A trial looking at erlotinib for advanced non small cell lung cancer (TOPICAL)

Summary of results

The research team found that erlotinib did help stop the cancer growing in some people. But that it didn’t always help people live longer. They found that it had more of an effect in women than it did in men.

This trial recruited 670 people with stage 3b or 4 non small cell lung cancer (NSCLC) who had not had chemotherapy before. Of these,

• 350 had erlotinib (including 135 women)
• 320 had dummy (placebo) tablets (including 126 women)

When the research team looked at the results a year after people started treatment, they found that the cancer had stopped growing in

• 4 out of every 100 people (4%) who took the placebo
• 9 out of every 100 people (9%) who took erlotinib

When they looked at this in more detail, they found a difference between men and women. The cancer had stopped growing in 3 times as many women who took erlotinib as men (15% compared to 5%).

They also looked at how many people lived for at least a year after starting treatment, and found that it was

• 14 out of every 100 people (14%) who took the placebo
• 16 out of every 100 people (16%) who took erlotinib

And again, they found a difference between men and women. Twice as many women as men lived for at least a year after treatment (24% compared to 12%).

The research team concluded that erlotinib had more of an effect on women with non small cell lung cancer than men.

The people taking erlotinib had some side effects including a rash and diarrhoea.

Other trials have suggested that erlotinib works best in patients with a change (mutation) in the epidermal growth factor receptors (EGFR) on their cancer cells. EGFRs are part of the signalling process telling the cell to grow. So the research team are testing the tumour samples of the people who took part to see if they have a mutation. They will then look at the results again to see if there is a link between this and how well they responded to treatment.

They have started this analysis and found that there were very few patients (less than 4%) with EGFR mutation. Most patients (more than 95%) had ‘wild type’ or non mutated EGFR. Analysis so far shows women with wild type EGFR may also benefit from erlotinib, but not men.

The trial team hope to publish more results once they have fully analysed the data.

We have based this summary on information from the team who ran the trial. The information they sent us has been reviewed by independent specialists (peer reviewed) but may not have been published in a medical journal. The figures we quote above were provided by the trial team. We have not analysed the data ourselves.