Palonosetron (PG) is a newer, safe, and effective long-acting 5-HT3 antagonist commonly used in adults, but data in children are limited. A randomized controlled trial was carried out among children with cancer during their first cycle of moderate or highly emetogenic chemotherapy to receive either PG or ondansetron (OG) with the aim of comparing their efficacy, safety, and cost-effectiveness. In total, 200 children (mean age, 8 y, male:female=1.8:1) were recruited, 100 in each arm. Complete response, defined as no vomiting, in acute (<24 h), delayed (24 to 120 h), and overall phases (0 to 120 h) was observed in 88%, 88%, and 81% of cases, respectively, for PG versus 84%, 79%, and 72%, respectively, for OG (P=0.42, 0.09 and 0.21, respectively). Complete protection rates, defined as no nausea and vomiting in children above 6 years of age, in acute, delayed, and overall phases were 84%, 81%, and 73%, respectively, for PG versus 79%, 67%, and 60%, respectively, for OG (P=0.44, 0.06 and 0.10, respectively). Overall, the efficacy and safety of PG in the prevention of chemotherapy-induced nausea and vomiting was comparable with OG, but PG was a more cost-effective and suitable choice for busy centers in resource-limited countries.
*Department of Pediatrics, All India Institute of Medical Sciences, Bhopal
†Pediatric Hematology Oncology Unit, Department of Child Health
‡Department of Biostatistics, Christian Medical College, Vellore, Tamilnadu, India
Supported by Intramural research grant from Christian Medical College Vellore.
Oral presentation at the 48th Congress of International Society of Pediatric Oncology (SIOP) 2016, October 20, 2016, Dublin, Ireland. Bagged “Young Investigator Award” at SIOP 2016, Dublin, Ireland.
N.K.C. and L.G.M.: conceptualized the report. N.K.C., W.N.N., and D.B.: were involved in drug administration, data collection, and presentation to the institutional Data Safety and Monitoring Board. M.G.: was involved in statistical analysis. N.K.C.: prepared the manuscript.
The authors declare no conflict of interest.
Reprints: Rikki R. John, DNB (Pediatrics), Pediatric Hematology Oncology Unit, Department of Child Health, Christian Medical College, Vellore-632004, Tamilnadu, India (e-mail: email@example.com).
Received May 30, 2018
Accepted October 21, 2018