GIST Support WikiThis page is for information related to Nilotinib (Tasigna) formerly called AMN107, one of the Clinical Trial Drugs. Feel free to add your own experiences with the drug in the comments section or any other links to useful resources.
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[edit] Basic Information
Manufacturer: Novartis
For information from the manufacturer link here.
Molecular Targets: PDGFR, KIT (also Bcr-Abl which is not relevant to GIST)
GIST Support International website page: link here
Q & A
21 Jan 2008
Subject: Updates about the AMN107 trial
(AMN107, Nilotinib, Tasigna) = three names for the same drug (the laboratory name, the generic name, the brandname)
I spoke to Leslie Fields and Dennis Williams from Novartis on Friday who provided for us some updates about the phase III AMN107 trial. Leslie is the patient advocacy contact person--always cheerful and friendly, and Dennis is a physician in their scientific division. It was an enjoyable phone call, and I thank them for their time and helpfulness.
1) The Compassionate Access program for AMN107 is now closed in the US due to FDA guidelines that apply once an investigational drug is publicly available on the market. AMN107 (Nilotinib, Tasigna) has gained FDA approval for chronic myeloid leukemia. The compassionate access program was to help patients gain access to AMN107 who were not able to enter the trial at a time when there were no prescription avenues to get the drug. If you are a GIST patients wanting to try AMN107 you should: a) try to enter the phase III clinical trial, b) try to obtain it by prescription as your insurance might now cover it as an off-label indication, c) if you are unable to get the drug through a trial or by your insurance coverage, then contact the Novartis Patient Assistance Program for Tasigna, and they will help you get the drug.
2) The phase III AMN107 trial is designed to enroll 237 patients, mostly in europe. It is a registration trial with the goal of collecting data to meet the FDA requirements to license the drug for the prescription market for GIST. About 25 us pts have been enrolled at 11 trial sites are in the USA. To qualify for this trial a patient must have tried both Gleevec and Sutent. ((I am unclear about which dosages) Novartis estimates that the trial may be finished with patient accrual sometime this spring...perhaps March or April...but these are estimates. http://clinicaltrials.gov/ct2/show/NCT00471328?term=amn107&recr=Open&rank=5
3) More trials for AMN107 are under consideration. A US based trial at four sites (sponsored by the investigational sites and not by Novartis) is in planning for those patients who have tried other drugs besides Gleevec and Sutent. The 4 sites would be chosen in part with geographical location in mind to help patients with their travel.
3) Further into the future, a trial of Tasigna as a second line of defense for patients who have had only Gleevec.
20 october, 2007
MARINA EXPLAINS:
AMN107 is a derivative of Gleevec. Half of the AMN107 molecule ("the working end"--the engine) is the same as Gleevec. The other half of AMN107 molecule (the trunk and tail lights) is completely different than Gleevec.
IT was learned later that Gleevec itself has some unfavorable molecular shapes that are not optimal for binding to the protein--the tail end of the Gleevec molecule is like the big ole bulky tail light fins like on a 1960's Caddy, with an oversized chrome bumper too--trailer hitch included. So they redesigned the trunk and tail lights of GLeevec and came up with a more aerodynamic streamlined model (or a better protein fit)--AMN 107.
AMN107 can "forgive" some secondary mutations that lead to Gleevec resistance--mutations in exon 17 of KIT for example...exon 17 of KIT is where Gleevec where the trunk and tail lights of Gleevec are crowded unfavorably with the protein.
Still, there are some parts of GLeevec and AMN107 that are exactly the same..."the working end" (the engine--V8 engine--high octane leaded fuel--) which docks near the "P Loop" and other important areas.
There is something called the "gatekeeper mutation" T670I, which is where the protein forms a critical interaction to the "engine" of the GLeevec molecule as well as the engine of the AMN107 molecule (which are two of the same engines). Pts who have the gatekeeper mutation would be less likely to benefit from either Gleevec or AMN107--as the gatekeeper interacts with the same "engine".
If you want to see a picture of the gatekeeper mutation in action, then check out this article for the binding of Gleevec to a protein called ABL--Look at the picture on page 3. http://www.biochem.mpg.de/en/rd/ullrich/publications/002-04.pdf ABL has the analogous gatekeeper mutation the T670I mutation in KIT...the number for ABL is T315I. Look on page and you can see how the protein residue marked 315 closely hugs Gleevec...and you can get a sense how a mutation at 315 may interfere with Gleevec binding.
THen some patients have secondary Gleevec resistance causing mutations
that are in the area of the trunk and tail lights of Gleevec--exon 17 of KIT. AMN107 with its streamlined shape (the fins on the tail lights and the heavy chrome bumper has been redesigned to something sleeker) is not affeced by some of the exon 17 mutations that disrupt Gleevec binding... So some pts with secondary mutations in exon 17 benefit from a switch to AMN107.
ALso AMN107 achieves a much higher cellular concentration that Gleevec, and so for this reason, it may work better against wild type KIT and might we speculate better for exon 9 KIT, where there is a "functional resistance" that is perhaps caused by local elevations in the concentration of KIT's growth factor--SCF...More AMN107 in the cell means more horsepower to "block that KIT" (KIT...KICK...it is college football season...)
AMN107, in theory, might be a better first line of defense drug for GIST than GLeevec itself...I would anticipate a trial at some point in the future that does a head-on comparison against Gleevec as first line of defense, once AMN107 makes it to market for third line of defense (pts who no longer receive benefit from both Gleevec or Sutent). Someday the Gleevec story might be like the penicillin story..each drug was one the greatest breakthrough drugs of all time, in the history books, but eventually becomes replaced by second generation agents as the first choice..perhaps by AMN107.
Sutent and Sorafenib are completely different than the Gleevec molecule. They intereact with KIT protien in a different way. Both Sutent and Sorafenib can block the gatekeeper mutation T670I. Yet, they may be sensitive to secondary mutations that Gleevec (or AMN107) can block. For this reason, combinations of kinase inhibitors might be important to block a wider range of mutations. This is the same lesson as the field of HIV treatments, where simultaneously administered combinations of anti-HIV drugs were much more effective than sequential delivery of single agent drugs. http://clincancerres.aacrjournals.org/cgi/content/abstract/13/16/4874?ck=nck
Cheers,
Marina
5, April 2007
Q: What is Super Gleevec? Why is it different or the same? If it were radically different, it could be called anything. How does relate to Stutent or some other medications?
A #1: Super Gleevec has an improved molecular structure to bind into the target proteins over the original imatinib molecule. The original imatinib (Gleevec) molecule was developed in the era of the early 1990's when not much was known about protien kinases.
