We finally received the test results this week that the doctors needed to begin discussing a game plan of treatment for Todd. I was getting anxious to know the preliminary bone marrow biopsy results, so I called Dr. Hamilton's office at the Cleveland Clinic on Tuesday, September 13, 2016, to ask if she had got them back from the lab yet . They are usually back the following Friday or Monday after the biopsy on Wednesday. I was told that the labs had been running behind, but they would check with Dr. Hamilton. She called me around 12:00 that afternoon with the news: His blasts counts were up to 8%. Not the news we wanted to hear. I was glad they weren't higher, but disappointed they had jumped from <1% in July to 8% now! The air conditioning in our office had been out; it was about 80 degrees in there. So, when I got this news, I had to sit down. I felt dizzy and faint. I was already overheated, needed to eat, and then got this news. I was shaken.
I asked the doctor if she thought the blast counts would continue to jump up that much again (desperate question), but she of course she wasn't sure what they would do, but she tried to reassure me that she didn't think they would skyrocket past the 20% criteria classification of Acute Myeloid Leukemia (AML), but there are no guarantees with cancer. She said that these results confirmed what we all had suspected: the cancer was no longer responding to the AG221. I had asked her at the last appointment if it was possible that the drug could still keep his blast counts down even though there was no hematological response in the blood counts. She said, it was possible, but she didn't think it was likely, nor did she think that it would help him to continue taking it for that hope only. It wouldn't make that much of a difference. So, the biopsy results confirmed this: continuing the drug was not keeping the blast counts down anymore either.
At this point in the day, she still had not received the genetic panel results back from the specialty lab. She still wanted to wait until she got these back and spoke with a few colleagues before making a treatment recommendation. She also said that they were still waiting to hear back from Celgene, the drug company of the medication Revlimid, regarding an estimate of how much we would have to pay for the drug under our current insurance. I brought up the option of Vidaza, which Todd has been on before to reduce the blast cells, and she confirmed that this may still be an option.
Dr. Hamilton asked me if I wanted to tell Todd the biopsy results or if I wanted her to call him. I was very busy at work, and wanted Todd to have the opportunity to ask any questions or discuss any concerns with her; so she called him and gave him the news. We had a chance to talk on my lunch break and he said the blast counts being at 8% was about what he expected. He was surprised it wasn't worse. I tried to encourage him; we still had options and there is a team of doctors working on getting a new treatment regimen together for him. We would go or do whatever it takes!
He had been extremely tired since his last transfusion of one unit of blood at the Cleveland Clinic last Wednesday, September 7, 2016. This week's appointment on September 14, was at the local oncologist's office for a CBC to see if he needed a transfusion. I knew he was weak, but he refused a wheelchair and walked in on his own. By the time we got back to the treatment area, he felt like he was going to pass out. They hurried and got him into a bed and covered him with warm blankets and placed a cool washcloth on his forehead while they prepped his port for the blood draw. I got him a Boost shake to drink, because he still hasn't had much of an appetite. While waiting for the CBC results to come back, I called Sam, the trial nurse at Cleveland Clinic to see if they had received word from the genetic mutation panel because the local oncologist had told Todd that they received them the day before.
Cleveland had received the results, but they were so vague that no one really understood them. Dr. Hamilton had called and asked the pathologist to explain them to her. Of course, he hadn't called her back yet. The results looked positive for the IDH2 mutation, which he had prior to treatment with AG221, but they were not sure about the IDH1 mutation. We started discussing the trial of AG881 in New York, that Dr. Eytan Stein had mentioned. Originally, I thought Todd needed to have both mutations before he met the criteria for the trial, however, after researching, it only needed to be one or both. Todd has read a lot about the drug and the drug company AGIOS. From his understanding AG881 was only a combination of AG221 for IDH2 and AG120 for IDH1. If he didn't have the IDH1, the AG881 would be worthless, since we knew his cancer had stopped responding to the AG221. This dashed my hopes of this trial. I found out later anyway, that he DID NOT HAVE the IDH1 genetic mutation, so this option was seemed out.
Once we got the CBC results back, it was easy to understand why Todd was feeling so weak. His hemoglobin had gone from 8.3 plus one unit of blood last Wednesday to 6.8 this Wednesday! At first the nurse said his hemoglobin was 6.2 and his platelets were in the teens. She said the doctor wanted to know if he wanted 1 unit or 2 units of blood. We both freaked out and said 2! Of course! This was the lowest his hemoglobin has been in over a year! I don't know if it was that low when he was in the hospital last October with the pneumonia! They usually always give him 2 units if the hemoglobin is below 8. Todd and I began to question what she had told us. Maybe she had made a mistake. Maybe the hemoglobin was at 8.2 not 6.2, then the question of only giving one unit for being under 8.5 would make sense. So I asked her to double check the results. We looked at the printed results together. The hemoglobin was 6.8, platelets at 13,000, whites at 1.2 and ANCs at .6!!! Every time I see such low numbers, I can't stop the expletive that comes out of mouth in disbelief and anger. There was no denying it. These numbers sucked.
When we told Todd the actual numbers, he was in disbelief too. He began to worry that if his counts were this bad, his blast counts in the marrow had probably increased too. I wheeled him down to Universal Care and they got him in a room right away. The nurses there are so awesome! They really care about the patient and the family. They always take my phone number so that when I leave to go into work, they can contact me with any changes or concerns. We've been pretty happy with his care at Soin Medical Center. They are always worried about how long it takes Todd to get the blood products and the transfusion process, but we have always understood that it takes time and don't mind the wait at all. We always get out of the hospital faster than they predict. This day, Todd was finished by 6:00 p.m. I was happy that our daughter Abby was able to come sit with him in his room to help pass the time. It is hard for me to go into work while he is there, but I know he is in good hands and that I can be there in about 20 minutes if I'm needed. If anyone would like to come sit with him during the transfusion process, it would be appreciated. In the future, however, they want him to come in a day early to get his CBC and type and screen and then have the transfusions scheduled for the next day so that they can order the blood products ahead of time and shorten his wait time. I'm not sure if this is really that helpful because he will have to get up early and go to the hospital two days instead of one, but we are willing to try it.
NEWS FLASH:
This is how fast and stressful everything changes. While typing this post, I received a call from his transplant doctor, Dr. Hamilton, who finally had her recommendation for treatment to discuss with me. She had already talked to Todd, but I always have a lot of questions to ask, so she graciously reaches out to me. She had discussed Todd's case with the other doctors in the Leukemia/Oncology/Transplant area, her colleagues at University Hospitals in Cleveland, and Dr. Eytan Stein at Memorial Sloan Kettering in New York City.
