HER2 Support Group Forums - View Single Post - BREAST CANCER UPDATE 7 of 2006:expert interviews

Christine MH-UK · 12-12-2006, 12:58 PM

There are so many her2 positive patients around and lapatinib was not close to entering trials in patients with early breast cancer when this trials finished enrolling patients (2004 or earlier). Maybe Genenetech/Roche figured that the extra time they spent enrolling patients would be easily compensated for by getting to a significant improvement in disease free survival earlier.

I do find it interesting, given the generally overpowered nature of these trials, that on the HERA trial the size of the trial was increased substantially from the original protocol. Back in early 2005 I figured that this increase must indicate that HERA trial would have marginal results. However, since the overall trial was really successful, I wonder whether the trial size was increased in the hopes it would strengthen the case for two years over one year.

I am troubled by the strong incentives that seem to exist for researchers to keep on postponing the announcement about the 2-year arm. The researchers involved undoubtedly want the 2 year arm to have better disease free survival than the 1 year arm. Still, one and a half years after the 1 year arm results were announced at ASCO, we are still in the dark about what has gone on with the 2 yr arm. If the 2-year arm is no better than the 1 year arm then Genentech/Roche stand to lose alot since oncologists seem interested in checking out the results of some small, independent trials, namely Finher and the one in Miami that Hurley did, where the results suggest that herceptin is such a great chemosensitizer that only the 9-12 weeks of herceptin during chemo may be necessary. Now, if the only difference between 9-12 weeks of herceptin-based chemo followed by an anthracycline and anthracycline followed by herceptin-based chemo followed by the rest of the year of herceptin was cost, that wouldn't trouble me, but the FinHer study and the Hurley study seem to indicate that the level of cardiotoxicity is much lower when herceptin is only used with a taxane (+/- carboplatin) and then followed by an anthracycline. I think also that the length of the treatment makes it very difficult for some patients to get back to normal life.

12-12-2006, 12:58 PM	#4
Christine MH-UK Senior Member Join Date: Sep 2005 Posts: 414	It was probably not done to block a competitor There are so many her2 positive patients around and lapatinib was not close to entering trials in patients with early breast cancer when this trials finished enrolling patients (2004 or earlier). Maybe Genenetech/Roche figured that the extra time they spent enrolling patients would be easily compensated for by getting to a significant improvement in disease free survival earlier. I do find it interesting, given the generally overpowered nature of these trials, that on the HERA trial the size of the trial was increased substantially from the original protocol. Back in early 2005 I figured that this increase must indicate that HERA trial would have marginal results. However, since the overall trial was really successful, I wonder whether the trial size was increased in the hopes it would strengthen the case for two years over one year. I am troubled by the strong incentives that seem to exist for researchers to keep on postponing the announcement about the 2-year arm. The researchers involved undoubtedly want the 2 year arm to have better disease free survival than the 1 year arm. Still, one and a half years after the 1 year arm results were announced at ASCO, we are still in the dark about what has gone on with the 2 yr arm. If the 2-year arm is no better than the 1 year arm then Genentech/Roche stand to lose alot since oncologists seem interested in checking out the results of some small, independent trials, namely Finher and the one in Miami that Hurley did, where the results suggest that herceptin is such a great chemosensitizer that only the 9-12 weeks of herceptin during chemo may be necessary. Now, if the only difference between 9-12 weeks of herceptin-based chemo followed by an anthracycline and anthracycline followed by herceptin-based chemo followed by the rest of the year of herceptin was cost, that wouldn't trouble me, but the FinHer study and the Hurley study seem to indicate that the level of cardiotoxicity is much lower when herceptin is only used with a taxane (+/- carboplatin) and then followed by an anthracycline. I think also that the length of the treatment makes it very difficult for some patients to get back to normal life.