Herceptin and early breast cancer: available evidence is insufficient to make reliable judgments


Intense debate surrounds the use of Herceptin for early breast cancer. Promising results were initially presented at the American Society of Clinical Oncology 2005 annual meeting.

In October, these studies were published in the New England Journal of Medicine ( NEJM ).

In an accompanying editorial, Gabriel Hortobagyi, at The University of Texas M.D. Anderson Cancer Center, described the results as “ simply stunning ” and “ revolutionary ”.

This extremely positive comment had like consequence a very high demand for rapid access to Herceptin.

According to an editorial, published in The Lancet, the excitement is premature.

The studies, reported in NEJM:

- represent interim efficacy analyses.

- use different dosing regimens, making comparisons and conclusions additionally more difficult.

“ Comparisons are further hampered by the omission of crucial overall and disease-free survival data, as well as information on cardiotoxicity. It is clear that Herceptin can precipitate severe heart failure in some patients. “

The Lancet concludes “ The best that can be said about Herceptin’s efficacy and safety for the treatment of early breast cancer is that the available evidence is insufficient to make reliable judgments. It is profoundly misleading to suggest, even rhetorically, that the published data may be indicative of a cure for breast cancer. “

Source: The Lancet, 2005


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