Treatment Question

[Sheila]

Greg, Dont know if you read my last post, but depending on the results of the scan, I would still see about adding the Herceptin back into the mix...especially with the previous liver involvement...all things to discuss with the Dr.

[MJsHusband]

Hi Sheila, yes I got your message. Thank you.

[MJsHusband]

The responses I've received have been pretty positive for adding Herceptin back in the regimen with Tykerb and Xeloda. I discussed it with MJ last night and we are going to have it added back in June after the results of her Pet/CT scans.

I mentioned to MJ that many on here feel she should be getting scans every 3 months instead of 6. She's pushing back on that idea for now. She doesn't want to experience scanxiety that frequently. Of course I can't make her.

Are there any studies showing that finding something 1-3 months earlier makes a big difference in overall survivability? I know most of the articles I read about for new treatments make a big deal about adding 3 months to disease-free survival/progression-free survival, but not as much about overall survivability, which is the most important area to increase in my opinion (although I know it is the hardest to extend). I am new to all this but keep reading and learning so that I can be as helpful as I can. I'm having to learn all these new terms and concepts.

Again, thanks for the invaluable comments that everyone has posted. Every one of them has been helpful. And thanks for the congratulations comments concerning our wedding in Jamaica. It was amazing and so glad that we were able to go there and get married on the beach at this crazy point in our lives.

~Greg

[phil]

I dont know of studies about frequency of scans, but I know MGH's docs do them 3 months apart when cancer keeps coming back, as in your wifes case , since Jan. I think you will hear the same from others on this site who are being treated for Stage Iv at research hospitals. So our cumulative experience says scans every 3 months , for a good long while after re-occ. The tumor marker blood tests are good indicators too. Lorraine gets them every 2 months. Were up in 2010, before t dm-1 , have dropped to 14 since Sept , 2011. Lorraine has scanxiety every scan , but has seen the benefit of quick decision to drop txs not working ( abraxane after 2 months of no help ) and switching just in time to t dm-1. We are gearing up for her next scan May 15, which is 4 months after 18 months of every 3 months, because t dm-1 is working so well.
If i had a chance to get t dm-1 in those trials i talked about , i'd take it. In one everyone gets it, and the other, Theresa, 2 out of 3 get it, with the 3rd getting tyk/ xel. or other physicians choice. I hear that Theresa is nearly full, about 900, so 600 are getting the new super -herceptin.
W/in a yr, many researchers feel that t dm-1 will be " standard of care " for metastatic Her2, at varying dose levels, and combined w/ pertuzumab. When w/ in the next yr ? Well , thats up to our FDA, who knows ?? , it will be w-in a yr , but Sept ? Nov ? Jan ?? i say go for it if you can get it.
If your wife tolerates tyk/ xel., i would still strongly , strongly encourage frequent scans,blood marker tests. Just this yr . Those who know me know I can be a nag about this drug t dm-1 , and aggressive tx for an aggressive cancer, but theres very good reason , its life or death, and it works , esp. for those w/ liver mets, not too much bone involvement yet , like Loraine. Show this to your wife, and show her Lorraine on youtube " FDA Blocks Life Saving Cancer Drug Rally , Part 4. " Shes Living Proof . This is probably the best breast cancer drug for her2 in 15 yrs , since herceptin itself. Alright, done nagging , for now anyway...

[MJsHusband]

Thanks for "nagging" Phil. I appreciate your perspective and knowledge. I'll pass what you've said along to MJ. I have read about the Theresa trial but haven't considered it so far. I'm glad to know the T-DM1 drug is working for Lorraine and many others and glad that there is a backup in case the Tykerb/Xeloda/Herceptin combo doesn't pan out. I just wish the FDA would make it available sooner. I hate that some people don't have time to wait for this approval. I've read a few sad postings about that.
~Greg

[Adriana Mangus]

Hi Greg,

I agree with the other gals on the site, it appears MJ has received the appropriate treatment. She's fortunate to have you as her health advocate.

MJ will do well with the treatments, also there are countless clinical trials. You can check them out @ http://clinicaltrials.gov

Congratulations on the wedding.

Love,

Adriana

[MJsHusband]

Thanks Adriana. I will check out that clinical trials site. I see you have been in a TDM1 trial. Are you still involved in it? I don't see any update on your signature after August 2010 so not sure what your status might be these days. I hope things are going well for you. I guess TDM-1 is the great hope for everyone on this site. Hopefully it will perform better than Herceptin.