Imatinib is a great drug--and has saved the lives of many. Nevertheless, once more data was available (in particular X Ray crystal structures at the atomic level showing how imatinib fit inside the target protein) it became clear there were some unfavorable aspects regarding the shape of the imatinib molecule. Some parts of imatinib were bulky and were bumping into the protein causing an unfavorable interaction. Thus, the idea to modify some of the structure of imatinib while leaving other parts of the imatinib structure the same. AMN107 (Nilotinib, Tasigna) has parts of its molecular structure that are the same as imatinib's. Other parts are totally different. The result is a drug that might bind better to some of the mutants of KIT that do not bind imatinib as well. Also AMN107 achieves a higher cellular concentration of drug than does imatinib.
I do not know why this is the case but think (but am not positive) that the AMN107 trial is planned as a third line of defense, for people who have tried two other therapies.
Answer #2: A Phase II trial for AMN107 (nilotinib or Tasigna) against GIST is cheduled to begin soon and not much information is available about it from the Phase I trial, we really do not know how it will work out against GIST.
You may be able to get nilotinib on a compassionate use basis outside of the trial by contacting Novartis.
[edit] Comments from Trial Participants
[edit] Dave B
July 04, 2007
First posting- Dave B
Dr Margaret Von Mehren at Fox Chase Cancer Center is my oncologist. She suggested that I contact Dr. David D'Adamo at MSKCC. I called his office Monday and am waiting for a reply.
I'm participating in a stage 3 trial of Nilotinib at Fox Chase. There has been significant growth of the liver metasteses (%18-%20) during the first 6 months of the trial and PET scan detection of new starter sites in my lungs and a suspect site on my heart.
I get headaches a few hours after every dose of Nilotinib that may or may not be a reaction to the drug. A MRI and ECG are scheduled to see if the headaches are related to tumour growth or something else and to check the heart spot.
I'll drop out of the Nilotinib study as soon as I get a good alternative. I'm hoping that the Sorafenib mechanism is different enough from the Gleevec-Sutent-Nilotinib mechanism that I'll see better results.
Dave
July 19, 2007
The Nilotinib hasn't worked for me. I spoke with Dr. D'Amado at Sloan Kettering about the Sorafenib but decided against it. It's too similar to the other blockers that didn't work for me. I'm going to try flavopiridol chemotherapy, also at Sloan Kettering.
Apoptosis appeals to me at this point!
Dave
Dave's History: Diagnosis was 4 1/2 years ago now. There have been two major surgeries, two RF ablations, Gleevec, Sutent, and a Nilotinib trial. Nilotinib hasn't worked so I'm trying to hook up with the Sorafenib trial at Sloan-Kettering.
19 Jul 2007 Subject: Re: Liver surgery: yes or not?
I had two surgeries. The first was to remove the big initial tumor that was sqeezing and actually grew into my large intestine. There was a 6" section of intestine removed with the tumor. The cut for that one was vertical- from my sternum to about 3" below the navel.
There were multiple sites on my liver, from the initial diagnosis, that stayed small for about a year while I took Gleevec.
The second surgery was on my liver. A single tumor grew pretty quickly after a year on Gleevec and we (oncologist, surgeon, and me) decided to remove it. They also took my gall bladder since I was experiencing gall bladder attacks. The cut for that one was from just under my rib cage on the right side to just under the rib cage under my left breast.
The liver surgery scar was much more difficult to deal with. The muscles above and below the scar seemed to be working independently for a while and it took a good three months before I could "feel" the muscle and skin below the scar.
There were also two radio frequency ablation procedures in the two years after the liver surgery that burnt up 5 or 6 small but growing tumors. I wouldn't get that procedure again. I felt like they were just doing it because it was a cool new procedure. It didn't stop anything from growing and, in my unprofessional laymans opinion, simply started up the smaller tumors that weren't growing.
Would I recommend liver surgery? Tough question. Mine was based largely on the rapid growth of a single tumor. That's much different than your fathers situation where the sites are stable. We never talked surgery when the sites weren't growing. I just got CAT scans every three months to keep an eye on them.
I do believe that both big surgeries saved and prolonged my life. They certainly improved my overall health and gave the various medications time to work on the smaller sites (Gleevec, then Sutent, then a trial on Nilotinib). I had lot of faith in the oncologist and the surgeon because both of them laid out all the risks ahead of time and left the final decision in my hands.
I hope this helps
Dave (Phila. PA. USA)
20 Aug 2007
I'm on the last few days of the stage 2 clinical trial of Nilotinib at Fox Chase Cancer Center. The CAT/PET scans show that it hasn't worked for me but there are people from the stage 1 trial still taking it a year later with good results. I hope it works for you.
August 25, 2007
I'm starting a stage 1 clinical trial of Doxyrubicin & Flavopiridol at Sloan-Kettering Thursday.
I don't know anything about exon numbers.
Good luck, Dave
20 Oct 2007
Subject: Re: Nilotinib AMN-107 Clinical Trial
I participated in the Nilotinib stage II trial at Fox Chase. The trial qualifier was Gleevec and Sutent failure. It didn't work for me but the folks running the trial told me that there are people from the stage I trial over a year ago that are still taking it and doing very well.
There were sinus headaches for about a month while I was taking it- always about one hour after the dose and lasting 1/2 hour to 45 minutes but they eventually stopped.
The dosage was two 200 mg tablets twice a day- a total of 800 mg a day. They were spaced an hour before and two hours after eating so you have to develop a workable schedule. Mine was 5:00 AM, 5:00 PM.
Hope this helps
Dave
Dave switched to Nexavar - see Nexavar page
28 Nov 2007 Subject: Re: question on sutent and AMN 107
The folks at Fox Chase did the stage 1 trial and are doing the stage 2 trial for Nilotinib. I participated in the stage 2 trial. It didn't work for me but there are folks from the stage 1 trial who are still taking it successfully (over a year) and some people on the stage 2 trial are doing well.
Dave
26 Feb 2008
Subject: Headaches on AMN107
I got "sinus" headaches during the first 3 months of a 6 month AMN107 trial. I even got a MRI to make sure it wasn't tumors.
[edit] Harold G
July 07, 2007
My dad, Harold G, has been on compassionate use AMN107 for about 9 weeks and after a scan 2 weeks into it, his livers levels went from poor to normal range. He was scanned this past week and there is no growth, the drug is holding though no shrinkage. He is still 120 lbs and constantly exhausted no matter what we do.
When working through the process to receive the drug, it's good to know who who has the ball at all points in the process. We had found our request got hung up for 2 weeks because our hospital sent paperwork back to Novartis with a change to the protocol so it took time to venture into Novartis' legal dept. Then it has to come back to your hospital review board that usually meets once a month. So we got the hospital to see who could call a phone mtg or whatever to avoid waiting until the next meeting. Following up with the steps did help us- the process took 6 weeks. Getting the initial info to Norvatis from your oncologist seemed to be easy, latest scans, proof of failing Gleevec, then Sutent, etc.