I was shocked to learn that her recommendation was the AG881 Drug Trial at Memorial Sloan Kettering. I thought this option was OUT! Apparently, this drug is not what we thought it was, instead, it is a "souped-up, second generation"version of the AG221 he was on. I was leaning toward the tried and proven treatments or "standard of care" treatments already available (i.e Revlimid and Vidaza) before hearing this. When I brought this up, she said that although Todd had seen some response to Vidaza in the past, it didn't help much the last time he was on it after his failed transplant. It lowered his blast count some, but it did not help with this blood counts at all. Therefore, she really didn't consider this a "positive response" to the drug. With Revlimid, we are limited to it helping the anemia or Red Blood cells only. Todd's other counts are already dangerously low, and this drug is known to lower platelets, which he cannot afford to have happen since they are already so low he has to get platelet transfusions.
She didn't know much about how AG881 worked or what it contained, but recommended we consult with Dr. Stein. In her opinion, this is the best option to help increase all three blood counts increase and decrease the blast counts. We discussed that the treatment options are getting thin. Her colleagues at University Hospital suggested a second transplant, which Dr. Hamilton feels is still an option we really need to seriously consider. I told her that I couldn't speak for Todd completely, but that in general we did not consider this a good option; instead, we consider this a last resort after we have exhausted all other options. I told her I didn't know if we were ready to go the the "hell" that a transplant inflicts. I told her that personally, I found the option scary. Not only did it not have a high success rate, but if it did work, then Todd would have to face the possibility of getting Graft v. Host Disease that could be detrimental. She reiterated that this is the ONLY CURATIVE OPTION. That every other option is just temporary. They would obviously use a different donor, but I wasn't impressed with the long-term success rates of bone marrow transplants. I guess we just need to be careful not to wait too long to take this option; he needs to be healthy enough for a transplant.
This news, that we would have to go to New York, was not upsetting in itself. However, I called Todd back after my conversation with Dr. Hamilton, and his mind was racing ahead of all the implications and changes in our lives that would be necessary to pursue this trial treatment. This would mean extensive travel: every week for the first month, then every two weeks thereafter. We would need resources to go and he would need me to go with him. My ability to work full-time could be in jeopardy, which means keeping our house would be impossible. I didn't want to jump too far ahead, and I think we would be smart just to take things a day or week at a time. We really need to speak with Dr. Stein to see how feasible getting on the study would be.
Putting the house on the market again would be stressful. I'm not sure I can handle all the work involved. This time it would be definite; we would keep it on the market until it sold! I would need lots of help: cleaning out the house, getting rid of stuff we couldn't take with us, boxing up, keeping the house immaculately clean and ready to show, and then finding a new place, preferably one that would be move-in ready. This is when I broke down into tears. I know our house is often too much to take care of. I have been mowing the grass and doing almost all the cleaning. With Lewis back at college and Ellie back in school and sports, and Todd unable to get out of bed, most of the chores are left to me.
Please be in prayer for wisdom for us and the doctors. That travel arrangements would fall into place. I've already contacted the Corporate Angel Network about arranging a potential flight and the Hope Lodge in New York City to see if we could stay there instead of a hotel.
Todd's cough is getting worse and he is now limping. It seems like when his counts get low, certain areas get inflamed, and this time it is his foot again. He still doesn't have much of an appetite. The doctor said this was likely from the MDS itself. Getting him to eat regularly requires great effort. He has been trying to drink his Boost shakes when he can't bring himself to eat.
Thanks goes out to my parents who are a pillar of strength and help. My dad (age 69 with congestive heart failure!) has been helping me with yard work. Todd's mom is still bringing food, but even she is having a hard time walking. Pastor Chuck Moore at Hillside Chapel has been faithful in staying in touch and visiting Todd. Our neighbors Dan and Sharon have also been very supportive.
NEEDS: I hate this part, but we do have needs. We have a few dead trees in the yard that need to come down. Neither Todd nor my Dad are able to do this. If anyone can refer us to someone who could give us a reasonable rate to take these down, it would be greatly appreciated. I could really use some mulch in the front flower beds, if anyone has extra mulch or has the time to chip and shred our tree branches for mulch, that would be appreciated. I probably need to have a garage sale, which is a lot of work! I would have to do it on a Saturday when I am off work, but I might need help preparing for it.
Of course, I always worry about Todd being home all day alone. When I'm not there, he doesn't eat. It would be great if someone could tempt him by bringing food over and sitting with him for a short visit. He really doesn't feel like going out to eat, as he barely feels like getting out of the house at all.
He will have a CBC drawn at Soin on Monday, September 19, 2016, as they don't want to wait a full week this time to see if he needs a transfusion.
Also, on September 21, we will be celebrating our 25th Wedding Anniversary. I hate that he is so sick. The celebration will likely be low key at home. I'm just thankful he won't be in the hospital and that we made it successfully to such a significant milestone!
Thank you all for the love and support.
FOR MORE INFORMATION:
AG881 General Trial Information: https://clinicaltrials.gov/ct2/show/NCT02481154
AG881 Trial at Memorial Sloan Kettering: https://www.mskcc.org/cancer-care/clinical-trials/15-252
Success of AG221 (showing average response time of 15.7 months):
http://annonc.oxfordjournals.org/content/27/4/599
Showing posts with label relapsed MDS. Show all posts
Showing posts with label relapsed MDS. Show all posts
Friday, September 16, 2016
Friday, April 1, 2016
One Year on AG-221 Trial Drug
As of March 23, 2016, Todd has been taking the trial drug AG-221 for one year! It's hard to believe how precarious Todd's health was this time last year: getting blood transfusions every 6-12 days; having no immune system (no ANCs and no White Blood Cells); and having no energy-barely able to get out of bed. Today, one year later his counts are good (for him)! The disease, while still present, has not proliferated, and his cancerous blast counts are low! Besides being in remission, we couldn't ask for anything more!
To give you an idea, here is a comparison of the differences in his counts from last year to now:
Year: 2015 2016
Whites: .2 3.99
Hemoglobin: 7.3 11.8
ANCS: 0 3.15
Platelets: 70,000 57,000
As you can see, he has had a remarkable increase in his White count, Hemoglobin, and ANCs. His platelets vary now between 55,000-75,000, which is about the same as they were a year ago. His platelets have not responded as well. In trial terminology this is considered as a hematological response without platelet recovery. That being said, his platelets are still high enough to prevent any serious bruising or the need for transfusions (usually when platelets fall below 10,000).
