Comparing gene-targeting therapy to standard chemotherapy in patients with early stage NSCLC

This study compared gefitinib (Iressa) to cisplatin (Platinol)-based chemotherapy for treating patients with EGFR-mutation positive, early stage non-small-cell lung cancer, after surgery. The authors concluded that while treatment with gefitinib improved disease free survival compared to chemotherapy, they were unable to calculate overall survival and more study is needed.

Ideally, surgery is the first option to treat early non-small-cell lung cancer (NSCLC). Patients are then treated with follow-up chemotherapy with cisplatin and vinorelbine (Navelbine) to improve the treatment overall. More effective treatments are required however.

Genetic mutations (changes) in a gene called EGFR can be involved in cancer. EGFR-TKIs such as gefitinib are anti-cancer drugs which work by targeting this mutation specifically. It is possible that treating EGFR-mutation positive patients with gefitinib after surgery may be more beneficial than chemotherapy.

This trial compared the effectiveness of gefitinib and cisplatin-based chemotherapy in treating patients with early stage, EGFR-mutation positive NSCLC after surgery. Patients who had undergone surgery for tumor removal were treated with either gefitinib or cisplatin and vinorelbine. Follow-ups were carried out every 12 weeks until disease progression or death. 

222 patients were included. 111 group 1 patients were treated with gefitinib while 111 group 2 patients were treated with cisplatin and vinorelbine. Average follow-up was 36.5 months.

By the end of the trial, 59% of group 1 and 53% of group 2 patients had relapsed or died.

Average disease free survival (DFS, time from beginning until disease relapse) for significantly longer for group 1 patients (28.7 months) compared to group 2 patients (18 months). 

58% of group 1 patients experienced side effects while 80% of group 2 patients experience side effects. For group 1 patients the most common serious side effects were related to liver damage. For group 2 patients the most common serious side effects were reduced immune cells and vomiting.

The authors concluded that there was an improvement in DFS for patients treated with gefitinib compared to chemotherapy.

The study was unable to calculate overall survival and therefore more research is needed to determine whether gefitinib would be more beneficial than chemotherapy.