Cure Alveolar Soft Part Sarcoma International (iCureASPS)

Hi everybody,

Sree has enrolled in the cediranib trial at NCI. He has multiple lung mets, largest is at 1.5cms(was 1 cm 3 months ago), there are 2 more at 9mm and many smaller than that. I'll keep you all posted on how things go.

Regards
Arch

Dear Arch,
Thank you for your thoughtful update regarding Sree's enrollment in the Cediranib Trial. My best wishes are with him and your family, and I am holding very tight to Hope that he will tolerate the drug well and have a very successful and sustained response to the treatment. I am sorry to hear about the increased growth of his lung mets during the past three months, but they are still relatively small, and Hopefully the Cediranib will cause dramatic shrinkage and necrosis. Do you know how many ASPS patients are now enrolled in the NIH Trial, and what the maximum enrollment is? I will be anxiously awaiting your next update. Please take care and give Sree my best wishes for treatment success and healing.
With special caring thoughts and continued Hope,
Bonni

Dear Bonni,

Thank you for the wishes.
Sree is the 12th patient on the protocol and they will be enrolling upto 24 patients. The nurse did mention that they have lined up 2 to 3 patients for screening each week, so I think the trial may not be open for too long.

Arch

Hello again dear Arch,
Thank you for your very prompt response and for the shared information regarding the number of patients currently enrolled in the Trial. Hopefully the other ASPS patients in the Trial who don't already participate on this Board will write to share their treatment experience and results. I will write to Dr. Kummar to ask her if she will make information about our CureASPS Web site available to all of her patients in case they are not already aware of our organization. Take care Arch.
With deepest gratitude for sharing, and with special caring thoughts and continued Hope,
Bonni

Hi All,

Its 10 days since Sree started the cediranib trial, side effects so far have been throat problems. When we have a bad throat infection, we sometimes lose our voice and have to make a lot more effort to be heard, its something like that for him, ofcourse there is no infection, so we think it could be because of cediranib.
We spoke to the PI and she said she would be worried if its actually a throat infection. He drinks a lot of luke warm fluids, which seem to help temporarily.
Has anyone else had such problems ?

Arch

Arch, Paul fro UK told me that he experienced some hoarseness and problems with the voice - his GF even thought it is very sexy - it is mostly likely the side effect with cediranib, may be it affects males more?

Hi Arch,
Throat problems are a known possible side effect of the Cediranib, so I assume that this is what Sree is experiencing rather than a throat infection. When Brittany first started her Cediranib Trial we were told that she would probably develop a hoarse and raspy voice within the first few weeks, but she never did experience this side effect of the medication. She did have some difficulty swallowing during the first few months, but that doesn't seem to be a problem any longer. She continues to have mouth sensitivity and severe acid reflux. For the mouth sensitivity she has to avoid any kind of spicy foods, and she uses children's toothpaste because regular toothpaste burns her mouth. I Hope that Sree's throat problems are tolerable, and will eventually dissipate.Thank you for keeping the Board updated on his side effects thus far. Please give Sree my best wishes.
With special caring thoughts and continued Hope,
Bonni

Hi All,
Here are our updates at the end of 2 cycles.
Cediranib does have an effect on his tumors, there is 26% shrinkage in the mets that they are watching, so he will continue the trial.
However, side effects have increased and are causing concern.Side effects for him are -

1) Elevated liver enzymes,ever since starting the trial they are always higher than the normal range. The recent CT scan talks about some "fatty infiltration of the liver", this is something new and the doctor did not discuss it with us, I just saw it in the scan report which I received today. Since it was not there in his previous scans, I assume this is also a side effect.

2) Some protein was found in his urine, the dipstick test showed quite a bit and so he was asked to stop taking cediranib until the 24 hour urine test is done. The 24 hour urine test however did not show very high levels of protein and so he restarted cediranib after a 3 day break.

3) Diarrhea - He had a severe episode of diarrhea and it coincided with his NIH visit, he was admitted in the day hospital and given IV fluids. He had not eaten anything since morning in preparation for the scans and he also developed very bad acidity.On the whole, he had a tough time going from one appointment to the other on that day. On other days diarrhea has not been that bad.

4) His voice hoarseness, mouth sensitivity, fatigue and mild hand and feet sensitivity continue. However, all these became much better during his 3 days break from cediranib.

5) I don't know if this is related or not, but in the last couple of days, he has had painful muscle cramps on his right calf(the primary site). One evening, when he went for a walk, he had a painful muscle pull and had to just sit down for 15 mins until it resolved on its own. On another day, he got it while driving and found it difficult to drive. He stopped on the shoulder for some time until it resolved.

Some of these side effects are well known, but some others seem new. If anything helped with these side effects for any of you, please do let me know.

Hello Arch
I am very glad to hear that the tumors are showing a reaction to the drug!

I wanted to post to you that i have the same problems with my right calf and i atribute this to the radiation damage done to my calf! I when i streatch I have to make sure in the morning that i do not streatch that calf or i also get this pain and i feel for him because i kn ow how bad it is!!! Tell him to move his foot only side to side and up and down when the pain starts that has helped me a lot!
I could contact the surgon also and ask him if has any sugjestions.

As we have spoken i am a phone call away and woud love ot talk about this stuff wit oyu when you have time i know how busy you both must be!

