title: Aprepitant as an add-on therapy in children receiving highly emetogenic chemotherapy: a randomized, double-blind, placebo-controlled trial.
abstract: BACKGROUND
  Aprepitant, a neurokinin-1 receptor antagonist, in combination with 5 HT-3 antagonist and dexamethasone is recommended in adults receiving moderately and highly emetogenic chemotherapy to reduce chemotherapy-induced vomiting (CIV). Data for use of aprepitant in children is limited and hence aprepitant is not recommended by Pediatric Oncology Group of Ontario guidelines for prevention of CIV in children <12 years.
  
  
  METHODS
  A randomized, double-blind, placebo-controlled trial was conducted at a single center in chemotherapy naïve children (5-18 years) receiving highly emetogenic chemotherapy. All patients received intravenous ondansetron (0.15 mg/kg) and dexamethasone (0.15 mg/kg) prior to chemotherapy followed by oral ondansetron and dexamethasone. Patients randomly assigned to aprepitant arm received oral aprepitant (15-40 kg = days 1-3, 80 mg; 41-65 kg = day 1, 125 mg and days 2-3, 80 mg) 1 h before chemotherapy. Control group received placebo as add-on therapy. Primary outcome measure was the incidence of acute moderate to severe vomiting, which was defined as more than two vomiting episodes within 24 h after the administration of the first chemotherapy dose until 24 h after the last chemotherapy dose in the block. Complete response (CR) was defined as absence of vomiting and retching during the specified phase.
  
  
  RESULTS
  Of the 96 randomized patients, three were excluded from analysis; 93 patients were analyzed (50 in aprepitant arm and 43 in placebo arm). Acute moderate and severe vomiting was reported in 72 % patients receiving placebo and 38 % patients receiving aprepitant (p = 0.001). Complete response rates during acute phase were significantly higher in aprepitant arm (48 vs. 12 %, p < 0.001). No major adverse effects were reported by patients/guardians.
  
  
  CONCLUSIONS
  This double-blind, randomized, placebo-controlled trial shows that aprepitant significantly decreases the incidence of CIV during acute phase when used as an add-on drug with ondansetron and dexamethasone in children receiving highly emetogenic chemotherapy.
authors: Department of Medical Oncology, Dr. B.R.A. Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi, 110029, India. sambakh@hotmail.com.
authors: Sameer
authors: S
authors: Bakhshi
authors: Department of Medical Oncology, Dr. B.R.A. Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi, 110029, India.
authors: Atul
authors: A
authors: Batra
authors: Department of Medical Oncology, Dr. B.R.A. Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi, 110029, India.
authors: Bivas
authors: B
authors: Biswas
authors: Department of Medical Oncology, Dr. B.R.A. Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi, 110029, India.
authors: Deepa
authors: D
authors: Dhawan
authors: Department of Medical Oncology, Dr. B.R.A. Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi, 110029, India.
authors: Reeja
authors: R
authors: Paul
authors: Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, 110029, India.
authors: Vishnubhatla
authors: V
authors: Sreenivas
mesh_terms: D061605:Administration, Intravenous; D000293:Adolescent; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use; D000932:Antiemetics / Q000627:therapeutic use*; D000077608:Aprepitant; D002648:Child; D002675:Child, Preschool; D003907:Dexamethasone / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D060828:Induction Chemotherapy; D008297:Male; D009025:Morpholines / Q000627:therapeutic use*; D009325:Nausea / Q000139:chemically induced / Q000517:prevention & control*; D009369:Neoplasms / Q000188:drug therapy; D064729:Neurokinin-1 Receptor Antagonists / Q000627:therapeutic use*; D017294:Ondansetron / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D009864:Ontario; D012074:Remission Induction; D058831:Serotonin 5-HT3 Receptor Antagonists / Q000627:therapeutic use*; D014839:Vomiting / Q000139:chemically induced / Q000517:prevention & control*
chemical_list: D000893:Anti-Inflammatory Agents; D000932:Antiemetics; D009025:Morpholines; D064729:Neurokinin-1 Receptor Antagonists; D058831:Serotonin 5-HT3 Receptor Antagonists; D000077608:Aprepitant; D017294:Ondansetron; D003907:Dexamethasone
keywords: Anti-emetics; Aprepitant; Pediatric cancer