Medizinische Universität Graz Austria/Österreich - Forschungsportal - Medical University of Graz
Gewählte Publikation:
SHR Neuro Krebs Kardio Lipid Stoffw Microb
Fink, W; Zimpfer-Rechner, C; Thoelke, A; Figl, R; Kaatz, M; Ugurel, S; Schadendorf, D.
Clinical phase II study of pegylated liposomal doxorubicin as second-line treatment in disseminated melanoma.
Onkologie. 2004; 27(6):540-544
Doi: 10.1159/000081335
Web of Science
PubMed
FullText
FullText_MUG
- Co-Autor*innen der Med Uni Graz
- Ugurel-Becker Selma
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- Abstract:
- Background: Stage IV melanoma has a poor prognosis with a median survival of 3-11 months from diagnosis of distant metastases. Response rates in first-line regimens range around 15-20%. Non-responders have a median survival around 6 months. Currently, no second-line treatment in advanced melanoma has been established. Patients and Methods: In a clinical phase II study we evaluated the efficacy of liposomal doxorubicin (Caelyx(R)) in 30 patients (17 m, 13 f) with progressing metastatic melanoma who had failed a previous chemotherapy. Liposomal doxorubicin was given in an outpatient setting at a dose of 50 mg/m(2) i.v. on d1, d22, d43 and d64, subsequently at 40 mg/m(2) at d85 before first staging and in 4-week intervals thereafter. Treatment was very well tolerated with 100 cycles given in total. Response rate, survival time, time-to-progression and toxicity were assessed. Results: Erythrodysesthesia was the most severe toxicity in 6% at CTC grade 3. Liposomal doxorubicin was of limited clinical efficacy with 21 patients progressing within the first 12 weeks. However, 7 patients were treated 3-9 months and were stable for >90 days, achieving 5 SD, 1 PR and 1 CR. Median survival after initiation of second-line treatment was 214 days (95% CI: 151-304 days) with 7 patients surviving >300 and 5 patients >400 days. Conclusions: Liposomal doxorubin as monotherapy is well tolerated but of limited clinical efficacy. Whether the survival benefit of a significant proportion of patients (20%) holds true in larger cohorts and whether the efficacy of liposomal doxorubicin can be improved by combinations without compromising the low toxicity profile needs further studies.
- Find related publications in this database (using NLM MeSH Indexing)
- Adult -
- Aged -
- Antineoplastic Agents - administration and dosage
- Antineoplastic Combined Chemotherapy Protocols - administration and dosage
- Comorbidity -
- Doxorubicin - administration and dosage
- Drug Administration Schedule -
- Female -
- Female - epidemiology
- Hematologic Diseases - epidemiology
- Humans -
- Male -
- Melanoma - drug therapy Melanoma - mortality Melanoma - secondary
- Middle Aged -
- Neoplasms, Unknown Primary - drug therapy Neoplasms, Unknown Primary - mortality
- Palliative Care - methods
- Polyethylene Glycols -
- Risk Assessment - methods
- Risk Factors -
- Survival Analysis -
- Treatment Outcome -
- Find related publications in this database (Keywords)
- second-line treatment
- survival
- doxorubicin, pegylated liposomal
- melanoma