After not hearing back from the drug company whether Todd could only go once a month for his trial visits as promised, I finally sent a message to his bone marrow transplant doctor telling her that we were unhappy with how the administration of the trial has been going. We haven't received any financial reimbursements for months, none of our appointments have been made ahead of time like they should be, and when they have been scheduled, they have been for inconvenient times (8:30 a.m. when they know we have almost a 4 hour drive to get there). I "offered" to go straight to the Principal Investigator at Cleveland Clinic or the Drug Company itself, but the doctor finally got confirmation that Todd no longer needs to go to the Cleveland Clinic for his Day 15 appointments just to get blood work done. They have arranged for Todd to have his Day 15 blood work at our local Compunet Lab. This means he will only need to go to the Cleveland Clinic on his Day 1 appointments, only once per month! What a relief! No more driving up to Cleveland every two weeks! I'm so grateful! As to the appointments and reimbursements: they are short-staffed and trying to hire more help.
In other news, we just received his preliminary bone marrow results from his latest biopsy from March 23, 2016:
With all this good news we should be on an emotional high-right? Unfortunately, we are not. There are still other complications in our lives right now, that we are not able to fully enjoy these blessings to the fullest. First, Todd has been suffering from persistent diarrhea. He can't seem to eat anything, without immediately having diarrhea (no fun). He isn't dehydrated, but it is starting to wear on him. We have discussed the issue with the doctor at the last visit, and they have called in lab orders for Todd to bring in a stool sample (which he isn't real motivated to do-who would?).
Second, I still have not been able to find a full-time job. It hasn't been for the lack of trying. I put in about 5 job applications per week, which is very time consuming, because everything has to be done online and some places require mandatory personality testing, etc. My friends have been diligent in helping me find postings, but I don't have anyone who can help me get my foot in the door anywhere! I've been substitute teaching about 2-3 days a week, and spending some time volunteering at Wright State University Libraries in their Digital Services Department, where I am working on a project. Never have I experienced such a depressing cycle: applying, following-up, and receiving some type of rejection notice. Not only is it wearing on me, but it is wearing on Todd, who also feels helpless that he can't work, and that I have to go through this. (He has always been the bread-winner and has faithfully provided for our family; now, he is so limited and cannot work because of the cancer). After I fill out applications, I feel so encouraged and confident that I can do the job! But, weeks later, disappoint sets in when I learn I didn't get the job. I just don't know what it takes...
Third, we are considering selling the house again. We have half-heartedly put the for sale by owner sign back out in the yard, but nothing else. It is not enough to get us the attention we need, so we need to consider getting back online for sale, or hiring a realtor to list it. The process of having the house ready to show all the time and the thought of moving is so stressful, that this really needs to be a last resort option once again.
Lastly, we both feel like a lot of circumstances are out of our hands. I am doing all I can, he is doing all he can, but its not enough to get us where we need to be. This has led to moments of despair for both of us, at least temporarily. Then, we both come around to putting things back into perspective! His health is better than it has been in a long time, I am healthy, the kids are healthy, we have a roof over our head, and food on the table! God is good!
Prayer requests and needs:
Please pray that I can find a full-time job soon. I have one prospective meeting next week, and one job interview at Target, but I fear that they will not be hiring full-time nor above minimum wage. I have about two more months in which I can substitute teach, then school will be out for the summer. Abby and Lewis have begun looking for summer jobs too, as college classes will let out in a few months.
Please pray we can get answers to Todd's persistent diarrhea and that it will subside.
Pray for encouragement! And as always, with me working and volunteering as much as possible, Todd is home alone. He sleeps pretty late each morning, but I'm sure he would welcome a lunch invitation or just having some company.
Praises and shout-outs: Thanks to Chris and Jessica White for raising our spirits by taking us out to eat and then hanging out with us! To Gary Johnson, for helping Todd get the snow throwing attachment off and installing the mower blade onto our Zero-turn lawn mower. Now we can mow our own grass instead of paying someone to do it (which will save us money). Todd has already started training Ellie on how to mow the grass! To Vicki Kennedy and Dana Johns who are forever looking for job postings and sending them to me! You both are so helpful! To my friend Darsie Wohler for getting me out of the house one day for lunch and some girl talk! And to Pastor Chuck Moore, who faithfully stays in touch with us so he can pray for our needs.
To give you an idea, here is a comparison of the differences in his counts from last year to now:
Year: 2015 2016
Whites: .2 3.99
Hemoglobin: 7.3 11.8
ANCS: 0 3.15
Platelets: 70,000 57,000
As you can see, he has had a remarkable increase in his White count, Hemoglobin, and ANCs. His platelets vary now between 55,000-75,000, which is about the same as they were a year ago. His platelets have not responded as well. In trial terminology this is considered as a hematological response without platelet recovery. That being said, his platelets are still high enough to prevent any serious bruising or the need for transfusions (usually when platelets fall below 10,000).
After not hearing back from the drug company whether Todd could only go once a month for his trial visits as promised, I finally sent a message to his bone marrow transplant doctor telling her that we were unhappy with how the administration of the trial has been going. We haven't received any financial reimbursements for months, none of our appointments have been made ahead of time like they should be, and when they have been scheduled, they have been for inconvenient times (8:30 a.m. when they know we have almost a 4 hour drive to get there). I "offered" to go straight to the Principal Investigator at Cleveland Clinic or the Drug Company itself, but the doctor finally got confirmation that Todd no longer needs to go to the Cleveland Clinic for his Day 15 appointments just to get blood work done. They have arranged for Todd to have his Day 15 blood work at our local Compunet Lab. This means he will only need to go to the Cleveland Clinic on his Day 1 appointments, only once per month! What a relief! No more driving up to Cleveland every two weeks! I'm so grateful! As to the appointments and reimbursements: they are short-staffed and trying to hire more help.
In other news, we just received his preliminary bone marrow results from his latest biopsy from March 23, 2016:
Results: "Persistent Myelodysplastic Syndrome. Hypercellular Marrow (90%) with Trilineage Hematopoiesis, Erythroid Hyperplasia, Multilineage Dysplasia and 2% Blasts. Increased Iron Stores and Increased Ring Sideroblasts. Mild Microcytic Anemia, Thrombocytopenia and Absolute Lymphopenia."This is a long way to say that he has 2% cancer blasts in the marrow, which is Low! And he is still mildly anemic and all three of his blood counts: white, red, and platelets are low. We haven't received the latest cytogenics back yet, but the prior biopsies have not shown any major changes. They still show he has complex chromosomal mutations, but no new additional mutations.
