Adding cetuximab to platinum-based chemotherapy improves survival for patients diagnosed with advanced non-small cell lung cancer of any subtype, according to a presentation at the annual meeting of the American Society of Clinical Oncology.

The large phase III study was the first to document that a targeted drug has a survival benefit as first-line treatment for all subtypes of non-small cell lung cancer. The study evaluated addition of cetuximab to the platinum-based chemotherapy regimen of cisplatin and vinorelbine.

"Patients with advanced non-small cell lung cancer [NSCLC] have limited treatment options and life expectancy is short, so the survival increase shown in this study is an important step for these patients" said Robert Pirker, MD, an associate professor of medicine at Medical University of Vienna in Austria and the study's lead author.

"These results clearly establish cetuximab in combination with chemotherapy as a new standard in first-line treatment of NSCLC."

The current standard of care for patients newly diagnosed with advanced disease is cisplatin or carboplatin combined with a "third-generation drug," namely, vinorelbine, gemcitabine, paclitaxel or docetaxel. Earlier studies of gefitinib and erlotinib did not show an additional benefit as part of first-line standard chemotherapy. These agents are currently approved for patients whose initial chemotherapy has failed.

In the current study, 1,125 patients in 30 countries were randomized to chemotherapy with cisplatin and vinorelbine alone (568) or chemotherapy plus cetuximab (557); 94 percent of patients had stage IV disease.

Overall survival was longer for patients who received cetuximab plus chemotherapy (11.3 months) compared with those receiving chemotherapy alone (10.1 months). Additionally, the response rate was better in combination arm (36.3 percent) than in the arm with chemotherapy alone (29.2 percent).

The benefit of cetuximab was seen in patients with all histological subtypes, including adenocarcinoma and squamous cell carcinoma, the two most common subtypes. Other targeted therapies for lung cancer have only proven effective against certain subtypes.

As expected, the most frequent side effect was an acne-like rash, which was manageable with medication. Moderate rashes were seen more frequently in patients receiving cetuximab (10.4 percent) than in patients receiving chemotherapy alone (0.2 percent).

The authors noted more studies will evaluate cetuximab for patients with earlier stages of the disease based on the positive findings of the current trial. Cetuximab may be tried in combination with chemotherapy or chemoradiotherapy for patients with locally advanced disease or as an additional treatment after surgery in patients with early-stage disease.