FDA approves Roche drug for late-stag...

FDA approves Roche drug for late-stage metastatic breast cancer

There are 1 comment on the Reuters story from Feb 22, 2013, titled FDA approves Roche drug for late-stage metastatic breast cancer. In it, Reuters reports that:

U.S. health regulators approved a new drug made by Roche Holding AG for some patients with late-stage metastatic breast cancer who fail to respond to other therapies.

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Since: Dec 05

Reading, PA

#1 Feb 22, 2013
In regards to response to anti-HER2 therapy after treatment with Kadcyla, I’ve heard from breast cancer patients who were bumped from the T-DM1 clinical trial because of disease progression, which meant that their cancer was growing despite the drug. Bumped off the trial because of disease progression? Wonder how many more patients there were like this?

Response rates (how much a tumor decreased in size) can be inflated when excluding patients during clinical trials (evaluable patients). Patients not considered “evaluable” are often those who do not get the benefit of an entire treatment plan. The response rate is calculated after removing patients, who die or have been excluded, from the calculation. This inflates the response rate.

But clinical oncologists want to publish their papers. They need to report on the outcomes of their experiments, but if they had to wait for survival data, it could take years until all the data was aggregated. That wouldn’t bode well for them to participate in pharma-sponsored trials in the future.

Response rates give clinical oncologists the opportunity to take a more optimistic look at therapies that have limited success. They can describe results as being complete remission, partial remission or simply clinical improvement.

If they treat all patients for three weeks, they can fairly evaluate the efficacy of a compound, which takes that lone (on average) before it can be regarded as effective. If they disregard all patients who die or were excluded after onset of therapy, and include only those treated three weeks or more, they can improve their data.

To justify their existence, they have to publish papers. That’s what they do.

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