With all this good news we should be on an emotional high-right? Unfortunately, we are not. There are still other complications in our lives right now, that we are not able to fully enjoy these blessings to the fullest. First, Todd has been suffering from persistent diarrhea. He can't seem to eat anything, without immediately having diarrhea (no fun). He isn't dehydrated, but it is starting to wear on him. We have discussed the issue with the doctor at the last visit, and they have called in lab orders for Todd to bring in a stool sample (which he isn't real motivated to do-who would?).
Second, I still have not been able to find a full-time job. It hasn't been for the lack of trying. I put in about 5 job applications per week, which is very time consuming, because everything has to be done online and some places require mandatory personality testing, etc. My friends have been diligent in helping me find postings, but I don't have anyone who can help me get my foot in the door anywhere! I've been substitute teaching about 2-3 days a week, and spending some time volunteering at Wright State University Libraries in their Digital Services Department, where I am working on a project. Never have I experienced such a depressing cycle: applying, following-up, and receiving some type of rejection notice. Not only is it wearing on me, but it is wearing on Todd, who also feels helpless that he can't work, and that I have to go through this. (He has always been the bread-winner and has faithfully provided for our family; now, he is so limited and cannot work because of the cancer). After I fill out applications, I feel so encouraged and confident that I can do the job! But, weeks later, disappoint sets in when I learn I didn't get the job. I just don't know what it takes...
Third, we are considering selling the house again. We have half-heartedly put the for sale by owner sign back out in the yard, but nothing else. It is not enough to get us the attention we need, so we need to consider getting back online for sale, or hiring a realtor to list it. The process of having the house ready to show all the time and the thought of moving is so stressful, that this really needs to be a last resort option once again.
Lastly, we both feel like a lot of circumstances are out of our hands. I am doing all I can, he is doing all he can, but its not enough to get us where we need to be. This has led to moments of despair for both of us, at least temporarily. Then, we both come around to putting things back into perspective! His health is better than it has been in a long time, I am healthy, the kids are healthy, we have a roof over our head, and food on the table! God is good!
Prayer requests and needs:
Please pray that I can find a full-time job soon. I have one prospective meeting next week, and one job interview at Target, but I fear that they will not be hiring full-time nor above minimum wage. I have about two more months in which I can substitute teach, then school will be out for the summer. Abby and Lewis have begun looking for summer jobs too, as college classes will let out in a few months.
Please pray we can get answers to Todd's persistent diarrhea and that it will subside.
Pray for encouragement! And as always, with me working and volunteering as much as possible, Todd is home alone. He sleeps pretty late each morning, but I'm sure he would welcome a lunch invitation or just having some company.
Praises and shout-outs: Thanks to Chris and Jessica White for raising our spirits by taking us out to eat and then hanging out with us! To Gary Johnson, for helping Todd get the snow throwing attachment off and installing the mower blade onto our Zero-turn lawn mower. Now we can mow our own grass instead of paying someone to do it (which will save us money). Todd has already started training Ellie on how to mow the grass! To Vicki Kennedy and Dana Johns who are forever looking for job postings and sending them to me! You both are so helpful! To my friend Darsie Wohler for getting me out of the house one day for lunch and some girl talk! And to Pastor Chuck Moore, who faithfully stays in touch with us so he can pray for our needs.
Sunday, September 27, 2015
Todd among Patients with Objective Response to AG221
Todd has had two appointments this month, both with good results. His first appointment was on September 9, 2015, where he had blood work done and an appointment with his doctor and trial study nurse at the Cleveland Clinic. His counts were great for him: White count was 2.8; Hemoglobin 10.3; Platelets held steady at 74,000. Due to the amount of homework I had, Todd drove up and back by himself, so I could get it all done. He was supposed to "face-time" me with his phone, but forgot!
His second appointment was on September 23, 2015, and like the first, he just had blood work done and a visit with the doctor. I was able to go with him this appointment so I could talk to his doctor and nurse. (No more relying on him to face-time me!) His results were good: White count was 2.75; ANCs 2.42; Hemoglobin 9.6; Platelets held steady at 70,000.
While his numbers are steady and stable, they seem to have reached a plateau. I discussed these feelings with the doctor and research nurse, asking if his numbers can still go higher at this point or if this was the best they were going to get. The answer was not as clear as I had hoped. Basically, anything is possible. So, there is a chance that they can continue to increase.
I asked about a broad general comparison of how the other patients in the study at Cleveland Clinic are doing. Apparently there are 10-12 people on the study there now, but none are having as good of a response as Todd has had. Many are having a difficult time with the side effects. The age of patients range from age 39-70+. Todd's results, in my opinion, have been great! No transfusions and his increased immunity have been an answer to prayer. He still suffers from some nausea, fatigue, and diarrhea. The increased bilirubin is also there, but not as inhibiting as the other side effects.
I made sure the doctor had a good look at him since he seems to have picked up a virus that is going around. Two of our kids have seem to have picked it up too. He looked alright and she did not feel that putting him on antibiotics would be of any benefit. He is still taking his antiviral medication once per day. We were told to just to watch for symptoms of fever and to be careful not to take anything that could mask a fever.
I also asked how the study was doing overall and if there was any new data, but there has not really been anything new since some findings in June, 2015, which I will review here. Nothing new will be out until the American Society of Hematology (ASH) Convention in December 2015.
From what I have read, as of June, 2015, the patient on the drug the longest at that point was 15 months. As this drug mainly targets Acute Myeloid Leukemia (AML) patients, it was interesting for me to see the response rate in patients, like Todd, who have MDS. According to an Agios Press Release from June 12, 2015, "of the 14 patients with myelodysplastic syndrome (MDS), seven achieved an objective response, including two CRs, one CRp and four mCRs." (Agios, June 12, 2015, np). CR is complete remission. CRp is incomplete platelet recovery. mCR is marrow complete remission. So, I would say that Todd is likely in that 7 who have achieved an objective response.
I'm anxious to see what the results will be in December, when the next set of numbers are released. I listened to an audio interview with Chris Bowden, M.D., Chief Medical Officer with Agios Pharmaceuticals at the Caaccord Genuity 35th Annual Growth Conference, August 12-13, 2015, Boston MA. He said that AG221 is the first drug to be approved for AML in several decades (Bowden, August 2015, minute 3:45). He describes the urgency for relapsed patients to receive treatment, as their condition is in "dire straights" and I couldn't agree more. That's exactly how I would have described Todd's condition earlier this year.
Bowden continues to discuss AML later in the interview, stating that there is a real possibility of doctors sequencing every patient's genome at the time of diagnosis to see what kind of gene mutations they are dealing with. Then, the doctor can evaluate what drugs are out there that can be used to treat that specific mutation. He feels that doctors will be trying to determine the IDH status of their patients at diagnosis and in treatment. (Bowden, August 2015, minute 19:30-26:07).