Harold G - he was diagnosed Oct 2001, Gleevec 4 yrs, Sutent 1 yr.
23 Aug 2007
HI Everyone,
I am hoping someone on AMN107 can help us. My father has been on compassionate use of this drug for about 4 months. It is not shrinking the cancer - but it is holding it for which we are very grateful. The problem is he is more and more tired, unable to do anything. He walks to the mailbox and that's it. He spends the day in the recliner and I am wondering if anyone has any ideas on how to strengthen him - we are doing protein and an appetite aid since he is 120 lbs. I desperately want to give him a better quality of life - he was never a sit around guy (former carpenter) and this is awful. His eyes burn so he can no longer read or watch TV more than a few minutes. He naps frequently and only sleeps intermittently at night. Two different sleep aids he has taken haven't helped. What is everyone else on this experiencing and any ideas?
Thanks Carrie Daughter of Harold G
Harold switched to Nexavar - see Nexavar page
[edit] Donnie Ray
25 Sep 2007 Subject: Starting Amn107
Fellow Gisters
I just wanted to let everybody know I finally got to start the Compasionate use Amn107, Just started this morning so it's to early to report on any side affects. Im a little weak still from surgery but healing up just fine. I don't know whats around the corner for me but I can say with great joy, It's good to have some hope once again as it has been quite a battle to get my hands on these little evasive yellow pills.
Feeling very blessed!
[edit] Gerald
9 Nov 2007
Subject: Tasigna (Amn107)
Today I picked up the prescription of Tasigna (AMN107) for my husband, Gerald. He will begin taking it tomorrow. It came packaged very nicely - in a box containing four individual packets, one for each week. In each packet the capsules were laid out and marked for each day of the week. All this for $5655.70. I had really expected to be more costly. This is less than Gleevec. I don't understand at all how the prices of meds are figured. I have two hopes: first that it will be effective and second that by next month our insurance will cover the charges. If the insurance will not cover it, I will have to back to trying to get on a compassionate basis. Hate that thought.
Gerald is barely eating and has lost lots of weight and is a bag of bones. He is vomiting "gucky, phegmey stuff" and bile which is gross. He is bedridden and we now have hospice services which are great. I am really pinning my hopes on this new drug and praying it will be effective. We are greatful to be able to have it at any price.
Deanne wife of Gerald, GIST pt since 2000
15 Nov 2007
It is with deep sadness that I report Gerald's death from GIST early this morning. His tender body was just fighting too much disease to survive. I had faith in Tasigna (AMN107) but we received too late for it to have any effect. The past few weeks have been difficult for him but now he is at peace.
During the past month we celebrated his 70th birthday and our 45th wedding anniversary. We were blessed with a wonderful, happy life together.
I know I will miss him deeply but I will be fine and not allow this cancer to destroy me also.
I appreciate wonderful support from this list and the great knowledge that is shared. Thanks to all.
Deanne Snodgrass wife of Gerald, GIST pt since may 2000
[edit] Tony P
29 Jan 2008
Subject: AMN-107/Sutent Side Effects
It has been some time since I have posted but do go through the posts every day.
I thought I would update you on what Tony has been through and where he is heading in this GIST journey.
As told previously he was originally on Gleevec which he became intolerant to and then on to Sutent. This too did not stabilized his liver lesions. He went from 50mg Sutent 4 weeks on, 2 weeks off to 37.5mg daily on a continuous basis. His lesions continued to grow slowly but over a period of time he had to have a liver resection due to a 9cm lesion which grew too close to the vena cava. So, in June 2006 he had his liver resection. He is still taking 37.5 mg Sutent and has had new lesions develop in his liver since the surgery. Overall, he has been on Sutent for over 3 years and his lesions have been growing very slowly.
During the month of January he was accepted in the AMN-107 Clinical Trial at Moffitt Cancer Center. Unfortunately his randomization was not to receive the Nilotinib but to remain on the Sutent. Although this was not what we were hoping for it, at least, keeps the door open to crossover and receive the Nilotinib if his tumors continue to grow.
Would like to hear from those taking the Nilotinib, what they are experiencing and whether or not they are seeing any results. You are welcome to email directly or through GSI posts.
For those who are taking sutent and are wondering about the side effects of long term use, I will list Tony's side effects.
Elevated blood pressure (controlled by medication), taste alteration (changes constantly) sometimes spicy food helps and sometimes it doesn't. He is constantly trying different foods and/or seasonings to help alter the bitter taste he gets from the meds. Diarrhea and/or loose stools (caused by meds or by diet). Having a colostomy does not help the situation. He alters his diet by eating foods that have a binding effect (bananas, potatoes, pasta, yogurt). Not all digestive systems are the same. One has to try what works best for them.
Additionally, he has some yellowing of his skin tone, his hair has turned completely grey (including eyebrows and eyelashes). We now call him the "Silver Fox". Had some mouth irritation in the beginning but that has faded.
So, all in all, the side effects come and go and one has to deal with them. Remember, however, everyone's system will react differently based on your overall physical well being. Good luck to all.
Love and Peace, Kay - Wife of Tony P
24 Feb 2008
Subject: Acceptance Into Clinical Trial
Life has been a whirlwind of late, as with most of you, due to getting accepted into the AMN-107 Clinical Trial.
As previously told, Tony has been on Gleevec and Sutent, had a liver resection and still the lesions grow in his liver. They have started growing more rapidly of late and he had applied to enter the AMN-107 Trial.
Finally, after months of paperwork and red tape he signed the final protocol papers and received his first dose of Nilotinib on Wednesday 2/20/08 at Moffitt Cancer Center. We saw Dr. Garrett for the last time since our next appointment will be March 21st. which will be after he leaves on March 14th. We will be seeing Dr. Williams who will be taking over the AMN-107 trial.
Of course we are interested to find out what side-effects others are having. Is there anyone from this group that is currently taking or has taken this medication? We would appreciate receiving any information you would be willing to share.
We will keep this group up-to-date on how Tony is managing this medication as well as how it is working. We are at least hoping to get stabilization but shrinkage would be gladly accepted.
Your thoughts and prayers are always needed.
Love and Peace, Kay -Wife of Tony P
5 Mar 2008
Subject: Side Effects - AMN-107
As you know Tony in in the AMN-107 Clinical Trial. He has been on the medication for about 2 weeks now and has already started with some side effects.
1. Headache - On & Off, When there is no headache he still has a foggy feeling in his head. 2. Bad Taste - Extreme bad taste which only diminishes when he is eating but returns soon thereafter. 3. Edema - His ankles started swelling a few days ago. Since he also has neuropathy it makes his walking more difficult and slower. 4. Fatigue - He has been getting tired more often than when he was on Sutent or Gleevec.
