Erlotinib versus chemotherapy as first-line treatment for patients with advanced EGFR-positive non-small cell lung cancer

This phase III trial compared chemotherapy to erlotinib (Tarceva) as first line treatment for EGFR-positive non-small cell lung cancer (NSCLC) patients. The safety and efficacy of the treatments were compared to decide which treatment is most beneficial for advanced cancer patients.

Non-small-cell lung cancer (NSCLC) cells may contain different genetic mutations that cause these cells to divide and spread rapidly, promoting tumor formation. A mutation in the epidermal growth factor receptor (EGFR) gene is responsible for one form of NSCLC in which cells over-produce the EGFR protein. Patients with EGFR-positive NSCLC respond to treatment with a class of drugs known as tyrosine kinase inhibitors (TKIs). TKIs, such as erlotinib or gefitinib (Iressa), block the stimulating action of the EGFR protein on cellular growth.

Erlotinib has been shown to improve progression free survival (PFS; the amount of time until the disease worsens or progresses) compared with chemotherapy in several Asian trials, but no study to date has shown a similar benefit for patients in Europe or the United States.

This trial included 173 patients with advanced EGFR-positive NSCLC from 43 medical centers in Europe. 86 patients were randomly assigned to receive erlotinib as first line treatment (initial treatment of choice), while 87 patients were assigned to receive standard chemotherapy.

Results showed that erlotinib significantly increased PFS compared to chemotherapy. PFS was 9.7 months for patients treated with erlotinib, compared to a PFS of 5.2 months for patients treated with standard chemotherapy.

However, both treatments were associated with side effects (toxicities). A rash was reported in 13% of patients given erlotinib compared to none of none patients treated with chemotherapy. Neutropenia (a dangerously low white blood cell count) was reported in 22% of patients receiving chemotherapy compared to none of the patients receiving erlotinib.

This trial concluded that tyrosine kinase inhibitors, such as erlotinib, were more beneficial than chemotherapy as first line treatment for patients with advanced EGFR-positive NSCLC.

Larger trials comparing erlotinib to standard chemotherapy are needed to confirm these results.

This study was partially funded by Hoffmann-La Roche, the manufacturers and distributors of erlotinib (tarceva) in Europe.

Consult with your physician regarding the benefits of erlotinib in the treatment of EGFR-positive non-small cell lung cancer.