Treatment Decision Time

[CourtneyL]

You ladies and gentleman have always been such an incredibly helpful sounding board. I'm hoping you can offer some guidance/thoughts about my latest predicament.

I am currently enrolled in the t-cell vaccine trial at the University of Washington. So far I have received the 3 vaccine injections and the leukapheresis whereby they extracted my T-cells (which have hopefully developed an immune response from the vaccine). The t-cells are currently frozen and awaiting defrosting where they will then grow additional t-cells and infuse them back into me. The trial finishes with another 3 rounds of vaccine booster shots. The idea is that the t-cells infusions will super charge my immune system to identify and destroy the remaining cancer cells.

The wrinkle is that over the past few weeks I have been experiencing some back pain and my tumor markers have been slowly climbing. My CA 15-3 in February was 35 and it is now at 48.4 - suggesting some disease progression. I panicked a little and called up the folks at U of W for advice. Dr. Salazar said that the vaccine could cause the spike and inflammation (hence the pain) but that I should get a PET in the interim to see what is going on. Onc called today with the PET results and the results are mixed. Lungs and liver are NED (Thank GOD for small miracles!) but bones are a mixed bag. There was some regression but also some progression as well as "a new focus". Huh?

I optimistically suggested to my onc that perhaps this was bone healing or active bone marrow producing magic t-cells. He said "no, its probably a new met." He said we could try a systemic treatment but that would push back the t-cells for months. He favors switching to Denosumab instead of Zometa (see my other post on this issue) and proceeding with the t-cells. I asked about targeted radiation and he doesn't think it would get them all.

My concern is that if the t-cell therapy is not robust enough we would have to do more systemic therapy down the road and that might compromise the immune response by destroying all of my supercharged t-cells. Do I proceed with the t-cells now (which will also involve one dose of Cytoxan) and hope for the best? Or do I do a systemic treatment now (probably Navelbine) in hopes of lowering the tumor burden as much as possible and then get the t-cells in a few months?

Decisions, decisions.

Congratulations if you actually made it to the end of this long-winded post. And thank you in advance for any thoughts/input that you may have on this scenario.

[Darlene Denise]

Sweet Courtney:

I'm not usually a "Standard of Care" kinda girl, but, in this case I vote for the Navelbine/Herceptin and do the terrific T cells after you have regained control. I have not been convinced that the immune system can push "active" cancer back in the metastatic setting with current therapeutic vaccines. JMHO.

I am really pissed that we are having to vote on such a situation with you. I would much rather be celebrating NED status and hearing about your travels.

You are one brilliant, lovely lady and I know you will decide on the best approach.

Stay strong....Darlene

[Laurel]

Courtney,

Gosh, such a tough decision! Firstly, please know how rotten I feel about this new area of focus! Hated damn disease!!! I guess my question is simply whether the t-cell vaccine works? Is it aggressive enough to contain the cancer and put it back in the bottle, or is it an unknown gamble? If it is a pretty sure shot, then I guess I'd be inclined to roll the dice. If not, then I'd go with the tried and true hoping to get it under wraps again. Then if permitted, I'd take those frozen t-cells and pray they work their proposed magic!

Don't you wish you had that crystal ball at times like these to really KNOW what to do? I will pray for healing and clarity for you.

[StephN]

Dear Courtney -
Thanks for the very thorough explanation of the vaccine trial you are in and the crossroad in front of you.

Please remind us what drugs are you getting right now. I thought it was Herceptin and Tykerb?

Sorry there is a bone spot thought to be a new met. But very glad the PET was good in the other areas.

[CLTann]

Dear Courtney,

Your path is clear. Go for the best and known treatment for your cancer. You are more important to yourself and your family. Vaccine trial is secondary to you. Best luck.

[flynny]

Courtney, I too agree with the Navelbine/Herceptin route. From what others have done it seems like it could really help you and then do the vaccine trial afterwards. This decision must be weighing on you in so many ways. I wish I had the magic answer, but unfortunately all I can do is send you good thoughts your way!

Sarah

[chrisy]

ok, slightly different twist...What would Dr. Salazar recommend? I find it interesting that your onc favors the t-cell "unproven" approach - what are his reasons for that? Perhaps he feels the switch to denosumab will work on the apparent new mets; and is his "standard of care" answer. It also makes me think that he feels that moving to a chemo regimen (navelbine) at this time is not warranted, and that this is a good time to take the shot on the vaccine.