You may be asking why all the information about AML when Todd has MDS. Well, the two are closely related blood cancers. The main difference is the amount of blast cells used to classify them. About 30% or roughly 1/3 of all MDS patients will progress to AML. The diagnosis of AML is given when the patient has blasts cells of 20% or higher. Thank God Todd's blast cells have never reached that level.
I just wanted to give this quick medical update and will discuss personal notes in a later post. Thanks.
References:
Agios. Press Release. June 12, 2015. Web. Retrieved from: http://investor.agios.com/phoenix.zhtml?c=251862&p=irol-newsArticle&ID=2058805
Chris Bowden. Audio Interview. Caaccord Genuity 35th Annual Growth Conference, August 12-13, 2015, Boston MA. Web. Minutes 0:00-6:10; Minute 19:30. Retrieved from: http://wsw.com/webcast/canaccord18/agio/index.aspx
Minute 19:30+
http://www.businesswire.com/news/home/20150612005174/en/Agios-Announces-Data-Ongoing-Phase-1-Dose#.Vgg9k5frTm4
http://www.reuters.com/article/2015/06/12/agios-leukemia-idUSL1N0YX2TI20150612
longest MDS patient on drug 16 months in June 2015
His second appointment was on September 23, 2015, and like the first, he just had blood work done and a visit with the doctor. I was able to go with him this appointment so I could talk to his doctor and nurse. (No more relying on him to face-time me!) His results were good: White count was 2.75; ANCs 2.42; Hemoglobin 9.6; Platelets held steady at 70,000.
While his numbers are steady and stable, they seem to have reached a plateau. I discussed these feelings with the doctor and research nurse, asking if his numbers can still go higher at this point or if this was the best they were going to get. The answer was not as clear as I had hoped. Basically, anything is possible. So, there is a chance that they can continue to increase.
I asked about a broad general comparison of how the other patients in the study at Cleveland Clinic are doing. Apparently there are 10-12 people on the study there now, but none are having as good of a response as Todd has had. Many are having a difficult time with the side effects. The age of patients range from age 39-70+. Todd's results, in my opinion, have been great! No transfusions and his increased immunity have been an answer to prayer. He still suffers from some nausea, fatigue, and diarrhea. The increased bilirubin is also there, but not as inhibiting as the other side effects.
I made sure the doctor had a good look at him since he seems to have picked up a virus that is going around. Two of our kids have seem to have picked it up too. He looked alright and she did not feel that putting him on antibiotics would be of any benefit. He is still taking his antiviral medication once per day. We were told to just to watch for symptoms of fever and to be careful not to take anything that could mask a fever.
I also asked how the study was doing overall and if there was any new data, but there has not really been anything new since some findings in June, 2015, which I will review here. Nothing new will be out until the American Society of Hematology (ASH) Convention in December 2015.
From what I have read, as of June, 2015, the patient on the drug the longest at that point was 15 months. As this drug mainly targets Acute Myeloid Leukemia (AML) patients, it was interesting for me to see the response rate in patients, like Todd, who have MDS. According to an Agios Press Release from June 12, 2015, "of the 14 patients with myelodysplastic syndrome (MDS), seven achieved an objective response, including two CRs, one CRp and four mCRs." (Agios, June 12, 2015, np). CR is complete remission. CRp is incomplete platelet recovery. mCR is marrow complete remission. So, I would say that Todd is likely in that 7 who have achieved an objective response.
I'm anxious to see what the results will be in December, when the next set of numbers are released. I listened to an audio interview with Chris Bowden, M.D., Chief Medical Officer with Agios Pharmaceuticals at the Caaccord Genuity 35th Annual Growth Conference, August 12-13, 2015, Boston MA. He said that AG221 is the first drug to be approved for AML in several decades (Bowden, August 2015, minute 3:45). He describes the urgency for relapsed patients to receive treatment, as their condition is in "dire straights" and I couldn't agree more. That's exactly how I would have described Todd's condition earlier this year.
Bowden continues to discuss AML later in the interview, stating that there is a real possibility of doctors sequencing every patient's genome at the time of diagnosis to see what kind of gene mutations they are dealing with. Then, the doctor can evaluate what drugs are out there that can be used to treat that specific mutation. He feels that doctors will be trying to determine the IDH status of their patients at diagnosis and in treatment. (Bowden, August 2015, minute 19:30-26:07).
You may be asking why all the information about AML when Todd has MDS. Well, the two are closely related blood cancers. The main difference is the amount of blast cells used to classify them. About 30% or roughly 1/3 of all MDS patients will progress to AML. The diagnosis of AML is given when the patient has blasts cells of 20% or higher. Thank God Todd's blast cells have never reached that level.
I just wanted to give this quick medical update and will discuss personal notes in a later post. Thanks.
References:
Agios. Press Release. June 12, 2015. Web. Retrieved from: http://investor.agios.com/phoenix.zhtml?c=251862&p=irol-newsArticle&ID=2058805
Minute 19:30+
http://www.businesswire.com/news/home/20150612005174/en/Agios-Announces-Data-Ongoing-Phase-1-Dose#.Vgg9k5frTm4
http://www.reuters.com/article/2015/06/12/agios-leukemia-idUSL1N0YX2TI20150612
longest MDS patient on drug 16 months in June 2015
Monday, August 3, 2015
No news is Good News
Since my last post, Todd has had two visits at the Cleveland Clinic, both with great results: disease and counts are both stable! The visit for Day 1, Cycle 4, on July 16, 2015, was one of the 10-hour trial days! It was a long one! We went up the night before and stayed at the Hope Lodge again. His first blood draw was around 7:15 am and his last draw was about 7:15 p.m. making it really a 12 hour day for us, although the testing runs from 9:00 a.m. to 7:00 p.m. Since Todd's brother was still in town (Dayton, OH) visiting, we drove straight back home 3 1/2 hours so we could be home to have breakfast with him and his wife on Friday morning before they had to catch their flight home to Florida.
This was first time anyone had to access his new Power Port (chest port/catheter/central line) in his chest, and the first nurse did not have any success after 2 attempts. They had to bring in another nurse to try to put the special needle in, with Todd's research nurse, Ashley, and a third nurse standing by to assist! The problem? They weren't using a large enough needle to access the port! We learned through the third attempt and with the advice of his trial nurse, that they need to use a 1" 90 degree special needle to access it successfully. Unfortunately, the first nurse, in her failed two attempts, only succeeded to inject several syringes full of saline into the chest cavity around the port! No harm was done, since it was just saline under the skin, but it did plump up the area around the port a bit! Oh well, they were able to put the needle in and install a connector with a cap so they could use that the entire day for his multiple blood draws.
