Randomized controlled trial on the effect of 1-hour infusion of vincristine versus push injection on neuropathy in children with cancer (final analysis).
Cancer Med
; 12(19): 19480-19490, 2023 10.
Article
in En
| MEDLINE
| ID: mdl-37732486
ABSTRACT
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.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Peripheral Nervous System Diseases
/
Neoplasms
/
Antineoplastic Agents, Phytogenic
Type of study:
Clinical_trials
/
Prognostic_studies
Limits:
Child
/
Humans
Language:
En
Journal:
Cancer Med
Year:
2023
Type:
Article
Affiliation country:
Netherlands