title: Phase II trial of cisplatin, gemcitabine and treosulfan in patients with metastatic uveal melanoma.
abstract: Gemcitabine plus treosulfan (GeT) is under investigation in metastatic uveal melanoma. In this phase II trial, cisplatin was added to a GeT regimen to investigate the efficacy and toxicity of two alkylating agents in combination with gemcitabine. Patients received 30 or 40 mg/m of cisplatin, 1000 mg/m of gemcitabine and 3000 mg/m of treosulfan on days 1 and 8. Therapy was repeated on day 29. A maximum of six cycles was administered. Nineteen patients were included in the trial, of whom 17 were evaluable for response. No objective response was observed; seven patients (41%) had stable disease and 10 (59%) progressed. The median progression-free survival of all 19 patients was 3.0 months [95% confidence interval (CI), 1.8-3.1]; the median overall survival was 7.7 months (95% CI, 1.9-13.8). Grade 3 and 4 thrombopenia and leucopenia occurred in eight and nine of the 19 patients, respectively. The addition of cisplatin to the GeT regimen results in excessive haematological toxicity without improvement in efficacy.
authors.affiliation: Department of Internal Medicine III (Haematology, Oncology and Transfusion Medicine), Charité, Campus Benjamin Franklin, Hindenburgdamm 30, 12200 Berlin, Germany. alexander.schmittel@charite.de
authors.forename: Alexander
authors.initials: A
authors.lastname: Schmittel
authors.forename: Max E
authors.initials: ME
authors.lastname: Scheulen
authors.forename: Nikolaos E
authors.initials: NE
authors.lastname: Bechrakis
authors.forename: Dirk
authors.initials: D
authors.lastname: Strumberg
authors.forename: Joachim
authors.initials: J
authors.lastname: Baumgart
authors.forename: Norbert
authors.initials: N
authors.lastname: Bornfeld
authors.forename: Michael H
authors.initials: MH
authors.lastname: Foerster
authors.forename: Eckhard
authors.initials: E
authors.lastname: Thiel
authors.forename: Ulrich
authors.initials: U
authors.lastname: Keilholz
mesh_terms: D000328:Adult; D000368:Aged; D000740:Anemia / Q000139:chemically induced; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage; D018906:Antineoplastic Agents, Alkylating / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002066:Busulfan / Q000008:administration & dosage / Q000031:analogs & derivatives; D002945:Cisplatin / Q000008:administration & dosage; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D018450:Disease Progression; D005260:Female; D006801:Humans; D007970:Leukopenia / Q000139:chemically induced; D008297:Male; D008545:Melanoma / Q000188:drug therapy / Q000401:mortality / Q000556:secondary; D008875:Middle Aged; D016019:Survival Analysis; D013921:Thrombocytopenia / Q000139:chemically induced; D014604:Uveal Neoplasms / Q000188:drug therapy / Q000401:mortality / Q000473:pathology; D000093542:Gemcitabine
chemical_list: D000964:Antimetabolites, Antineoplastic; D018906:Antineoplastic Agents, Alkylating; D003841:Deoxycytidine; C018404:treosulfan; D002066:Busulfan; D002945:Cisplatin; D000093542:Gemcitabine