The results from July 16 visit were: Hemoglobin 10.3; WhiteBC 2.06; ANCS 1.85 (Low end of the normal range) and Platelets up to 75,000. Everything but the ANCS are still below the normal range, but for Todd, these numbers mean stability, no transfusions, and no neutropenia! His bilirubin was still high at 3.0 but within acceptable trial limits. EKG was good! They sent him home with a seat-belt protector to provide a cushion between the bandaged injection site and the seat-belt. Apparently, some patients with low platelets suffer from leaking through the port injection site after leaving.
For the most recent visit, Day 15, Cycle 4, he had to drive up to Cleveland Clinic just to do one round of lab work! Our research nurse tried very hard to get the authorities in charge of the trial, to allow Todd to have the lab work done here in Dayton, instead of Cleveland, but the lab work has to be done at the trial facility. I had multiple assignments due for school, so Todd ended up driving by himself that day. He left about 7 am, got there about 11 am and immediately turned around and after eating lunch was home by about 3:00 p.m. I think this is the first time he has been to Cleveland without me in years, but I appreciated that I was able to stay home and work on my schoolwork (which I did for about 15 hours that day!). With my work and training schedule, there may be times we may need someone to go up with Todd. I know many have already expressed a desire to go with him, and be sure, we may take you up on it in September!
The preliminary lab work for that visit was about the same. Hemoglobin at 9.9; WBC at 1.99 and Platelets at 62,000.
So, you can see that no news from us since the last posting, just means that everything is stable!
His next visit will be on August 13, 2015, for Day 1,Cycle 5. At this appointment he will have to be there early, to have his blood drawn before the in-clinic dosing of the AG-221 at 9:00 a.m. They also have an echocardiogram, EKG, and another bone marrow biopsy scheduled throughout the day.
In regards to news of the trial going on At Cleveland Clinic for AG-221, they are still trying to get potential candidates to enroll. I believe there are only two patients at present, one of which is Todd. The latest press release from Agios is here: Ag-221 June 2015 Press Release providing a follow-up for the European Hematology Association held in June.
I'm encouraged that I have heard from several other people who have stumbled upon this blog, or who have begun to follow it, because they have family members that are struggling with MDS too. I was blessed enough to hear from one reader, who has a family member on the same AG-221 trial. Its so nice to know that we are not alone and that anything I write may be helpful to someone else!
Personal Notes:
No luck selling our house yet. We have continued to drop the price, and friends and family are graciously posting our listing and telling their friends. The once-hot market seems to have cooled quickly. Two other houses in our neighborhood have also gone on the market for sale, so we have picked up some traffic and calls from that. Unfortunately, the other houses are not really comparable to ours in terms of space or amenities, so we may not be what they are looking for.
We were about to close the PNC account that was set up for Todd (The Todd Cade Care Fund) because there were monthly fees and no new deposits, but then we learned that there had been some recent deposits and we decided to keep it open. Thank You to whomever made the donations. I have been using it for grocery money, etc. We are truly blessed by your thoughtfulness.
I've started my part-time job, but I have been spending most of my time doing online training courses, in-person training classes, and some on-the-job training. I had a pretty full schedule last week with training, finishing up a class presentation from my graduate school summer course, and turning in 4 assignments for my workshop class. I am completely finished with the one summer class, and will finish my workshop class this weekend. Then I will have a break until August 31, when I begin my final Fall class and Practicum at The University of Dayton Archives.
The kids are getting ready for school to start soon! Hannah Lewis has an 18th birthday coming up in a few weeks, and then will leave for college! Abby has successfully transferred to Wright State University and will start classes the same time I do! Ellie will begin her Freshman year of high school this month too! So much to do...
I appreciate your prayers, as I am very discouraged spiritually. I'm trying to focus on anything good that happens, and not see the bad things as unfair or unjust. My latest mantra has been that I'm healthy, I have all my needs provided for, and that my children are healthy, and so is Todd! I can't deny that our lives are drastically different, especially in light of our financial situation and our stress levels. I feel that some have been so generous while others have been prejudicial; it doesn't bother me, but I wish I could do more for the kids and make things easier for them. Sometimes, I feel that people avoid our family, because they know of Todd's illness and our situation, they either don't have the words to say, or don't want to invest emotionally or otherwise in our family or our crisis. But, as soon as I say this, I can admit that God has raised up others in their place who have brought a meal, made the effort to visit with us, and continue to offer their love and support in so many ways. Our families have been supportive (I couldn't ask for more!) and I have been blessed with great friends!
I have been trying to use prayer books or orchestrated prayers to guide me in prayer. So, please feel free to send me your favorite prayers to meditate on! Thanks. God bless.
This was first time anyone had to access his new Power Port (chest port/catheter/central line) in his chest, and the first nurse did not have any success after 2 attempts. They had to bring in another nurse to try to put the special needle in, with Todd's research nurse, Ashley, and a third nurse standing by to assist! The problem? They weren't using a large enough needle to access the port! We learned through the third attempt and with the advice of his trial nurse, that they need to use a 1" 90 degree special needle to access it successfully. Unfortunately, the first nurse, in her failed two attempts, only succeeded to inject several syringes full of saline into the chest cavity around the port! No harm was done, since it was just saline under the skin, but it did plump up the area around the port a bit! Oh well, they were able to put the needle in and install a connector with a cap so they could use that the entire day for his multiple blood draws.
The results from July 16 visit were: Hemoglobin 10.3; WhiteBC 2.06; ANCS 1.85 (Low end of the normal range) and Platelets up to 75,000. Everything but the ANCS are still below the normal range, but for Todd, these numbers mean stability, no transfusions, and no neutropenia! His bilirubin was still high at 3.0 but within acceptable trial limits. EKG was good! They sent him home with a seat-belt protector to provide a cushion between the bandaged injection site and the seat-belt. Apparently, some patients with low platelets suffer from leaking through the port injection site after leaving.
For the most recent visit, Day 15, Cycle 4, he had to drive up to Cleveland Clinic just to do one round of lab work! Our research nurse tried very hard to get the authorities in charge of the trial, to allow Todd to have the lab work done here in Dayton, instead of Cleveland, but the lab work has to be done at the trial facility. I had multiple assignments due for school, so Todd ended up driving by himself that day. He left about 7 am, got there about 11 am and immediately turned around and after eating lunch was home by about 3:00 p.m. I think this is the first time he has been to Cleveland without me in years, but I appreciated that I was able to stay home and work on my schoolwork (which I did for about 15 hours that day!). With my work and training schedule, there may be times we may need someone to go up with Todd. I know many have already expressed a desire to go with him, and be sure, we may take you up on it in September!
