Jun 12, 2015

Negative results of CETUXIMAB


The Journal of Clinical Oncology has removed an editorial about a clinical study that analyses the efficacy of cetuximab (Erbitux, Merck in Europe; Bristol-Myers Squibb/Eli Lily in the United States) in the treatment of a particular type of metastatic colorectal cancer (CRC).

The article was available online since November 17th in the section of the journal called Comments and Controversies, and then it was withdrawn. It was reposted on November 28th without any changes and enclosed a note from the editor explaining the reasons why no corrections were needed.

The article was written by three international academics: Bernard Nordlinger (France), Graeme J. Poston (United Kingdom) and Richard M. Goldberg (Ohio).

They stated that the results of the study using a new Eloxatin Peri-Operative Chemotherapy (EPOC), which were published earlier this year (Lancet Oncology. 2014;15:601-611), should not change clinical practice.

New EPOC, used in the treatment of metastatic CRC, was limited to operable colorectal liver metastases, and it demonstrated that the addition of cetuximab to surgery and chemotherapy shortened progression-free survival.

Although negative results have been obtained, the authors think that this isn’t a reason to discourage clinicians from using cetuximab in this situation.

In addition, the authors said that "three other published studies examining preoperative cetuximab in this setting" have all "found benefit with the addition of cetuximab."

"We believe that confirmatory clinical trials are needed before clinicians should act on these findings," the authors concluded.

Multiple Factual Errors; Repost Next Week 

The article had multiple errors according to an official from Cancer Research UK, which sponsored the New EPOC study.

"We have been advised that the commentary contains factual errors and speculation. The [New EPOC] authors will produce a rebuttal to JCO in due course, preferably when the commentary is revised to remove the errors of fact," said Kate Law, Cancer Research UK's director of clinical trials, in an email to Medscape Medical News.

A member of the American Society of Clinical Oncology, which publishes the Journal of Clinical Oncology, stated that the article would be reposted next week, including the reasons for removing it, as well as its corrections.

Cetuximab has been approved by the US Food and Drug Administration for use in patients with metastatic CRC without the KRAS mutation (wild-type), and whose tumors express the epidermal growth factor receptor (EGFR) protein. Moreover, the drug is compatible with the use of chemotherapy.

In Europe, the drug is approved for EGFR-expressing RAS wild-type metastatic CRC.

The New EPOC study focused on patients with CRC metastases limited to the liver.

The use of cetuximab in this setting cannot be recommended. 

In the study, patients were randomly assigned to chemotherapy with or without cetuximab for 12 weeks, followed by surgery and then a further 12 weeks of chemotherapy with or without cetuximab.

The chemotherapy backbone was either oxaliplatin and fluorouracil or oxaliplatin and capecitabine.

Progression-free survival was significantly shorter in the chemotherapy-plus-cetuximab group than in the chemotherapy-alone group.

The researchers conclude that "the use of cetuximab in this setting cannot be recommended."

Written by Dr. David Alcantara and Paula RuĂ­z for The All Results Journals.

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