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 

作者机构：Department of Medical OncologySun Yat-sen University Cancer CenterState Key Laboratory of Oncology in South ChinaCollaborative Innovation Center for Cancer MedicineGuangzhouGuangdongP.R.Chin Department of Day WardFirst Affiliated Hospital of Xinjiang Medical UniversityUrumqiXinjiangP.R.China Department of Medical OncologyJiangxi Cancer HospitalNanchangJiangxiP.R.China Department of Medical OncologyShaanxi Provincial Cancer HospitalXi’anShaanxiP.R.China Department of Medical OncologyThe First People Hospital of XiangtanXiangtanHunanP.R.China Department of Medical OncologyThe First People Hospital of FoshanFoshanGuangdongP.R.China Department of Medical OncologyShenyang Tenth People’s HospitalShenyangLiaoningP.R.China Respiratory MedicineFuzhou Pulmonary Hospital of FujianFuzhouFujianP.R.China Department of Medical OncologyAffiliated Cancer Hospital&Institute of Guangzhou Medical UniversityGuangzhouGuangdongP.R.China Department of Medical OncologyThe Central Hospital of LishuiLishuiZhejiangP.R.China Department of Medical OncologyChongqing Three Gorges Central HospitalChongqingP.R.China Department of Medical OncologyThe First Affiliated Hospital of Hainan Medical UniversityHaikouHainanP.R.China Department of Medical OncologyHunan Province Tumor HospitalChangshaHunanP.R.China Institute of Materia MedicaLuoxin Pharmaceutical Group Co.LtdShanghaiP.R.China 

出 版 物：《Cancer Communications》 (癌症通讯（英文）)

年 卷 期：2023年第43卷第2期

页      面：246-256页

核心收录：

学科分类：1002[医学-临床医学] 100214[医学-肿瘤学] 10[医学] 

主　　题：aprepitant chemotherapy-induced nausea and vomiting clinical trial fosaprepitant neurokinin-1 receptor antagonists nomogram nomogram personalized risk model 

摘      要：Background:Highly emetogenic chemotherapy induces emesis in cancer patients without *** 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 ***: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 *** primary endpoint was complete response(CR)during the overall phase(OP)with a non-inferiority margin of 10.0%.Logistic regression modelswere used to assess the risk factors ofCRand no *** 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:A total of 720 patients were randomly *** during the OP in the fosaprepitant group was not inferior to that in the aprepitant group(78.1%vs.77.7%,P=0.765)with a between-group difference of 0.4%(95%CI,-5.7%to 6.6%).Female sex,higher cisplatin dose(≥70 mg/m2),no history of drinking and larger body surface area(BSA)were significantly associated with *** 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 stratify patients with high-or low-risk *** nausea and CR rate were significantly higher in the low-risk group than in the high-risk group(P0.001).Conclusions:Fosaprepitant-based triple prophylaxis demonstrated non-inferior control for preventing CINV in patients treated with cis