Phase II study of necitumumab plus modified FOLFOX6 as first-line treatment in patients with locally advanced or metastatic colorectal cancer

E. Elez, A. Hendlisz, T. Delaunoit, J. Sastre, A. Cervantes, R. Varea, G. Chao, J. Wallin, J. Tabernero

Research output: Contribution to journalArticleResearchpeer-review

16 Citations (Scopus)

Abstract

© 2016 Cancer Research UK. All rights reserved. Background: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).Methods: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.Results: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%).Conclusion: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.
Original languageEnglish
Pages (from-to)372-380
JournalBritish Journal of Cancer
Volume114
Issue number4
DOIs
Publication statusPublished - 1 Feb 2016

Keywords

  • advanced colorectal cancer
  • EGFR
  • KRAS
  • modified FOLFOX6
  • necitumumab

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