katrina on cediranib from U.K

[Amanda]

I am trying to get help in asking them to keeo the drug available and i asked for names and phone numbers and information in a thread here ... I am at a stand still till i get this information :/

[Katrinauk]

I was due to start the cediranib trial in august 2011, but the trial was temperarily on hold due to production problems. In octoberbit reopened andbi was entered into the trial. My inc explained to me that the cediranib would only be available to me until 2013, I assumed that was just in UK. I had planned on looking into entering the trial in another country.

As I posted on Brittanys page, some action needs to be taken against this rediculous decision. A petition, appeal ect. I am signed to a media agency, and I can have work with papers, mags, tv ect. So my thoughts are, if I set up interveiws with mags and papers, have an update of my story, and include astrazenecas plan to discontinue production of cediranib, have it printed internationally, then somehow set up an online petition for anybody to sign and leave comments. I'm thinking it will cause such a rage, I may get a meeting with parliament from it. I mean that's talking big, but a possibility. Good idea?

[Katrinauk]

Oh my the way......Bonnie, I am on 30mg of cediranib. Overall I cope with the side affects, and it doesn't stop me from doing my everyday things. It's just the gastro problems that can be debilitating for me. Now with this lack of sleep due to the insomnia, I am feeling very tired.

Johannes, Thankyou for your post, its always very encouraging to read other patients are doing well on cediranib. I had my thc levels. Necked with my last lot if bloods, and they were all fine.

My blood pressure was raised, and I had protein in urine, but after further tests the following day, np and protein had lowered, and no concerns with continuing the trial, which is brilliant.

[Bonni Hess]

Dear Katrina,
Thank you for the additional shared information about your Cediranib dosage, and also for your excellent ideas regarding possible action which could be taken to try to bring media attention to AstraZeneca's very disturbing decision to discontinue development of Cediranib. I would like to encourage you to contact Professor Judson at the Royal Marsden to get his input and Hopefully his support in appealing AstraZeneca's decision. I am working with Yosef (Yossi) Landesman, founder and president of CureASPS, to have the information regarding this very concerning issue posted on the Home page of this Web site so that it is more visible to more people, as not everyone regularly follows all of the threads on this Board and they may not be aware of the information which I posted on the Cediranib thread. Also, Yossi is going to discuss the issue with the research oncologists at Dana Farber with whom he has a close working relationship.
As Amanda has pointed out, it is critically important for more ASPS Community people to get involved in protesting/appealing this decision because it affects not only those patients who are currently benefiting from it, but also those who could possibily benefit from it in the future. Although Cediranib has unfortunately not been successful in providing long term sustained disease stability and significant tumor shrinkage for several of the ASPS patients who have tried it, based on my personal observations of those who posted anecdotal treatment information and results, in most cases it did seem to provide at least 20% initial tumor shrinkage and about six+ months of stable disease before resistance to the medication developed and progression heartbreakingly occurred. Those of us fighting this very challenging disease know that any tumor shrinkage and disease stability is a victory which buys us precious time until a more effective treatment can be found. Also, possibly in future trials Cediranib could be combined with other drugs which might prove to be more successful, but this option tragically won't be available if Cediranib development and production are discontinued. Without Cediranib, it is almost certain that Brittany would have devastatingly lost her courageous battle a couple of years ago since she had an unresectable and untreatable met in the head of her pancreas and rapidly progressing widely disseminated disease. Sadly, Cediranib is not the permanent cure that we all need and are so desperately seeking, but it is one of the few currently available drugs that has at least shown some success and offered our ASPS Community much needed Hope. Hopefully, that potential for a successful response and the Hope that it brings won't now be taken away from us.
Take care Katrina, and thank you again for your valued input.
With warm hugs, special caring thoughts, healing wishes, and continued Hope,
Bonni

[Katrinauk]

Ok so I have spoke to my uncle who works in the pharmeceutical business, and he is high in his game too.
He responded with some advice of best routes to take to appeal against this decision.
He said:

"The first port of call would be to find out if they are going to be selling off the intellectual property, or is there a combination drug in the pipeline. There jas always been conflict between business and morality. Is the drug been shown as a cure, or means to suspend progression? (which I will let him know), a cure will obviously be easier to fight for. y I will ask a few questions here and see if there are any options for continuation of supply, but in the meantime you have time to prepare your defense".

