Nieuweboer, A.J., de Graan, A.M., Hamberg, P., Bins, S., van Soest, R.J., van Alphen, R.J., . . . Mathijssen, R.H. (2016). Effects of budesonide on cabazitaxel pharmacokinetics and cabazitaxel-induced diarrhea: A randomized, open-label multicenter phase II study. Clinical Cancer Research. Advance online publication.
To evaluate the effects of budesonide on cabazitaxel-induced diarrhea during two treatment cycles
Patients were randomized to receiver cabazitaxel plus prednisone or cabazitaxel plus prednisone with 9 mg budesonidedaily for 44 days. Budesonide was given for the first two courses and was begun two days before chemotherapy administration. Loperamide was used for diarrhea.
PHASE OF CARE: Active antitumor treatment
Among those receiving budesonide, 18% had grade 2 or 3 diarrhea, compared to 12% in the comparison group. Seven patients were hospitalized for diarrhea during treatment. No difference in diarrhea grade or prevalence existed between study groups.
Budesonide had no significant effect on the incidence or severity of diarrhea.
Budesonide was not shown to be effective to reduce the prevalence or severity of diarrhea among patients receiving cabazitaxel.