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Cochrane Database of Systematic Reviews

Clinical Articles, News & Views

Trastuzumab for breast cancer – survival benefits versus heart risks

Treating women who have human epidermal growth factor receptor 2 (HER2) positive breast cancer with trastuzumab, a new-generation antibody, significantly increases the chance of life being prolonged, and reduces the chance of tumours reappearing once therapy stops, according to a systematic review1 published recently in The Cochrane Library.

However, the review also concluded that women given trastuzumab have a higher risk of experiencing problems with their heart.

To provide clinicians and patients with accurate evidence of trastuzumab’s harms and benefits, a team of researchers based in Milan and Modena, Italy, were keen to study available clinical trial data. They identified eight trials that involved 11,991 women with HER2-positive operable breast cancer who had been assigned randomly either to receive trastuzumab or not, in addition to other treatments. Women were followed by clinicians for several years (three on average).

The overall finding was that breast cancer mortality was reduced by one-third, but the risk of heart toxicity went up five times for women receiving trastuzumab compared with women receiving standard therapy alone.

If 1,000 women were given standard therapy with no trastuzumab then after three years about 900 would survive, but if 1000 women were treated with standard chemotherapy and trastuzumab for one year, about 933 would survive.

“This means that for every 1000 women treated with trastuzumab, 33 more women will have their lives prolonged,” said lead researcher Lorenzo Moja who works in the Department of Public Health at the University of Milan. In addition, about 95 more women will remain disease-free once therapy has stopped, he added.

However, the study showed that the treatment isn’t free of problems. About 26 in 1000 women taking trastuzumab experienced serious heart toxicity, 21 more than the chemotherapy alone group.  “These heart toxicities are often reversible if the treatment is stopped straight away,” said Moja.

The researchers conclude that in women at higher risk of recurrence and with no signs of a weak heart, trastuzumab offers far more benefits than risks. The balance of risks to benefits is less clear and must be carefully evaluated in women at lower risk of recurrence, however. “The oncologist should share the decision with the patient, after careful consideration of the risks and benefits,” says Roberto D’Amico, senior scientist at the Clinical Trial Unit of the Department of Oncology of the University of Modena.


1. Moja L, Tagliabue L, Balduzzi S, Parmelli E, Pistotti V, Guarneri V, D’Amico R. Trastuzumab containing regimens for early breast cancer. Cochrane Database of Systematic Reviews 2012. doi: 10.1002/14651858.CD006243.pub2

Published on: June 25, 2012

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