Cure Alveolar Soft Part Sarcoma International (iCureASPS)

She started a trial in August 2017.

Pam began the Anlotinib trial on August 16, 2017, with a dosage of 12mg for 14 days and then off 7 which is a cycle. The side effects for Pam have been a lot of nausea and vomiting and loss of appetite. Pam started have many migraines and was taking Topamax and Imitrex, but they continued to get worst so Pam decided that she would not continue unless we could change her dosage which Dr. Wilky lowered it to 10mg on February 21, 2018. Pam also began taking Propranolol and Nortriptyline to help with the migraines. This has helped as she may now only have one migraine per cycle and has less nausea. Pam has been having a Ct Scan (Chest/Abdomen/Pelvis every 3 months and her next scan is scheduled for April 15th.

Hello Karl and Pam
I’m sure sorry to hear of the past migraine history but so glad to know they are becoming less with the current additional meds .

How has the Anlotinib been doing for Pam’s exsisting tumors? Does Pam still have the liver tumors ?
Truly good to hear from you .

Love ,

Hi Karl ,
Checking in to see how Pam is doing on Anlotinib ?

Write when able .
Love ,

Hello Debbie, good to hear from ya. Pam will start cycle 37 tomorrow (Sept 9) with the Anlotinib. She has had a lot of nausea and her appetite has not been good lately. I think if it were not for all the damage that has been done to her spine she would be doing better. That said, as Olga has stated many times about these trials that the target is pretty much what is looked at and many times you might have a problem elsewhere and need a different type of scan, case in point. Pam's liver is the target and this has been stable but in January her CT report made a note of compression of the T11 and we wanted to have it looked at but due to a change in our doctor in Miami things feel through the cracks. We decided to transfer to Houston as the Oncologist we had when we were in Houston before was over the Anlotinib trial there. An MRI of her spine showed new tumor growth in the T11 also noted Epidural disease at the C2 (Bilsky 1c), C7 (Bilsky 1a) and L4 (Bilsky 1a) the T11 (Bilsky 2) which she had surgery on July 24th. The procedure was an MRI ablation (LITT) to the T10, T11, T12 and followed with SBRT. The plan now is SBRT to the C2 which will happen after the next MRI on September 29th. Since the target for the trial is the liver Pam was allowed to continue for now so kinda bittersweet. We also had a brain MRI and all was clear, the met's in her lungs are stable. So on we go, we will just take one day at a time and pray for the best. We feel we are in good hands at MDA.

Hello Karl and Pam
I’m glad that Pam has been allowed to be on Anlotinib and has had the opportunity to address the spine tumors to date .

The liver tumors that disqualified Pam from the Keytruda /axitinib trial , have not progressed since 2017( August )?

Is Pam still on propranolol and the migraine Med Nortriptyline ?

Is there any chance of Pam moving back to another ICI?
There’s been good results from patients with ASPS with bone involvement , on atezolizumab. : )

https://www.cureasps.org/forum/viewtopi ... =85&t=1294
And with Pam’s current stability , it appears that maybe there’s a step up to go to a next level?

I know in looking back , the majority of the bone mets have been resolved by Keytruda / axitinib . However the now current bone issues are making a reappearance ?
The epidural disease, was it from anesthesia and or possible pain management procedures ?


Is Pam on bone building meds of any sort ?

It’s truly good to hear from you all, and our thoughts and prayers are with Pam as September 29 approaches.

Love ,

Hi Debbie, The liver tumors have not changed since 2017. Her migraines have finally been controlled with the Propranolol and Topamax she stopped taking the Nortriptyline about 3 months ago as it caused her to have acid reflux and meds to control that did not work, fortunately, she has not had a migraine since. Our plan has been to go back to an ICI when the Anlotinib stopped working. We will have our first visit with our oncologist September 30th since all this has hit us and see where we go from here. There is a long story regarding Pam not being on an ICI but I do not think this is the place to discuss it.
I appreciate the link on atezolizumab, I have it on my list to discuss with our doctor.
If your thoughts of a step up in level are referring to upping the dosage on Anlotinib? I don't think she can handle it. First, she started out on 12 mg and had to lower it and even on the 10mg it's hard on her so if we make a change it will probably be to an ICI.
Pam has not had any pain management procedures only pain meds as far as an anesthesia effect on the epidural disease I really could not say. She is on Xgeva for her bone treatment and will continue monthly injections.
Thanks for all your interest and information it all is appreciated. I'm surprised that there is no other post here of people in this Anlotinib trial, with 11 different locations one would think we would hear from others?