Hopefully the side effects will diminish when his system gets accustomed to the medication and works.
If anyone has or has had the Bad Taste side effect and found something to help alleviate it please let me know.
Will keep you updated.
Love and Peace, Kay - Wife of Tony P
26 Mar 2008
My husband Tony was on Sutent for over 2 years and the only side effects he had was altered taste and elevated blood pressure. Everyone's body seems to accept the medication differently.
He had severe side effects from Nilotinib - AMN-107. He is now going back on Sutent.
Love and Peace, Kay
26 Mar 2008
Subject: Re: (Kay/Tony AMN107)
Hi Betty,
Tony is no longer in the AMN-107 Trial. His side effects were headache, edema, bitter slimy bad taste and blood level variations. His hemoglobin went down to 8.9 and had to have an injection of Aranesp. He also had progression of his tumors over the Resist limit.
Good luck to Charlie, hope it works for him
26 Mar 2008
Subject: Left AMN-107 Trial
Hi All,
Just wanted to give you an update on my AMN-107 experiences. Started the trial medication on February 20th and had tumor progression based on CT taken March 20th.
There was sufficient progression for me to be ousted from trial and have been put back on Sutent, 25mg. alternately with 50mg. every other day. The side effects of Nilotinib was significantly worse than with the Sutent. So much so that my hemoglobin level was down to 8.9 and received a shot of Aranesp.
So, here we go again on the roller coaster. We are looking to get another opinion from one of the experts. I believe I read some time ago that Dr. Demetri would look at a scan if sent to him via US mail.
Beverly, was that you who posted that information? If so could you let me know what the procedure is. If not whoever posted that would you please contact me. Anyone can contact me directly at BrotherATP@msn.com.
28 Mar 2008
Subject: Re: Tony - Nilotinib - going back on Sutent-To Minnie
Hi Minnie,
Tony went back on Sutent because there is nothing else for him right now. If he doesn't take anything then his lesions will grow at a faster pace. Gleevec is out, he was on it for 14 months and then was progressing rapidly. We are currently looking for a new bullet to stop these lesions from growing and maybe even shrink them.
It's all in God's hands, he will walk with us to the right path.
Love and Peace, Kay - Wife of Tony P
4 Apr 2008
Subject: Re: Help - Getting into a New Trial
I have been in contact with someone at DF and we are going to have a telephone conference today. I will keep Dr. Wagner's telephone number available.
Love and Peace, Kay
4 Apr 2008
Subject: Re: Help - Getting into a New Trial-To Minnie
Hi Minnie,
Thanks, I already have a copy of the Reach Application ready for our next doctors visit in two weeks just in case we are not able to do something in a trial.
Hope and pray that Nilotinib works for you. As you say, "It's all in God's Hands".
Love and Peace, Kay
4 Apr 2008
Subject: New Trials
Wanted to let everyone know that if you are in the AMN-107 trial you will not be eligible for XL820.
Just found out the Tony is ineligible because of the AMN-107. Well, off to see if we can get Sorafenib. Hopefully the doctor won't give us any flack. If he does, we will find another doctor.
[edit] Doris
31 Jan 2008
Subject: listmate needs advice on Tasigna / nilotinib / AMN107
Our listmate Doris Talley wrote: I will be getting Tasigna as off label on Friday. I would like to hear from someone who is now taking this drug as to the side effects and what their experiences are with it. I was going to go to Sarah Cannon in Nashville to see if I would be eligible for any to their clinical trials, but had to cancel because I am not strong enough to go.
If you can tell Doris about your experience on nilotinib / AMN107 / Tasigna, please e-mail her direct at doristalley2@triad.rr.com and also copy the list so others can benefit from what you say. THANKS! Julie
24 Feb 2008
My mom, Doris, is also on AMN-107, but not through a trial. Maybe my dad will see this and can respond better about the side effects. As for our experience, however, I know it can't be as bad as sutent side effects...
Let us know how Tony fares on it!
February 28, 2008
Listmates, Doris's daughter Suzanne asked that I forward to the list her message about Doris' passing yesterday. Those of you who met Doris and husband Wayne at the NC area get-togethers the last 2 years will remember her well. I am sorry to be the bearer of this sad news. Julie
From: Suzanne Hawkins
We lost her this morning. I want to thank you and all of the others on the list for all of the help, hope, and inspiration you gave her and us. We appreciate it and will never forget.
[edit] Charlie S
6 Feb 2008
Two years ago we found after checking Walmart, Walgrens and Target that Target was the cheapest place for the one month of Gleevec that Charlie needed. That has probably changed in two years. Today Charlie starts AMN107 so we are sure hoping it will work long enough to get his foot healed in order to go back on Sutent. Going to the Dr two and three days a week for the last 7 months is really starting to wear on both of us.
25 Feb 2008
My husband Charlie also started AMN107 about three weeks ago but also not through a clinical trial. Gleevec had failed but Sutent even at a low does was working but the side effects from Sutent caused painful open ulcers on his foot and leg until he was in danger of losing his leg. He has been off the Sutent since early Jan and the ulcers are really showing improvement abe= t slowly. So far on the 800 mg AMN107 the only problem he is having is some diaharria and a slight rash. Now we hope the drug is working.
25 Feb 2008
Minnie. I totally forgot that Charlie has been complaining about headaches also since he started the AMN107. Says they only last for an hour or so and get better. Do yours last all day? He also had an EKG before starting the drug and then about 10 days into taking it. So far ok. Hope you can get releif from your pain with the new drug.
26 Feb 2008
Charlie is having blood work every two weeks so goes back this Friday. As of two weeks ago the Dr was thinking a CT scan at 6 to 8 weeks so that would make it mid March to late March. How soon will you have another one? He does seem more tired but his energy has never been too high. When not on Sutent his blood pressure is much lower like 100/60 which I think causes some of the tiredness. The one other thing that I have notice is that his personality seems to have changed a little as seems much shorter on patience and as very touchy about the strangest things. Not sure how this could be attributed to the AMN107 but who knows. I do remember seeing on here fairly recently another member who had been on Amn107 and had sinus headaches especial= ly for an hour or so after taking the pills. His rash seems to stay about the same and is only behind his ears the the back of his neck but his skin is more flushed. Here's hoping for the best for all of us on AMN107.
6 Mar 2008
Subject: Re: Side Effects - AMN-107
Charlie has been on AMN107 now for 3 weeks starting his 4th week. He too has the headaches that come and go and a little water retention but luckily so far has not complained about any bad taste. Fatigue is common for him on any of the medications he has had. I do not see bad taste is listed as one of the common side effects. Good luck to you both on this drug. I guess I have been a little concerned if the drug is working as his side effects have been minimal compared to Sutent.
