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

British Journal of Cancer
E ElezJosep Tabernero

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 wa...Continue Reading

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Citations

Oct 4, 2016·Clinical Pharmacokinetics·Amanda LongJohan Wallin
Jul 22, 2018·Expert Opinion on Drug Metabolism & Toxicology·Elizabeth Jiménez AguilarLuis Paz-Ares Rodríguez
Dec 7, 2018·Future Oncology·Asunción Díaz-SerranoLuis Paz-Ares
Sep 29, 2020·Frontiers in Immunology·Mohamed A AlfalehAnwar M Hashem
Dec 14, 2018·Future Oncology·Maya HabreHampig Raphael Kourie
Sep 6, 2020·Biomedicine & Pharmacotherapy = Biomédecine & Pharmacothérapie·Yi LuQinghua Yao

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