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Addition of aprepitant improves acute emesis control in children and adolescents receiving induction chemotherapy for acute myeloid leukaemia: a randomised, open-label trial
  1. Atul Sharma1,
  2. Shuvadeep Ganguly1,
  3. Santosh Kumar C1,
  4. Ashwati S Pillai1,
  5. Deepa Dhawan1,
  6. Vishnubhatla Sreenivas2 and
  7. Sameer Bakhshi1
  1. 1Medical Oncology, Dr. B.R.A. Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi, India
  2. 2Biostatistics, All India Institute of Medical Sciences, New Delhi, India
  1. Correspondence to Dr Sameer Bakhshi, Department of Medical Oncology, Dr. B.R.A. Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi 110029, Delhi, India; sambakh{at}hotmail.com

Abstract

Objectives More than 50% patients develop emesis during induction therapy for acute myeloid leukaemia (AML). The addition of aprepitant for emesis control in children receiving induction for AML have not been explored.

Methods A single-institutional randomised, open-label trial (NCT02979548) was conducted where children between 5 and 18 years with the diagnosis of AML being planned for 3+7 induction regimen were included. All study participants received ondansetron (0.15 mg/kg) every 8 hours for 8 days starting 30 min prior to chemotherapy. Children belonging to aprepitant group additionally received aprepitant capsules (15–40 kg=days 1–3, 80 mg; >40 kg=day 1, 125 mg and days 2–3, 80 mg) starting from 1 hour prior to chemotherapy. The proportion of patients with complete response (CR) in chemotherapy induced vomiting (CIV) in acute phase (day 1–8), delayed phase (day 9–13), overall and initial 96 hours were recorded along with severity of vomiting and adverse effects.

Results Total 78 children were randomised (Aprepitant group: 37 and control group: 41). The proportion of patients with CR in CIV was significantly higher in Aprepitant group in acute phase (p=0.007), overall phase (p=0.007) and in initial 96 hours (p<0.001) but it was not different in delayed phase (p=0.07). The first episode of vomiting was also significantly delayed in aprepitant group (p=0.02). Adverse effect profile was similar in two groups.

Conclusion Aprepitant significantly improves emesis control in children receiving induction therapy for AML, especially in acute phase and should be routinely incorporated as part of antiemetic prophylaxis.

Trial registration number The study was registered at ClinicalTrials.gov (NCT02979548).

  • leukaemia
  • paediatrics
  • supportive care
  • nausea and vomiting
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Footnotes

  • AS and SG contributed equally.

  • Contributors SB, VS and AS conceived the study, performed analysis and wrote the paper. AS, SKC, ASP and DD conducted the research. SG performed analysis and wrote the paper. All authors approved final version of the manuscript. The corresponding author (SB) is the guarantor of the study findings and the data that supports the findings on behalf of all the co-authors.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Disclaimer The funding agency had no role in design of the study, data collection, analysis, interpretation; in writing of report or in the decision to submit the result for publication.

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Ethics approval The study was approved by institutional ethical committee.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement Data are available on reasonable request. The data that support the findings of the study is available from the corresponding author on reasonable request.

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