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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.
- Source :
-
BMJ supportive & palliative care [BMJ Support Palliat Care] 2023 Oct; Vol. 13 (e1), pp. e156-e162. Date of Electronic Publication: 2020 Oct 29. - Publication Year :
- 2023
-
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.<br />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.<br />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.<br />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.<br />Trial Registration Number: The study was registered at ClinicalTrials.gov (NCT02979548).<br />Competing Interests: Competing interests: None declared.<br /> (© Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ.)
- Subjects :
- Humans
Child
Adolescent
Aprepitant therapeutic use
Induction Chemotherapy adverse effects
Nausea chemically induced
Nausea drug therapy
Morpholines therapeutic use
Vomiting chemically induced
Vomiting drug therapy
Vomiting prevention & control
Acute Disease
Dexamethasone adverse effects
Antiemetics therapeutic use
Leukemia, Myeloid, Acute complications
Leukemia, Myeloid, Acute drug therapy
Drug-Related Side Effects and Adverse Reactions
Antineoplastic Agents adverse effects
Subjects
Details
- Language :
- English
- ISSN :
- 2045-4368
- Volume :
- 13
- Issue :
- e1
- Database :
- MEDLINE
- Journal :
- BMJ supportive & palliative care
- Publication Type :
- Academic Journal
- Accession number :
- 33122168
- Full Text :
- https://doi.org/10.1136/bmjspcare-2020-002595