HER2 Support Group Forums - View Single Post - Genentech's Trastuzumab Emtansine (T-DM1) Reduces The Risk Of Cancer Worsening

gdpawel · 06-07-2012, 01:23 PM

T-DM1 worked in less than half the patients treated in prolonging the disease-free interval and was not without significant side effects. T-DM1 patients had fewer grade 3 or higher side effects (40.8%) compared to those who received standard treatment (57%), but it's important to remember that these results are interim and the final story won't be known until 2014. It may be somewhat better than anything else available at the moment, but it remains to be seen if it is a "magic bullet," "smart bomb," or "miracle" drug.

I heard of women 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?

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.

06-07-2012, 01:23 PM	#13
gdpawel Senior Member Join Date: Aug 2006 Location: Pennsylvania Posts: 1,080	Re: Genentech's Trastuzumab Emtansine (T-DM1) Reduces The Risk Of Cancer Worsening T-DM1 worked in less than half the patients treated in prolonging the disease-free interval and was not without significant side effects. T-DM1 patients had fewer grade 3 or higher side effects (40.8%) compared to those who received standard treatment (57%), but it's important to remember that these results are interim and the final story won't be known until 2014. It may be somewhat better than anything else available at the moment, but it remains to be seen if it is a "magic bullet," "smart bomb," or "miracle" drug. I heard of women 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? 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.