Reference Detail

Ref Type Journal Article
PMID (26766738)
Authors Elez E, Hendlisz A, Delaunoit T, Sastre J, Cervantes A, Varea R, Chao G, Wallin J, Tabernero J
Title Phase II study of necitumumab plus modified FOLFOX6 as first-line treatment in patients with locally advanced or metastatic colorectal cancer.
Journal British journal of cancer
Vol 114
Issue 4
Date 2016 Feb 16
URL
Abstract Text 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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Molecular Profile Treatment Approach
Gene Name Source Synonyms Protein Domains Gene Description Gene Role
Therapy Name Drugs Efficacy Evidence Clinical Trials
Drug Name Trade Name Synonyms Drug Classes Drug Description
Variant Impact Protein Effect Variant Description Associated with drug Resistance
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
KRAS wild-type colorectal cancer predicted - sensitive Fluorouracil + Leucovorin + Necitumumab + Oxaliplatin Phase II Actionable In a Phase II clinical trial, the combination of Portrazza (necitumumab) and FOLFOX in colorectal cancer patients resulted in an objective response rate (ORR) of 63.6% (28/44) in the overall intent-to-treat population, with KRAS wild-type patients achieving an ORR of 87.5% (14/16), including complete response in 25% (4/16), and partial response in 62.5% (10/16) of patients (PMID: 26766738). 26766738
KRAS mutant colorectal cancer predicted - sensitive Fluorouracil + Leucovorin + Necitumumab + Oxaliplatin Phase II Actionable In a Phase II clinical trial, the combination of Portrazza (necitumumab) and FOLFOX in colorectal cancer patients resulted in an objective response rate (ORR) of 63.6% (28/44) in the overall intent-to-treat population, with an ORR of 56.5% (5/9; all partial responses), and stable disease in 44.4% (4/9) of KRAS-mutant patients (PMID: 26766738). 26766738