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A pharmacokinetically guided dose-escalation feasibility study of vincristine in Kenyan children with cancer (CHAPATI study)
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  • Aniek Uittenboogaard,
  • Mirjam van de Velde,
  • Lisa van der Heijden,
  • Leah Mukuhi,
  • Niels de Vries,
  • Sandra Langat,
  • GILBERT OLBARA,
  • Alwin Huitema,
  • Terry Vik,
  • Gertjan Kaspers,
  • Festus Njuguna
Aniek Uittenboogaard
Emma Kinderziekenhuis Amsterdam UMC

Corresponding Author:[email protected]

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Mirjam van de Velde
Emma Kinderziekenhuis Amsterdam UMC
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Lisa van der Heijden
Netherlands Cancer Institute
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Leah Mukuhi
AMPATH Kenya
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Niels de Vries
Netherlands Cancer Institute
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Sandra Langat
AMPATH Kenya
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GILBERT OLBARA
Moi University
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Alwin Huitema
Prinses Maxima Centrum voor Kinderoncologie
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Terry Vik
Indiana University School of Medicine
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Gertjan Kaspers
Emma Kinderziekenhuis Amsterdam UMC
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Festus Njuguna
Moi University
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Abstract

The low incidence of vincristine-induced peripheral neuropathy (VIPN) in Kenyan children may result from low vincristine exposure. We performed a pharmacokinetically (PK) guided dose-escalation feasibility study of vincristine in Kenyan children (NCT05844670). Vincristine PK exposure was assessed with a previously developed nomogram. A 20% dose increase was recommended for participants with low exposure and no VIPN, hyperbilirubinemia or malnutrition. None of the fifteen participants developed VIPN. Low vincristine exposure was seen in only one participant: a dose increase was implemented without side-effects. Average vincristine exposure was high. In conclusion, the participants did not develop VIPN despite having high vincristine exposure.
08 Feb 2024Assigned to Editor
08 Feb 2024Submission Checks Completed
08 Feb 2024Submitted to Pediatric Blood & Cancer
09 Feb 2024Review(s) Completed, Editorial Evaluation Pending
09 Feb 2024Reviewer(s) Assigned
08 Mar 2024Editorial Decision: Revise Minor
04 Apr 2024Assigned to Editor
04 Apr 2024Submission Checks Completed
04 Apr 2024Review(s) Completed, Editorial Evaluation Pending
04 Apr 2024Reviewer(s) Assigned
12 Apr 2024Editorial Decision: Accept
06 Jun 2024Assigned to Editor
06 Jun 2024Submission Checks Completed
06 Jun 2024Review(s) Completed, Editorial Evaluation Pending
10 Jun 2024Editorial Decision: Accept