7 Mar 2008
Subject: Re: Side Effects - AMN-107
Thanks for asking. The ulcers on the left side are about 90% healed. The right side seems to be progressing at a much slower rate. Charlie did go back on a wound vac and the Dr thinks this will really speed it along. If the AMN107 is not working he will have to go back to Sutent and deal with the open sores as well as possible. The ulcers also disqualify him from some other trials. The wound specialist did say 6 months to heal. Sure hope this new drug will give him enough stable time to allow the ulcers to finish healing. He had a bad time all around on Sutent but even at a low dose it was working but the problems it created were so bad. Of course if AMN107 is like Sutent he did not have any side effects the first two cycles but seem to develop them after the Sutent built up in his system. Hope Tony's taste improves.
26 Mar 2008
Subject: Re: (Kay/Tony AMN107)
Sorry to hear that Tony was having so much trouble with side effects from AMN107. May I ask what kind of side effects he was experiencing? I was hoping to hear that he was doing well on the drug. So far Charlie has few side effects from Amn107 and will have a scan tomorrow but no results until next week as Dr is on vacation. We are hoping he won't have to go back on Sutent as his side effects from Sutent were terrible even though it was still working for him. Good luck to Tony with his return to Sutent. Thanks for your imput.
3 Apr 2008
Subject: Another AMN 107 failure
Sorry to have to report that Charlie has gotten no benefit from AMN107. The tumors have almost doubled in size and number. That certainly dashed our hopes for an answer to our prayers. He will go back on Sutent and will probably end up with losing his leg but it's that or his life. One side of his foot is healed but today he is having a appletgraft (skin graft) put on the other side. The wound Dr will probably refuse to put it on when we tell him Charlie is going back on Sutent as it will never heal. We will start with 25mg 4 weeks on and two weeks off and I guess hope for the best. Most of the trials out there will not accept him if he has open wounds anyway. Sure disappointing as we were hoping for better news.
17 Apr 2008
Subject: Re: Need info on AMN 107
Sorry you are having progression. My husband, Charlie, tried AMN107 for about 7 weeks in Feb and March. Unfortunatley he had major progression of the exsisting tumors and several small new ones so we know it was a failure for him. The only good thing was he had miminal side effects from the drug. Mostly slight headaches and skin flushing. We were very dissapointed in the lack of sucess but hope you have better luck if you try the drug. He has gone back to Sutent now but it causes him terrible side effects. Minnie had written in her Journal that AMN107 was working for her as it was the first time she has had a stable report in a while. So don't give up hope on the drug. Best wishes to you.
[edit] Minnie
FEBRUARY 16, 2008
Dear family and friends,
I’m sorry to bring bad news but I found out yesterday that there appears to have been some progression of the disease. The lesions in the dome, the mid portion and left lobe of the liver have increased in size and activity. There was again noted to be a focus of increased activity in the left side of the pelvis that continues to be undetermined but more than likely GIST. This means I will be moving on to the trial drug that comes in many names: Tasigna/Nilotinib/AMN107. To those folks who understand, this drug is a novel tyrosine kinase inhibitor targeting KIT, PDGFR, and Bcr-Abl and inhibiting the proliferation of both IM-sensitive and -resistant cells in vitro. How about that for sounding smart? Before some of you get too impressed, I just copied that line from the abstract. I can barely find my keys or remember what I need to do today.
This drug is supposed to be more potent but it doesn’t mean the side effects are more intense. I will need EKGs monthly because it can be pretty hard on the heart and the fact that I’m on methadone doesn’t help. Most frequent adverse events include skin toxicity, fatigue, myalgia, headache, abdominal pain, nausea, vomiting, diarrhea, constipation, hyperbilirubinemia and edema. Because I am overly sensitive to medication I will start with half the recommended dose so instead of 400 mg twice a day, I will only take 400 mg once a day. I’m not exactly sure how I will go up. I had a baseline EKG done yesterday, another one a week from when I start the drug and then monthly. I should have the drug and start on it by Tuesday or Wednesday this coming week. I don’t really expect anything different as far as side effects go. This is not much different from the side effects I’ve heard or experienced before.
I know this is not encouraging news but I have to tell you, God is so faithful and continues to bless. After getting the results I called the boys who are both in Vegas for a soccer tournament. I hate having to tell them bad news but I know God will always cover. But it’s so different knowing God will cover and then seeing Him cover. I called Dan first of course. He was silent and then said, it’s a bummer but we have to remember to take things a day at a time – and may I add a prayer at a time. He was more worried about how I am with the news than himself. That's Dan. I am so blessed. I really think he's a keeper. I told him to let Daniel know and then he called me a couple of minutes later and asked me to call Daniel. When I told Daniel the first thing he said was “Mom, God is still good.” How about that for God's grace and mercy!
Yes Daniel, God is still good!!!!
Till the next update…
In His grip,
Minnie
1 Chronicles 16:34 O give thanks to the LORD, for He is good; for His loving kindness is everlasting.
25 Feb 2008
Subject: Re: Acceptance Into Clinical Trial
I just started on Nilotinib as well - exact same day that Tony started. How is Tony doing on it so far? As for me, I am okay - the side effects are manageable. I have a bit of a rash on my face and feel pretty tired but nothing I can't handle. Fatigue has become part of my life so I'm used to it. My pain has been increasing as of late but I don't think it's because of the Nilotinib. I had a bad cold and I think it's also from the tumors. My pain pump is on the lower right side of my abdomen or below my liver. I noticed that I feel pain when I turn the wrong way and the pain goes all the way to my back. I have it on both sides but the right more than the left when I turn the wrong way. My pain doctor cannot increase the dose of the meds in my pain pump because my blood pressure is low again. Sutent actually helped to increase my blood pressure but now that I'm off Sutent my blood pressure has gone down again. It was 85/57 when I saw him last Thursday so I have to stay on this current dose. One of the meds in my pain pump is a blood pressure medicine so we have to be extra careful when we increase the dose of the Clonidine.
I don't know how to describe or explain this symptom or where it is from - I have pain when I touch my forehead, right where my eyebrows are located to the sides (temples) and cheekbones and goes all the way down to the lower part of the bottom sockets of my eyes. It's not an intense kind of pain but I have to be careful when I touch those bony areas. The pain goes a lot deeper than the skin that's for sure. I'm sorry I can't describe it well. I'm hoping that if somebody is experiencing the same symptoms or knows anything about this, he/she can let me know.
Please keep us updated on how Tony is doing. Did he also get an EKG before he started Nilotinib and will get another one a week after taking Nilotinib and then monthly thereafter?
Thanks a bunch.
