Phase II trial of GM-CSF in advanced prostate cancer.

摘要: Objectives. Prostate-specific antigen onlydisease progression following definitivetherapy is significant therapeutic dilemma. The benefit of hormonal therapy remainsunproven and associated with significanttoxicity, more pronounced chronic use. Biochemical hormonaltherapy has no standard treatment. Newapproaches to the management this subsetof patients are needed. A previous studyin advanced prostate cancer demonstratedbiologic activity granulocytemacrophage-colony stimulating factor. Thepurpose study was evaluate theactivity granulocyte macrophage-colonystimulating factor in a less heavilypretreated population. Materials methods. Sixteenpatients cancer, 7hormonally naive, 9 androgenindependent, were treated factoradministered subcutaneously at 250 μgthree times week for up 6 months. measurements wereobtained every 2 weeks. Results. No patient achieved anobjective response. Six patientsdemonstrated 10–15% decline theirbaseline prostate-specific whichwas maintained during entire treatmentperiod. Five these rise theirprostate-specific studycompletion. Therapy well tolerated,with only 1 grade 3 event which nottreatment-related. Conclusions. Granulocytemacrophage-colony factordemonstrates modest biologic evidence ofactivity as manifestedby Further investigation mechanism additional clinical evaluationof agent seems warranted.