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Randomized phase II study of cetuximab plus cisplatin/vinorelbine compared with cisplatin/vinorelbine alone as first-line therapy in EGFR-expressing advanced non-small-cell lung cancer

Rosell, R. ; Robinet, G. ; Szczesna, A. ; Ramlau, R. ; Constenla, M. ; Mennecier, B. C. ; Pfeifer, W. ; O'Byrne, K. J. ; Welte, T. ; Kolb, R. ; Pirker, R. ; Chemaissani, A. ; Perol, M. ; Ranson, M. R. ; Ellis, P. A. ; Pilz, K. ; Reck, M.

Annals of oncology, 2008-02, Vol.19 (2), p.362-369 [Periódico revisado por pares]

Oxford: Oxford University Press

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Título:
Randomized phase II study of cetuximab plus cisplatin/vinorelbine compared with cisplatin/vinorelbine alone as first-line therapy in EGFR-expressing advanced non-small-cell lung cancer
Autor: Rosell, R. ; Robinet, G. ; Szczesna, A. ; Ramlau, R. ; Constenla, M. ; Mennecier, B. C. ; Pfeifer, W. ; O'Byrne, K. J. ; Welte, T. ; Kolb, R. ; Pirker, R. ; Chemaissani, A. ; Perol, M. ; Ranson, M. R. ; Ellis, P. A. ; Pilz, K. ; Reck, M.
Assuntos: Adult ; Aged ; Antibodies, Monoclonal - administration & dosage ; Antibodies, Monoclonal - adverse effects ; Antibodies, Monoclonal, Humanized ; Antineoplastic agents ; Antineoplastic Combined Chemotherapy Protocols - administration & dosage ; Antineoplastic Combined Chemotherapy Protocols - adverse effects ; Biological and medical sciences ; Carcinoma, Non-Small-Cell Lung - drug therapy ; Carcinoma, Non-Small-Cell Lung - mortality ; Carcinoma, Non-Small-Cell Lung - pathology ; Cetuximab ; cisplatin ; Cisplatin - administration & dosage ; Cisplatin - adverse effects ; Confidence Intervals ; Dose-Response Relationship, Drug ; Drug Administration Schedule ; epidermal growth factor receptor ; Female ; first-line ; Follow-Up Studies ; Humans ; Lung Neoplasms - drug therapy ; Lung Neoplasms - mortality ; Lung Neoplasms - pathology ; Male ; Maximum Tolerated Dose ; Medical sciences ; Middle Aged ; Neoplasm Invasiveness - pathology ; Neoplasm Staging ; NSCLC ; Pharmacology. Drug treatments ; Pneumology ; Probability ; Reference Values ; Risk Assessment ; Survival Analysis ; Treatment Outcome ; Tumors of the respiratory system and mediastinum ; Vinblastine - administration & dosage ; Vinblastine - adverse effects ; Vinblastine - analogs & derivatives ; Vinorelbine
É parte de: Annals of oncology, 2008-02, Vol.19 (2), p.362-369
Notas: istex:BD642849AC5EF304AE8CEED582177B887185DEDC
ark:/67375/HXZ-7H6F3CHP-M
Descrição: Background: The Lung Cancer Cetuximab Study is an open-label, randomized phase II pilot study of cisplatin and vinorelbine combined with the epidermal growth factor receptor (EGFR)-targeted monoclonal antibody cetuximab versus cisplatin and vinorelbine alone, in patients with advanced EGFR-expressing, non-small-cell lung cancer (NSCLC). End points of the study are activity, safety and pharmacokinetics. Patients and methods: Following randomization, for a maximum of eight cycles, patients received three-weekly cycles of cisplatin (80 mg/m2, day 1) and vinorelbine (25 mg/m2 on days 1 and 8) alone or following cetuximab treatment (initial dose 400 mg/m2, followed by 250 mg/m2 weekly thereafter). Results: Eighty-six patients were randomly allocated to the study (43 per arm). Confirmed response rates were 28% in the cisplatin/vinorelbine arm (A) and 35% in the cetuximab plus cisplatin/vinorelbine arm (B). Median progression-free survival (PFS) was 4.6 months in arm A and 5.0 months in arm B, with PFS rates at 12 months of 0% and 15%, respectively. Median survival was 7.3 months in arm A and 8.3 months in arm B. The 24-month survival rates were 0% and 16%, respectively. The cetuximab combination was well tolerated. Conclusion: In the first-line treatment of advanced NSCLC, the combination of cetuximab plus cisplatin/vinorelbine demonstrated an acceptable safety profile and the potential to improve activity over cisplatin/vinorelbine alone.
Editor: Oxford: Oxford University Press
Idioma: Inglês

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Randomized phase II study of cetuximab plus cisplatin/vinorelbine compared with cisplatin/vinorelbine alone as first-line therapy in EGFR-expressing advanced non-small-cell lung cancer

Rosell, R. ; Robinet, G. ; Szczesna, A. ; Ramlau, R. ; Constenla, M. ; Mennecier, B. C. ; Pfeifer, W. ; O'Byrne, K. J. ; Welte, T. ; Kolb, R. ; Pirker, R. ; Chemaissani, A. ; Perol, M. ; Ranson, M. R. ; Ellis, P. A. ; Pilz, K. ; Reck, M.

Oxford: Oxford University Press

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