Hello again Karl,

With the Xgeva , are calcium levels checked regularly ?
As I’ve read before , TKIs can and will deplete the bones .
And I’d hope the Med would aid sufficiently in keeping levels within a normal spectrum?

https://www.cureasps.org/forum/viewtopi ... mia#p10956

Side affects of it include nausea , huh .

Another interesting article on calcium deficiency.

https://www.cureasps.org/forum/viewtopi ... 419#p10962

The step up I was referring to would be to moving to an ICI.

Karl ,
Thank you sooo much for your contribution to the Anlotinib post and all other reports that you have do unselfishly provided.

I agree that more folks should be reporting . :/

Thanks, Debbie, yes her calcium levels are checked at least every 30 days or more. Gotcha on the step up, we shall see. I'll let you know how things turn out. Appreciate the links.

You are welcome.
Also great news on no migraines for 3 months! Those can certainly be debilitating and cause nausea.
Does the trial perform a test on a tumor for EGFR?

Blood sugar looking ok?

There is no direct test on tumors in this trial but EGFR is checked on each blood draw along with blood sugar.

Karl,
So how are the levels seen? Looks like thru cell waste, creatinine. Its like a liquid biopsy?
I'm aware of possible EGFR mutations being found thru tumor pathology, but this is eGFR ( estimated glomerular filtration rate ) testing of circulating tumors ?

I assume this test is performed to test for a possible resistance to anlotinib in addition to your kidney’s health ?
Thanks for sharing as its quite interesting as well as educational.

Debbie,
It is my understanding it is seen through creatinine levels. After the AXI/Prembro trial in Miami Pam has said NO more biopsies, she has had enough.
I also assume the levels are being monitored for kidney health. Pam's creatinine level has stayed slightly elevated on Anlotinib but not by much.

I have few questions.
1. I am not sure how do you know if Anlotinib is working? As I understand, the liver mets that have progressed on K+A trials are stable since that one time progression - could have been the massive lymphocytes infiltration and the following that scarring - it is really hard to tell in some cases. Was there any response/size reduction in any other visible mets? What is the reason you think Pam should stay on Anlotinib clinical trial, why is it considered as a positive thing to stay on it?
2. When the new mets appeared - were they extensively scanned for evaluation? The pseudoprogression can happen at any time after ICI drug is over, there are cases when it happened 2 years after the ICI drugs discontinuation. Have they closely reviewed the previous scans to see if these newly found mets have been there but missed before?

Hello Olga, Interesting questions. First I'm not the doctor they are and we are learning on the job so to speak. I would have to assume if there are no new activities then the med must be working and that to me is reason enough to have continued. Unfortunately, as I mentioned in an earlier statement to Debbie our doctor was watching the liver as it was the target and when Pam's Ct scan showed possible compression in her T11 we had just lost our doctor and this fact fell through the cracks. Olga, I hear your concern about the K+A trial. I had the same concerns as I felt and stated I thought it was premature to pull her as what was bothering me is Pam was put in the hospital and put on steroids for neck pain because of compression of the C3-C4. The very next scan is when the flair up in the liver was seen, all other mets were mixed some increased some decreased. We were able to get Ipilimumab and Nivolumab to start a new treatment unfortunately after one treatment Pam had colitis and was taken off of that. Our request was to continue on the Nivolimab but was told we needed to get in the Anlotinib trial and could go back to Nivolimab at a later date if things didn't work out. Now for staying on Anlotinib, I'm not sure Pam will this has all just hit us and we have been discussing finding an ICI to get on. Hope to get some answers Sept 30th. These new findings have certainly changed things.
On question 2, We just found out about the mets and yes they have been researched back to 2014 scans and none seem to have been missed. Keep in mind we have changed cancer centers and so I have found that the technique used in reading the scans seems to be different from one center to another. I can say without a doubt that there is a big difference in the depth they go to at MDACC.
I'm sure we could continue to debate what was but my focus is where to go from here, time will tell. Pam and I truly appreciate yours and Debbie's input and concerns you both have helped a lot of us trying to understand what to do but as you know every case has its own complex issues and there does not seem to be a black or white answer. We just keep pushing forward and pray for a break.