Cetuximab slightly increases overall survival in patients with non-small-cell lung cancer

A phase III study has shown that adding cetuximab to standard platinum-based chemotherapy for patients with non-small-cell lung cancer (NSCLC) extends survival of patients by just over one month compared with chemotherapy alone. Thus cetuximab represents a new treatment option for patients with NSCLC. The findings of the FLEX study are reported in an Article in this week’s edition of The Lancet, written by Professor Robert Pirker, Medical University of Vienna, Austria, and colleagues.

Cetuximab works by targeting epidermal growth factor receptor (EGFR), which is involved in the cell signaling machinery responsible for tumour growth. In this randomised trial, 1125 patients who had not previously had chemotherapy and were aged 18 years of over, with advanced NSCLC, were randomly assigned in a 1:1 ratio to chemotherapy (a combination of cisplatin and vinorelbine) plus cetuximab (557 patients), or chemotherapy alone (556). Cetuximab was continued after the end of chemotherapy until disease progression or unacceptable toxicity had occurred. The researchers found that survival was longer in the cetuximab group compared with the chemotherapy only group (11.3 months versus 10.1 months).

The authors conclude: “Cetuximab added to platinum-based chemotherapy can be regarded as a new standard first-line treatment option for patients with EGFR-expressing advanced non-small-cell lung cancer. Cetuximab also provides new opportunities for clinical research into the treatment of non-small-cell lung cancer at earlier stages.”

In an accompanying Comment, Dr Roy S Herbst, Department of Thoracic/Head and Neck Medical Oncology, University of Texas MD Anderson Cancer Center, Houston TX, USA, and Dr Fred R Hirsch, University of Colorado, Denver, CO, USA say: “Cetuximab potentially fills an unmet medical need for patients with advanced NSCLC... However, the size of the survival benefit in FLEX was small; additionally, the trial found that cetuximab had no effect on progression-free survival.”

They conclude: “Further biomarker studies will be important to try to understand exactly which patients will benefit most from any given therapy, and the development of new targeted agents will require this more personalised approach to cancer.”