Abstract
Thirty-four evaluable patients with metastatic malignant melanoma were entered into a phase-II study designed to assess the response rate and analyze the long-term therapeutic efficacy of recombinant interferon (rIFN) alpha-2a and dacarbazine. Patients received 14 days of daily subcutaneous r-IFN alpha-2a (3 x 10(6) IU/day), followed by 9 x 10(6) IU on alternate days, as long as objective response lasted, in combination with i.v. dacarbazine started on day 7 (400 mg/m2) and repeated every 21 days (dacarbazine doses were escalated to 800 mg/m2). In 11 patients, 6 complete (17.6%) and 5 partial (14.7%) responses were seen, with an overall response rate of 32.3% (95% confidence interval: 16%-48%). The median survival time of the responding patients was significantly better than that of patients with progressive disease (P = 0.01) and the median response time of the patients showing complete response was longer than that of the partially responding patients (14 and 7 months respectively, P = 0.06).
Publication types
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Clinical Trial
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Clinical Trial, Phase II
MeSH terms
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Adult
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Aged
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Antineoplastic Combined Chemotherapy Protocols / administration & dosage
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Antineoplastic Combined Chemotherapy Protocols / adverse effects
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Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
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Bone Neoplasms / drug therapy
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Bone Neoplasms / mortality
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Bone Neoplasms / secondary
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Chi-Square Distribution
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Dacarbazine / administration & dosage
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Dacarbazine / adverse effects
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Dacarbazine / therapeutic use*
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Drug Synergism
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Female
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Humans
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Injections, Intravenous
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Injections, Subcutaneous
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Interferon alpha-2
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Interferon-alpha / administration & dosage
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Interferon-alpha / adverse effects
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Interferon-alpha / therapeutic use*
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Liver Neoplasms / drug therapy
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Liver Neoplasms / mortality
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Liver Neoplasms / secondary
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Lung Neoplasms / drug therapy
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Lung Neoplasms / mortality
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Lung Neoplasms / secondary
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Lymphatic Metastasis
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Male
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Melanoma / drug therapy*
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Melanoma / mortality
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Melanoma / secondary
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Middle Aged
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Prospective Studies
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Recombinant Proteins
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Skin Neoplasms / drug therapy
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Skin Neoplasms / mortality
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Skin Neoplasms / secondary
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Survival Analysis
Substances
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Interferon alpha-2
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Interferon-alpha
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Recombinant Proteins
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Dacarbazine