Phase II trial assessing granulocyte-macrophage-colony stimulating factor, ketoconazole plus mitoxantrone in metastatic castration-resistant prostate cancer progressing after docetaxel treatments.
INTRODUCTION
This study evaluated objective response and safety for the combination of granulocyte macrophage-colony stimulating factor (GM-CSF), ketoconazole, and mitoxantrone in castration-resistant prostate cancer (CRPC) patients who previously failed docetaxel-based chemotherapy.


METHODS
Treatment consisted of 400 mg TID ketoconazole, 12 mg/m(2) mitoxantrone every 3 weeks, and 250 μg/m(2) GM-CSF.


RESULTS
Twenty-nine patients were evaluable for response. Median overall survival (OS) for all patients was 18.03 months. Patients with a higher PSA decrease experienced an increased OS and progression-free survival (PFS).


CONCLUSION
This combination demonstrated significant antitumor activity with reversible toxicity in CRPC patients who previously failed docetaxel-based therapy.