Blessings, Minnie
26 Feb 2008
Hi Betty,
Thanks for the info on AMN 107 and how Charlie is reacting to it. Yes, the headaches do not last all day long. They seem to come and go. I also have a rash on my face. It's not severe but it seems to have spread since it first started to show up around day 3 or 4. I am keeping a close eye on it. I think I will try to find a mild facial cleanser so as not to aggravate it even more.
The good news is the flu didn't come like I thought it would. I felt like I was coming down with the flu or last week but I guess I am just getting used to the medication. I still feel the pain around my face all the way to the jaws when I touch the areas but I'm not congested. I highly doubt this is a sinus infection but I will check into it. (Thanks Linda for sharing that thought).
I am due an EKG. I had one prior to starting and I'm supposed to have another one a week after I started so I will get one tomorrow. I am on day 7.
Is Charlie experiencing other side effects? I notice my pain has been increasing. It starts in the upper abdomen, radiates to the shoulders and goes to the back. I had my pain pump refilled last week but my pain doc did not want to increase the dose of the meds. My BP has gone down again since stopping Sutent. It was down to 85/57 or something like that last week. He didn't want to increase the dose and take the risk of my BP going down even more. One of the meds in the pump is a blood pressure medicine so it can cause my BP to nose dive. Mornings tend to be rough and getting out of bed is not easy. That's when my pain is most intense. It gets better as the day goes but I'm feeling more tired than usual and I think it's because the pain can be draining. I try not to nap although I get really sleepy as sleeping seems to make me feel worse. I feel more tired and wake up with a lot more pain. I hope I don't sound like I'm complaining. I am actually doing well. These side effects are very manageable so far compared to when I was on Gleevec or Sutent. I am not nauseous at all so I am so grateful for that. I'm just trying to find out if others taking this drug are experiencing similar symptoms.
Last question - how long will it be before Charlie gets a scan to find out if Nilotinib is working? I'm sorry this is long.
Blessings, Minnie
27 Feb 2008
I actually don't know when my next scan will be. I have an appointment to see my oncologist on March 14 and I will ask her then.
I don't know about patience and being overly sensitive to the strangest things. I have to say I have those moments and probably more if I ask my boys:). For me, frustration over what I can't do anymore can sometimes do that to me.
My rash started with small spots on my cheeks but has now spread to my whole face. It wasn't as itchy when it first showed up but it's starting to bother me a bit, every once in a while. I think I just have to pull my hair back so it doesn't touch my face.. I feel and look flushed most of the time. Sometimes my husband even thinks I have a fever.
Thank you so much for sharing Charlie's experience with Nilotinib. It helps a lot. Take care.
Blessings remain, Minnie
MARCH 10, 2008
Dear family and friends,
We saw Dr. Basche last Friday to discuss how I should proceed with Nilotinib. Because of issues with toxicity, I’ve had to take a break from the drug after being on it for a couple of weeks. I am on a one week break and will restart again today, Monday. I ask for your prayers as my pain has gotten pretty intense. My pain doctor is open to doing the celiac plexus block once again but we want to pray through this and make sure this is where God wants me to go. Please pray for wisdom, discernment and continued strength to persevere.
On a lighter note, our other son, Paul, has been home for a while. He arrived the beginning of February and will be with us until the end of March. As always, he is such a joy and a blessing to us. My sister-in-law and one of my very best friends in the world, Cora, has also been here with us the past couple of weeks but will be going home tomorrow. I wish she can stay much, much longer. She spent her time getting big projects done for me while allowing me to enjoy the other chores I like doing. She and Krissie even tag teamed on some of the projects. I’m going to miss her soooo much.
Dan and Daniel were gone again this past weekend as they wrapped up a study they started about a couple of months ago with other fathers and sons. It's called Passage to Manhood. I was initially hesitant to add another activity to Daniel’s already hectic schedule but thankfully as Dan prayed through it, he felt God’s strong leading to do this with Daniel so they went. We know we can always trust God to provide what He requires and He did. The “graduation” ceremony yesterday blew me away. The fathers and sons shared what they learned and then the fathers gave each of their sons their blessing as they welcomed them into manhood. I highly recommend this program to all the fathers out there whose sons are entering manhood. Please do not miss this opportunity to have this time with your sons. If you are interested, feel free to email us and Dan can give you more details. I cannot thank God enough for what I witnessed yesterday. He is good!!!!
Till the next update…
In His grip,
Minnie
James 1:12 Blessed is the man who persevere s under trial, because when he has stood the test, he will receive the crown of life that God has promised to those who love him.
MARCH 15, 2008
Dear family and friends,
I finally decided to go ahead with the celiac plexus block. My pain is not easing up - it only seems to get more intense with each passing day and the break-through pain medicine is not working. The appointment is already set for March 25 but before I can even head out to the pain clinic, I will need to go to the lab to check my white blood cell count. If I am found to be neutropenic that morning, I can’t have the procedure. It’s all in God’s hands.
As some of you probably remember, the last time I had this done I woke up 15 hours later than when I was expected to be out of the hospital. Instead of this being an out-patient procedure, I ended up staying in the hospital overnight. Needless to say, it was a bit traumatic for everyone. To avoid the same problem, the pain doc will try a different kind of anesthetic. I am not expecting to stay overnight but we’ll go ahead and pack toiletries and an extra set of clothes in case things don’t go as planned. Thankfully Daniel will be on spring break during that time so we don’t have to worry about making sure he is covered.
I continue to ask for your prayers for strength to endure this pain. It sure isn’t easy but thankfully God is always good.
Till the next update…
In His grip,
Minnie
Lamentations 3:25-26 The LORD is good to those whose hope is in him, to the one who seeks him, it is good to wait quietly for the salvation of the LORD.
27 Mar 2008
Subject: Tony - Nilotinib - going back on Sutent
Kay wrote: He (Tony) had severe side effects from Nilotinib - AM-107. He is now going back on Sutent.
Hi Kay,
I'm sorry to hear Tony had problems tolerating Nilotinib. I have problems with toxicity as well that I have had to take a week break too. I went for two weeks straight and took a week off and then had to do it again recently. I won't get a scan until middle of April so I don't know if this is going to work. I hope it would since Gleevec worked well for me a for a few years while on a suboptimal dose.
May I ask why Tony's going back on Sutent if he had disease progression while on Sutent?
I also saw your note on the Caring Bridge guestbook page and I want to thank you for your prayers. You don't know how much it means to us to know that people lift us up in prayer.
