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Benefit of Herceptin in more breast cancer cases

Trastuzumab improves event-free survival in locally advanced or inflammatory breast cancer

OnMedica Staff

Friday, 29 January 2010

Women who have HER2-positive locally advanced or inflammatory breast cancer should be offered trastuzumab (Herceptin) as well as chemotherapy, shows research – known as the NOAH trial – published today in The Lancet.

Researchers examined the effect of trastuzumab on locally advanced breast cancer, which accounts for 6-10% of new cases of breast cancer and has a worse prognosis than early operable disease, and on inflammatory breast cancers.

Women in the study all had HER2-positive locally advanced or inflammatory breast cancer, and were treated with neoadjuvant chemotherapy – doxorubicin, paclitaxel, cyclophosphamide, methotrexate and fluorouracil. Half of these women were randomised to also receive one year’s trastuzumab (117 women) and the others had no trastuzumab (118 women). A further group of 99 women with HER2-negative disease received the same chemotherapy regimen and no trastuzumab.

Trastuzumab significantly improved event-free survival in women with HER2-positive disease. Three-year event-free survival was 71% for those treated with trastuzumab as well as chemotherapy, compared with 56% for women receiving chemotherapy only. For the cohort of women with HER2-negative tumours, it was 67%.

Despite concerns about cardiotoxicity when trastuzumab is administered concurrently with doxorubicin, only two women given trastuzumab developed symptomatic cardiac failure, which in both cases was successfully treated with cardiac drugs.

The authors say: “The results of the NOAH study have shown that in patients with HER2-positive locally advanced or inflammatory breast cancer, addition of one year of trastuzumab (starting as neoadjuvant and continuing as adjuvant therapy) to neoadjuvant chemotherapy improved overall response rates, almost doubled rates of pathological complete response, and reduced risk of relapse, progression, or death compared with patients who did not receive trastuzumab. We recorded a benefit of trastuzumab in all subgroups tested, including women with inflammatory disease (27% of HER2-positive patients) who benefited substantially from trastuzumab.

They conclude: “Our results suggest that neoadjuvant trastuzumab should be offered to patients with HER2-positive locally advanced or inflammatory breast cancer alongside neoadjuvant chemotherapy, in addition to the established use of adjuvant trastuzumab post-surgery.”

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