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Published on: September 3, 2013
Phase II trial of GM-CSF in advanced prostate cancer
R Dreicer1, W A See, E A Klein
1Department of Hematology/Oncology, Cleveland Clinic Foundation, OH 44195, USA. Dreicer@ccf.org
Objectives:
Prostate-specific antigen only disease progression following definitive therapy is significant therapeutic dilemma. The benefit of hormonal therapy remains unproven and is associated with significant toxicity, more pronounced with chronic use. Biochemical progression following hormonal therapy has no standard treatment. New approaches to the management of this subset of patients are needed. A previous study in advanced prostate cancer demonstrated biologic activity of granulocyte macrophage-colony stimulating factor. The purpose of this study was to evaluate the activity of granulocyte macrophage-colony stimulating factor in a less heavily pretreated population.
Materials And Methods:
Sixteen patients with advanced prostate cancer, 7 hormonally naïve, and 9 androgen independent, were treated with granulocyte macrophage-colony stimulating factor administered subcutaneously at 250 microg three times a week for up to 6 months. Prostate-specific antigen measurements were obtained every 2 weeks.
Results:
No patient achieved an objective response. Six patients demonstrated a 10-15% decline in their baseline prostate-specific antigen which was maintained during the entire treatment period. Five of these 6 patients demonstrated a rise in their prostate-specific antigen following study completion. Therapy was well tolerated, with only 1 grade 3 event which was not treatment-related.
Conclusions:
Granulocyte macrophage-colony stimulating factor demonstrates modest biologic evidence of activity in prostate cancer as manifested by prostate-specific antigen response. Further investigation of the mechanism of activity and additional clinical evaluation of this agent seems warranted.
Insights
Granulocyte-macrophage colony-stimulating factor (GM-CSF) showed modest activity in prostate cancer patients, with some experiencing a temporary PSA decline. Further research is warranted for this agent in prostate cancer management.
Area of Science:
- Oncology
- Urology
- Immunotherapy
Background:
- Prostate-specific antigen (PSA) progression after definitive therapy presents a challenge.
- Hormonal therapy for PSA-only progression has unproven benefits and significant toxicity.
- Novel therapeutic strategies are needed for patients with biochemical progression after hormonal therapy.
Purpose of the Study:
- To evaluate the activity of granulocyte-macrophage colony-stimulating factor (GM-CSF) in prostate cancer patients with less extensive prior treatment.
- To assess GM-CSF's efficacy in a population with PSA-only disease progression.
Main Methods:
- Sixteen patients with advanced prostate cancer (7 hormone-naïve, 9 androgen-independent) received subcutaneous GM-CSF (250 mcg thrice weekly for up to 6 months).
- Prostate-specific antigen (PSA) levels were monitored every two weeks.
Main Results:
- No objective responses were observed.
- Six patients (37.5%) achieved a 10-15% PSA decline, maintained throughout treatment.
- Five of these six patients experienced PSA increase post-treatment; therapy was well-tolerated.
Conclusions:
- GM-CSF demonstrates preliminary biological activity in prostate cancer, indicated by PSA response.
- Further investigation into GM-CSF's mechanism of action and clinical utility is recommended.
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