Tell him i am cheering for him

Dear Amanda,

Thanks for letting me know about your leg pain, since Sree has developed this pain recently, I assumed it had something to do with cediranib.
Maybe its the radiation or maybe its both of them together causing this. His is like a muscle pull, and when it happens its very painful to move his leg in any direction.
Its a sharp pain, lasts for 10-15 mins and then its ok.

I will be in touch with you dear Amanda. You may also call me anytime you want someone to talk to, I'm sending a private message with my number just incase you don't have it.

Arch

Dear Arch,
It is with greatest happiness that I read your thoughtful update regarding Sree's very good and encouraging results from his two month Cediranib status scans. I and my family are sharing your joy and the strengthened Hope of his successful response to the treatment thus far, but are very sorry that he is experiencing increasing concerning side effects from the medication, and am Hoping that these will eventually resolve as his body adjusts to the Cediranib, or that at least they will become more manageable and tolerable. Brittany has thankfully not yet experienced the elevated liver enzymes or the hoarse voise, and only had a small amount of protein show up in her urine during the past two monthly urine tests which Dr. Sawyer is now monitoring. She continues to experience diarrhea, fatigue, mouth sensitivity, and hand and foot syndrome, in addition to nausea, lack of appetite, extreme muscle weakness, severe acid reflux and heartburn, and occassional episodes of the Charlie Horse like cramping that you described that Sree experienced. Dr. Sawyer has recomended Imodium for the diarrhea, but the problem is Brittany goes from severe diarrhea to severe constipation which makes it difficult to use the Imodium which makes the constipation worse. Dr. Sawyer has advised us that muscle deterioration and loss is a known consequence of tyrosine kinase inhibitors like Cediranib, so weight bearing exercises are vitally important to try to rebuild muscles and strength. Brittany uses children's toothpaste for the mouth sensitivity and avoids any kind of spicy foods. Her hand and foot syndrome symptoms are becoming increasingly painful with the development of thick callouses on the balls of her feet, so she applies vaseline and wears socks at night to try to soften the condition. The severe muscle cramping seems to be helped by taking potassim supplements. I Hope that this information is helpful, and I Hope too that the other patients on this Board who are receiving Cediranib treatment or their family members will write to share their side effects and any other suggestions to treat them. In the meantime, please take care Arch, give Sree my very best wishes, and keep in touch with the Board as you are able.
Sharing the great joy of Sree's wonderful scan results with much happiness, special caring, and continued Hope,
Bonni

Dear Bonni,

Thanks for the suggestions.
Sree takes loperamide for his diarrhea, it does help. He will try your other suggestions and I will keep you updated on how things go.
We were told that as of now all patients on this trial at NCI are having a positive response to cediranib, side effects are the concern right now.
Sree has not had any dose reductions, but they are keeping an eye on the proteinuria and the liver enzymes.

With best wishes
Arch

Dear All,

Sree had his scans this Monday at NCI,here are the updates.
After the initial shrinkage of 26% in the first 8 weeks, the lung mets are stable now, there is no further shrinkage. Ofcourse we had hoped for more shrinkage, but its ok..we'll continue and see what happens after 2 more cycles. He has now started his 5th cycle on Cediranib. His next scans will be in Aug.

Arch

Dear All,

Sree finished his 6th cycle on cediranib and had his scans last week. One of his lung mets has grown a little(less than 2 mm), all other mets are stable. An increase of 1mm to 2 mm is within the realms of error, so he is basically considered stable and he has started his 7th cycle on the trial.
Side effects have been mild, he still has some fatigue, sensitive tongue, hand & foot and off late moderate hairfall. His BP and blood work are normal.

We discussed with Dr.Kummar about taking hormone replacement for hypothyroidism associated with TKI use, she told us that not treating the hypothyroidism
was not an option because that could cause many other problems. She told us that there are many theories floating around, but no real evidence to show that treating the hypothyroidism would negate the effects of the TKI and when hypothyroidism is left untreated it could cause many other serious complications.
Sree continues to take 75 microgms levothyroxine per day and his TSH which had shot up to 25 has dropped down to 10 now. Its still a little more than the normal range, we have a follow up with his endocrinologist shortly.

Best wishes to everyone out there fighting this disease...take care.

Arch

Dear Arch,
Thank you for the thoughtful update on Sree's six month staging results. I am sorry that one of his mets appears to have grown a little, but that very small amount of increase could certainly be attributed to scan error since the measurement depends on where the scan slices the tumor. I am so grateful that the rest of his mets appear stable, and that his side effects have been mild. Six months of stability with this disease is a real victory and very encouraging, and it certainly seems to indicate that the Cediranib is working to prevent new tumors and increased tumor growth. Thank you for sharing the information which you obtained from Dr. Kummar regarding hormone replacement for TKI related hypothyroidism. This is the same opinion which was expressed to us by Dr. Sawyer regarding this matter. I Hope that Sree, you, and your family have enjoyed a wonderful summer. Please give Sree my best wishes, take care, and know how deeply appreciated your faithful updates and shared information regarding Sree's Cediranib experience and scan results are. I will be anxiously awaiting your next update and holding very tight to Hope for continued good news of disease stability and tumor shrinkage.
With special caring thoughts, healing wishes for Sree, and continued Hope,
Bonni