Immunoembolization of Malignant Liver Tumors, Including Uveal Melanoma, Using Granulocyte-Macrophage Colony-Stimulating Factor. Journal of clinical oncology : official journal of the American Society of Clinical Oncology [J Clin Oncol] Journal article | | Title | Immunoembolization of Malignant Liver Tumors, Including Uveal Melanoma, Using Granulocyte-Macrophage Colony-Stimulating Factor. | | Author(s) | Sato T, Eschelman DJ, Gonsalves CF, Terai M, Chervoneva I, McCue PA, Shields JA, Shields CL, Yamamoto A, Berd D, Mastrangelo MJ, Sullivan KL | | Institution | Department of Medical Oncology; Division of Interventional Radiology, Department of Radiology; Division of Biostatistics, Department of Pharmacology and Experimental Therapeutics; Division of Surgical Pathology, Department of Pathology; and Division of Ocular Oncology, Wills Eye Institute; Jefferson Medical College of Thomas Jefferson University, Philadelphia, PA. | | Source | J Clin Oncol 2008 Oct 6. | | Abstract | PURPOSE: We conducted a phase I study to investigate the feasibility and safety of immunoembolization with granulocyte-macrophage colony-stimulating factor (GM-CSF; sargramostim) for malignant liver tumors, predominantly hepatic metastases from patients with primary uveal melanoma.
PATIENTS AND METHODS: Thirty-nine patients with surgically unresectable malignant liver tumors, including 34 patients with primary uveal melanoma, were enrolled. Hepatic artery embolization accompanied an infusion of dose-escalated GM-CSF (25 to 2,000 microg) given every 4 weeks. Primary end points included dose-limiting toxicity and maximum tolerated dose (MTD). Patients who completed two cycles of treatments were monitored for hepatic antitumor response. Survival rates of patients were also monitored.
RESULTS: MTD was not reached up to the dose level of 2,000 microg, and there were no treatment-related deaths. Thirty-one assessable patients with uveal melanoma demonstrated two complete responses, eight partial responses, and 10 occurrences of stable disease in their hepatic metastases. The median overall survival of intent-to-treat patients who had metastatic uveal melanoma was 14.4 months. Multivariate analyses indicated that female sex, high doses of GM-CSF (>/= 1,500 microg), and regression of hepatic metastases (complete and partial responses) were correlated to longer overall survival. Moreover, high doses of GM-CSF were associated with prolonged progression-free survival in extrahepatic sites.
CONCLUSION: Immunoembolization with GM-CSF is safe and feasible in patients with hepatic metastasis from primary uveal melanoma. Encouraging preliminary efficacy and safety results warrant additional clinical study in metastatic uveal melanoma. | | Language | ENG | | Pub Type(s) | JOURNAL ARTICLE
| | PubMed ID | 18838710 |
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