Late Herceptin preliminary results...

[RobinP]

I thought Becky's post about late Herceptin deserved a post of its own here. Well, I hope you don't mind Becky that I copied your post again and put it here below:

It was very clear at ASCO that the 2 yr results will not come out until 2008. The new news at ASCO on Hera was that they created a new arm in the trial using the (approximately) 500 women who took up the offer of receiving Herceptin (who were initially in the observation arm). They are calling this the censored observation arm (although the presenter called them the "delayed Herceptin" arm).


I stated earlier that I did ask a question during this session on the amount of delay between the last chemo and receiving Herceptin in this arm but the investigator said he "would not" answer that question. Very preliminary results showed a benefit (9 month data that was not statistically significant yet).

Oh well on the 2 yr data. We all knew it wouldn't be ready yet.

Kind regards

Becky

[RobinP]

You may recall that once the adjuvant Herceptin trials reported such huge increases in DFS, just last year at the 2005 ASCO and 2005 SABC, many older diagnosed her2+s that didn't get Herceptin in their adjuvant treatment started it late, sometimes years later.I think many of those individuals were left with a challenging choice, whether to do delayed Herceptin or not, since the benefits of Herceptin were not given for late initiation. Suddenly we now learn that there is an arm of late users in the HERA trial that is being evaluated with seemly positive preliminary results.

I am not surprised with the results being positive. However, I do think there will be less and less positive returns for Herceptin as time to start delayed treatment increases. What exactly is the time limit is the question. However, one would expect that those most likely to relapse, with more positive nodes, would continue to have high residual risk for a longer period of time from initial diagnosis. And these patients would probably benefit the most with Herceptin given late compared to patients with low risk for relapse.

Also, we know that most her2+ events occur the first few years after diagnosis, with a peak of relapse about 18-24 months after diagnosis. I would assume that those starting late adjuvant during or prior to this peak of relapse MAY obtain a particular advantage over those starting after this peak with delayed Herceptin.

More and more we are learning that potential risk for cardiac toxicity with adjuvant Herceptin is low, particularly if trastuzumab is given sequentially, after anthracyclines. I would expect the trend of low cardiac toxicity to follow with late Herceptin as well. So I don’t see cardiac issue being a major problem with late Herceptin, at least in the short run. Of course, no one knows the long term toxicity of Herceptin which may be even more of a consideration with late delayed Herceptin.

As always true, every update and advance in the clinical trials, only provides us with more questions to replace those already answered. It would be nice if we had the answers to all of our questions more quickly so that everyone would make the best choices possible for optimal treatments. However, particularly in the case of the use of late Herceptin, not much direction was offered from the ASCO and SABC conferences last year, when at the same time so much information was given to those newly diagnosed. I commend all patients and physicians who had to make difficult decisions regarding late Herceptin when the major cancer societies gave no direction.

[Becky]

Well put Robin.


I agree with your assessment on the delayed Herceptin group (especially if results show that those that benefit the most are those that are 1-3 yrs from the last chemotherapy (based on the fact that more recurrences occur 18 -24 months out)).

I benefited from last year's ASCO since I was 3 months from my last chemotherapy when the news broke. I started Herceptin June 17, 2005 and therefore, my last infusion should be my next one. However, my onco will be giving me 5 extra (every 3 wk) infusions to carry me beyond 2 yrs from diagnosis to give me better coverage during this critical time. However, he does not want to go to 2 years of Herceptin without data (and there won't be data). However, the short term DFS rate should be better with 2 yrs of Herceptin. But the OS rate and long term DFS may not be better. Time will tell.

Kindest regards

Becky

[penelope]

So my question is 18-24 months out from what...the end of chemo, surgery or diagnosis?

[Becky]

Usually it is from diagnosis (in my mind) but some do say from the first chemotherapy treatment (which isn't that far away from diagnosis).


Becky

[rinaina]

what is dfs and os? sometimes forum members,(probably me too) post and use initials for things assuming everyone knows what it means. perhaps we could all benefit from a post listing the abbreviations and their real meanings from someone who knows what all these abbreviations are. Thank you.

[RobinP]

Thanks for all of your updates on this topic Becky from the ASCO. I tried to get the live webcast of the discussion from Dr. Winer online but it isn't there, at least yet. However, I did see some of Dr. Hudis's webcast from the ASCO. Interestingly, he seemed to have some preliminary indications that two year Herceptin may be benificial due to the high peak of relapse during this time. The survival curve for one year of Herceptin actually has dipped SLIGHTLY at the end of therapy where you would start to see the beginning of the relapse peak, and then it levels out again after the peak. You may want to look closely at this webcast.

addendum:
OS overall survival
DFS= disease free survival

[chrisy]

Rainina
DFS is disease-free-survival
OS is overall survival.

it's quite an alphabet soup!

Take care
Chris

[rinaina]

Chrisy, thank you for clearing this up for me...there are so many initials used for everything and I am slowly learning them all. I really appreciate your help.

[astrid]

Actually, I am starting Herceptin on June 14th and that will be 3 months from chemo and 7 months from diagnosis. This may be normal for a lot of women undergoing treatment. I was diagnosed before thanksgiving and with the holidays did not have surgery until Dec and then started chemo in January and then radiation in April and have just finished up. I know there are some oncologists who give Herceptin with chemo; however my oncologist gives it after chemo and radiation. I think there are two schools of thought on that one and the jury is still out on which is more effective. What do you all think??

[rinaina]

I don't know what to think, I guess you just have to trust your oncologist to make the best decision based on your particular case. Mine is doing chemo first with A/C and then herceptin along with radiation for me, stage1 grade3 her2+ er/pr- node negative. Have to trust someone and my onc comes so highly recommended by both drs and patients so I will trust him.