Axitinib

[Olga]

Dear patients, we have received an information from UK ASPS patient that Pf.Judson enrolls the patients that failed cediranib into the Axitinib trial, she had already had her first scan on a trial and it is a regained stability (she started to progress after a long break after she ended her cediranib participation voluntarily). There is a clinical trial phase 1 open in US for solid tumors, what interesting is that in UK it is already phase 2 and is specifically for soft tissue sarcomas, so I would say it looks promising. They probably already had finished Phase 1 and had sarcoma responders and that prompted them to open the Phase 2 stage for the soft tissue sarcomas.

[Bonni Hess]

Dear ASPS Community Friends,
I have received an update from Clare Clarke. Clare is an ASPS patient from England who was diagnosed seventeen years ago. She was previously on Cediranib which she discontinued after suffering severe and debilitating side effects from the medication, and is now participating in an Axitinib Clinical Trial after experiencing some disease progression last fall. Clare has graciously given me permission to share information about her Axitinib Clinical Trial experience and results thus far. Thankfully her most recent scans show continued stable disease. An excerpt of her update is as follows:
"my latest scan results, all reported stable, no new growth. I am on quite a low dose of 3mg, not the 5mg I started on, as I was getting side the throat ulcer problem again. I suppose I don't really think it's going to have the drastic effect of cediranib, but am happy to continue with it for now. I still do get some throat problems, but it's manageable and I had thought I was getting some knee problems too, which on the cediranib trial caused me to stop. But it seems to be ok now. I've even managed to do some very gentle 30 min jogs about 8 times in the last 2 weeks. I've also seen some posts out there, which seem to show that axitinib can be very good for kidney cancer patients, so I think it's worthwhile continuing with the drug to show that the side effects are minimal on a relatively healthy person. This drug could make a big difference to others."
I am very grateful for Clare's thoughtful and invaluable shared information, and am very Hopeful that the Axitinib will provide continued and sustained disease stability for her. With her permission, I will continue to update the Board on her behalf.
With special caring thoughts and continued Hope,
Bonni

[Ivan]

Thanks for the update, Bonni. How long has she been on this new drug?

[Bonni Hess]

Hi Ivan
Clare began the Axitinib Trial in September 2010 which I provided information about in my December 12th, 2010 update in Clare's Cediranib topic updates. Perhaps you could re-locate that entry to this Axitinib topic so that people can more easily follow Clare's Axitinib Trial experience and results from the beginning of her Trial participation. Thank you for all of your and your mom's help in keeping the Forum better organized with entries placed in the most appropriate topic section.
With much gratitude, special caring thoughts, and continued Hope,
Bonni

[Bonni Hess]

Dear ASPS Community Friends,
I just received the following thoughtful update from Clare Clarke regarding her Axitinib Clinical Trial experience, side effects, and results, and I am sharing it with her permission:

I've just had my latest scan results a week ago, termed stable with 4mm growth of one lesion near the top of my right lung. I am staying on the drug for now, though I do feel that it's effect is beginning to wane, though this has no scientific solidity! The ulcers in my throat have disappeared ( great to be able to sing) and I've been getting pains in my chest; I have been reassured that it's just heartburn, I had thought that I was having a stroke on one severe day! I have been given lansoprazole to deal with that. I am begininng to get muscle and bone aches and pains, arthralgia is the term apparently, but not severe yet. If my legs and knees get worse though, as they did on cediranib, I would feel it best to stop the drug. I do feel I should keep on as long as I can for the moment, so that the drug gets more approval for other cancer patients.

While it is disappointing that the scans indicate that there has now been 4mm of growth in one of Clare's lung mets, her disease thankfully appears to be stable in terms of no new tumors, and she had six months of no detectable increased growth in her lung mets.
I have recently learned about another UK ASPS patient who both Clare and I think is also now on the Axitinib Trial. The patient said that she will be receiving her first scan results within the next two weeks to try to determine if her Clinical Trial medication has been effective. I have encouraged her to write to the Board to share her story and her treatment information, so Hopefully she will do that as we all know how vitally important shared anecdotal treatment information is in this challenging battle.
I am deeply grateful to Clare for her continued thoughtful sharing of her ASPS treatment information as well as her gracious willingness to continue to stay on the Axitinib for now in order to help the drug get approved to help other cancer patients for whom it may be effective. My very best wishes are with Clare for the Axitinib to be very successful in stabilizing her disease and shrinking her lung mets.
With special caring thoughts and continued Hope,
Bonni

[Ivan]

Thanks for the update, Bonni. It certainly seems the *nib drugs are all somewhat effective in ASPS - some more, some less. It's good to start having a few working options which at least seem to stabilize for 6 months to a year, or possibly shrink and allow surgical treatment when it wasn't possible before.