~Greg

[kk1]

Greg;

It's counter intuitive but please let MJ know that the scanxiety is actually much less when you are scanned more frequently. If you have or had mets and wait six month between scans it's REALLY scary, after a few months your mind starts to imagine tumors "going wild". When it's every 12 weeks the anxiety doesn't build up and your mind learns to think "well it hasn't been so long so how bad can it be---I can deal with what ever is coming". I have found 3 month scans build my confidence and let's me plan and live my life better, and as I said I think my key to longevity has been always catching a met when it is small.

Also Phil and Becky are on target, ask about always being on Herceptin as it works better synergistically. Just because she develops a met does not mean Herceptin is not working. My analogy is there are multiple doors and windows for the HER/NEU cancer to enter the cell. Just because it found a back door doesn't mean you should give up and throw open the front door by discontinuing Herceptin. If someone breaks a window and burglars your house don't you still keep the doors locked? You would not say the dead bolt failed lets remove all the locks.

And finally you might want to ask about routine CTC blood testing in between scans as part of the monitoring, and I don't see you mention the ER/PR receptor status of the mets or primary.

[phil]

Lots of wisdom inwhat kk1 is saying. hers another thought, if you are going to try tyk/ xel. anyway, why not take 2 out of 3 chance on getting t dm-1 , if you dont, your fallback is tyk./xel. Thats Theresa, its a big trial. If you look at its hx., and its "suspisciously unique " randomization of 2 to 3 , I think its the co's attempt to get as many on t dm-1 and still satisfy This FDA's forcing them to do trials . Most trials would have a 50/50 randomization, or maybe 3 ' arms ", . if my guess is corect, kudos to Genentech. They know, and we know that they have a breakthrough drug.
The main trial This FDA is forcing , EMILIA , is done, data will go to to FDA soon, next month ? Then This FDA typically will take 6 months to approve. It shows that t dm-1 is superior to tyk/xel. How superior ? I am betting a lot, in survivability, and in QOL. tyk/xel is notoriuos for dirrhea, and " hand/foot syndrome , my wife had it all, droppped 15 lbs off an already 4 yr battling thin frame, wore gloves w/ lotion to bed every night as her fingers cracked. Turned the palms of hands, soles of feet orange T dm-1 : platelets for some , that can be managed w forwarning , dose reduction.

[Mandamoo]

Phil - don't you have to have measurable disease to be eligible for any of the TDM1 trials - from what MJ'shusband has said, last scans showed no measurable disease. My understanding of measurable disease is a tumour of at least 2 cm measurable on standard CT with contrast, I think you can get in with a 1cm tumour using different 3d CT - it is usually according to RECIST criteria. I also believe to participate in theresa you have had to have tried Tykerb and xeloda combination to qualify.

Another consideration is that participation in a TDM1 trial - even if you draw the control arm and receive treatment of your physician's choice can exclude you from further TDM1 studies.

I recently participated in the Bolero 3 trial and we had to find something large enough to get me in (In the end we 'measured' an axilla node at 21mm) - my lung tumours were the concern - there were more than 40 but none over 1cm and not close to 2cm so ineligible by them when they are the life threatening ones.

For what it's worth - I am on Tykerb xeloda currently and have had a response when nothing else has reduced my lung tumours. I am managing side effects ok - with a slight dose reduction - every body is different. If I could I would have herceptin with the Tykerb but it is not funded in Australia to have the two combined and it would cost us $60 000 per annum to fund herceptin.

Let's hope the FDA approves TDM1 soon because we are usually about 3 years behind in approvals in Australia. Also want to see pertuzamab approved so there are more options to try.
Good luck,
Amanda

[phil]

Good points. I have not read up on theresa 's specifics exclusions , etc. Aggressive cancer calls for aggressive tx. I like that you and your docs looked for measurable disease. Our docs saw that Lorraine ws on adria again, awful drug. They said , " well, she could get more , but shes close to lifetime limit, so.. they let her in to t dm-1 access. We need to explore all options, ask all ? of our docs.
A very good point is that This FDAs' new OS stats mean that ,in theresa, if you progress on physicians "choice ', you cant get tdm-1. 2 out of 3 is better odds than usual trials. As i have said before, its gen .'s way of getting t dm-1 to the most , while satisfying This FDAs randomization rule. Theresa may close soon. So , no decision is easy.
Pert is coming soon, and t dm-1's big trial data ( EMILIA)is done, is going to FDA this month or next, so i think t dm-1 might get out before end of this yr. Then everyone here can get it.. So check all trials, the pert /tdm-1 in Ny, Boston gives everyone t dm-1. If your cancer strongly overexpresses her2 only, has come back on tac, and you cant get t dm-1 in any other trial, theresa might be a choice.
I sur eplan to turn the heat up on fda this yr. Our rally on youtube in Dec. made one big mistake : we thought our media contacts would come to us . Nope. So, we must go to them.
Anyone want to picket outside ASCO in June ? Copy our shirts, or if i can i'll send you Chicagoans some. Dont think i can swing it, but we will definitely be outside the Internatl BIO tech Convention in Boston June 18. In our pink Fix The FDA shirts. All you Bostonians , stay tuned !!