I will in the meantime contact proffessor judson, and ask him for his support and any avenues he knows of for us to take. I will be contacted my media managment on Friday to ask for a new print up to be done. They will love this story, and it will sell papers, so I can't imagine them refusing. I will be arranging a meeting with my oncologist team to gather information also.
As I have stated I have sent an email to the cheif executive officer of astra zeneca global, requesting a response with an adequate reasoning for their decision to let people die. Explaining that we are human beings with tragic stories, not just a number in a trials book, ect.
I have found that the headquarters for astra zeneca is in London, do if I arrange the papers and set up an online petition for anybody to sign, asking for support in the papers print up, I will print the petition off and drive to London and handbit to them personally, I may even try to set up a meeting with the cheif executive also.
I am currently awaiting the contuation of my documentary to be filmed, so I will get that going again, and get this info filmed for that, so it can also be aired on tv at a later date also.
I just hope I have enough energy to do all of this on my own, but I do promise to do all I can to help us and future asps patients.

[Katrinauk]

WEEK 13:

So I have just finished week 13 on my cediranib trial, amd it has been a tough week for me.

* Insomnia- this has worsened this wweek quite significantly, I am literally awake all night long until 5-6am. This is now starting to aafect my day and how I feel, so a trip to the docs for sleeping pills I think.

*headaches/migraines- I have had around three migraines this week and mild headaches in between, this could be worsened by the lack of sleep.

*dihorrea- I have suffered only a couple bout of loose stools this week, accompanied by the usual crippling stomach pains.

*vomiting- I have continued to vomit if I eat anything that lies quite heavy on my stomach, especially cooked foods.

*apeptite- Almost a complete loss of apetite now, I really strugglinmg to even force any food down now, as it makes me feel extremely nauseous.

*food irritation- I cannot eat food that contains even a tiny drop of cooking oil. Dairy products are viscious to my stomach. Leading to vomiting, and extfremely painful stomach cramps and dihorrea.

*toothache- Again I am suffering with my onlt two filled teeth. It seems to happen maybe twice per cyle, where my tooth/teeth will inflame, cause the most irritating itch deep under the tooth, and sometimes agonising pain for a few days, then it will suddenly disappear.

* My skin has lightened further, my nails are now much darker than my skin. I have my pigment of yellow tones.

*mouth sensitivity- remains slightly worse than to begin with, my hand and foot syndrome remains the same, at a level where it is sore to undo a bottle cap.

*NEW SIDE AFFECT- Small spots that have appeared on my back and shouders, they started appearing about three weeks ago, but they are definaly increasing in number. They can be sore to touch, and some have a white head develop on them.

TIPS ON DEALING WITH SIDE AFFECTS

MOUTH SENSITIVITY- change to a childrens toothbrush, use a childrens toothpaste, preferably a non minty one (maybe strawberry), use a non alcahol mouth wash, again a childrens one. By switching to these products, Brushing time is far less painful, i no longer feel like my tongue is on fire. Also speaking from previous experience with sutent, do not brush your tongue, this irritates, and worsens the mouth sensitivity dramaticallY.

DIHORREAH/SICKNESS/WEIGHT LOSS- Avoid food cooked in any fat/cooking oil, and dairy products seem to be a problem for many on this trial too, as do I. The main change I have made that has helped with my dihorrea and weight loss, is taking my cediranib pill at bedtime, as apposed to the daytime. I have found that taking longer after I had eaten, the less dihorea I suffered, hence leading to less weight loss by the end of the week. By doing this i have gone from losing 5-7lb a fortnight, to now only 2-3lb weight loss a fortnight. It realy has helped.
I find it has also regulated when I have a bout of loose stools, before my bowels would be very sporadic, whereas now, by taking my pill of a bedtime hours away from food, I open my bowels by he morning, and pretty much at ease for most of the day, making going out much easier without the worry of needing the tolet.

APETITE- As my apetite is now almost non existent, I find that eating little and often has really helped. If anybody also has a problem with forgetting to eat because you dont get hungry, then maybe set an alarm for evry two hours, and try eating something small, maybe a handful of nuts, some fruit, some wheat crackers.

