ORLANDO, FL — May 20, 2002 — Fotemustine demonstrated activity against liver metastases from ocular melanoma and increased median survival to 14.8 months, according to researchers.. Serge Leyvraz, MD, of Centre Pluridisciplinaire d’Oncologie, Lausanne, Switzerland, and colleagues from four other centres in Europe reported the findings here Sunday at the 38th Annual Meeting of the American Society of Clinical Oncology (ASCO).
Dr. Leyvraz said the median survival seen with fotemustine, an investigational nitrosourea with high hepatic extraction rate, “is significantly better than the historical median survival of less than 6 months from time of liver metastases.” Based on these favorable results, a phase III trial of intravenous versus intra-arterial fotemustine is planned, he said. The study enrolled 31 men and 35 women with ocular melanoma metastatic only to the liver after a median of 2.5 years from time of melanoma diagnosis. Results from 62 fully evaluable patients were presented.
Patients had hepatic artery catheters implanted either surgically or by interventional radiology. Hepatic arterial fotemustine was administered at 100 mg/m² over four hours weekly for four weeks, followed by a five-week break. After the break, fotemustine was initiated every three weeks until progression, side effects, or patient refusal. All treatment was administered on an outpatient basis and was well tolerated, Dr. Leyvraz said.
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