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Multicentre, open, noncomparative Phase II trial to evaluate the efficacy and tolerability of fotemustine, cisplatin, alpha-interferon and interleukin-2 in advanced melanoma patients.
- Source :
-
Melanoma research [Melanoma Res] 2009 Apr; Vol. 19 (2), pp. 100-5. - Publication Year :
- 2009
-
Abstract
- The efficacy and tolerability of fotemustine, cisplatin, alpha-interferon and interleukin-2 biochemotherapy were evaluated in advanced melanoma patients. The schedule consisted of fotemustine (100 mg/m) and cisplatin (75 mg/m) intravenous on day 1, followed by subcutaneous interleukin-2 at a dose of 4.5 MIU on days 3-5 and 8-12 and alpha-interferon at a dose of 3 MU three times/week, every 3 weeks for six cycles. Sixty patients were evaluated for tumour response, 12 of whom had brain metastases (BM). One patient (1.7%) with BM achieved a complete response and partial responses were observed in 10 patients (16.7%), including one BM patient. Overall response rate was 18.4 and 16.6% in BM patients (median response duration 8.2 months). Disease control, defined as overall response and stable disease, was 58.4% in all patients and 75% in patients with BM. Median time to progression was 3.2 months (4.2 months in BM patients). Median overall survival was 8.9 months (7.6 months in BM patients). Toxic events were mild to moderate. This combination was well tolerated and showed acceptable clinical activity, especially in BM patients.
- Subjects :
- Adult
Aged
Antineoplastic Combined Chemotherapy Protocols adverse effects
Brain Neoplasms drug therapy
Brain Neoplasms secondary
Cisplatin administration & dosage
Cisplatin adverse effects
Combined Modality Therapy
Disease Progression
Female
Humans
Immunologic Factors administration & dosage
Immunologic Factors adverse effects
Interferon-alpha administration & dosage
Interferon-alpha adverse effects
Interleukin-2 administration & dosage
Interleukin-2 adverse effects
Male
Melanoma mortality
Melanoma secondary
Middle Aged
Nitrosourea Compounds administration & dosage
Nitrosourea Compounds adverse effects
Organophosphorus Compounds administration & dosage
Organophosphorus Compounds adverse effects
Salvage Therapy
Skin Neoplasms mortality
Survival Analysis
Antineoplastic Combined Chemotherapy Protocols therapeutic use
Immunologic Factors therapeutic use
Immunotherapy adverse effects
Interferon-alpha therapeutic use
Interleukin-2 therapeutic use
Melanoma drug therapy
Skin Neoplasms drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1473-5636
- Volume :
- 19
- Issue :
- 2
- Database :
- MEDLINE
- Journal :
- Melanoma research
- Publication Type :
- Academic Journal
- Accession number :
- 19262411
- Full Text :
- https://doi.org/10.1097/CMR.0b013e328328f7ec