I hope these tips help others as they have helped me.

[Bonni Hess]

Dear Katrina,
Thank you once more for your very detailed and conscientiously shared information on your Cediranib side effects and your helpful suggestions for dealing with them. I am so very sorry for all of the pain and suffering that you are having from the negative side effects, and I certainly know from Brittany's almost identical Cediranib side effects how debilitating they can be, but I am grateful that you, like Brittany, are still able to maintain a positive attitude and enough strength and energy to remain active and move forward with your Life in spite of everything that you are going through. In addtiion to all of the side effects which you described, Brittany also initially had splinter hemorrhages at the base of her fingernails which gradually disappeared. Have you also had this side effect?
I am posting my comments regarding AstraZeneca's devastating decision to discontinue development of Cediranib on Amanda's
"INFO please" thread, but I wanted to again express my deepest gratitude to you for everything that you are doing, and all of your wonderful ideas, to try to appeal and reverse this decision which has such very serious implications for EVERYONE in the ASPS Community, and which EVERYONE needs to get involved in protesting.
I Hope that you will start feeling better and getting some relief from your suffering. I mentioned previously that medical marijuana or marinol are helpful in reducing nausea and stimulating appetite if this is something which you are interested in pursuing with your oncologist. Take care Katrina and know that you are held very close in my heart and my most caring thoughts.
With special gratitude, deepest caring, healing wishes, and continued Hope,
Bonni

[Katrinauk]

Hey bonnie,
In answer to your question about splinter heamorrages, I did have these too, on week 2/3 which then disappeared by week 9.
Thankyou for your kind words about my positivity, I suppose I sometimes forget the way I am, because my determination takes over. It is just 'me' to be upbeat and positive, so I don't think nothing of it. So Thankyou for bringing it to my attention.
I feel like every moment is precious, and should be cherished, and regardless of this horrible disease, I count my blessings everyday, always have done.
I have some new info from astrazeneca and my uncle which I will also post in amandas thread.

[Bonni Hess]

Dear Katrina,
I am very encouraged about you having had splinter hemorrhages because when Brittany developed them, Brittany's extremely dedicated and knowledgeable Clinical Trial oncologist showed us some research information which said that splinter hemorrhages may be an indication of a positive response to TKI drugs. It would be very interesting to find out if other Cediranib patients who have or have not had a successful response to Cediranib had splinter hemorrhages following the start of their Cediranib medication.
Regarding your very positive attitude, based on personal observations, I truly feel that having a positive attitude helps to strengthen the immune system which helps the body to better fight disease. Of course it tragically doesn't always win the battle, but it certainly makes the journey easier for the patient and the patient's loved ones. Those of us involved in fighting this insdious disease have a unique understanding of how very precious and fragile Life is, and how important it is to Live each day to the fullest with purpose and passion, as you obviously do.
With warm hugs, special caring thoughts, healing wishes, and continued Hope,
Bonni

[Katrinauk]

WEEK 13:
Ok guys, so.....this week has actually been a tough one for me. Previously, my side affects were very mild, and did not stop me from normal, daily activities. However this past week has somewhat been a completely different matter, as my side affects have suddenly and dramatically got worse.

NAUSEA:
I feel nausous most of every day, I find that it is worsened by the smell of food, especially cooked food.

VOMITING:
I have vomited evry day this week. Although it only occurs after I eat. If I eat any more than a palm sized portion of food, it is very difficult to fight against the nausea, and I will inevitably vomit approximately half an hour after eating.I also find this if i drink a fair bit of fluids in one go. Prior to the vomiting, I get some strong, sharp upper abdominal pains. It is almost like my body has suddenly forgot how to digest since starting the cediranib.

DIHORREA:
I have had dihorrea more frequently this week, about 3/4 times a day, accompanied by the usual cramping pains. Altough I have noticed that having more frequent dihorrea, it seems to have delayed or banished the sever onset I have experienced each month since starting the cediranib. On the other hand, I usually experience that on week 2/3 of each cycle, so maybe it is yet to some, as I am only in week 2 of this cyle.I will be observing that anyhow.

INSOMNIA:
My insomnia worsened, so much so, that I found I'd be up at 7am with my daughter, and I'd be awake still, at 6am the following morning. Over the past three nights, I have had at least five hours sleep, which is the same as I usually sleep anyway.