[phil]

Further thought , aggressive means Take Action ! < I mean interms of if you have strong her2 , metastasizing quickly, dont wait, look into t dm-1 trials. Ask gen for comp. use , they may be more flexible as pert nears app. and the main t dm-1 testing is done

[MJsHusband]

I'm hoping we are not at the point where we need to request compassionate use. Do you all think we are at that point where we are quickly running out of options? Should I lower my expectations for Tykerb/Xeloda? MJ started her second round of Xeloda this week in addition to the 5 daily Tykerb pills.

I am hoping TDM-1 is a game changer, like Herceptin was thought to be. It seems Herceptin doesn't work for everyone and for those who do respond, it stops working on it's own after a number of months/years. I am reading about the success some are having using Herceptin in combination with other chemo drugs and that's a good thing. I guess I'm a bit let down after Herceptin allowed the endometrial tumors to grow so quickly. To me, it's not the "game changer" that I first read about when MJ was diagnosed. I still remember the hope I had when I first read "Her2 had a poor prognosis before Herceptin". Now I can't help but think, what if it doesn't work in combination with other drugs for MJ? I saw a study that even when Herceptin is added to Tykerb, overall survival is only extended 4 months. Is it too much to want more than that?

Sorry for the "blah" posting today. It's just how I'm feeling.

~Greg

[phil]

We went to MGH, saw the Theresa criteria on the wall there, " at least 2 prior regimens of hre2 directed therapy ', Lorraine had had herc nav, herc / gemzar, herc / carbo, tyk/xel twice, i dont know if TAC counts . ( It should ! nasty ! )
We didnt get t dm-1 today, those plats mysteriuosly dropped ! , as they can do, to 56,000. Can get txed at 50,000, but doc wants to wait, try next wk. We are not concerned, but plats are fragile. Can jump, or drop 10,000 in a day. L's have been slowly climbing, to 82,000 last time. Like a step-ladder, but havent been as low as 56,000 in months. Our doc thinks we caught a little extra dip, says , " They probably would be up if we checked them later today. " Ahhh, just as I was talking like a little platelet " guru "...humbling. We still believe in the plt support measures we have mentioned before.

[phil]

greg, I posted about the theresa trial info , in response to kk1's input, then saw your post.
Having " Blah ' days is completely understandable, in fact , having raging mad days, crying days ... and laughing days, is part of the deal too. I'm looking at abeautiful pic on my desk of us in Naples , Fla. 2 yrs ago, and we had a great time in Aruba 3 yrs ago, even w/ nasty tyk/xel s/e. I hope you have great pics of jamaica. Good times are only sweeter , after hard ones.
Herceptin is a game-changer. As many as 20% of her2 pts need only herc. I know many others who got herc , w TAC, ( like taxotere, carbo , herc ) , and maybe f/u herc. Yrs NED now. Many do not post on the web, they are off living thier life, maybe doing a walk ix ayr. I greatly appreciate those who are NED who stay on the web, give us encouragment, advice.
They are discovering more and more genetic sub-types of bc, and probably will find sub-types w/in her2 +. Some her2 , like Lorraine, and yuor wife, probably have other mutations than her2 overexression, that havent been discovered yet. Some respond to tykerb, some have few s/e from tyk/ xel or tyk/herc. my wife had strong s/e but still toughed it out for months.
Whats encouraging about t dm-1 for strong overexpression of her2, is , even if there are other mutations in Lorraines cancer , T DM-1 doesnt care , it uses herc to home in on the mutated cells , and the dm-1 blows them up. End of story . Thats a game-changer.
I didnt know all this in the first 2yrs or so, but i ahve learned a swe go along. have you seen Lorraine ? On youtube ? If you want to see a " before T dm-1 " pic , go to southshoreexpress.com, type in " Lorraine heidke-mccartin ". You will see her in 2010, holding our newest granddau, w . a baseball cap hiding her wisps of hair from adria. Then watch her in the Rally video. She went SKIING last winter for the first time in 5 yrs ! Only 5 months on tdm-1, 4 months after that pic. I think some of my feedback to you has been really more about not being at a top research hosp., like Johns Hopkins , and not w/ a " friend of your onc ".
battling aggressive cancer is about being aggressive, " surprising the cancer " w/ new combos , You have many weapons left, many ! But research oncs know most about which , and when , to deploy.
Your wife had liver mets , like my wife, and had pretty quick progression after some months , on herc. Like Lorraine. But w/ L herc still worked , w. navelbine, then gemzar , for probably over 2 yrs. Tyk/xel works better for some than my wife.
Pertuzumab may be better than herc., and will be out very soon , June ? , t dm-1 i believe by end of yr. I think that anyone in a trial who progresses then , can drop out and get approved drugs like herc/ t dm-1.
This is going to be a historic yr for her2 bc tx, w/ pert and t dm-1 coming out . Thats why i wa sthrowing out looking into theresa, becuase 2 /3rds get t dm-1 . The others could ride tyk/xel or some other " physicians choice " as long as it works, or until progr. Then drop trial, go to combos w/ pert , t dm-1 later in yr.
Tyk /xel works !! Its a good tx to go w/ for aggressive her2 , But I strongly recommend moving tx to a top bc research hospital . No time to feel bad for docs, esp. ones w/ ? about overall tx planning .

