Clinical phase II study of pegylated liposomal doxorubicin as second-line treatment in disseminated melanoma
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 ha...
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| Main Authors: | , , , , |
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| Format: | Article (Journal) |
| Language: | English |
| Published: |
December 08, 2004
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| In: |
Onkologie
Year: 2004, Volume: 27, Issue: 6, Pages: 540-544 |
| ISSN: | 1423-0240 |
| DOI: | 10.1159/000081335 |
| Online Access: | Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1159/000081335 Verlag, lizenzpflichtig, Volltext: https://www.karger.com/Article/FullText/81335 
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| Author Notes: | W. Fink, C. Zimpfer-Rechner, A. Thoelke, R. Figl, M. Kaatz, S. Ugurel, D. Schadendorf |
| Summary: | 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?) 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/m2 i.v. on d1, d22, d43 and d64, subsequently at 40 mg/m2 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. |
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| Item Description: | Gesehen am 11.12.2020 |
| Physical Description: | Online Resource |
| ISSN: | 1423-0240 |
| DOI: | 10.1159/000081335 |