FATIGUE:
On Tuesday, I suffered my first bout of fatigue. I could barely hold my head up, or walk, and all I wanted to do was sleep. It was a complete battle all of the day, as being a single mother, I had to really push myself to get up and carry on, which just exhausted me all the more. Luckily my daughter slept early that night (she usually cant sleep untill midnight), so I was able to have a long night of sleep. Since then, I am sleeping better, I can get to sleep by 2am. I am thinking that the fatigue was maybe induced by the lack of sleep.

MOUTH SENSITIVITY:
Previously the mouth sensitivity has been mild enough that it only affected me to eat certain foods. Now, however it is a completely different matter. I am further struggling with food limitations, even basil stings my tongue now. I cannot drink tea, I can drink coffee, hot chocolate, just not tea for some reaon, i faced that very same problem when I was on sutent (sunitinib). I cannot eat ice cream, so the sensitivity to hot and cold has heightened. When the natural movement of the mouth occur when salivating and swallowing, the suction on my tomgue is very uncomfortable. Also, when I talk and my lips brush my teeth, it is making the inside of my lips sore. It is also now becoming difficult to bear the burning whilst brushing my teeth with a toddlers, mild paste. I have had to reduce the size of the paste I use down to a pea sized amount, and just brush more regularly throughout the day. I have tried many toothpastes when I was on the sunitinib, such as a natural, fennel paste-OUCH! I tried an aloe vera based paste, thinking it would soothe my mouth, but as it was minty, even though mild minty, it still caused an extreme burning sensation onmy tongue.

HAND AND FOOT SYNDROME:
I have a constant burning and tingling sensation on both hands, underside of hands to be precise, and the same sensation but milder on the soles of my feet too. As I have mentioned before, I am finding it uncomfortable to open bottle caps for example, which is now even moreso. I struggle to grip anything tightly, aspecially if its heavy, it feels as though my skin is blistered. I still occasionally do some family members hair for them, being that I am a qualfied hairdresser. I did my sisters extentions last week, and it took a prolonged amount of time to complete, as I had to regularly stop due to how ssore and swollen my hands felt, they were not swollen to look at, but definately a swollen and blistered senstaion by time I had finished.

I have been suffering a few more headaches, but what with the dehydration of vomiting, dihorrea, and lack of sleep, that could very well be why. I have also experineced some more of those sharp chest pains that I have previously mentioned also. They last just a few seconds at a time, but are quite uncomfortable, and sometimes quite scary if Im honest.

So guys 'n' gals, thats all I have for you this week, you know..just a little bit, ha ha ha!
take extra special care.
xxx

[Katrinauk]

Hey guys, sorry for the delayed update, what with family issues and worsened side effects, I have not been able to do so.

WEEK 14:
So, this week has been pretty much like the last week, continued mouth sensitivity, increased problems with insomnia, I have only been getting around an hour of sleep/rest. Same issues with nausea, intact I have realised that by continuously forcing food down my throat really does not help, so therefore decided to only eat when I feel hungry. Hunger is almost a distant memory now, although I am eating something small once a day, e.g a sandwich or cereal.

WEEK 15:
AGAIN this week has been pretty much the same, energy levels are very minimal, lack of sleep, hunger and motivation. To top it all off at the beginning of the week I suffered pain in a bad tooth, with turned into a huge infection. This is something I have found to be a problem on sutent too. I was put on some antibiotics and told my tooth should be removed, which I am very hesetant about given the fact that heammerage is an issue on these treatments. Even though I will have to come off cediranib for five days prior to extraction, and three days after. I wonder if its even worth the risk.
On the 10th it was my 26th birthday for which I went quad biking, it was a risk with my leg, but it went well, and was super fun. Although it did tire me.

REVEIW ON 9TH.
SOOOO after a very lengthy hospital visit, I was finally informed that my disease is still stable, with minimal growth of some of the smaller tumours by mm's. No shrinkage or disappearance unfortunately, but I am happy with the stability.