The preliminary lab work for that visit was about the same. Hemoglobin at 9.9; WBC at 1.99 and Platelets at 62,000.
So, you can see that no news from us since the last posting, just means that everything is stable!
His next visit will be on August 13, 2015, for Day 1,Cycle 5. At this appointment he will have to be there early, to have his blood drawn before the in-clinic dosing of the AG-221 at 9:00 a.m. They also have an echocardiogram, EKG, and another bone marrow biopsy scheduled throughout the day.
In regards to news of the trial going on At Cleveland Clinic for AG-221, they are still trying to get potential candidates to enroll. I believe there are only two patients at present, one of which is Todd. The latest press release from Agios is here: Ag-221 June 2015 Press Release providing a follow-up for the European Hematology Association held in June.
I'm encouraged that I have heard from several other people who have stumbled upon this blog, or who have begun to follow it, because they have family members that are struggling with MDS too. I was blessed enough to hear from one reader, who has a family member on the same AG-221 trial. Its so nice to know that we are not alone and that anything I write may be helpful to someone else!
Personal Notes:
No luck selling our house yet. We have continued to drop the price, and friends and family are graciously posting our listing and telling their friends. The once-hot market seems to have cooled quickly. Two other houses in our neighborhood have also gone on the market for sale, so we have picked up some traffic and calls from that. Unfortunately, the other houses are not really comparable to ours in terms of space or amenities, so we may not be what they are looking for.
We were about to close the PNC account that was set up for Todd (The Todd Cade Care Fund) because there were monthly fees and no new deposits, but then we learned that there had been some recent deposits and we decided to keep it open. Thank You to whomever made the donations. I have been using it for grocery money, etc. We are truly blessed by your thoughtfulness.
I've started my part-time job, but I have been spending most of my time doing online training courses, in-person training classes, and some on-the-job training. I had a pretty full schedule last week with training, finishing up a class presentation from my graduate school summer course, and turning in 4 assignments for my workshop class. I am completely finished with the one summer class, and will finish my workshop class this weekend. Then I will have a break until August 31, when I begin my final Fall class and Practicum at The University of Dayton Archives.
The kids are getting ready for school to start soon! Hannah Lewis has an 18th birthday coming up in a few weeks, and then will leave for college! Abby has successfully transferred to Wright State University and will start classes the same time I do! Ellie will begin her Freshman year of high school this month too! So much to do...
I appreciate your prayers, as I am very discouraged spiritually. I'm trying to focus on anything good that happens, and not see the bad things as unfair or unjust. My latest mantra has been that I'm healthy, I have all my needs provided for, and that my children are healthy, and so is Todd! I can't deny that our lives are drastically different, especially in light of our financial situation and our stress levels. I feel that some have been so generous while others have been prejudicial; it doesn't bother me, but I wish I could do more for the kids and make things easier for them. Sometimes, I feel that people avoid our family, because they know of Todd's illness and our situation, they either don't have the words to say, or don't want to invest emotionally or otherwise in our family or our crisis. But, as soon as I say this, I can admit that God has raised up others in their place who have brought a meal, made the effort to visit with us, and continue to offer their love and support in so many ways. Our families have been supportive (I couldn't ask for more!) and I have been blessed with great friends!
I have been trying to use prayer books or orchestrated prayers to guide me in prayer. So, please feel free to send me your favorite prayers to meditate on! Thanks. God bless.
Monday, June 22, 2015
Cancerous Blast Cells down to 2%
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| Todd celebrates Father's Day with our children: Hannah Lewis, Ellie, and Abby |
It is hard to believe that Todd started his third cycle of AG-221 trial drug last Thursday, June 18, 2015, at his last visit to the Cleveland Clinic. We were prepared for another 10 hour day of blood draws for Day 1, Cycle 3, but the required testing protocol for this day 1 was different. We went up and stayed at the Hope Lodge in Cleveland the Wednesday night before. His Thursday testing day started early with a 7:40 a.m. doctor's appointment and exam. Overall the doctor was pleased with the response that Todd has had on the drug so far.
Everything looks like a "GO" for having his Hickman Central Catheter removed on the next visit, Day 15, Cycle 3 on July 2, 2015. Todd questioned the need for the port that they are going to put in instead. The doctor agreed that it wasn't 100% necessary, but that it would be easier than being poked or having a temporary arm port put in each time he comes. It would be nice to have in case it is needed in the future, but that isn't the main motivation for putting it in. If Todd's condition would worsen, they could always install a port or another catheter at that time, but right now his numbers are the best they have been since transplant, so it is just a good time to do it. The port would require a lot less care. It is under the skin, and it would only need to be flushed with Heparin every 6 weeks or so. This would have to be done by a nurse, so it would be done during his regular monthly visits to the Cleveland Clinic. If his platelets are under 50,000 there is a good chance that they will want to transfuse him with platelets before or during the procedure.
While his research nurse was drawing blood, she noticed natural clotting at the cap for the first time. (This is a good thing that his blood could clot or stop on its own). After the usual tests, he was sent to have an Echo cardiogram done, which is something he hasn't had done since his pre-trial tests. After that he had his routine EKG and then was sent to be prepped for his bone marrow biopsy (number 15 I think). By then, we had the blood test results back; they were stunningly wonderful!
His hemoglobin was at 10.2! His whites were 2.79; ANCs at 2.29 and platelets at 46,000. His bilirubin is still higher than usual, at 3.4, which is up slightly from the last blood draw. They also ran a metabolic panel and all of his cholesterol numbers looked good.
After his bone marrow biopsy, we were free to head home. We had a showing to a realtor (on behalf of his clients) of our house on Friday, so we needed to rest-up. I was tired because I had been in Columbus, Ohio, with Hannah Lewis for college orientation at the Columbus College of Art of Design on Monday and Tuesday before leaving for Cleveland on Wednesday afternoon.
Todd was feeling good for Father's Day, on Sunday, June 21. My parents came over and we made dinner for everyone in honor of Father's Day. All the kids were home, even though Hannah Lewis and Abby had to go into work later that day.
