Iressa does not improve survival for patients with the most common form of lung cancer

October 27, 2005

A randomised trial in this week's issue of The Lancet has found that the lung cancer drug Iressa (gefitinib) is not associated with a significant improvement in survival for people with non-small cell lung cancer (NSCLC). However, the study did find some evidence of benefit among never-smokers and patients of Asian origin.

Lung cancer causes more than 1 million cancer related deaths each year worldwide; NSCLC accounts for 80% of all lung cancer. With current first-line chemotherapy regimens median survival is 7-10 months. However, for patients who have chemotherapy resistant disease, treatment options are limited and new therapies are needed. Iressa was approved in a number of countries for the treatment of NSCLC after two trials showed that the drug could improve tumour shrinkage in previously treated patients with advanced NSCLC.

Nick Thatcher (Christie Hospital, Manchester, UK) and colleagues recruited 1692 patients with chemotherapy resistant disease from 210 centres in 28 countries into the trial. 1129 patients were assigned to receive Iressa and 563 a placebo. The investigators found that survival did not differ significantly between the two groups. However, when the researchers looked at subgroups of the participants they found that the drug significantly improved the median survival by 4 months for patients of Asian origin and by 2.8 months for patients who had never smoked.

Professor Thatcher comments: "While the result is disappointing, in that gefitinib was not associated with a significant improvement in survival in a general population of NSCLC patients, there was an increase in survival in patients of Asian origin and in patients who never smoked. We now need to find pragmatic ways of identifying which patients are more likely to benefit with these new treatments." (Quote by e-mail; does not appear in paper)

In an accompanying comment Roy Herbst (Anderson Cancer Center, Texas, USA) states: "EGFR inhibitors, including gefitinib, certainly have a role in the management of selected patients with lung cancer but, it will now be important to conduct prospective studies to identify and validate the molecular markers which predict for their maximal effect" (Quote by e-mail; does not appear in published comment)
-end-
Contact: Professor Nicholas Thatcher, Department of Medical Oncology, Christie Hospital, Wilmslow Rd, Withington, MANCHESTER, M20 4BX, UK. T) +44 (0) 161 446 3745 Nick.Thatcher@christie-tr.nwest.nhs.uk

Comment: Dr Roy Herbst, Dept. of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX 77030, USA. T) 713-792-6363 rherbst@mdanderson.org

Lancet

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