Available evidence on Herceptin is insufficient
Available evidence on trastuzumab (Herceptin) is insufficient to make firm judgements on its efficacy and safety, an editorial in this week's issue of The
Lancet argues (2005;366:1673).
“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,” the authors say. “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 judgements.”
Results of three studies showing that trastuzumab roughly halved the
risk of recurrence in women with surgically removed breast cancer were
published in The New England Journal of Medicine last month
(2005;353:1659 and 1673)
One study showed a hazard ratio of 0.54 (95 per cent confidence interval
0.43–0.67; P<0.0001) for recurrence of breast cancer, contralateral
breast cancer, second non-breast malignant disease or death.
The other two studies were analysed and reported together and showed
a hazard ratio of 0.48 (95 per cent confidence intervals 0.39–0.59;
P<0.0001) for recurrence of breast cancer, second primary cancer or
death.
However, both reports describe cardiotoxic effects of trastuzumab in
a number of the women studied and, The Lancet says, “it is clear
that Herceptin can precipitate severe heart failure in some patients”. |
The
Pharmaceutical Journal
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