Validation of different personalized risk models of chemotherapy‐induced nausea and vomiting: results of a randomized, double‐blind, phase III trial of fosaprepitant for cancer patients treated with high‐dose cisplatin

作者：Yuanyuan Zhao, Bing Zhao, Gang Chen, Yinlan Chen, Zijun Liao, Haiming Zhang, Weineng Feng, Yinyin Li, Heng Weng, Weidong Li, Yuefen Zhou, Biyong Ren, Yanda Lu, Jianhua Chen, Zhenteng Liu, Zhenzhong Su, Wenliang Wang, Li Zhang · 发表于：癌症：英文版 · 年份：2022 · DOI：10.1002/cac2.12397 · 被引用次数：16 · 研究领域：Nausea and vomiting management、Chemotherapy-induced organ toxicity mitigation、Enhanced Recovery After Surgery

BACKGROUND: Highly emetogenic chemotherapy induces emesis in cancer patients without prophylaxis. The purpose of this study was to evaluate the efficacy and safety of a fosaprepitant-based triple antiemetic regimen for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients with solid malignant tumors, determine risk factors and externally validate different personalized risk models for CINV. METHODS: This phase III trial was designed to test the non-inferiority of fosaprepitant toward aprepitant in cancer patients who were to receive the first cycle of single-day cisplatin chemotherapy. The primary endpoint was complete response (CR) during the overall phase (OP) with a non-inferiority margin of 10.0%. Logistic regression models were used to assess the risk factors of CR and no nausea. To validate the personalized risk models, the accuracy of the risk scoring systems was determined by measuring the specificity, sensitivity and area under the receiver operating characteristic (ROC) curve (AUC), while the predictive accuracy of the nomogram was measured using concordance index (C-index). RESULTS: ), no history of drinking and larger body surface area (BSA) were significantly associated with nausea. The AUC for the acute and delayed CINV risk indexes was 0.68 (95% CI: 0.66-0.71) and 0.66 (95% CI: 0.61-0.70), respectively, and the C-index for nomogram CINV prediction was 0.59 (95% CI, 0.54-0.64). Using appropriate cutoff points, the three models could strat...