title: Second-line chemotherapy of metastatic malignant melanoma with intravenous treosulfan: a phase II multicentre trial.
abstract: The purpose of this multicentre phase II trial was to evaluate time to progression, survival time, rate of objective tumour response and toxicity of second-line intravenous treosulfan chemotherapy in stage IV melanoma patients. Thirty-one patients with measurable stage IV malignant melanoma and prior chemotherapy with a dacarbazine-containing regimen were included. Of this group, 26 patients were evaluable. All patients received treosulfan (8 g/m intravenously on day 1; cycle repeated every 28 days up to six courses). Patients were evaluated for tumour response, survival time and toxicity. No objective responses (complete or partial) were observed. Five patients (19%) showed no change and 21 had progressive disease after treosulfan treatment. Four patients experienced a minor or mixed response. The median time to progression was 1.8 months (95% confidence interval [CI] 1.6-2.1 months) and the median overall survival was 6.5 months (95% CI 3.1-10 months). The 1 year survival rate was 33.9% (95% CI 15.4-52.3%). Leukocytopenia and thrombocytopenia (Common Toxicity Criteria grades 3 and 4) occurred in 15% and 18% of cases, respectively. The non-haematological toxicity of this outpatient regimen was mild. In conclusion, intravenous treosulfan treatment does not induce objective response rates when used as a second-line treatment of metastatic malignant melanoma.
authors.affiliation: Department of Dermatology, University Hospital Hamburg, Martinistr. 52, D-20246 Hamburg, Germany. neuber@uke.uni-hamburg.de
authors.forename: Karsten
authors.initials: K
authors.lastname: Neuber
authors.forename: Uwe
authors.initials: U
authors.lastname: Reinhold
authors.forename: Andrea
authors.initials: A
authors.lastname: Deutschmann
authors.forename: Claudia
authors.initials: C
authors.lastname: Pföhler
authors.forename: Peter
authors.initials: P
authors.lastname: Mohr
authors.forename: Uwe
authors.initials: U
authors.lastname: Pichlmeier
authors.forename: Joachim
authors.initials: J
authors.lastname: Baumgart
authors.forename: Axel
authors.initials: A
authors.lastname: Hauschild
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018906:Antineoplastic Agents, Alkylating / Q000009:adverse effects / Q000627:therapeutic use*; D002066:Busulfan / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D018450:Disease Progression; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008545:Melanoma / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary; D008875:Middle Aged; D009367:Neoplasm Staging; D016879:Salvage Therapy; D012878:Skin Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D015996:Survival Rate; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D018906:Antineoplastic Agents, Alkylating; C018404:treosulfan; D002066:Busulfan