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Hauschild, A; Dummer, R; Ugurel, S; Kaehler, KC; Egberts, F; Fink, W; Both-Skalsky, J; Laetsch, B; Schadendorf, D.
Combined treatment with pegylated interferon-alpha-2a and dacarbazine in patients with advanced metastatic melanoma: a phase 2 study.
Cancer. 2008; 113(6):1404-1411
Doi: 10.1002/cncr.23722
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PubMed
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- Co-Autor*innen der Med Uni Graz
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Ugurel-Becker Selma
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- Abstract:
- BACKGROUND. Dacarbazine (DTIC) and pegylated interferon (IFN)-alpha-2a have both demonstrated some efficacy as single agents in metastatic melanoma. To the authors' knowledge, the current study is the first to test a combination of these 2 agents in a phase 2 trial. METHODS. Twenty-eight patients with stage IV melanoma without brain metastases were treated with DTIC (at a dose of 850 mg/m(2) every 3 weeks) combined with weekly pegylated IFN-alpha-2a at a dose of 180 mu g. The study was initiated to evaluate the efficacy and tolerability of the combination. The primary study end-point was objective response. RESULTS. Twenty-five patients were evaluable for response. Two patients (8.0%) achieved a complete response that continued for >480 days and 746 days, respectively. Four patients (16.0%) demonstrated a partial response, and another patient experienced stable disease. Six of 7 nonprogressive patients had either not received treatment or had not developed disease progression during adjuvant IFN treatment for stage II/III disease. The median duration of response was 236 days, the median progression-free survival was 56 days, and the overall survival time was 403 days. Few grade 3 toxicities and only 1 grade 4 toxicity were observed (according to National Cancer Institute Common Toxicity Criteria). CONCLUSIONS. The combination of DTIC and pegylated IFN-alpha-2a was found to be well tolerated in patients with metastatic melanoma. The response rate of 24%, including 2 long-lasting complete responses, is encouraging, but must be confirmed in larger trials.
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Adult -
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Aged -
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Antineoplastic Agents, Alkylating - therapeutic use
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Antiviral Agents - therapeutic use
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Bone Neoplasms - drug therapy Bone Neoplasms - secondary
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Dacarbazine - therapeutic use
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Drug Carriers -
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Drug Therapy, Combination -
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Female -
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Humans -
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Interferon Alfa-2a - therapeutic use
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Liver Neoplasms - drug therapy Liver Neoplasms - secondary
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Lung Neoplasms - drug therapy Lung Neoplasms - secondary
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Lymphatic Metastasis -
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Male -
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Melanoma - drug therapy Melanoma - pathology
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Middle Aged -
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Neoplasm Staging -
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Polyethylene Glycols - therapeutic use
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Prognosis -
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Prospective Studies -
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Survival Rate -
- Find related publications in this database (Keywords)
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dacarbazine
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pegylated interferon-alpha-2a
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metastatic melanoma
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response
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survival