Tough decisions. Some oncs, and patients, believe less is more - since this is a marathon and hitting hard with chemo is not always the best choice. And the hope is of course with the vaccine, proven or not.

I can't really inform your choice, although it seems you have 2 good options. I'd ask both sets of doctors what they'd recommend and why; then try not to overthink it: trust your instincts and make your choice.

Good luck Courtney, keep us posted!

[ElaineM]

I agree with your doctor. I would do what he recommends, but you have to make the choice you know is best for you. Good luck.

[hutchibk]

Are you ER+? If so, are you taking anything to address that target? After 3 yrs without it (thinking that it was doing us no good), we added Aromasin last summer as a small measure (added to Tykerb/Herc and 3 mo Zometa), to see what it might do...and it seemed to buy us some results... we did it at the same time that we radiated a bone spot and the pituitary spot and everything held well and looked NED until April when we saw a new little spot on my adrenal. At that point we only switched my Aromasin to Tamoxifen and 15.3 has dropped from 38 to 23ish. Will MRI the adrenal in a couple of weeks.

Make sure you MRI the bone spots that are showing on PET/CT for measurement and further info. My Rads Onc now reads EVERY MRI to be sure what we are looking at. We have experienced the occasional report tell us that they see a new spot, only to find out that it was necrotic. My rads onc takes no more chances, he is the final determining set of eyes.

Beyond that, what does your doc think about you getting into the expanded access T-DM1 trials... My onc(s) think that that is my next best idea that could really gain us some ground and some hold time. Just waiting for it to open up in Texas.

I am guessing that you might have to give up on the vaccine and T-cell therapy if you are showing progression... sigh.

[Lori R]

Courtney,
I think Chrisy makes a good point about questioning the Oncs further.

Seems like there could be some middle ground between 2 good options. Bear with me for a few random thoughts....could you take the Denosumab and see if it knocks down the markers? If you wait a month to see the results would the "big thaw" be done and you wouldn't have missed a beat on the U of W trail?

Many on the site have indicated Navelbine isn't as harsh yet appears to be very effective. So...not a bad choice either.

Sorry....not a lot of guidance here...can the U of W team provide a comittment that after Navelbine that you could jump back into the trial?

Certainly thinking of you. There is no "wrong" answer. Both approaches seem appropriate.

Please keep us posted....Lori

[StephN]

Courtney's sig says ER/PR - . I usually remember the gals who are double minus - like me!

We have fewer treatments to rely on. One more reason the vaccine trials are particularly attractive to us hormone neg types. And why we line up for the other trials quickly.

Chrisy has a good point, to my mind.

[bejuce]

Hi Courtney,

Sorry to hear that you have another hurdle to overcome. I don't have much to offer in terms of my opinion on what to do, but please know that I'm praying for you and your doctors to come up with an effective treatment plan.

I also wanted to ask you if you have considered going to UCLA to Dr. Slamon's team for a consultation. I say this because last weekend I participated in the CDMRP peer review panel for the DoD and had the privilege of being in the same panel as Dr. Hurvirtz who works with Dr. Slamon. She was very positive and told me that UCLA has lots of trials going on. Let me know if you're interested - I can PM you her contact info.

Good luck!

[Rich66]

The wording is a little unclear to me. You only have bone mets? or don't know yet?

Also..
Has the vaccine included GM-CSF or G-CSF?

[chrisy]

Courtney, I thought of this after logging off, and Brenda's comment reminds me. Sounds like the possible progression/new bone met was identified with a Pet. Would it make sense to confirm this with a bone scan?

[Darlene Denise]

I don't have bone mets, but, don't you consider the type of bone met to determine the best diagnositc scan? Lytic bone mets show best on Pet and Blastic bone mets show best on bone scan from my understanding.

Also, doesn't Alk Phos and Calcium levels give additional indication?

So awesome to see so many caring ladies jump in and try to help make sense of all this madness for our friend, Courtney.

Let's keep thinking, caring and supporting!!!! You guys rock!

Darlene

[CourtneyL]

Wow, I am overwhelmed by the number of incredibly thoughtful and helpful responses. This really is the best support group on the web - and the most well-informed. I knew I could count on you for some deep analysis. Let's see if I can address most of your questions, comments.

