Phase II trial assessing granulocyte-macrophage-colony stimulating factor, ketoconazole plus mitoxantrone in metastatic castration-resistant prostate cancer progressing after docetaxel treatments.

Robert J Amato, Somyata Saxena, Mika Stepankiw

文献索引：Cancer Invest. 31(3) , 177-82, (2013)

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摘要

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.Treatment consisted of 400 mg TID ketoconazole, 12 mg/m(2) mitoxantrone every 3 weeks, and 250 μg/m(2) GM-CSF.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).This combination demonstrated significant antitumor activity with reversible toxicity in CRPC patients who previously failed docetaxel-based therapy.