Take care, Minnie
MARCH 31, 2008
Dear family and friends,
Daniel drove me to Denver to see Dr. Basche last Friday. It was his very first long drive with just the two of us (without Dan) and he did such a great job. If I am not mistaken, he has met the 50 hours required of driving time to get his driver’s license but he still has to wait another month or so to get his driver’s license because he has to have his permit for a year before he can get his license. Dan and I agree he is ready to drive on his own. I was so proud of him and felt a little funny during the trip. When he opened my door and offered his hand to help me out of the car, I couldn’t help but smile. I told him that it wasn’t so long ago when I was the one who opened his door so I can carry him and put him on his stroller. Now he’s the one who opens my door to assist me either to walk or help me to the wheelchair. I know it’s silly but I got emotional over it and had to get myself together before we got to the doctor’s office. I thank God for him. God is sooo good!
My last appointment was not as encouraging. Daniel and I were able to talk about the appointment when we grabbed a bite to eat on our way home. I wanted to make sure he understood and knew how he felt about it. I thank God for the maturity He has given Daniel and the wisdom He gave Dan to guide Daniel through this.
I lost about 4 lbs. instead of the usual gaining a pound here and losing a pound there. I am working hard on gaining it all back as Dan is threatening Ensure again. I can eat because food doesn’t taste funny but it’s really hard to keep my weight up. I have to admit I still can’t eat a lot but I think I eat more than I used to.
What’s not so encouraging is my alkaline phosphatase count is up again. I don’t have the most recent one from Friday but the March 7 test showed that it has gone up to around 454. That can mean that the tumors are active and the liver is in distress. My platelets are also extra high which is more than likely from the inflammation from the liver. These two numbers tell us that my next scan which will be in two weeks might show more disease progression. So in case this might be so, we need to be ready with our next plan. As some of you know, tolerance is always a problem for me. I am on a suboptimal dose still because I can’t even go on for two straight weeks without having problems with side effects or toxicity that I have to take a break. We need to make a decision if I should go ahead and go for the optimal dose of 400 mg and see if I can endure it and if I continue to have problems then move on to another drug. The good news is I heard there’s another drug on clinical trial that I might be able to get as an off-label script. If I can avoid having to travel I would. I can barely make those trips to Denver without having to pay a price so it will be nice to be able to try another drug off-label than go to a clinical trial elsewhere. Please pray for wisdom and discernment for the decisions that need to be made.
I don’t think the celiac block is working or going to work. It’s been a week and I didn’t feel much different. It’s the prednisone that seems to help with the pain. I noticed that when I forgot it the other day, I paid for it. What next? I really don’t know.
Thankfully we have a very big God. Because I am His, I am never out of hope. Life is good and life is full because He is our God. He is faithful every step of the way and He has blessed me with all of you to sustain us through prayer. Your love and support mean so much to us. You are all God’s gifts to us so thank you. Please keep your prayers, emails, notes, cards, etc. coming. They lift me up more than you'll ever know. I apologize that I am not able to reply sooner but please know I read them all and treasure them so.
Like always, we’ll take it a day at a time, a moment at a time, a prayer at a time.
Till the next update.
In His grip,
Minnie
Matthew 6:33-34 But seek first his kingdom and his righteousness, and all these things will be given to you as well. Therefore do not worry about tomorrow, for tomorrow will worry about itself. Each day has enough trouble of its own.
April 11, 2008
Dear family and friends,
After months of not so encouraging news, I finally have some good news to share. While this last report still states that there is extensive metastatic disease it also reported no disease progression! There’s a tumor that seemed to have shrunk and is less active and one that grew and is a bit more active but both of the changes were so small that it’s hard to say if the tumors really shrunk or grew. It’s encouraging because this is the first report we’ve seen that showed no new tumors or significant growth in size or activity in a long time. What my oncologist would like to do is for me to try to increase my current dose of 200 mg to 300 mg and see if I can tolerate it. Her hope is we will see improvement at a higher dose if we are truly seeing stability now. If I can’t go any higher, I will stay at this dose and get another scan down the road to see if this dose can keep the tumors stable. If not, I will then switch to another drug.
Now for the not so good news. My hematocrit (HCT) count is pretty low so I will need to go back to the hospital on Monday to get a blood transfusion. I don’t have to stay there overnight but I will need to be there for six hours. The other not so good news is I lost another two pounds so my weight is back in the 80s range again. The prednisone was supposed to help me gain some weight but it obviously didn’t. We’ll continue to work on this one but for now we will celebrate this report. It’s been a while since I’ve seen the boys smile from ear to ear. I can’t even begin to describe how it felt when I told them. Daniel’s face lit up and… oh that smile got to me. God is good!
Till the next update…
In His grip,
Minnie
Psalm 52:9 I will praise you forever for what you have done; in your name I will hope, for your name is good. I will praise you in the presence of your saints.
17 Apr 2008
Subject: Re: Need info on AMN 107 - for Maura
Maura's post: My most recent scans show progression of my liver tumors. AMN-107 may be an option for me, I am looking for info regarding side effects, successes, etc.
Hi Maura,
As always, I'm a day behind and a dollar short:(. I meant to respond to you when I saw your post but the this week has been rough. I'm so sorry to hear of your disease progression. I hope and pray you and your family are experiencing God's peace and comfort at this time.
Yes, AMN107 seems to work for me. This is the first report I've had since Oct 2007 that showed stability, no significant growth and no new tumors. There were two tumors that the radiologist mentioned. One shrunk and the activity was less and the other grew and the activity increased but the numbers were so small my oncologist said they can't really say if it shrunk or grew. Somebody here mentioned that sometimes the slice makes a difference.
Having said that, the side effects of this drug are not easy to tolerate. Granted I have always been overly sensitive to medication. I've had to take some breaks along the way and couldn't go up to the optimal dose because of toxicity and tolerance. Because of this last report my onc would like to push and see if we can go a little higher to 300 mg from 200 mg and see if we can see real shrinkage or real stability on the next report. In my excitement I agreed with her when I saw her last week. But this week has been horrible. I had a blood transfusion last Monday because my hematocrit was quite low. The following day I felt like I had the flu. I was having low-grade fevers off and on and chills and I was so tired I couldn't get out of bed. The pain was more intense and I couldn't get a comfortable position. I was also sweating like crazy so the chills always followed. I felt rotten. I thought all the symptoms were going to go away but they didn't. I finally went to the ER today after my onc's nurse convinced/ordered me (my onc is on vacation) to go. My oncologist actually called me from her vacation because the nurse called her last Tuesday. I didn't get her message so I didn't think it was a big deal but I didn't know she was really worried that I might have had some adverse reaction to the blood transfusion. I felt a bit better yesterday and felt worse today so I gave in and went to the ER this afternoon. The good news is I don't have any adverse reaction to the blood transfusion but the ER doc and the on call oncologist can't explain why I feel this way. They referred me back to my oncologist. When we got home, I went to the Novartis site and read up on the 12 page medication guide on AMN107, abstracts and all that I can find about it (GSI site and others). It looks like what I have and am feeling are side effects of this drug - AMN107. Now I'm not so sure I'm ready to go up on the dose come Monday. My onc will be coming back tomorrow from her vacation so I will talk to her then.
