A trial looking at radiotherapy and chemotherapy after surgery in women with womb (endometrial) cancer (PORTEC 3)

Cancer type:

Womb (uterine or endometrial) cancer

Status:

Results

Phase:

Phase 3

This trial compared radiotherapy on its own with radiotherapy and chemotherapy in women with womb (endometrial) cancer. This trial was supported by Cancer Research UK.

More about this trial

Doctors usually treat womb cancer with surgery. Some women have radiotherapy after surgery, especially if there is a high risk that the cancer will come back. In this trial, women had stage 1 womb cancer that was at a high risk of coming back (grade 3). Or they had stage 2 or stage 3 womb cancer.

Radiotherapy to the pelvis can help to stop cancer coming back in that area of the body. But it can’t stop cancer coming back elsewhere in the body.

Doctors think that chemotherapy during and after radiotherapy will help stop cancer coming back in another part of the body. But they don’t know this for certain. All chemotherapy drugs have side effects. So it’s important that patients don’t have treatments that don’t work. Having chemotherapy and radiotherapy together is called chemoradiotherapy.

The aims of this trial were to:

find out if it’s better to have chemoradiotherapy or radiotherapy on its own after surgery for womb
learn more about the side effects of these treatments and how they affect quality of life

Summary of results

The trial team found that chemoradiotherapy was not useful for women with stage 1 and 2 womb cancer. It might be helpful for some women with stage 3 cancer.

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

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All women had external radiotherapy to their pelvic area. They had this once a day from Monday to Friday over about 6 weeks. Some women also had internal radiotherapy if cancer cells had been found in their cervix.

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:

tiredness (fatigue)
diarrhoea
feeling or being sick
infections
tingling or numbness due to nerve changes
muscle or joint pain
hair loss

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.