title: Adjuvant intra-arterial hepatic fotemustine for high-risk uveal melanoma patients.
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.
authors.affiliation: Multidisciplinary Oncology Center, University of Lausanne Hospitals (CHUV), Lausanne-CHUV, Switzerland. vvoelter@celgene.com
authors.forename: Verena
authors.initials: V
authors.lastname: Voelter
authors.forename: Ann
authors.initials: A
authors.lastname: Schalenbourg
authors.forename: Sandro
authors.initials: S
authors.lastname: Pampallona
authors.forename: Solange
authors.initials: S
authors.lastname: Peters
authors.forename: Nermin
authors.initials: N
authors.lastname: Halkic
authors.forename: Alban
authors.initials: A
authors.lastname: Denys
authors.forename: Gudrun
authors.initials: G
authors.lastname: Goitein
authors.forename: Leonidas
authors.initials: L
authors.lastname: Zografos
authors.forename: Serge
authors.initials: S
authors.lastname: Leyvraz
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects; D017024:Chemotherapy, Adjuvant; D005260:Female; D005500:Follow-Up Studies; D006499:Hepatic Artery / Q000187:drug effects; D006801:Humans; D007261:Infusions, Intra-Arterial; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000556:secondary*; D008297:Male; D008545:Melanoma / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy; D008875:Middle Aged; D009607:Nitrosourea Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D009943:Organophosphorus Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D012306:Risk; D055502:Secondary Prevention; D016019:Survival Analysis; D014604:Uveal Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy
chemical_list: D000970:Antineoplastic Agents; D009607:Nitrosourea Compounds; D009943:Organophosphorus Compounds; C054368:fotemustine