 63.4%。
该风险评分能很好地区分短期死亡率低、中、高风险的复发性卵巢癌患者。它可以帮助识别短期死亡率高风险的风险组，用于临床试验中的随机分组，并为姑息化疗提供决策支持。
