Adjuvant intra-arterial hepatic fotemustine for high-risk uveal melanoma patients

Melanoma Res. 2008 Jun;18(3):220-4. doi: 10.1097/CMR.0b013e32830317de.

Abstract

Uveal melanoma metastases occur most commonly in the liver. Given the 50% mortality rate in patients at high risk of developing liver metastases, we tested an adjuvant intra-arterial hepatic (i.a.h.) chemotherapy with fotemustine after proton beam irradiation of the primary tumour. We treated 22 high-risk patients with adjuvant i.a.h. fotemustine. Planned treatment duration was 6 months, starting with four weekly doses of 100 mg/m(2), and after a 5-week rest, repeated every 3 weeks. The survival of this patient group was compared with that of a 3 : 1 matched control group randomly selected from our institutional database. Half of the patients experienced > or =grade 3 hepatotoxicity (one patient developing cholangitis 8 years later). Catheter-related complications occurred in 18%. With a median follow-up of 4.6 years for the fotemustine group and 8.5 years for the control group, median overall survival was 9 years [95% confidence interval (CI) 2.2-12.7] and 7.4 years (95% CI 5.4-12.7; P=0.5), respectively, with 5-year survival rates of 75 and 56%. Treatment with adjuvant i.a.h. fotemustine is feasible. However, toxicities are important. Although our data suggest a survival benefit, it was not statistically significant. Confirming such a benefit would require a large, internationally coordinated, prospective randomized trial.

Publication types

  • Controlled Clinical Trial

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Antineoplastic Agents / administration & dosage
  • Antineoplastic Agents / adverse effects
  • Chemotherapy, Adjuvant
  • Female
  • Follow-Up Studies
  • Hepatic Artery* / drug effects
  • Humans
  • Infusions, Intra-Arterial
  • Liver Neoplasms / drug therapy*
  • Liver Neoplasms / secondary*
  • Male
  • Melanoma / drug therapy*
  • Melanoma / mortality
  • Melanoma / pathology
  • Melanoma / radiotherapy
  • Middle Aged
  • Nitrosourea Compounds / administration & dosage*
  • Nitrosourea Compounds / adverse effects
  • Organophosphorus Compounds / administration & dosage*
  • Organophosphorus Compounds / adverse effects
  • Risk
  • Secondary Prevention
  • Survival Analysis
  • Uveal Neoplasms / drug therapy*
  • Uveal Neoplasms / mortality
  • Uveal Neoplasms / pathology
  • Uveal Neoplasms / radiotherapy

Substances

  • Antineoplastic Agents
  • Nitrosourea Compounds
  • Organophosphorus Compounds
  • fotemustine