PMID- 28941006 OWN - NLM STAT- MEDLINE DCOM- 20180102 LR - 20181202 IS - 1545-5017 (Electronic) IS - 1545-5009 (Linking) VI - 65 IP - 2 DP - 2018 Feb TI - Palonosetron is nonsuperior to ondansetron in acute phase but provides superior antiemetic control in delayed phase for pediatric patients administered highly emetogenic chemotherapy. LID - 10.1002/pbc.26815 [doi] AB - PURPOSE: Chemotherapy-induced nausea and vomiting (CINV) in children remains to be a major side effect despite antiemetic treatment. Palonosetron is a new generation 5-HT(3) receptor antagonists effective against acute and delayed nausea and vomiting. This study aimed to compare the therapeutic values of palonosetron and ondansetron in preventing pediatric CINV. METHODS: A prospective, randomized, double-blind, parallel controlled study was conducted in 0-18 years old cancer patients administered highly emetogenic chemotherapy, with different dosage of palonosetron or ondansetron, both followed by dexamethasone. The patients were observed for vomiting and nausea from 0 to 120 hr after chemotherapy initiation. All adverse events (AEs) during the study period were recorded. This study was registered with the Chinese Clinical Trial Registry, number ChiCTR-TRC-14004891. RESULTS: Between August 2014 and July 2016, 565 patients were randomly assigned to receive 5 mug/kg palonosetron (n = 185), 10 mug/kg palonosetron (n = 186), and 3 x 150 mug/kg ondansetron (n = 194), of whom 181, 185, and 189, respectively, were included in the efficacy analysis. Complete response (CR) rates during the acute phase were 69.1, 69.7, and 64.6%, respectively, in the 5 mug/kg palonosetron, 10 mug/kg palonosetron, and ondansetron groups. In the delayed phase, 10 mug/kg palonosetron (CR, 53.5%) showed superiority to 5 mug/kg palonosetron (CR, 39.8%) and ondansetron (CR, 32.8%) groups (P < 0.05). The most frequently observed drug-related AEs were nervous system disorders, mainly headache, with an incidence of 2.8, 2.2, and 2.6% in each group, respectively. CONCLUSION: Combination of palonosetron plus dexamethasone is highly effective in controlling acute and delayed CINV, with palonosetron superior to ondansetron. CI - (c) 2017 Wiley Periodicals, Inc. FAU - Tan, Juan AU - Tan J AD - Outpatient Department of Children's Hospital of Chongqing Medical University, Lijia Campus, Chongqing, China. FAU - Wang, Shan AU - Wang S AD - Department of Pediatric Surgical Oncology, Children's Hospital of Chongqing Medical University, Chongqing, China. AD - Ministry of Education Key Laboratory of Child Development and Disorders, The Children's Hospital of Chongqing Medical University, Chongqing, China. FAU - Liang, Xiaohua AU - Liang X AD - Ministry of Education Key Laboratory of Child Development and Disorders, The Children's Hospital of Chongqing Medical University, Chongqing, China. FAU - Li, Chang-Chun AU - Li CC AD - Department of Pediatric Surgical Oncology, Children's Hospital of Chongqing Medical University, Chongqing, China. AD - Ministry of Education Key Laboratory of Child Development and Disorders, The Children's Hospital of Chongqing Medical University, Chongqing, China. FAU - Zhang, Jun AU - Zhang J AD - Department of Pediatric Surgical Oncology, Children's Hospital of Chongqing Medical University, Chongqing, China. AD - Ministry of Education Key Laboratory of Child Development and Disorders, The Children's Hospital of Chongqing Medical University, Chongqing, China. FAU - Zhao, Zhenzhen AU - Zhao Z AD - Department of Pediatric Surgical Oncology, Children's Hospital of Chongqing Medical University, Chongqing, China. AD - Ministry of Education Key Laboratory of Child Development and Disorders, The Children's Hospital of Chongqing Medical University, Chongqing, China. FAU - Kong, Xiang-Ru AU - Kong XR AD - Department of Pediatric Surgical Oncology, Children's Hospital of Chongqing Medical University, Chongqing, China. AD - Ministry of Education Key Laboratory of Child Development and Disorders, The Children's Hospital of Chongqing Medical University, Chongqing, China. FAU - Deng, Xiaobin AU - Deng X AD - Department of Pediatric Surgical Oncology, Children's Hospital of Chongqing Medical University, Chongqing, China. AD - Ministry of Education Key Laboratory of Child Development and Disorders, The Children's Hospital of Chongqing Medical University, Chongqing, China. FAU - Peng, Liang AU - Peng L AD - Department of Pediatric Surgical Oncology, Children's Hospital of Chongqing Medical University, Chongqing, China. AD - Ministry of Education Key Laboratory of Child Development and Disorders, The Children's Hospital of Chongqing Medical University, Chongqing, China. FAU - Yang, Chao AU - Yang C AUID- ORCID: 0000-0002-2502-3861 AD - Department of Pediatric Surgical Oncology, Children's Hospital of Chongqing Medical University, Chongqing, China. AD - Ministry of Education Key Laboratory of Child Development and Disorders, The Children's Hospital of Chongqing Medical University, Chongqing, China. LA - eng PT - Comparative Study PT - Journal Article PT - Randomized Controlled Trial DEP - 20170922 PL - United States TA - Pediatr Blood Cancer JT - Pediatric blood & cancer JID - 101186624 RN - 0 (Antiemetics) RN - 0 (Isoquinolines) RN - 0 (Quinuclidines) RN - 4AF302ESOS (Ondansetron) RN - 5D06587D6R (Palonosetron) RN - 7S5I7G3JQL (Dexamethasone) SB - IM MH - Adolescent MH - Antiemetics/*administration & dosage/adverse effects MH - Child MH - Child, Preschool MH - Dexamethasone/administration & dosage/adverse effects MH - Double-Blind Method MH - Female MH - Humans MH - Infant MH - Infant, Newborn MH - Isoquinolines/*administration & dosage/adverse effects MH - Male MH - Nausea/chemically induced/*drug therapy MH - Neoplasms/drug therapy MH - Ondansetron/*administration & dosage/adverse effects MH - Palonosetron MH - Prospective Studies MH - Quinuclidines/*administration & dosage/adverse effects MH - Vomiting/chemically induced/*drug therapy OTO - NOTNLM OT - 5-HT3 receptor antagonist OT - antiemetics OT - chemotherapy-induced nausea and vomiting OT - multiple-day chemotherapy OT - ondansetron OT - palonosetron EDAT- 2017/09/25 06:00 MHDA- 2018/01/03 06:00 CRDT- 2017/09/24 06:00 PHST- 2017/02/04 00:00 [received] PHST- 2017/08/15 00:00 [revised] PHST- 2017/08/18 00:00 [accepted] PHST- 2017/09/25 06:00 [pubmed] PHST- 2018/01/03 06:00 [medline] PHST- 2017/09/24 06:00 [entrez] AID - 10.1002/pbc.26815 [doi] PST - ppublish SO - Pediatr Blood Cancer. 2018 Feb;65(2). doi: 10.1002/pbc.26815. Epub 2017 Sep 22.