Here are the side effects that I think may be related to Nilotinib. I'm sure I'll miss something but here's what I remember for now. Dry eye, eye pain (it really hurts, like there's something pushing your eyeball) / Flushed / Low-grade fevers off/on / Shortage of breath / Pain when breathing deeply / More pain in the lower abdominal area along with the other abdominal areas that I've always had trouble with and goes all the way to the back / Nausea / night sweats (I change PJs about three times a night. You wake up cold and wet. I only have so many running shirts that have wick protection & they don't work as well anyway when you are soaking wet) / fatigue & weakness / Flu-like symptoms / Chills / Headache / Diarrhea / constipation / Bloated feeling / Weight loss - I've lost six pounds the past four weeks / Leg cramps / Loss of appetite, the food is starting to taste funny but not metallic - they either taste too salty or overly sweet - I feel full after two-three bites / Dry mouth / I also noticed that my nose is constantly dripping / Liver enzymes and blood counts have been out of whack
I don't want to discourage you with this list because as I said, I have always been overly sensitive to medication from day one. I know you were able to tolerate much higher doses than I could when I first started on Gleevec. I haven't really talked to my onc about these side effects because our last meeting was disrupted when she saw my blood work and wanted to get me admitted to get a blood transfusion. Even though I had my notes ready, I just wanted to go home to celebrate and make sure I didn't get admitted to get a blood transfusion and wait until Monday. Yes, stupid I know - I just wasn't thinking! No excuse for my foolishness so now I have to get on the phone with her which I hate because it's so hard to talk on the phone when you are always trying to catch your breath and I sure don't have the energy to drive to Denver tomorrow. Aaarrggghhh!!!!!
As frustrating as these side effects can be, I know God is going to get me through. He's not going to leave me or forsake me. I know I will not have to walk this alone and I know this didn't come as a surprise to Him. So I will have to take it a day at a time, a moment at a time, a prayer at a time and see where God leads.
Hope this helps. Take care.
In His grip, Minnie
[edit] Butch
5 Mar 2008
Subject: Re: Tumor Fever Butch
Update on Butch, we finally saw Dr. Tap at UCLA on Friday after being hospitalized last week in San Diego for 4 days and waiting 5 days for a follow up. Anyway, he took one look at Butch and called for an admission to UCLA, Butch had a ct scan on Friday that showed he now has mets in his omentum which apparently were not there in January and did not show on the MRI done last week at UCSD?
Dr. Tap believes that this is causing the abd pain, bloody ascites and issues with his bowels and is contributing to his weight loss and overall deterioration. He has acted quickly starting him on AMN107, diuresing him with lasix, giving him protonix for stomach issues and morphine for pain, yesterday they drained a right lung pleural effusion via thoracentesis to alleviate his feeling of fullness. His appetite is good but physically he has no room for food or drink so he is down 25lbs.They pondered IV nutrition but it also adds fluid which will increase the swelling that we are trying to get off his belly to make him more comfortable. Dr Tap states that he will only give AMN about 1 month to work as he may need to act quickly and get Butch on something like a HSP inhibitor. Incidentally, Marina he has had a 99.4 temp for about a month now. Anyway, as always we are all ears for your suggestions, opinions and guidance, if anyone knows when oral hsp-inhibitor trials are opening and where they will be that would be great, we just left UCLA (after 5 days) but we live in San Diego. Thanks for all your support and knowledge.
Kerry
Wife of Butch dx'd 1/2000, whipple procedure primary in stomach exon 11, ckit pos, liver mets 1/2001 gleevec trial UCLA 4/2001 shrinkage, resistance 10/05 dose increased, 3/06 started sutent played around with sutent to completely eval effectiveness until 9/06-no response from sutent, 2/07 sirtex spheres UCSD-ineffective, trial opens at UCLA 9/07 randomized to gleevec supposedly stable dx as of 1/08 however wt. loss, back pain, random infections (urine, respiratory) plague him, 2/1/08 sudden onset of abd pain with extreme abd swelling brought to er CT scan no change from 1/08 ct scan, sent home with dx of mild ascites, dehydration, partial ileus, r lung pleural effusion, returned back to Er 2/22/08 for severe abd pain with distention admitted 2.6 liters blood tinged ascites removed via interventional radiology, MRI abd-no significant change from last CT in 1/08, sent home on marinol for appetite, lactulose for constipation, morphine for pain. Recheck appointment with Dr. Tap UCLA 2/29/08 Dr. Tap orders admission for pain control, nutrition and thoracentesis released from UCLA 2/5/08
21 Apr 2008
Subject: Help Nexavar denied, spinal metastasis Butch
Hello List,
Butch was just released from 5 days in the hospital. The outcome was horrible news. He has deteriorated steadily since February with weight loss, ascites and pain however they had put a picc line in and started TPN ( he did not tolerate this at all) anyway last Tuesday he had a high fever so I brought him to the ER, his WBC count was 24,000 they admitted him gave him IV antibiotics and we were cruising right along until Thursday his PMD made a special trip to see us in the hospital which we thought was very nice however her news was not, she told us that the ct scan done in the ER showed worsening of his peritoneal mets with NEW mets to the spine. She told Butch "we need to get you out of the hospital to enjoy the good days you have left" I can barely breathe as I write this. I really did not know that GIST goes to the spine?
Dr. Tap at UCLA was informed he is also quite shocked as this was not seen at UCLA 3 weeks ago. Butch had been taking AMN 107 since 2/29 I guess we can say that is not working, he also has built up ascites again which we are attributing to the AMN. Anyway, Nexavar was Dr. Tap's next option until another trial became available however the insurance denied it and b/c we made over $45,000 yr Nexavar reach denied him to get it for free, it costs $5,500.00 a month
I am beside myself, not sure which way to turn next, the good news is since the infection is improving ( WBC 12,000 on Sat. ) he is feeling really good and eating well. He does not want to give up ( he is 37 yrs old), ANY input at this time would be soo appreciated.
Sincerely, Kerry
22 Apr 2008
Subject: Re: Help Nexavar denied, spinal metastasis Butch
Hello everyone, Thanks for the overwhelming support and advisement. First off Butch is feeling great he has been eating and much better since he left the hospital but after seeing Dr. Tap today he does not really think that will last for long especially with the ascites accumulating. SOOOO, In a nutshell he recommended a HSP trial first then we can have nexavar if needed later. I appreciate all of your feedback/suggestions. I have some homework to do so that we can make the decision, we would like to stay close to California if possible Butch loves it here and we have our dogs here so we will see what happens. Thanks for all of your interest, encouragement, ideas. I hope that all of you and your loved ones stay well. Sincerely, Kerry