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Herceptin shrinks inflammatory breast cancer tumours

New data show that the addition of Herceptin to chemotherapy prior to breast cancer surgery completely eradicates tumours in nearly three times as many women with inflammatory breast cancer compared with chemotherapy alone

New data show that the addition of Herceptin (trastuzumab) to chemotherapy prior to breast cancer surgery (neoadjuvant therapy) completely eradicates tumours in nearly three times as many women with inflammatory HER2-positive breast cancer compared with chemotherapy alone.

Inflammatory breast cancer is a highly aggressive form of the disease and the tumours spread quickly, often leading to the need for full mastectomies, and it has a worse outlook than other breast cancers.

HER2-positive disease is diagnosed in up to 30 per cent of all breast cancer cases. It receives much attention from researchers as tumours are typically fast-growing and there is a high likelihood of relapse. Neoadjuvant therapy is administered to patients to help make inoperable tumours shrink and become removable, thus promoting breast conserving surgery.

The results from the NeOAdjuvant Herceptin (NOAH) study demonstrated that Herceptin plus chemotherapy led to the complete disappearance of the tumour in the breast (a pathological complete response to treatment) in nearly three times as many patients with inflammatory breast cancer (55 per cent, compared with 19 per cent), compared with chemotherapy alone.

Furthermore, the combination led to complete disappearance of the tumours from both the breast and the lymph nodes (a total pathological complete response to treatment) in 48 per cent of patients, compared with only 13 per cent of those who received chemotherapy alone. The treatment was well tolerated with acceptable cardiac safety. The trial is ongoing and event-free survival data are maturing.

The results, presented at the European Cancer Conference (ECCO 14) in Barcelona, were significant, as treatment with Herceptin in this setting may actually lead to more breast conserving surgery and most importantly to potentially improved survival.

Professor Wolfgang Eiermann, medical director of the Red-Cross-Clinik in Munich, said:  "This Herceptin data is very important for women with inflammatory HER2-positive breast cancer, an extremely aggressive cancer. Women could have their tumours eradicated by treating with Herceptin and chemotherapy prior to surgery which could lead to fewer mastectomies, and more importantly, fewer deaths from this type of breast cancer."

Herceptin is marketed in the US by Genentech, in Japan by Chugai and internationally by Roche. It is approved for use as a first-line therapy in combination with paclitaxel where anthracyclines are unsuitable, as first-line therapy in combination with docetaxel, and as a single agent in third-line therapy. It is also approved for use in combination with an aromatase inhibitor for the treatment of post-menopausal patients with HER2 and hormone receptor co-positive metastatic breast cancer.

Herceptin is one of Genentech's top-selling drugs and is growing rapidly, with total sales of USD 1.2bn in FY06, up 65 per cent on FY05. The heart failure risks of Herceptin are well-documented and are included in the drug's FDA-approved warning label.

24th September 2007

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