[Bonni Hess]

Dear ASPS Community Friends,
I have been in recent communication with Clare Clarke regarding her Axitinib Clinical Trial experience and results, and sadly she had to discontinue the medication in July due to very concerning severe chest pains resulting from the toxicity of the Axitinib. The following is an excerpt from her thoughtful e-mail update to me:

I stopped taking axitinib at the end of July because I was getting some severe chest pains that I've never had before. I had ecgs, gastroscopy etc as we thought it may have been an ulcer in my digestive tract. My doctor at Christie has recently named this effect as pericarditis, caused by drug toxicity. It is nearly a month since I stopped the drug, the pains have lessened in severity and occurence. My scan from mid-July shows now growth (I think that this is a typographical error and that she meant to write NO growth), but the heart pains were continually very sharp and could cause other more immediate serious problems than the sarcoma, so Dr Mike agrees that I was right to make the decision to stop! I hope to start the new cediranib trial in the autumn, it will be interesting to see whether it could have success again, though I suppose I may be resistant to it.

I continue to be deeply grateful to Clare for her graciously allowing me to share her updates with the Board so that we can all learn and benefit from her treatment experiences. My very best wishes are with her for a very successful response and outcome to her new Cediranib Clinical Trial which she is scheduled to begin sometime this fall. With her kind permission, I will continue to share her updates with the Board, but will no longer post them under the Axitinib topic since she is no longer receiving that medication. However, if there is anyone else on this Board who is currently participating or has previously participated in an Axitinib Clinical Trial I would like to strongly encourage you to write and share your treatment experience and results. Shared anecdotal treatment information is critically important to all of us in this very difficult battle with this very challenging disease in helping us to make the best treatment decisions possible based on actual patient experience whether it is/has been positive or negative. EVERYONE!! needs to actively participate, share, upate, and work together! The more people who share, the more information we will all have, and conversely, the fewer people who share, the less information there is available to all of us to learn from.
With special caring thoughts and continued Hope,
Bonni

[Bonni Hess]

Dear ASPS Community Friends,
I received this additional thoughtful clarification from Clare regarding her most recent update which I posted yesterday:

sorry about typo, yes no growth is thankfully correct. Yes, I'm quite happy for you to share things, but I do think people should be aware that side effects can be very specific to an individual. I have been told that very few people had been taking axitinib for as long or continually as me. I certainly have not been told that this side effect has occurred in others. I wouldn't want to discourage people from this promising drug.

With special caring thoughts and continued Hope,
Bonni

[Olga]

Thank you both, Clare and Bonni for keeping us posted about this drug. The side effects and efficacy are only getting known to the doctors during the trial and it is all very interesting.

[Katrinauk]

I wonder if theres any knowlede as to whether clare was on any other treatment prior to her cediranib trial???

[Bonni Hess]

Dear Katrina,
I don't know which treatments Clare received prior to Cediranib, but I think that she is thankfully about a 15 year ASPS survivor .
I am in occassional communication with Clare and just recently received an e-mail from her with the following information regarding her current treatment status:

"I'm all stable at the mo' and had thought I would be starting on the double blind cediranib trial before xmas, but they have decided not to put me on it because my disease is stable & also I still have some pericarditis side effects as a result of the axitinib trial. I must admit I'm wondering if it will ever go, as I've had some chest pains on & off everyday since April. But hey ho, not worrying, just part of life! Managed to lose some extra pounds caused by the last 2 trials so feeling otherwise fit & healthy, plus knees & leg muscles feel strong again!"

It is wonderful and very encouraging that Clare is having continued disease stability , and I am wondering if the stability can be attributed to the effect of the Axitinib treatment. I am so deeply grateful for Clare's continued shared information and her gracious willingness for me to share it on this Board. I Hope that anyone else who is receiving/has received Axitinib treatment will share their anecdotal treatment information and results on this Discussion Board so that all of us in the ASPS Community can more closely follow and learn about this promising new drug.
Shared information remains one of our most powerful weapons in fighting this very challenging disease! We need EVERYONE to participate and share!
With special caring thoughts and continued Hope,
Bonni

[Katrinauk]

Thankyou for sharing that Bonnie. I ask about Clares treatment prior to cediranib. As I know she is in England also, basedbat christies hospital in Manchester I believe.
My omcologist has never mentioned axitinib to me, until I read about it here about a month ago, and found that it was a trial taking place here in England. When I questioned whether axitinib would be a treatment option for me if cediranib fails, I got told no, as I would have already been on two previous treatments (sutent and cediranib). So if Clare had indeed been on sutent before cediranib too, then I at least know I have some grounds to fight for it on.
I asked here if dasatinib was available, and can you believe, they use that for kidney cancer here, but I couldn't have it, as it hasn't been trialled for asps. Dammit! So cediranib and axitinib are the only two active and available options for asps over here after sutent. I wonder if you might ask Clare for me?

[Olga]

No need to ask Clare - I remember that. The previous drug before of the cediranib she was on (and had a good response too for awhile) was PDX101, ask Pf.Judson about the fate of this drug - it was his trial as well. More info is here:
Paul was on that drug also, unfortunately he was lost due to a brain met left untreated while he was participating in a cediranib trial - it is not a rare occasion when some mets respond to a drug while the other ones are resistant (esp. in the other locations where they might be missed if the trial is focused on a targeted mets area):
http://www.cureasps.org/forum/viewtopic.php?f=21&t=68