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

Autor: Uittenboogaard A; Pediatric oncology, Emma Children's Hospital, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.; Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands., van den Berg MH; Pediatric oncology, Emma Children's Hospital, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands., Abbink FCH; Pediatric oncology, Emma Children's Hospital, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands., Twisk JWR; Department of Epidemiology and Biostatistics, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands., van der Sluis IM; Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands.; Department of Pediatric Oncology, Erasmus Medical Center Rotterdam/Sophia Children's Hospital, Rotterdam, the Netherlands., van den Bos C; Pediatric oncology, Emma Children's Hospital, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.; Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands., van den Heuvel-Eibrink MM; Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands., Segers H; Department of Pediatric Hemato-Oncology, University Hospitals Leuven and Catholic University Leuven, Leuven, Belgium., Chantrain C; Department of Pediatrics, Clinique du MontLégia, The Centre Hospitalier Chrétien, Liège, Belgium., van der Werff Ten Bosch J; Department of Pediatric Onco-Hematology, Universitair Ziekenhuis Brussel, Brussels, Belgium., Willems L; Department of Paediatric Haematology-Oncology and Stem Cell Transplantation, Ghent University Hospital, Ghent, Belgium., Kaspers GJL; Pediatric oncology, Emma Children's Hospital, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.; Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands., van de Velde ME; Pediatric oncology, Emma Children's Hospital, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.
Jazyk: angličtina
Zdroj: Cancer medicine [Cancer Med] 2023 Oct; Vol. 12 (19), pp. 19480-19490. Date of Electronic Publication: 2023 Sep 21.
DOI: 10.1002/cam4.6550
Abstrakt: 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.
(© 2023 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.)
Databáze: MEDLINE
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