Rich - yes, I am dealing with bone-only disease at this point. The brain, lung and liver involvement has completely resolved. Victory numbers 1, 2 and 3! Now we're just working on victory number 4. And yes, the vaccine does include GM-CSF to help improve the immune response. I can send anyone who is interested the exact trial protocol.

Darlene - I totally agree. I'm not usually a "standard of care" gal myself but in this case, I am inclined to agree. For what its worth, my alk pho and calcium levels are both in the normal range.

To answer your question, Laurel, and address your recommendation Elaine, I don't think these vaccines are robust enough to really handle lots of active disease. I think their real benefit comes from being able to ward off new disease and new progression. But I am not certain on this. I need to talk with Dr. Salazar to see if she thinks it is in the realm of possibility that the t-cells could be an effective treatment. I don't necessarily like the idea of taking a gamble. The odds are pretty good that a switch to Herceptin/Navelbine while taking a break from the trial would knock back some of these bone mets. So Darlene, CLTann and Sarah - I totally see why you are of the opinion that chemo is the way to go for now. And Lori, yes, I'd be able to hop back on the trial after a 3-week wash out period whenever we decided to stop the Navelbine. Chrisy - yes, I am really interested in what Dr. Salazar has to say. As she is not my primary onc, I'm expecting she'll say "its up to you". This is what she told a friend of mine in a similar situation.

But this does make me wonder why my onc is recommending that I press on with the trial. I think I know why. I think the reason my onc isn't recommending systemic therapy in the interim is because of toxicity issues. We talk about this being a marathon and not wanting to burn through our chemo options to quickly if we don't really need to. On the scale of seriousness, bone mets are lower than brain, lung or liver. He has confidence that a switch from Zometa to Denosumab for my "osteoporosis", with continued Herceptin, and now t-cells, may just be enough to contain the beast.

Steph - I'm currently on Herceptin and Zometa as I participate in the trial. No chemo allowed. However, as I mentioned, I can postpone the t-cell portion indefinitely since they are frozen and not going anywhere. Another thought I had, in addition to switching to Denosumab for my "osteoporosis" is to add Tykerb back in. But I progressed on Tykerb last year so I'm not sure if it would have any clinical benefit. Is it possible for a drug to work again if you progressed on it previously?

Brenda - Excellent suggestion to see a rad onc and get a consult. A part of me is not totally convinced that all of these are active bone mets. Would an MRI or bone scan be able to tell us more? Not crazy about the idea of a biopsy. And I'm trying to limit my radiation exposure (again, this is a marathon) so I don't really want to get a CT.

Weighing all of your wonderful advice, here is what I think I am going to do - (1) ask for a rad onc consult; (2) ask both Salazar and my onc which route they would choose and why (after they've spoken with each other sometime today). And I'll go from there. I know I am luck to be having these options at all and I am sorry to sound like a whiny baby.

And, yes, Marcia I have thought of paying Dr. Slamon a visit. He's in my back pocket arsenal and hopefully I never have to see him but nice to know that he's close by.

Thank you all SO much for your helpful advice. If you ever find yourself in San Francisco, I would LOVE to take you out to lunch and thank you personally for your support and love. I'll keep you posted as this saga unfolds. Stay tuned...

[CourtneyL]

One additional comment - the eternal optimist in me is not convinced that the trial is a total failure at this point even though we are seeing some bone progression. I received the 3 initial vaccines and then I had a large number of my t-cells extracted. So there probably aren't many t-cells in my system that have an immune response at this point. They took most of them out. The idea is that they will grow more t-cells in the lab from the ones they took out and this infusion of t-cells is the real "meat" of the trial that they think has the real effect. The vaccine was just to prime the t-cells for an immune response.

[hutchibk]

Just a little food for thought, but even though original DX was ER-, we are learning that mets can change... or be different from original DX. Without the ability to biopsy, I wonder if it is not worth considering the reasonably small measure of adding AI or Tamox for a few months to see what it might do? We kind jumped into that water in my case, and it has been an effective additional small measure treatment for me for about a year.

[Delaney]

Courtney,
You were one of the first people to offer me advice when I joined so I would like to add my heartfelt best wishes to all the others. You're like a talisman to me ( no pressure on you then!), you have done so well when faced with very difficult problems. I wish you continued success with your treatment and hope it all goes very very well for you. Best wishes.

