A trial looking at bevacizumab (Avastin) with chemotherapy before surgery for early HER2 negative breast cancer (ARTemis)

The trial team found that adding bevacizumab to chemotherapy increased the number of women whose breast cancer completely disappeared.

This was a phase 3 trial and 800 women took part. It was a randomised trial, the women were put into 1 of 2 groups by computer. Neither they nor their doctor could choose which group they were in.

• 401 women had chemotherapy only
• 399 women had bevacizumab and chemotherapy

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The chemotherapy the women had was a combination of docetaxel, fluorouracil, epirubicin, and cyclophosphamide (T-FEC).

The researchers looked at how many women had no sign of cancer in their breast or in the lymph nodes  nearby after treatment. This is called a complete response . They found that

• 17 women out of every 100 (17%) who had chemotherapy had a complete response
• 22 women out of every 100 (22%) who had bevacizumab and chemotherapy had a complete response

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After an average follow up of 3½ years the team looked at:

• how long the women were free of their cancer (disease free survival)
• overall how long they lived after treatment (overall survival)

They found there was no significant difference in disease free survival or overall survival between the 2 treatment groups. 

Side effects

The side effects of both treatments were as the researchers expected. These were

• A drop in blood cells causing an increased risk of infection, bruising and bleeding
• Infection
• Tiredness (fatigue)
• Diarrhoea and constipation
• Feeling or being sick
• Low blood pressure
• Numbness, tingling or pain in the hands and feet
• Protein in the urine
• Hair loss

The researchers found that more women having bevacizumab had a serious drop in their blood cells than those having chemotherapy alone.

Conclusion

The trial team concluded that for women with HER2 negative early stage breast cancer, the cancer completely disappeared in more women who had the combination of bevacizumab and chemotherapy than in women who had chemotherapy alone. And for women who had a small amount of cancer left after treatment, fewer in both groups needed to have their breast completely removed, compared to those who didn’t have a small amount of disease left.

They also concluded that adding bevacizumab didn't increase the length of time women lived without a sign of their cancer or the overall length of time they lived. So for the moment bevacizumab isn't recommended for women with early breast cancer. 

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