WEEK16:
So this week I actually started using a bit of weed using a vapouriser, to see if it will help with side effects. It certainly helps me to sleep at night that is for sure. I also found it has eliminated my nausea for the best part, although still not able to eat a great deal, but holding down more than before.
I have a friend who is battling cervical cancer, so I decided to treat her and myself to a spa day as my birthday was the 10th and hers the 14th. It was lovely to have a massage and manicure, facial ect.
That aside, I have had increased problems with muscle weakness, and fatigue. I have tried to do some exercise, but it tires me too much.
I have been looking into Tai chi, as it is not strenuous, and increases flexibility and muscle strength.
I am sleeping better now I am using the marijuana, but feeling so fatigued I don't feel the benefits of the extra sleep.

WEEK 17:
OH wow, what can I say, this week has been hurrendous, it just all seems to be getting worse. My body is aching from head to toe, migraines come daily now, muscle weakness and fatigue has worsened moreso, to the point that, my mum actually had ella one night for me, and I slept from 3pm-11am the following morning. My nausea has returned, and gastro pain has been quite awful too. Luckily, since taking laxido each day, I have not had the toturous pain I have endured previously. Although the pain of digestion, and opening of bowels is literally draining where itbis so painful. I have not been able to do anything much for myself this week, so its a god send that my mum has been off work to help me do housework, shopping, ect.
I really do hope that the muscular pain and migraines subside, as they are debilitating right now.
I have lost a little more weight, just a few pounds over the past few weeks, which is much less than before. In total I have now lost 22lb in 17weeks.

Sorry for the huge update. I will try my best to stay on top of it.
Take extra special care my fellow asps warriors. Xxx

[Bonni Hess]

Dear Katrina,
Happy belated 26th Birthday!! , and thank you so very much for your once again very thoughtful, conscientiously written, and detailed update and shared information. I am so happy that you were able to celebrate your birthday doing something fun which you really enjoyed, and that you were also able to have a day of well deserved pampering at a spa shared together with a special friend, and that the debilitating side effects of the Cediranib didn't prevent you from being able to do and enjoy both of the special birthday activities . As we all know so very well, each birthday is a real victory and deserves a very special celebration .
I am very grateful and encouraged that your four month status scans showed continued stable disease with no new tumors . Regarding the "minimal growth of some of the smaller tumours by mm's", the "minimal growth" is probably attributable to the differences in where the tumor was sliced by the MRI, but be sure that you verify with your oncologist that the scans are being compared to your initial scans from when you started the Trial, and not just to the previous scan two months ago as it can be misleading when "minimal growth" is noted from scan to scan instead of based on comparisons from the first scans, as Ivan has noted and documented in his personal thread. I know that you are disappointed that your scans didn't show any shrinkage or disappearance of your tumors, but you may remember that Brittany also didn't have any significant tumor shrinkage or disappearance until after several months of her Cediranib treatment so Hopefully you are having a similar Cediranib experience and results. My heart breaks for all of the increasing debilitating side effects that you are suffering from the Cediranib, and I am Hopeful that the marijuana will help to alleviate at least the nausea, vomiting, loss of appetite, and insomnia. I know that you are very fatigued and experiencing muscle weakness, but according to Brittany's Clinical Trial oncologist, Dr. Michael Sawyer, it is very important to at least try to do as many weight bearing excercises as possible to prevent deterioration and loss of muscle. Perplexingly, some of Brittany's side effects which had begun to subside have returned with a vengeance and she is again experiencing severe mouth sensitivity to the point that she can once again no longer eat Mexican food or Thai food even with the least amount of spices, and she has had to resume using children's toothpaste instead of a mild adult toothpaste. Since Brittany is the ASPS patient with the longest sustained disease stability on Cediranib who we and Dr. Sawyer are aware of, she is a pioneer in uncharted territory regarding what to expect in terms of her Cediranib experience.
The issue of your tooth extraction is certainly a dilemma due to the increased risk of hemorrhage with Cediranib and the risk of disease rebound when Cediranib is abruptly discontinued. However, Brittany was fine when she had to discontinue Cediranib for five days prior and several days following the resection of her superficial abdominal met. You certainly need to have the tooth extracted if it is causing infection and pain, so Hopefully this is something which you can have done soon with the approval of your Clinical Trial oncologist. Hopefully too, the short term break from Cediranib will give your body time to rest and recover from the toll that the Cediranib is taking on you. Regarding your concerning increasing migraine headaches, have you had a recent brain MRI to ensure that the migraines are Cediranib caused rather than tumor related? Brittany also suffers from ongoing headaches which we assume are Cediranib related, but due to her history of brain mets and the known risk of this disease to metastasize to the brain, she has brain MRI's every three months to ensure that there are no new brain mets causing the headaches. The brain MRI's are not done as a part of the Clinical Trial monitoring since she didn't have brain mets at the time that she started the Trial and the Trial only follows the areas where she had existing mets, but we feel that it is critically important to be pro-active in following the areas that aren't being monitored so that we can be as confident as possible that everything is stable, and not just the areas being followed by the Clinical Trial scans.
I Hope that your weight loss stabilizes and that the marijuana is helping you to feel much better. I Hope too that others on this Board will write to express their support and encouragement for you as that is such a vitally important part of the function of this Discussion Board.
Please take good care of yourself dear Katrina, know that my special thoughts and very best wishes are with you and precious little Ella, and keep in touch as you are able.
With deepest gratitude for your detailed update and very important shared information, and with happiest belated birthday wishes and hugs, deepest caring, healing wishes, and continued Hope,
Bonni

