Fibrinogen: A novel predictor of responsiveness in metastatic melanoma patients treated with bio-chemotherapy: IMI (Italian melanoma inter-group) trial

被引:6
作者
Michele Guida
Alessandra Ravaioli
Vanna Chiarion Sileni
Antonella Romanini
Roberto Labianca
Antonio Freschi
Salvatore Brugnara
Addolorata Casamassima
Vito Lorusso
Oriana Nanni
Ruggero Ridolfi
机构
[1] Department of Medical Oncology, Oncology Institute, Bari
[2] Istituto Oncologico Romagnolo, Forlì
[3] Department of Medical Oncology, Busonera Hospital, Padova
[4] Oncology Department, S. Chiara Hospital, Pisa
[5] Department of Radiotherapy/Oncology, Riuniti Hospital, Bergamo
[6] Aviano Cancer Institute, Aviano
[7] Oncology Center, S. Chiara Hospital, Trento
[8] Laboratory Department, Immunology Unit, Oncology Institute, Bari
[9] Department of Medical Oncology, Pierantoni Hospital, Forlì
[10] Department of Medical Oncology, Busonera Hospital, Padua
[11] Medical Oncology Unit, S. Chiara Hospital, Pisa
[12] Medical Oncology Unit, Riuniti Hospital, Bergamo
[13] Medical Oncology Unit, Monteluce Polyclinic, Perugia
[14] Department of Medical Oncology, Ragusa Hospital, Ragusa
[15] Medical Oncology Center, Sant'Anna Hospital, Como
[16] Medical Oncology Unit, S. Giacomo Apostolo Hospital, Castelfranco Veneto
[17] Oncology Outpatient Clinic, B. Ramazzini Hospital, Carpi, Modena
[18] Dept. of Med. Oncol./Oncohematology, University of Palermo, Palermo
[19] Department of Medical Oncology, A. Businco Hospital, Cagliari
[20] Department of Oncology, Castelli Hospital, Verbania
[21] Dept. of Medical Oncology/Hematology, Mantova
[22] Department of Medical Oncology III, A. Businco Hospital, Cagliari
[23] Oncology Unit, per gli Infermi Hospital, Faenza
[24] Department of Oncology I, Polyclinic Inst. San Donato Milan, Milan
[25] Oncology Center, Riuniti Hospital, Livorno
[26] Inst. of Hematology/Medical Oncology, University of Bologna, Bologna
[27] Dept. of Oncology Biology/Genetics, University of Genoa, Natl. Institute for Cancer Research, Genoa
关键词
Overall Survival; Fibrinogen; CDDP; Metastatic Melanoma; BCNU;
D O I
10.1186/1479-5876-1-13
中图分类号
学科分类号
摘要
Purpose. To evaluate a panel of pretreatment clinical and laboratory parameters in metastatic melanoma (MM) in order to verify their impact on response and survival in a single prospective multi-institutional phase III study comparing out-patient chemotherapy (CT) vs bioCT. Methods. A total of 176 patients were randomised to receive CT (cisplatin, dacarbazine, optional carmustine) or bioCT (the same CT followed by subcutaneous IL-2 plus intramuscular a-IFN-2b). Pretreatment total leucocytes, lymphocytes, eosinophyls, C-reactive protein (CRP), lactate dehydrogenase (LDH), erytrosedimentation rate (ESR), and fibrinogen were analyzed. Some clinical parameters (performance status, age, sex, and disease site) were also considered. As we found a positive trend for bio-CT with no statistical significance in OR (25.3% vs 20.2%) and OS (11 Mo vs 9.5 Mo), all analyses are stratified by treatment arm. Results. In univariate analysis, higher value of lymphocytes percentage (P < .0001), lower value of total leucocytes (P=.005), CRP (P=.003), LHD (P < .0001), ESR (P < .027), fibrinogen (P < .0001), and no liver disease were strongly related to a better survival. In a multivariate analysis, using the Cox proportional hazards model, only fibrinogen (P=.004), LDH (P=.009) and liver disease (P=.04) were found to have an independent role on clinical outcome in metastatic melanoma patients. Conclusion. Liver disease and higher LDH and fibrinogen levels had an important impact on survival in MM patients. In particular, fibrinogen has been recently reconsidered both for its determinant role in the host hemostatic system, and for its capability to provide protection against NK and LAK-cell-induced lysis. These observations could have some important implications for therapeutic approaches, in particular when immunological strategies are used. © 2003 Guida et al; licensee BioMed Central Ltd.
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