Phase II study of necitumumab plus modified FOLFOX6 as first-line treatment in patients with locally advanced or metastatic colorectal cancer
Elez, Elena (Vall d'Hebron Institut d'Oncologia)
Hendlisz, A. (Institut Jules Bordet (Belgium))
Delaunoit, T. (Centres Hospitaliers Jolimont (Belgium))
Sastre Valera, Javier (Hospital Clínico San Carlos (Madrid))
Cervantes, Andrés (Instituto de Investigación Sanitaria INCLIVA (València, Comunitat Valenciana))
Varea, R. (Eli Lilly and Company (Spain))
Chao, G. (Eli Lilly and Company (USA))
Wallin, J. (Eli Lilly and Company (Suècia))
Tabernero, Josep (Vall d'Hebron Institut d'Oncologia)
Universitat Autònoma de Barcelona

Data:	2016
Resum:	This single-arm phase II study investigated the EGFR monoclonal antibody necitumumab plus modified FOLFOX6 (mFOLFOX6) in first-line treatment of locally advanced or metastatic colorectal cancer (mCRC). Patients received 800-mg intravenous necitumumab (day 1; 2-week cycles), followed by oxaliplatin 85 mg m −2, folinic acid 400 mg m −2, and 5-fluorouracil (400 mg m −2 bolus then 2400 mg m −2 over 46 h). Radiographic evaluation was performed every 8 weeks until progression. Primary endpoint was objective response rate. Forty-four patients were enrolled and treated. Objective response rate was 63. 6% (95% confidence interval 47. 8-77. 6); complete response was observed in four patients; median duration of response was 10. 0 months (7. 0-16. 0). Median overall survival (OS) and progression-free survival (PFS) were 22. 5 (11. 0-30. 0) and 10. 0 months (7. 0-12. 0), respectively. Clinical outcome was better in patients with KRAS exon 2 wild type (median OS 30. 0 months (23. 0-NA); median PFS 12. 0 (8. 0-20. 0)), compared with KRAS exon 2 mutant tumours (median OS 7. 0 months (5. 0-37. 0); median PFS 7. 0 (4. 0-18. 0)). The most common grade ⩾3 adverse events were neutropenia (29. 5%), asthenia (27. 3%), and rash (20. 5%). First-line necitumumab+mFOLFOX6 was active with manageable toxicity in locally advanced or mCRC; additional evaluation of the impact of tumour RAS mutation status is warranted.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Advanced colorectal cancer ; Modified FOLFOX6 ; Necitumumab ; KRAS ; EGFR
Publicat a:	British Journal of Cancer, Vol. 114 (February 2016) , p. 372-380, ISSN 1532-1827

DOI: 10.1038/bjc.2015.480
PMID: 26766738

9 p, 306.4 KB

El registre apareix a les col·leccions:
Articles > Articles de recerca
Articles > Articles publicats