Oral gefitinib as effective as injected docetaxel for survival of lung cancer patients

November 20, 2008

Gefitnib is as effective a second-line treatment as docetaxel for patients with non-small cell* lung cancer. The INTEREST study, published in an Article in this week's edition of The Lancet, thus establishes gefitinib as a valid treatment option for people with this condition. The study was written by Dr Edward Kim, M. D. Anderson Cancer Center, Houston, Texas, USA and colleagues.

This randomised phase III study compares both treatments directly with one another, and analysed 1466 patients from 149 centres in 24 countries. All patients had non-small-cell lung cancer and had previously received at least one platinum-based chemotherapy regimen. They were then randomly assigned to receive gefitinib (250mg orally per day, 733 patients) or docetaxel (75mg/m2 intravenously lasting one hour once every three weeks, 733 patients).

The researchers found that overall survival was similar in both groups (median survival 7.6 months gefitinib vs 8.0 months docetaxel). In a pre-specified group of patients with high EFGR-gene-copy number**, survival was also similar between the two groups (8.4 months gefitinib vs 7.5 months docetaxel). Side effects more common in the gefitinib group were rash or acne (49% gefitinib patients vs 10% docetaxel) and diarrhoea (35% gefitinib vs 25% docetaxel). Side effects more common in the docetaxel group were neutropenia*** (74% docetaxel patients vs 5% gefitinib), asthenic**** disorders (47% docetaxel vs 25% gefitinib), and alopecia (36% docetaxel vs 3% gefitinib).

The authors conclude: "The clinical management of advanced non-small-cell lung cancer remains challenging, but an oral agent that has similar efficacy, has a more favourable tolerability profile, and results in better quality of life than intravenous chemotherapy is an important shift in the treatment paradigm for this disease and presents an alternative treatment option for patients. On the basis of these data, gefitnib is a valid treatment option for patients with pretreated advanced non-small-cell lung cancer."

In an accompanying Comment, Professor Michael Cullen , University Hospital Birmingham, UK, and Dr Nicholas Thatcher, Christie Hospital, Manchester, UK, say: No adequate substitute exists for well-designed, large randomised trials with important clinical and biological outcomes, and ultimately, such trials have the best chance of changing our practice and our understanding of disease."
-end-
Dr Edward Kim, M. D. Anderson Cancer Center, Houston, Texas, USA T) 713-792-6363 E) edkim@mdanderson.org

Comment: Professor Michael Cullen , University Hospital Birmingham T) +44 (0) 7831 601160 E) michael.cullen@uhb.nhs.uk

Notes to editors: *non-small-cell lung cancer (NSCLC): categorised by the large size and appearance of the malignant cells seen under the microscope. NSCLCs represent around 80% of all lung cancers.

**EFGR-gene-copy number: EGFR is a biomarker that did not have any effect in this study or with gefitinib vs chemotherapy

***neutropenia: an abnormally low number of a type of white blood cells called neutrophils

****asthenic disorders: fatigue or feeling low energy

For full Article and Comment, please see: http://press.thelancet.com/gefitinibfinal.pdf

Lancet

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