Randomized controlled trial on the effect of 1-hour infusion of vincristine versus push injection on neuropathy in children with cancer (final analysis)

Aniek Uittenboogaard, Marleen H van den Berg, Floor C H Abbink, Jos W R Twisk, Inge M van der Sluis, Cor van den Bos, Marry M van den Heuvel-Eibrink, Heidi Segers, Christophe Chantrain, Jutte van der Werff Ten Bosch, Leen Willems, Gertjan J L Kaspers, Mirjam Esther van de Velde

Onderzoeksoutput: Bijdrage aan tijdschriftArtikelpeer review

Samenvatting

INTRODUCTION: Vincristine is an integral component of treatment for children with cancer. Its main dose-limiting side effect is vincristine-induced peripheral neuropathy (VIPN). The VINCA trial was a randomized controlled trial that explored the effect of 1-hour infusion compared with push injection of vincristine on the development of VIPN in children with cancer. The short-term outcomes (median follow-up 9 months) showed that there was no difference in VIPN between the randomization groups. However, 1-hour infusion was less toxic in children who also received azoles. We now report the results of the final analyses (median follow-up 20 months), which includes treatment outcome as a secondary objective (follow-up 3 years).

METHODS: VIPN was measured 1-7 times per participant using the Common Terminology Criteria for Adverse Events (CTCAE) and the pediatric-modified total neuropathy score. Poisson mixed model and logistic generalized estimating equation analysis for repeated measures were performed.

RESULTS: Forty-five participants per randomization group were included. There was no significant effect of 1-hour infusion compared with push injection on VIPN. In participants receiving concurrent azoles, the total CTCAE score was significantly lower in the one-hour group (rate ratio 0.52, 95% confidence interval 0.33-0.80, p = 0.003). Four patients in the one-hour group and one patient in the push group relapsed. Two patients in the one-hour group died.

CONCLUSION: 1-hour infusion of vincristine is not protective against VIPN. However, in patients receiving concurrent azoles, 1-hour infusion may be less toxic. The difference in treatment outcome is most likely the result of differences in risk profile.

Originele taal-2Engels
Pagina's (van-tot)19480-19490
Aantal pagina's11
TijdschriftCancer Medicine
Volume12
Nummer van het tijdschrift19
DOI's
StatusGepubliceerd - 2023

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