Four large-scale, randomized clinical trials are now
under way to better identify the benefits and risks of Herceptin. "It's
very likely that Herceptin will be an effective therapy in early-stage
disease, based on what we've seen in metastatic breast cancer," says
Sloan-Kettering's Hudis. "But what's not so clear yet is how big an
impact it will have on survival and recurrence rates, and what the price
might be for a broad population in terms of heart failure. If we
improve survival rates by 2%, but it causes 4% of patients to have
significant heart failure, then you'd have a hard time figuring out what
to do next."
In the small group of study patients at
M.D. Anderson who received Herceptin, says Buzdar, none so far has
developed any heart problems almost two years after treatment. Some
doctors have prescribed Herceptin "off-label" for women with
non-metastatic breast cancer, but both Hudis and Isaacs are cautious.
They recommend women with early-stage breast cancer only take Herceptin
if they are in a clinical trial until more questions are answered about
the drug's risks and benefits.
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