Results
The results of this trial were published in February, 2018.
All women had surgery to remove their womb cancer before joining this trial. This was a
randomised trial.
The trial team recruited 686 women between November 2006 to December, 2013. The women taking part were put into 2 treatment groups by a computer. Neither they nor their doctor could decide which group they were in.
- Group 1 – women had radiotherapy on its own
- Group 2 – women had chemoradiotherapy followed by more chemotherapy
Women in group 2 also had
cisplatin chemotherapy on the day they started radiotherapy and again 3 weeks later. They then had
paclitaxel (Taxol) and
carboplatin chemotherapy once every 3 weeks for about 3 months.
The trial team were able to collect the results from 660 women:
- 330 women had radiotherapy
- 330 women had chemoradiotherapy followed by more chemotherapy
Survival
The researchers looked at how many women were alive after 5 years (overall survival). This included:
- 255 out of the 330 women (nearly 77%) in the radiotherapy group
- 269 out of the 330 women (nearly 82%) in the chemoradiotherapy group
The researchers also recorded the number of women who were alive and whose cancer had not come back. This is called failure free survival. At 5 years, this included:
- 227 women (nearly 69%) in the radiotherapy only group
- 247 women (nearly 76%) in the chemoradiotherapy group
Side effects
The researchers compared the side effects of women in the 2 groups. Those with severe side effects included:
- 41 women (12%) in the radiotherapy only group
- 198 women (60%) in the chemoradiotherapy group
For example, women in the chemoradiotherapy group had more problems with:
This applied to women during treatment and for about one year afterwards. After this time, the significant difference between the 2 groups disappeared.
The exception to this was nerve changes. The medical name for this is
neuropathy. A common symptom of neuropathy is numbness and tingling in the hands and feet. After 3 years numbness and tingling was reported by:
- 1 woman in the radiotherapy group
- 20 women (8%) in the chemoradiotherapy group
Women rated their symptoms of numbness and tingling as ‘quite a bit’ (moderate) or ‘very much’ (severe).
Conclusion
Overall, the trial team found that chemoradiotherapy increased the likelihood of the cancer not coming back. But chemoradiotherapy did not improve overall survival. The trial team concluded that the difference in survival between the 2 groups was not significant enough.
The researchers explain that the benefit to women is different for women who have:
- stage 1 and 2 womb cancer
- stage 3 cancer
Stage 1 and 2 womb cancer
The researchers do not recommend that these women have chemoradiotherapy following surgery. Radiotherapy on its own controlled the womb cancer in this group quite well.
Stage 3 cancer
Women with stage 3 disease had the greatest benefit with chemoradiotherapy. Although no significant difference was found in survival, chemoradiotherapy did help to reduce the risk of the cancer coming back. On balance, the researchers think the increase in side effects is justified by the fact that fewer women had cancer that came back (recurrent disease).
The researchers recommend that doctors discuss the risks and benefits of chemoradiotherapy with this group of women.
We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (peer reviewed) 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.