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.

• N = 227   
• MEDIAN AGE = 68 years
• AGE RANGE = 49–85 years
• MALES: 100%  
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: Ninety-one percent had prior chemotherapy, and 52% had prior radiation therapy.

• SITE: Multi-site   
• SETTING TYPE: Outpatient    
• LOCATION: Netherlands

PHASE OF CARE: Active antitumor treatment

• Randomized, open-label, phase II trial

• Common Terminology Criteria for Adverse Events (CTCAE)

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.

• Risk of bias (no blinding)
• Unintended interventions or applicable interventions not described that would influence results
• Use of loperamide was not reported

Budesonide was not shown to be effective to reduce the prevalence or severity of diarrhea among patients receiving cabazitaxel.