Dranitsaris George, Bouganim Nathaniel, Milano Carolyn, Vandermeer Lisa, Dent Susan, Wheatley-Price Paul, Laporte Jenny, Oxborough Karen-Ann, Clemons Mark
J Support Oncol. 2013 Mar;11(1):14-21. doi: 10.1016/j.suponc.2012.05.001.
Even with modern antiemetic regimens, up to 20% of cancer patients suffer from moderate to severe chemotherapy-induced nausea and vomiting (CINV) (> or = grade 2). We previously developed chemotherapy cycle-based risk predictive models for > or = grade 2 acute and delayed CINV. In this study, the prospective validation of the prediction models and associated scoring systems is described.
Our objective was to prospectively validate prediction models designed to identify patients at high risk for moderate to severe CINV.
Patients receiving chemotherapy were provided with CINV symptom diaries. Prior to each cycle of chemotherapy, the acute and delayed CINV scoring systems were used to stratify patients into low- and high-risk groups. Logistic regression was used to compare the occurrence of > or = grade 2 CINV between patients considered by the model to be at high vs low risk. The external validity of each system was assessed via an area under the receiver operating characteristic (AUROC) curve analysis.
Outcome data were collected from 97 patients following 401 cycles of chemotherapy. The incidence of > or =grade 2 acute and delayed CINV was 13.5% and 21.4%, respectively. There was a significant correlation between the risk score and the probability of developing acute and delayed CINV following chemotherapy. Both the acute and delayed scoring systems had good predictive accuracy when applied to the validation sample (acute, AUROC = 0.70, 95% CI, 0.62-0.77; delayed, AUROC = 0.75, 95% CI, 0.69-0.80). Patients who were identified as high risk were 3.1 (P = .006) and 4.2 (P< .001) times more likely to develop - grade 2 acute and delayed CINV than were those identified as low risk.
This study demonstrates that the scoring systems are able to accurately identify patients at high risk for acute and delayed CINV.
即便采用现代的止吐方案,仍有高达20%的癌症患者会出现中度至重度化疗引起的恶心和呕吐(CINV,≥2级)。我们之前开发了基于化疗周期的≥2级急性和迟发性CINV风险预测模型。在本研究中,描述了预测模型及相关评分系统的前瞻性验证。
我们的目的是前瞻性验证旨在识别中度至重度CINV高危患者的预测模型。
为接受化疗的患者提供CINV症状日记。在每个化疗周期之前,使用急性和迟发性CINV评分系统将患者分为低风险和高风险组。采用逻辑回归比较模型认为的高风险患者与低风险患者中≥2级CINV的发生情况。通过受试者操作特征曲线下面积(AUROC)分析评估每个系统的外部效度。
在401个化疗周期后,从97名患者中收集了结局数据。≥2级急性和迟发性CINV的发生率分别为13.5%和21.4%。风险评分与化疗后发生急性和迟发性CINV的概率之间存在显著相关性。当应用于验证样本时,急性和迟发性评分系统均具有良好的预测准确性(急性,AUROC = 0.70,95%CI,0.62 - 0.77;迟发性,AUROC = 0.75,95%CI,0.69 - 0.80)。被确定为高风险的患者发生≥2级急性和迟发性CINV的可能性分别是被确定为低风险患者的3.1倍(P = 0.006)和4.2倍(P < 0.001)。
本研究表明,评分系统能够准确识别急性和迟发性CINV的高危患者。