TY - JOUR
T1 - Randomized controlled trial on the effect of 1-hour infusion of vincristine versus push injection on neuropathy in children with cancer (final analysis)
AU - Uittenboogaard, Aniek
AU - van den Berg, Marleen H.
AU - Abbink, Floor C. H.
AU - Twisk, Jos W. R.
AU - van der Sluis, Inge M.
AU - van den Bos, Cor
AU - van den Heuvel-Eibrink, Marry M.
AU - Segers, Heidi
AU - Chantrain, Christophe
AU - van der Werff ten Bosch, Jutte
AU - Willems, Leen
AU - Kaspers, Gertjan J. L.
AU - van de Velde, Mirjam Esther
N1 - Funding Information: This research was funded by the Netherlands Organization for Health and Development (pro‐gram Proper Use of Medication; 836021006) and the Belgian Health Care Knowledge Centre (16015). Publisher Copyright: © 2023 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.
PY - 2023/10
Y1 - 2023/10
N2 - 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.
AB - 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.
KW - cancer
KW - children
KW - toxicity
KW - vincristine
UR - http://www.scopus.com/inward/record.url?scp=85171672267&partnerID=8YFLogxK
U2 - https://doi.org/10.1002/cam4.6550
DO - https://doi.org/10.1002/cam4.6550
M3 - Article
C2 - 37732486
SN - 2045-7634
VL - 12
SP - 19480
EP - 19490
JO - Cancer Medicine
JF - Cancer Medicine
IS - 19
ER -