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.
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Authors | Karsten Neuber, Uwe Reinhold, Andrea Deutschmann, Claudia Pföhler, Peter Mohr, Uwe Pichlmeier, Joachim Baumgart, Axel Hauschild |
Journal | Melanoma research
(Melanoma Res)
Vol. 13
Issue 1
Pg. 81-5
(Feb 2003)
ISSN: 0960-8931 [Print] England |
PMID | 12569289
(Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antineoplastic Agents, Alkylating
- treosulfan
- Busulfan
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Topics |
- Adult
- Aged
- Aged, 80 and over
- Antineoplastic Agents, Alkylating
(adverse effects, therapeutic use)
- Busulfan
(adverse effects, analogs & derivatives, therapeutic use)
- Disease Progression
- Female
- Humans
- Infusions, Intravenous
- Male
- Melanoma
(drug therapy, mortality, secondary)
- Middle Aged
- Neoplasm Staging
- Salvage Therapy
- Skin Neoplasms
(drug therapy, mortality, pathology)
- Survival Rate
- Time Factors
- Treatment Outcome
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