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Data on herceptin for early breast cancer currently insufficient for decision on its use


Yesterday Patricia Hewitt, the UK's Health Secretary, intervened directly to mediate a debate about access to the drug Herceptin for patients with early breast cancer. However, the available evidence on the efficacy and safety of Herceptin for early breast cancer is insufficient to make any reliable judgements, states an editorial by The Lancet published online today (Wednesday November 9, 2005). The UK's National Institute for Health and Clinical Excellence (NICE) should be given time to consider the evidence on the drug and must resist pressure from external groups, whatever the urgency and however well meaning, states The Lancet.

The studies on the use of Herceptin for early breast cancer were recently published in the New England Journal of Medicine (NEJM). An accompanying editorial in the NEJM stated that Herceptin "maybe even a cure" for breast cancer. However, the two studies represent interim efficacy analyses--a type of analyses that may show implausibly large treatment effects. A review in The Journal of the American Medical Association (JAMA) last week said, "clinicians should view the results of such trials with scepticism". The Lancet also notes that the two reports use different dosing regimens, making comparisons and conclusions difficult. Comparisons are further hampered by the omission of crucial overall and disease-free survival data, as well as information on cardiotoxicity. However, it is clear that Herceptin can precipitate severe heart failure in some patients, states the editorial.

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...Drug regulatory agencies and bodies such as NICE play an important part in translating research evidence into clinical guidance. It is vital that their decisions are made carefully after considering the totality of available evidence. They must be free from political, special interest, or media influence, no matter how well meaning. The debate about the availability of Herceptin to women with early breast cancer demands cooler heads than have so far prevailed, in politics, in public, and even in medical journals."


Lancet press office on 207-424-4949-4249,

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