A trial of anastrozole for hormone receptor positive women’s gynaecological cancers (PARAGON) (ANZGOG0903)

The trial team have reported some of the results of the PARAGON trial. The main findings so far are: 

• anastrozole controlled cancer growth for a little bit in some women but not for very long 
• the side effects were mild
• it improved quality of life  in women with womb cancer whose cancer hadn’t got worse

About this trial
338 women took part in total. They were put into groups depending on the type of cancer they had. 

The groups were as follows:

• epithelial ovarian cancer, primary peritoneal cancers and fallopian tube cancer (group A) – this part of the trial didn’t run in the UK 
• womb (uterine or endometrial) cancer (group B)
• sarcoma  of the womb (group C)
• other sarcomas such as sarcoma of the cervix  (group D)
• granulosa cell tumours (group E)

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Currently, results are available for:

• womb cancer (group B)
• granulosa cell tumours (group E)

The women had anastrozole for as long as it was working, and the side effects weren’t too bad.

Results for women who had womb cancer (Group B)
82 women joined this part of the trial. The trial team looked at how well treatment worked after 12 weeks of anastrozole. 

They found in:

• 6 women the cancer went away a little bit (a partial response)
• 30 women the cancer stayed the same (stable disease)
• 46 women the cancer got worse

The researchers looked at the number of women whose cancer stayed the same or got a bit better. They called this having a clinical benefit. The researchers worked out that this was just over 4 out of 10 women (44%). 

The average length of time before the cancer started to grow again was 3.2 months. 

Quality of life
Women filled in quality of life questionnaires  during treatment. The questionnaires asked about:

• emotional issues such as depression or worry
• how they were coping on a day to day basis
• symptoms such as tiredness and pain

At 3 months, women reported a better quality of life if anastrozole was helping them. For example, they had less pain and appetite loss.

Side effects
The side effects were as expected, and most were mild. The most common were:

• hot flushes
• joint pain 
• tiredness (fatigue)

Results for women who had a granulosa cell tumour of the ovary (group E)
This part of the trial included women who had a granulosa cell tumour of the ovary that had spread or come back after treatment. 

41 women joined this part of the trial. The trial team looked at how well treatment worked after 12 weeks of anastrozole. They looked at whose cancer got better or stayed the same. They had the results for 40 women. 

They found in:

• 1 woman the cancer got a bit better (a partial response)
• 31 women the cancer stayed the same (stable cancer)
• 8 women the cancer got worse

The researchers worked out that anastrozole helped 8 out of 10 women (80%). They say these women had a clinical benefit. 

They also looked at how long women lived before their cancer got worse. This was 8.6 months on average. 

At 6 months the cancer:

• hadn’t got worse in 23 women 
• had got worse in 16 women

1 woman continued to have treatment for 15 months and 1 woman had it for 53 months. 

Quality of life 
They didn’t look at quality of life in this group of women. 

Side effects
The side effects were mild. The only severe side effect was joint pain. And 1 woman had to stop treatment as a result. 

Main conclusions of PARAGON so far 

Womb cancer (group B)
The trial team concluded that at 3 months, anastrozole helped just under half of these women. The side effects were acceptable and it improved quality of life. 

Granulosa cell tumour of the ovary (group E)
The trial team concluded that anastrozole helped to keep the cancer under control for a little bit. But the tumours didn’t shrink as much as they had hoped. The side effects were mild. 

We hope to be able to summarise the results of other groups when they become available. 

All trial results help doctors and researchers understand more about different cancers and the best way to treat them. 

Where these results come 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 ) but may not have been published in a medical journal.  The figures we quote above were provided by the research team. We have not analysed the data ourselves.