Pre-surgical use of Herceptin (trastuzumab) in inflammatory HER2-positive breast cancer eradicates tumours in three times as many patients compared to chemotherapy alone, according to new research.

This form of breast cancer is very rare but extremely aggressive; the tumours spread quickly, often leading to the need for full mastectomies, and it has a worse outlook than other breast cancers.

Experts said the latest results, presented at the European Cancer Conference in Barcelona suggest treatment with Herceptin in this setting may actually lead to more breast conserving surgery and most importantly, to improved survival.

"This Herceptin data is very important for women with inflammatory HER2-positive breast cancer, an extremely aggressive cancer," said Professor Wolfgang Eiermann, the medical director of Munich's Red Cross Womens' Hospital. "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."

The results from the neo-adjuvant Herceptin (NOAH) study demonstrated that Herceptin plus chemotherapy led to the complete disappearance of the tumour in the breast in nearly three times as many patients with inflammatory breast cancer (55% vs. 19%) compared to chemotherapy alone. In addition, the combination led to complete disappearance of the tumours from both the breast and the lymph nodes in 48% of patients, compared to only 13% of those who received chemotherapy alone.

Acceptable CV safety

Researchers said the treatment was well tolerated with acceptable cardiac safety. Earlier studies had identified problems with cardiotoxicity. The trial is ongoing and further insights into survival may yet emerge.

Independent experts gave a cautious welcome to the results. Dr Sarah Cant, the policy manager at the research charity Breakthrough Breast Cancer, said: "There is currently no standard therapy available for women with HER2 positive inflammatory breast cancer, so all research in this area is to be welcomed. If long-term results from this study confirm that using Herceptin before surgery is effective, it could lead to an additional treatment option for these women.

"However, this study is at a very early stage and there is still a long way to go before we can be sure the results are definite. It is also important to remember that Herceptin is not currently licensed for use as a pre-surgery treatment and is not suitable for all women."

Out of 228 evaluable patients with HER2-positive breast cancer that were included in the study, 61 had inflammatory breast cancer (IBC). Of the 99 evaluable patients with HER2-negative breast cancer, 14 had IBC. 31 patients with HER2-positive IBC received Herceptin in addition to chemotherapy.

The NOAH protocol is a joint effort of Fondazione Michelangelo, Grupo SOLTI and Roche. MIchael day