Herceptin after many years...STILL EFFECTIVE!

Wahoooooo.. help to see things like this!  TY!!!!!!!!!!!

Needed that Lexis thank you... Im so over reading 'worst prognosis' articles on the net.

Hi Helena -

I think you are right, there probably is little or no difference between 1 year or 2 years of Herceptin treatment.  Otherwise they would be in a hurry to publish the data.  The press release from Roche says that the post treatment follow up period is 4 years.  In this time, if there had been a difference, it should have shown up by now.

Re 50% improvement vs 25% improvement in survival in HERA trial:   

There were 4 large studies (greater 1000 patients) looking at the effect of Herceptin in the adjuvant setting.  For analysis two studies (Trial NSABP B-31 and Trial NCCTG N9831) were combined to improve the statistical strength of the analysis.  Roche calls the combined study the "Joint Analysis".  In the joint analysis there was a 52% relative risk reduction when herceptin was added to chemo.

Another study, BCIRG 006 also compared chemo alone vs. chemo + H with two different chemo regimens (AC-T vs AC-TH or TCH).  The 1st interim analysis (after 23 months follow-up time) showed about a 50% relative risk reductin for AC-TH, and about a 40% relative risk reduction for TCH.  However, the difference between the AC-TH arm was not statistically significantly different from the TCH arm (meaning the difference could be due to chance). 

At the 2nd interim analysis of the BCIRG 006 study (after 36 months follow-up), the relative risk reduction for AC-TH was about 40% and for TCH was about 33%. 

In there HERA trial, Herceptin was given AFTER other chemo was completed, not at the same time as chemo as in the Joint Analysis and BCIRG 006 trials. It is thought that in adjuvant therapy, herceptin is more effective if given at the same time as chemo, so this could account for Herceptin not being quite as effective as it was for the Joint Analysis trials and the BCIRG 006 trial. 

Also in the HERA trial, according to the press release from Roche, as soon as the publication of the first analysis was published about 50% of patients in the group that did not receive H in the trial opted to receive H ('Crossed-over' to H treatment).  The results of this second analysis "include all women involved in the trial (intent to treat, ITT) showed a 25% reduction in risk of cancer recurrence for women receiving H compared to those on observation (no Herceptin)."  I believe this means that the analysis looked at those women who crossed over (received H after the 1st analysis) like they had not received H.  This would have biased the treatment effect low (since H was shown to have a benefit even when given later).  Thus the over-all treatment effect for the 2nd analysis appears less than it might actually be.  (Someone who is familiar with clinical statistics, please correct me if I've misinterpreted something.  Thanks)

Reasons for differences between trial results could be differences in the treatment (such as H after Chemo with the HERA trial), differences in the study population (for example the Joint analysis included on 5% node negative vs. 30% node negative in BCIRG 006 and HERA trials), or just chance.

I think that's correct.  I'm hoping someone will verify my interpretation regarding HERA treatment effect:

Actual treatment effect might be greater than shown in the 2nd analysis (due to crossover).

Anyone: Otter? Bluedasher? Jill323, Timothy? TenderIsOurMight?

Thanks,

Woo Hoo!  I'm so thrilled to read this! My onc put me on the one year regimen, and another patient on 6 months... not sure why the treatment plans were different since we both had the same diagnosis, but I suspect it was a budget issue for the other patient. I was depressed at first when I hear "one year" but now i'm glad that it happened. Whew!

Thanks for the link, Now we have more proof to back up our hope. Yippee