A trial looking at AZD4547 or paclitaxel for advanced stomach cancer (SHINE)

Cancer type:

Stomach cancer

Status:

Results

Phase:

Phase 2

This trial compared AZD4547 and paclitaxel for stomach cancer that has spread.

More about this trial

Doctors often use chemotherapy drugs such as paclitaxel (Taxol) to treat stomach cancer that has spread. This trial compared paclitaxel to a drug called AZD4547.

AZD4547 is a type of drug called a cancer growth blocker. This means it stops the signals that cancer cells use to divide and grow.

Laboratory research had shown that AZD4547 may work better for people whose cancer cells have a large number of copies of a specific gene. The gene is called fibroblast growth factor receptor 2, or FGFR2. So this trial was for people with stomach cancer which had extra copies of the FGFR2 gene.

The aims of this trial were to find out:

how well AZD4547 works for stomach cancer that has spread
more about the side effects

Summary of results

This trial showed that AZD4547 was not better than paclitaxel for stomach cancer that has spread and had extra copies of the FGFR2 gene.

Results

The trial recruited 71 people, and they were put into 1 of 2 groups at random:

41 people were in the AZD4547 group
30 people were in the paclitaxel group

AZD4547 is a tablet that you take twice a day for 2 weeks, and then don’t take for a week. Paclitaxel is a chemotherapy drug that you have into a vein once a week for 3 weeks out of every 4.

The research team looked at how long it was until the cancer started to grow. They found it was:

1.8 months for those who had AZD4547
3.5 months for those who had paclitaxel

When they looked at how long the people in both groups lived for, they found it was:

5.5 months for those who had AZD4547
6.6 months for those who had paclitaxel

Side effects

About 7 out of 10 people in each group had side effects. Some of these were mild or short lived. Less than 2 out of 10 people in each group had severe side effects.

The most common side effects of AZD4547 were:

loss of appetite
weakness or loss of energy (asthenia)
feeling sick
constipation
sore mouth (stomatitis)

The most common side effects of paclitaxel were:

hair loss
a drop in white blood cells
loss of appetite
extreme tiredness (fatigue)

There is more information about paclitaxel in our Cancer Drugs section.

Conclusion

The trial team concluded that AZD4547 was not better than paclitaxel for stomach cancer that had spread and had extra copies of the FGFR2 gene.

But even when a trial shows a treatment isn’t useful for a particular group of patients, it is still useful. It adds to our knowledge and understanding of cancer and how to treat it.

The team suggest that it might be useful to look at AZD4547 in a different group of patients, perhaps with different genetic changes.

Where this information comes from

We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item

) and published in a medical journal. The figures we quote above were provided by the trial team who did the research. We have not analysed the data ourselves.