Abstract | BACKGROUND: METHODS: In this non-interventional observation study, 120 children and adolescents with a median age of 11.8 years undergoing alloHSCT after a moderately or highly emetogenic conditioning (MEC or HEC) were analyzed. They received an antiemetic prophylaxis with granisetron (2 × 40 µg/kg d-1) with or without fosaprepitant (4 mg/kg; single dose, max. 1 × 150 mg/kg BW), and were analyzed in the control (CG; n = 60) or fosaprepitant group (FG; n = 60). The efficacy and safety of the two antiemetic prophylaxis regimens were analyzed and compared with respect to the acute (0-24 h) and the delayed (> 24-120 h) CINV phase and > 120-240 h after MEC or HEC administration. RESULTS: During MEC, significantly more patients in the CG experienced vomiting during the first 0-24 h (58.6 vs. 25.0%; p = 0.0156) and during > 24-120 h (93.1% vs. 57.1%; p = 0.0020), compared with the FG. Likewise, significantly more vomiting events (269 vs. 136; p < 0.0001) were registered in the CG. During HEC, significantly more patients in the CG experienced vomiting during the first 0-24 h (32.3 vs. 9.4%; p = 0.0319) compared with the FG. Significantly more vomiting events (241 vs. 99; p < 0.0001) were registered in the CG. Laboratory and clinical adverse events were not significantly different between the two groups (p > 0.05). CONCLUSIONS:
Antiemetic prophylaxis with fosaprepitant and granisetron was well tolerated, safe, and effective in pediatric patients undergoing alloHSCT. However, larger prospective trials are necessary to evaluate these findings.
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Authors | Karin Melanie Cabanillas Stanchi, Julia Vek, Patrick Schlegel, Joachim Vincent Rupprecht, Tim Flaadt, Simone Weber, Sebastian Michaelis, Peter Lang, Rupert Handgretinger, Michaela Döring |
Journal | Journal of cancer research and clinical oncology
(J Cancer Res Clin Oncol)
Vol. 146
Issue 4
Pg. 1089-1100
(Apr 2020)
ISSN: 1432-1335 [Electronic] Germany |
PMID | 32056007
(Publication Type: Journal Article, Observational Study)
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Chemical References |
- Antiemetics
- Morpholines
- fosaprepitant
- Granisetron
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Topics |
- Adolescent
- Antiemetics
(administration & dosage)
- Antineoplastic Combined Chemotherapy Protocols
(administration & dosage, adverse effects)
- Child
- Child, Preschool
- Female
- Granisetron
(administration & dosage)
- Hematologic Neoplasms
(drug therapy, therapy)
- Hematopoietic Stem Cell Transplantation
(methods)
- Humans
- Infant
- Male
- Morpholines
(administration & dosage)
- Nausea
(chemically induced, prevention & control)
- Transplantation Conditioning
(adverse effects, methods)
- Vomiting
(chemically induced, prevention & control)
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