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Phase II study of necitumumab plus modified FOLFOX6 as first-line treatment in patients with locally advanced or metastatic colorectal cancer
Élez Fernández, Mª Elena (Vall d'Hebron Institut d'Oncologia (VHIO))
Hendlisz, A. (Institut Jules Bordet (Belgium))
Delaunoit, T. (Centres Hospitaliers Jolimont (Belgium))
Sastre, J. (Hospital Universitario San Carlos)
Cervantes, A. (Universitat de València. INCLIVA Institut d'Investigació Sanitària)
Varea, R. (Eli Lilly and Company (Spain))
Chao, G. (Eli Lilly and Company (USA))
Wallin, J. (Eli Lilly and Company (Suècia))
Tabernero Caturla, Josep (Vall d'Hebron Institut d'Oncologia (VHIO))
Universitat Autònoma de Barcelona

Date: 2016
Abstract: 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.
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Language: Anglès.
Document: article ; recerca ; publishedVersion
Subject: Advanced colorectal cancer ; Modified FOLFOX6 ; Necitumumab ; KRAS ; EGFR
Published in: 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

The record appears in these collections:
Articles > Research articles
Articles > Published articles

 Record created 2018-02-07, last modified 2019-05-18

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