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A phase III clinical trial has shown that a new drug, gefitnib, is as effective a second-line treatment for patients with nonsmall-cell lung cancer (NSCLC) as the currently recommended therapy, docetaxel.
The study, led by Dr Edward Kim of the MD Anderson Cancer Centre in Texas, US, analysed data from 1,466 cancer patients in 24 countries.
Each patient had previously received at least one platinum-based chemotherapy treatment, before being randomly assigned to either a daily oral dose of gefitinib or a docetaxel injection every three weeks. Overall survival was similar in both groups, the researchers found.
The study’s authors, writing in The Lancet, say: “The clinical management of advanced nonsmall-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 nonsmall-cell lung cancer.”
Commenting on the findings, British experts Professor Michael Cullen and Dr Nicholas Thatcher said: 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.”
Copyright Press Association 2008