[phil]

In the above post I meant pertuzumab will be available soon for those who progress in a trial and drop out, T DM-1 by end of yr. for those who have to drop out of trial w/ other drugs.

[phil]

Oh , yeah , you're nowhere near having to think about comp. use !

[chrisy]

Greg,

Phil said a lot. All true.

There are lots of options, and this should be a very exciting year for her2 agent approvals.

One word about trial stats....they represent data points over everyone in the trial. It is also the MEDIAN, half the people had pfs of less tha 4 months , half had longer pfs. The lower "half" includes people who did not respond at all, while the upper half usually includes responders who have much, much longer..

My point is, statistics do not reflect how any individual will respond. So don't get hung up on "this will only buy us 4 months". Picture yourself on the far right tail of the curve. If you have not read it, I highly recommend "the median is not the message". You can googl it easily

It's hard not to second guess and play "what if?". You just have to do the best you can to do the research, align yourself with a top cancer center (most local oncologists are happy to work and play with these top researchers) , fight for what you think is best, and make the best choices you can. Easy, huh?

But I really second Phil's recommendation of having a relationship with a top onc, at a top research hospital, with expertise in your situation. Phil's righ on in his comments there - they have access to all the research going on, even unreported stuff, and can offer many options that are not available except at a large research facility.

Hang in there.

[her2 newBEE]

Greg,

My wife is in a very similar situation... stage 4 at dx, strongly Her2+ by FISH, and relatively young (37). She's a little more than a year into this. I would really agree with the voices on this thread calling for Herceptin to be added back into the mix (or at least looking at this strongly). The data does show that there is statistical benefit. As targeted therapy, my wife has Tykerb + Herceptin right now along with a standard chemo agent. There were some recent reports out of the Chicago seminar as well as the SA Breast Cancer Symposium in 2009 suggesting that H+Tykerb > Tykerb alone --> http://www.rttnews.com/1154913/glaxo...dy-update.aspx. And, there are more and more studies emerging bearing out that combining multiple targeted agents in the treatment of metastatic Her2+ BC seems to be a favorable approach.

Also, agree that TDM-1 & Pertuzumab probably hold forth the most promise right now. And, there is definitely benefit from being close to a research hospital where you have access to clinical trials. However, one thing you should weigh is the balance between aggressive treatment and toxicity. By all accounts, Lord willing, these drugs will be available by the end of the year. It would make me think twice about jumping into a trial that would include a heavily toxic chemo alongside a drug like T-DM1.

As for scans, I'm not sure how critical 3 months vs. slightly longer interlude is in the overall picture (a clinical trial will require scans every 3 months or so), but I do think that it is important that you push for your wife to at least get fairly regular brain MRIs.

[phil]

greg, lots of good feedback, throwing lots of stuff at you, but , meant to be helpful. Chrisys point about statistics is right on,. In fact, when first dx, Lorraine did not want to know what stage she was, saying " I am not a statistic ". And it is true !
after reading all above, I still say go get tx at a research hospital, take tyk/xel and go .
We were in the suburbs at dx. , saw anice guy, but he was ageneralist , tx'ed many types of cancer, had trained at Farber, " talked " w/ farber all the time. But he wanted to be conservative, hold back on chemo. We just knew in our gut that this was an aggressive cancer, and went to MGH for second opinion. Our onc., was aggressive, and went for aggr. tx, which was taxotere, adria, cytoxan, w/ herceptin following. Scans every 3 months . 9 months ( NED) later liver met back, right to herc./ navelbine.9 months (NED) later, liver ablation to one tumor, herc / gemzar for 18 months of NED, tyk/xel , etc. to t dm-1.
Going to MGH flat out saved Lorraines life, and t dm-1 saved it again !