[Bonni Hess]

Dear ASPS Community Friends,
Having been increasingly concerned about Katrina because she had not posted an update since February nor responded to my personal messages, I sent her a private Facebook message to which she thankfully and thoughtfully promptly responded and gave me permission to post it on the Board. The following is her today's response and update:

Hi bonnie, I am truly sorry for having not updated for so long. There just doesnt seem to be enough hours in the day to meet my daily demands alone. I have had some personal complications which has taken much of my time also. Now my little one has just started school, and I now have to look for a full time job, as the state here will not allow me to continue to stay at home regardless of my illness, so thats one of the concerns i face at the moment. I have no idea how i will pay to live, let alone have the energy to work. There are many more issues iv had to deal with over these last months too. So all i can do is apologise. I will find the time to do an update, and fill in the gaps. There has not been much change. I am still on the cediranib trial, sifned the new released contract of the trial now ending 2015 and not in december of this year, which was gratefully acknowledged by all the staff here for my effort to force that change.
I have remained dtable with no growth at all since i started the trial last october, which is fantastic. My heart is now functioning at a normal level, as is my blood pressure. I have had no dramatic changes in side effects, the worst being the gadtric issues, and i now am struggling to eat at all, i have lost a total of nearly 3 uk stone in weight. Oncs are not overly concerned, as i am still at a healthy weight of 9st12lb (uk measures). My side effects have not really stopped me from my daily activities, although when i get tired, i get extremely tired, as being a single mom, i have no time to rest. My support dystem has reduced, and my mom can no longer help much, due to her own ill health. My main issue with side effects is that it seems as though my digestive system has forgot hiw to function normally now, as bowel motions have always been very watery of consistence. So if i eat stodgy food, i have immense pains with digestion and excretion. Apart from that, i am exstatic of the resukts thus far, and remain positive and active. Feel free to forward this to the board on my uodates if you wish, and i will elaborate when i have the time.

I am deeply grateful that Katrina has graciously shared this updated information and allowed me to post it for her, and am extremely happy and very encouraged that she has now had almost a year of continued stability with no growth and no new tumors since starting her Cediranib Clinical Trial last October. Hopefully all of the other ASPS Cediranib patients will also write to update the Board with their Cediranib experience and results thus far.
With deepest gratitude to Katrina for her shared update, special caring thoughts, healing wishes, and continued Hope,
Bonni

[Olga]

Our kudos to Katrina for her efforts to force the trial end date change, what a lesson to everyone that even one person or a group can make a difference! Our thanks to Astra Zeneca for recognizing the needs of ASPS patients, I am sure that they could ignore our requests if they wanted to and there is some good will on their part - as well as the support of the NCI.

[Bonni Hess]

Dear Olga,
I enthusiastically second your kudos for Katrina, and your appreciation to Astra Zeneca and NIH for continuing to pursue Clinical Trial testing and development of Cediranib. As Katrina has proven, those of us in the ASPS Community CAN make a difference, but we ALL need to actively participate in the effort and become more involved in advocating for desperately needed ASPS research and development of new treatments.
With special caring thoughts and continued Hope,
Bonni