Herceptin for two years

You are right, results from the 2-yr arm of HERA are not available yet.  However, your onc obviously wants to decrease your risk as much as possible. (Based on this, I think you have a great onc; most aren't willing to go too far outside of "standard of care"). 

If it were me, it would depend on my MUGA results.  If your heart function has declined significantly, it may not be worth the risk to your heart.  If your heart function is good, and close to were it started, I would certainly consider it, especially if your insurance will pay for it.  I would continue to monitor heart function during treatment to make sure the Herceptin is not adversely affecting you.

Good luck.

I have one or two more Herceptin treatments, so this is really interesting! I'm very impressed that your onc is recommending this since the study results are not finalized.

Like Lexi, I'll be looking forward to your update.

I saw an abstract at the St. Gallen conference last week that they would not report the 2-year treatment data until 2011.....Kind of strange - it would be good to know earlier.

Here is the abstract:

 L. Gianni, A. Goldhirsch, R.D. Gelber, E. Azambuja, M. Procter, M. Untch, I. Smith, C. Jackisch, D. Cameron, S. Muehlbauer, B. Leyland-Jones, M. Piccart-Gebhart, J. Baselga, R. Bell,  for the HERA study team

Background: Trastuzumab, a recombinant monoclonal antibody against the HER-2 receptor, has been shown to significantly improve disease-free and overall survival in women with HER-2 positive early breast cancer when given concurrently with or sequentially after chemotherapy.
Materials and Methods: HERA is an ongoing international, multicenter, randomised phase III trial comparing one or two years of adjuvant trastuzumab given every three weeks with observation in 5,102 patients with HER-2 positive either node-negative (tumour size ≥1.0 cm) or node-positive early breast cancer who had completed locoregional therapy and had received at least four cycles of standard neoadjuvant or adjuvant chemotherapy. Central confirmation of HER-2 positivity and LVEF ≥55% after completing chemotherapy and radiotherapy were required prior to randomisation. The second planned interim analysis of the 1 yr vs 2 yr trastuzumab comparison in the HERA trial was conducted on October 20, 2008. The Independent Data Monitoring Committee (IDMC) recommended that the study continue as planned without disclosing data on the 2 yr trastuzumab group. In the observation and the 1 yr trastuzumab groups, 827 disease-free survival events (DFS) have been observed at a median follow up of 48.4 months after randomization, and are the subject to the present update.
Results: After release of the HERA and the combined B31 and N9831 results in 2005, a protocol amendment allowed for eligible observation patients to receive trastuzumab and data were continuously collected. Out of the 1698 observation patients, there were 885 observation patients who crossed over to trastuzumab. These late starter patients started trastuzumab at a median of 22.8 months (<1-52.7) from randomization.
The updated intent-to-treat (ITT) analysis of DFS confirmed a statistically significant benefit in favour of the patients who received 1 yr of trastuzumab following chemotherapy compared with observation (p < 0.0001). Additional analyses to examine the effect of the late start of trastuzumab in the observation group and the influence of the selective crossover on the treatment comparison will be presented.
Conclusion: The updated analysis of the HERA trial confirmed the benefit of delivering adjuvant trastuzumab for 1 yr after chemotherapy in women with HER2-positive tumors despite the substantive crossover of observation group patients to active treatment. The HERA study is ongoing and final results including the comparison of 1 yr vs 2 yrs trastuzumab are expected in 2011.

You know what I really think....

If there was that much of an advantage to 2 yrs vs 1 yr..something would have been reported by now. IF there is any significant advantage, I think it wouldn't be that much. And even if it was...would we qualify to take the extra year ...being 2,3,4, yrs from our original 1 year doses?

Obviously it is in Genetech/Roche's interest to see a result that supports the use of Herceptin for two years instead of one. The Finnish study did demonstrate benefit appeared equal for both 9 treatments vs the full year of Herceptin, if I recall correctly, but there need to be additional studies to corroborate those results.

I am more concerned with the end results of whether two years does offer any significant reduction in recurrence and survival as it impacts us, and society. If enough people survive better and longer it will offset the costs for the additional year of treatment, and if Herceptin can be given as a quick, subcutaneous injection the administration will be much cheaper, saving much in both labor and other resources, so that savings might be cost effective.

I prefer to be a cancer free taxpayer, than either disabled, ill, or dead. Especially if the total costs of treatment are equal, or not much more than one year of treatment. I guess we will find out as soon as possible if the results are good for Genetech/Roche. If not, we will wait until 2011, LOL. 

Good point rosesinwinter.

Thanks for posting 

That is an excellent point Jennifer.  The protocol for stage IV treatment with Herceptin is quite different at many institutions than that for stages 1-3.  The debate lies much more with early-stage breast cancers as to risk vs benefit ratio of varying lengths of Herceptin treatment. Clearly these risks have to be studied in appropriate clinical protocols and not just with the anecdotal accounts of practicing oncologists.  As a medical professional, I have seen several drugs taken off the market that were shown to have few side-effects in relatively small clinical studies but had serious side-effects when you could see them in use by tens of thousands of patients. In addition, the participants in clinical studies are often carefully screened and don't have the risk factors that those who will eventually use the medication may also have.

It sounds like your oncologist is willing to stand up for you!  Hope all goes well.