PMID- 33161724 OWN - NLM STAT- MEDLINE DCOM- 20210608 LR - 20210608 IS - 2304-3873 (Electronic) IS - 2304-3865 (Linking) VI - 9 IP - 5 DP - 2020 Oct TI - Safety and efficacy of aprepitant as mono and combination therapy for the prevention of emetogenic chemotherapy-induced nausea and vomiting: post-marketing surveillance in China. PG - 68 LID - 10.21037/cco-20-160 [doi] AB - BACKGROUND: The goal of this study was to evaluate aprepitant usage in the context of routine clinical practice with dose/regimens at the discretion of prescribers for chemotherapy-induced nausea and vomiting (CINV) treatments. METHODS: In this single arm, multicenter prospective study 1,000 patients with solid malignancies were enrolled across 21 centers in China. The primary endpoint was the rate of adverse events (AEs), including drug related AEs and serious AEs (SAEs). Secondary efficacy endpoints included the proportion of patients achieving complete response (CR; no vomiting, no nausea, and no use of rescue medication) within 120 h after highly emetogenic chemotherapy, the rates of no nausea and no vomiting, as well as quality of life (QoL). Multivariable logistic regression analysis was carried out to determine factors associated with the overall (0-120 h), acute (0-24 h) and delayed (25-120 h) CR. RESULTS: Of the 1,000 highly emetogenic chemotherapy treated patients enrolled in the study >/=1 AE, >/=1 drug related AE, >/=1 SAE and drug related SAE rates in 998 patients were 45.9%, 2.5%, 4.0% and 0.1%, respectively. Approximately half of the patients (455/990, 46.0%) received aprepitant as part of a 3-drug anti-CINV regimen consistent with prescribing guidelines. The overall CR (0 to 120 h) for anti-emetic drug use was 41.0%, with an acute CR of 66.0% and a delayed CR of 46.5%. The rates of no vomiting and no nausea after solely aprepitant anti-emetic therapy from 0 to 120 h were 70.9% and 43.0%, for dual anti-emetic therapy 86.9% and 64.6%, and for triple therapy 86.4% and 69.5%, respectively. Multivariate regression analysis revealed that triple anti-emetic therapy (P=0.038), male gender (P<0.001) and a history of chemotherapy (P=0.016) were significantly associated with the overall acute CR. CONCLUSIONS: Especially as a combination treatment, aprepitant is safe and efficient for preventing CINV in patients receiving highly emetogenic chemotherapy. FAU - Yang, Yunpeng AU - Yang Y AD - Department of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China; Collaborative Innovation Center for Cancer Medicine, Guangzhou, China. FAU - Yang, Nong AU - Yang N AD - Department of Medical Oncology Cancer Hospital, The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China. FAU - Wu, Lin AU - Wu L AD - Department of Thoracic Surgery Cancer Hospital, The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China. FAU - Ouyang, Quchang AU - Ouyang Q AD - Department of Breast Surgery Cancer Hospital, The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China. FAU - Fang, Jian AU - Fang J AD - Department of Medical Oncology, Beijing Cancer Hospital, Beijing Institute for Cancer Research, Beijing, China. FAU - Li, Jinfeng AU - Li J AD - Breast Cancer Prevention and Treatment Center, Beijing Cancer Hospital, Beijing Institute for Cancer Research, Beijing, China. FAU - Liao, Wangjun AU - Liao W AD - Department of Medical Oncology, Southern Medical University Nanfang Hospital, Guangzhou, China. FAU - Cai, Kaican AU - Cai K AD - Department of Thoracic Surgery, Southern Medical University Nanfang Hospital, Guangzhou, China. FAU - Huang, Jianjin AU - Huang J AD - Department of Medical Oncology, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China. FAU - Li, Jin AU - Li J AD - Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China. FAU - Zhang, Yiping AU - Zhang Y AD - Department of Medical Oncology, Zhejiang Cancer Hospital, Cancer Hospital of the University of Chinese Academy of Sciences, Institute of Cancer and Basic Medicine, Chinese Academy of Sciences, Hangzhou, China. FAU - Wang, Xiaojia AU - Wang X AD - Department of Medical Oncology, Zhejiang Cancer Hospital, Cancer Hospital of the University of Chinese Academy of Sciences, Institute of Cancer and Basic Medicine, Chinese Academy of Sciences, Hangzhou, China. FAU - Zhang, Helong AU - Zhang H AD - Department of Medical Oncology, The Fourth Military University Tangdu Hospital, Xi'an, China. FAU - Xu, Nong AU - Xu N AD - Department of Medical Oncology, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China. FAU - Zhao, Qiong AU - Zhao Q AD - Department of Medical Oncology, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China. FAU - Hu, Xingsheng AU - Hu X AD - Department of Medical Oncology, Cancer Hospital Chinese Academy of Medical Sciences, Beijing, China. FAU - Li, Wei AU - Li W AD - Department of Medical Oncology, The First Hospital of Jilin University, Changchun, China. FAU - Zhong, Wei AU - Zhong W AD - Department of Respiratory Medicine, Peking Union Medical College Hospital, Beijing, China. FAU - Zhong, Diansheng AU - Zhong D AD - Department of Medical Oncology, Tianjing Medical University General Hospital, Tianjin, China. FAU - Cheng, Gang AU - Cheng G AD - Department of Medical Oncology, Beijing Hospital, Beijing, China. FAU - Ye, Sheng AU - Ye S AD - Department of Medical Oncology, The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China. FAU - Zhong, Meizuo AU - Zhong M AD - Department of Medical Oncology, Xiangya Hospital Central South University, Changsha, China. FAU - Wang, Dong AU - Wang D AD - Department of Medical Oncology, The 3rd Affiliated Hospital of Army Medical University, Chongqing, China. FAU - Liu, Hui AU - Liu H AD - Department of Obstetrics and Gynecology, Chinese PLA General Hospital, Medical School of Chinese PLA, Beijing, China. FAU - Zheng, Jihua AU - Zheng J AD - Department of Medical Oncology, General Hospital of Guangzhou Military Command of PLA, Guangzhou, China. FAU - Liu, Xiaojian AU - Liu X AD - Department of Medical Oncology, Shanghai Pudong Hospital, Shanghai, China. FAU - Xu, Hong AU - Xu H AD - Department of Breast Surgery, Wu Jing General Hospital, Beijing, China. FAU - Zhang, Li AU - Zhang L AD - Department of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China; Collaborative Innovation Center for Cancer Medicine, Guangzhou, China. zhangli@sysucc.org.cn. LA - eng PT - Journal Article PT - Multicenter Study PL - China TA - Chin Clin Oncol JT - Chinese clinical oncology JID - 101608375 RN - 0 (Antiemetics) RN - 1NF15YR6UY (Aprepitant) SB - IM MH - Adolescent MH - Adult MH - Aged MH - Aged, 80 and over MH - Antiemetics/pharmacology/*therapeutic use MH - Aprepitant/pharmacology/*therapeutic use MH - China MH - Female MH - Humans MH - Male MH - Middle Aged MH - Nausea/chemically induced/*drug therapy MH - Product Surveillance, Postmarketing/*methods MH - Vomiting/chemically induced/*drug therapy MH - Young Adult OTO - NOTNLM OT - Aprepitant OT - chemotherapy-induced nausea and vomiting (CINV) OT - complete response OT - high emetogenic chemotherapy OT - post marketing surveillance EDAT- 2020/11/10 06:00 MHDA- 2021/06/09 06:00 CRDT- 2020/11/09 05:21 PHST- 2020/05/13 00:00 [received] PHST- 2020/09/07 00:00 [accepted] PHST- 2020/11/09 05:21 [entrez] PHST- 2020/11/10 06:00 [pubmed] PHST- 2021/06/09 06:00 [medline] AID - 10.21037/cco-20-160 [doi] PST - ppublish SO - Chin Clin Oncol. 2020 Oct;9(5):68. doi: 10.21037/cco-20-160.