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Oral drug as effective as IV chemotherapy

AstraZeneca’s anticancer drug gefitinib (Iressa) is as effective asintravenous chemotherapy (docetaxel) at improving overall survival innon-small-cell lung cancer (NSCLC) patients, phase III trial resultsshow

AstraZeneca’s anticancer drug gefitinib (Iressa) is as effective as intravenous chemotherapy (docetaxel) at improving overall survival in non-small-cell lung cancer (NSCLC) patients, phase III trial results show (Lancet 2008;372:1809).

The researchers say that this is the first time a targeted therapy has shown non-inferior overall survival to chemotherapy in patients with pre-treated advanced NSCLC. In the study, gefitinib also had a more favourable tolerability profile than docetaxel.

The phase III study evaluated survival with gefitinib, a tyrosine kinase inhibitor, versus docetaxel in 1,466 previously treated patients with locally advanced or metastatic recurrent NSCLC.

Median overall survival was 7.6 months in the gefitinib group and 8.0 months in the docetaxel group; one year survival was 32 per cent and 34 per cent, respectively. Median progression-free survival was similar for each anticancer drug.

Certain subgroups were expected to benefit more from gefitinib therapy but this was not observed.

AstraZeneca filed for approval for gefitinib with the European Medicines Agency in May 2008 for the treatment of locally advanced or metastatic NSCLC pretreated with platinum chemotherapy, based on phase III data from this trial.

In a previous phase III trial, which compared gefitinib and placebo in predominantly refractory patients unsuitable for further chemotherapy, gefitinib did not show a significant improvement in overall survival compared with placebo.

Citation: The Pharmaceutical Journal URI: 10040580

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