Source: DGNews  |  Posted 2 years ago

NEW YORK -- January 28, 2010 -- Trastuzumab (Herceptin) should be offered to patients with human epidermal growth factor receptor 2 (HER2)-positive locally advanced or inflammatory breast cancer alongside chemotherapy, according to a study published in this week’s edition of The Lancet.

Amplification or overexpression, or both, of HER2 is present in around 22% of early breast cancers, 35% of locally advanced and metastatic tumours, and in 40% of inflammatory breast cancers, and is associated with aggressive disease and poor prognosis. Patients with HER2-positive locally advanced or inflammatory breast cancer are therefore in particular need of effective treatment.

In the study, Luca Gianni, MD, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy, and colleagues assessed event-free survival in patients with HER2-positive locally advanced or inflammatory breast cancer receiving neoadjuvant chemotherapy with or without 1 year of trastuzumab.

The authors compared 1 year of treatment with trastuzumab (given as neoadjuvant and adjuvant treatment; n=117) with no trastuzumab (n = 118), in women with HER2-positive locally advanced or inflammatory breast cancer treated with a neoadjuvant chemotherapy regimen consisting of doxorubicin, paclitaxel, cyclophosphamide, methotrexate, and fluorouracil.

A parallel cohort of 99 patients with HER2-negative disease was included and treated with the same chemotherapy regimen.

The primary endpoint was event-free survival.

Trastuzumab significantly improved event-free survival in patients with HER2-positive breast cancer (3-year event-free survival, 71% with trastuzumab vs 56% without).

Trastuzumab was well tolerated and, despite concurrent administration with doxorubicin, only 2 patients (2%) developed symptomatic cardiac failure. Both responded to cardiac drugs.

“The addition of neoadjuvant and adjuvant trastuzumab to neoadjuvant chemotherapy should be considered for women with HER2-positive locally advanced or inflammatory breast cancer to improve event-free survival, survival, and clinical and pathological tumour responses,” the authors concluded.

In an accompanying comment, Melanie D Seal, MD, and Stephen K Chia, MD, Division of Medical Oncology, British Columbia Cancer Agency, Vancouver, British Columbia, said: “Almost all new systemic agents being studied in cancer are targeted agents. Understanding the target, and downstream and redundant effects, is essential if we truly are moving to personalised medicine. Adjuvant studies require thousands of women to show survival benefits, at high cost and often long follow-up. Studies such as NOAH illustrate the benefits and potential of neoadjuvant trials and should challenge the dogma of our current strategies of therapeutic trials in early-stage breast cancer.”

SOURCE: The Lancet