A pharmacokinetically guided dose-escalation feasibility study of
vincristine in Kenyan children with cancer (CHAPATI study)
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.