The INTEREST study

Design
The INTEREST (IRESSA Non-small-cell lung cancer Trial Evaluating REsponse and Survival against Taxotere) study was a randomised, open-label, parallel-group, phase III trial evaluating survival with IRESSA versus docetaxel in 1,466 patients with locally advanced or metastatic recurrent NSCLC who had previously received platinum-based chemotherapy. The primary endpoint of INTEREST was overall survival (OS), with the objective of demonstrating that IRESSA was non-inferior to docetaxel chemotherapy.1

Results
INTEREST demonstrated equivalent survival to docetaxel in patients with pre-treated advanced NSCLC. IRESSA is the only EGFR-TK inhibitor to have demonstrated non-inferior survival to chemotherapy in a head to head Phase III study in this setting. The study also showed that IRESSA has a more favourable tolerability profile and significantly more patients had a clinically meaningful and sustained quality of life improvement compared with docetaxel.1 Other studies in a similar patient population (SIGN and V-15-32) showed consistent results for IRESSA efficacy in comparison with docetaxel.2,3

References

1. Kim ES, et al. Gefitinib versus docetaxel in previously treated non-small-cell lung cancer (INTEREST): a randomised phase III trial. Lancet 2008;372:1809-1818.
2. Cufer T, Vrdoljak E, Gaafar R, et al. Phase II, open-label, randomized study (SIGN) of single-agent gefitinib (IRESSA) or docetaxel as second-line therapy in patients with advanced (stage IIIb or IV) non-small-cell lung cancer. Anticancer Drugs 2006;17:401-409.
3. Niho S, et al. Results of a randomized Phase III study to compare the overall survival of gefitinib (IRESSA) versus docetaxel in Japanese patients with non-small-cell lung cancer who failed one or two chemotherapy regimens. Abstract presented at American Society of Clinical Oncology (ASCO) 2007 Annual Meeting, Chicago, USA, 1-5 June 2007; abs 7509. J Clin Oncol Suppl, 2007.