[Rich66]

Anyone seen significant bone met control from chemos like Navelbine? I thought bones were the domain of Zometa..and soon..Denosumab.
There is also suggestion that ERBB plays a role so Herecptin and/or Tykerb might be good additions.
There is some suggestion that blood count supports like GM-CSF and G-CSF might increase bone mets. That's why I asked if the vaccine trial included those.

Some info and options here:
http://her2support.org/vbulletin/showthread.php?t=43192&highlight=Bone+mets

[Darlene Denise]

A friend of mine with bone mets only for 16 years now has had benefit from Navelbine on two occasions several years apart. It was given with Herceptin.

[Rich66]

So...no bisphosphonates or rads?

[CourtneyL]

So here is the latest after speaking with both Dr. Salazar at U of W and my own oncologist, Dr. Smith, here in San Francisco. They were both in total agreement that, even if I weren't on the trial, they would not recommend starting systemic chemotherapy at this point. They would watch and wait since some of the bones are improving and only a few aren't. They both agree with the switch to Denosumab to see what it can do.

And they both agree that since systemic treatment isn't really needed at this time, that I should absolutely proceed with the t-cell therapy at this time. Dr. Salazar even thinks that the vaccine and immune response could be responsible for some of the flair up. I don't exactly understand the mechanism of action for this but my oncologist analogized it by saying that it was like dumping lighter fluid on the bone mets - they flared up but they will die down and hopefully go away completely with the t-cell therapy.

So that's the deal. The apparent progression may be caused by the vaccine and immune response itself. It doesn't necessarily mean the vaccine is not working. They've seen this kind of inflammation before and are not concerned. They make it sound so simple and matter of fact. But there lack of concern (not for me but for the results of the PET) really put me at ease and made me agree that it isn't time to bring out the big chemo guns right now.

Thank you all so much for your input. It was immeasurably helpful in helping me to sort this all out. I went in with the right questions thanks to you and that made all the difference in the world.

The plan is to unthaw the t-cells in the next week or so and go for the t-cell injections over a three week period in August. Looking forward to another fun visit with you StephN! I'll let you know when I've got some confirmed dates.

[CourtneyL]

Rich - even though Denosumab is not a bisphosphonate, the effect is the same, but through an entirely different method. And no rads are being recommended at this time. If I did rads, I'd have to hold off on the t-cells even longer.

[Rich66]

Yeah..regarding the bisphosphonates and rads, was referring to Denise's post.

You wrote:

"Dr. Salazar even thinks that the vaccine and immune response could be responsible for some of the flair up."

I would be interested to know if the vaccine protocol includes GM-CSF, G-CSF or similar. The bit I read recently suggested Zometa could block the negative effects of GM-CSF, which is sometimes combined with vaccines.
I talked recently with a researcher who was investigating using Cytoxan to block unhelpful immune responses to cryotherapy so that helpful responses could turn local therapy into something with a systemic benefit. He seemed to think inflammation was helpful to the immune system. Strange..since inflammation has been considered largely negative to cancer patients.

[Darlene Denise]

Rich: She has had Zometa but never any rads. She has been on Herceptin since 1998. She has had many chemos and is being encouraged to try a trial with LY2382770. She has been fortunate enough to never have any bone pain. Her markers always have stayed on the high end.

[Rich66]

Denise,
So she had Zometa and progressed?

[Darlene Denise]

Rich: She has been on Zometa every 6 weeks for a number of years and has had some progression. Not new areas in the bone, just increased activity. Her recent set of scans showed two lymph nodes in the chest. Onc relies on her tumor markers a lot.

[Jackie07]

Courtney,

Glad things are settled. Thanks for the update and the valuable information you've shared with us.

[kiwigirl]

Hi Courtney. So pleased you got every thing sorted and your happy about your treatment. I'm not sure if your going to be at UW on Tuesday 13th July? I got on the study and that's my first day. If not... all the best and well done. Regards Jacqui

[schoolteacher]

Courtney,

I agree with what Brenda said. Did they say anything about a biopsy? The nature of the mets may have changed. Do you think they will biopsy? There is some type of inverse relationship between estrogen and HER2.

Amelia