Originally published as JCO Early Release 10.1200/JCO.2008.16.0705 on October 6 2008

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Immunoembolization of Malignant Liver Tumors, Including Uveal Melanoma, Using Granulocyte-Macrophage Colony-Stimulating Factor

Takami Sato, David J. Eschelman, Carin F. Gonsalves, Mizue Terai, Inna Chervoneva, Peter A. McCue, Jerry A. Shields, Carol L. Shields, Akira Yamamoto, David Berd, Michael J. Mastrangelo, Kevin L. Sullivan

From the 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

Corresponding author: Takami Sato, MD, Department of Medical Oncology, Thomas Jefferson University, 1025 Walnut St, Suite 1024, Philadelphia, PA 19107; e-mail: t_sato{at}mail.jci.tju.edu

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 µg) 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 µg, 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 µg), 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.

published online ahead of print at www.jco.org on October 6, 2008.

Supported by Grant No. ME-01-329 from the Commonwealth of Pennsylvania, Bonnie Kroll Research Fund, Siobhan McDonald Research Fund, Eye Melanoma Research Fund, and a grant from Bayer HealthCare Pharmaceuticals.

Authors’ disclosures of potential conflicts of interest and author contributions are found at the end of this article.

Presented in part at the 41st Annual Meeting of the American Society of Clinical Oncology, Orlando, Florida, May 13-17, 2005.

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				A. Yamamoto, I. Chervoneva, K. L. Sullivan, D. J. Eschelman, C. F. Gonsalves, M. J. Mastrangelo, D. Berd, J. A. Shields, C. L. Shields, M. Terai, et al. High-Dose Immunoembolization: Survival Benefit in Patients with Hepatic Metastases from Uveal Melanoma Radiology, July 1, 2009; 252(1): 290 - 298. [Abstract] [Full Text] [PDF]