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Posted by on Apr 21, 2016 in Colorectal cancer | 0 comments

In a nutshell

This study investigated the efficacy of necitumumab (Portrazza) and chemotherapy combined treatment for locally advanced (spread to the lymph nodes) or metastatic (spread to other areas of the body) colorectal cancer.

Researchers suggested that this combination was effective in patients who had not previously been treated, with manageable side effects. 

Some background

A genetic mutation (change) in the epidermal growth factor receptor (EGFR) has been associated with tumor growth. EGFR inhibitors are therapies that block the activity of EGFR, slowing tumor growth. EGFR inhibitors such as cetuximab (Erbitux) have been shown to be effective when combined with the chemotherapy FOLFOX. FOLFOX is a combination of the chemotherapies oxaliplatin (Eloxatin), folinic acid, and 5-fluorouracil (Efudex).

Necitumumab is a newer EGFR inhibitor. It is not clear whether necitumumab is effective when combined with FOLFOX in patients with locally advanced or metastatic colorectal cancer. 

Methods & findings

This study investigated the efficacy of necitumumab in combination with chemotherapy for treatment of colorectal cancer. This study included 44 patients with advanced colorectal cancer who had not undergone previous treatment. Patients were treated with necitumumab in combination with FOLFOX chemotherapy. Patients underwent a CT scan or MRI (method of imaging that uses magnetic fields) of the tumor every 8 weeks.

Overall survival (OS; time from beginning the trial to death from any cause), progression free survival (PFS; time to disease progression), objective response rate (ORR; number of patients whose tumors decreased by 50% or disappeared) and serious adverse effects were evaluated.

The ORR of was 63.3%. The OS was 22.5 months and the PFS was 10 months.

Common non-severe negative effects of the treatment included a lack of energy and strength (81.8%), diarrhea (54.5%), low levels of white blood cells (52.3%), and rash (70.5%). Common severe side effects included low levels of white blood cells (29.5%), lack of energy and strength (27.3%), and rash (20.5%). There were no deaths related to necitumumab.

The bottom line

This study concluded that a combination of necitumumab and chemotherapy was effective as a first-line treatment for locally advanced and metastatic colorectal cancer. The negative effects of the treatment were manageable.

The fine print

This study was funded by Eli Lilly and Company, the manufacturers of necitumumab.

Published By :

British Journal of Cancer

Date :

Jan 14, 2016

Original Title :

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

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