Unfortunately, Todd woke up sick this morning, Monday, June 22, about 5:45 a.m. throwing up. He continued to be sick throughout the morning. I knew we had all eaten the same food, so I made sure no one else had come down sick. It was just Todd. Not sure why, but he had a bad spell of nausea and it is possible that with the combination of eating a late snack later, his food just didn't sit well. I called the Research Nurse to check on the protocol for taking or not taking his trial drug this morning and to give them a head's up about him getting sick. He had no fever. So, after a battery of questions, they instructed that he had up to 6 hours past the 9:00 a.m. dose time to take the medication, or if not to skip it for the day and take it tomorrow morning. After his stomach calmed down, he was gradually able to take his medicine and then keep some Powerade and crackers down, then we added more food in during the day.
While talking with the Research team, who called to check on him about 4:30 p.m., they were able to give us the results from his bone marrow biopsy. It showed blast counts at 2%. This has been about the same as the last two marrows in which the results were between 0-5%. So, the disease is still present and his marrow is still producing some blast cells, but less of them and more healthy cells, giving him increased blood counts. They still would classify his disease as "Stable" with 2% blasts and that he is having a hematological response with the use of the trial drug. This is such a turnaround from just three months ago.
Personal family updates:
Summer is here and we long for a vacation of any kind, but no plans are in sight. Once Todd gets his Hickman Catheter out, he will at least be able to get into a pool! Abby is still working both jobs and is in the process of transferring from The University of Cincinnati to nearby Wright State University. The program is different from U.C., so her new major will be Psychology with a concentration in Behavioral Neuroscience. She is still entertaining the idea of going to Medical School.
Hannah Lewis will be leaving home for The Columbus College of Art and Design on August 20, 2015. We have a lot to do: dorm room shopping, financial aid paperwork, loan paperwork, etc., to get done before then.
Ellie returned safely from her 8th grade trip to Washington D.C. She is excited about being a Freshman in high school now (it is hard for the rest of us to believe!). She has started volleyball practices and conditioning. Tryouts will be in August. In the meantime, she is also doing some conditioning with the cross country team.
I'm beginning the third week of my summer class. My Archival description workshop starts mid-July and lasts for two weeks, but I already have a whole list of pre-class reading and projects to get started on! I'm back to applying for jobs, but this time just part-time. I've applied at Kroger and CVS as a pharmacy technician. I can't work full-time because I finally got my practicum set-up for the fall semester. I have to meet with my practicum supervisor this week to finalize my schedule and paperwork, but if all goes well, I will be training at the University of Dayton, in the special collections and archives department of the Library. So, I praise God for this. I was also able to get into my last needed class for the fall semester. With all this, I am set to graduate at the end of the fall semester. In the meantime, I have renewed my substitute teaching license for the upcoming school year.
Our house has been on the market for just over a month now. We have reduced the price, but we have not had the interest we were hoping for. So, we've decided to have a plan B, in case it takes longer to sell it. So, that's why I'm looking for part-time work.
How can you pray or help? Pray for a buyer for our house. It will take someone special to buy it. In the meantime, pray that we can continue to take care of our expenses. If you know of any part-time positions that I can work at in the evenings or weekends, please let me know. I know God will provide. My uncle past away this past week, so please remember my family, especially my beloved Aunt Sheila as we bury him this week.
We appreciate your love and support.
Sunday, June 7, 2015
Hickman scheduled to be Removed on July 2, 2015
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| Todd with Hannah Lewis on graduation day |
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| Todd with long-time friend Barry Wideman |
It is hard to believe that it has been six weeks since Todd has needed a blood transfusion! The AG-221 has been an answer to prayer!
We went up to Cleveland Clinic on Thursday, June 4, 2015, for Cycle 2, day 15 testing. It was an good day. Todd had his blood work drawn, an EKG done, and we met with his Transplant Doctor to discuss his progress. Unfortunately, they were not able to get his Hickman Central Catheter scheduled for removal on this visit, as previously hoped, but they did it scheduled for July 2, 2015, which will be Cycle 3, day 15, with limited testing. They will put in a port under the skin on his left side of his chest instead.
The blood work was great! Todd's hemoglobin climbed to 9.6; his white count to 2.59; his ANCs to 2.18; and his platelets (which have been lagging behind) to 43,000. While only the ANCs are considered within the"normal range," the counts are still low overall, but they are so much better from where he was before he started the drug!
The last bone marrow biopsy was a little confusing, with the blasts showing at 5%. Just 15 days prior, they were around 0-1%. The doctor reassured us that there was nothing to be worried about. Todd's counts are not necessarily increasing, but rather, this is typical of taking a sample. It can be off by a few percent each time. She still considers the disease as "stable" and Todd having a "hemeotological response" in the blood with the drug. Todd's EKG looked normal, and the only side-effects have been nausea, some fatigue, and high bilirubin which has caused some yellowing of his eyes. It is hard to determine whether the fatigue is actually from the drug or from his disease. Although his hemoglobin is high enough for him not to need a transfusion, it is still below normal and can cause fatigue.
He did lose more weight (a few pounds) from the last visit, which concerns me. The doctor was mildly concerned and discussed his nausea and eating habits. They are not worried, but reassured him that he can eat whatever sounds good to him. Since his transplant he has lost over 30 pounds and a lot of muscle mass.
We were blessed enough to be able to stay at the Hope Lodge there in Cleveland, which helps cut our expenses tremendously. The staff and facilities are awesome, but we have had a few issues with some of the other longer staying occupants who are not as happy with anyone new disrupting their "authority" or routine. Which is really a shame.
Personal notes:
We had a successful graduation party, although the weather was cold, windy, and a bit wet. It is hard to believe we have two out of high school and one going into high school!
We've had our house on the market now for about two weeks. We have lowered the price once to create additional interest and show that we are motivated to sell. We have had a few showings, but I find myself anxious with the waiting. Waiting for calls, waiting for showings, waiting to sell. We can't look for a new place without selling our house. All we can do is pray and wait. God has answered prayers in so many other ways, I know this one will be answered in his way and timing too.
Ellie leaves for her 8th grade trip to Washington DC in the morning. We are blessed that she received a partial scholarship by the travel company, World Strides to be able to go. We also received word from the Cleveland Clinic Foundation that they are going to pick up a few more months of Todd's COBRA health insurance premiums. I think this was facilitated by a social worker who came into Todd's room on a prior visit, asking how we were doing, and what needs we had.
We are so grateful for all our blessing and appreciate your prayers and support as always.
Tuesday, May 26, 2015
Hematological Response: End of Cycle 1 of AG-221
Todd reached a major milestone this past week, where he completed 28 days or the First Cycle of the trial drug study for AG-221. The Research Team kicked-off Day 1, Cycle 2, the following day, Thursday, May 21, 2015 with the standard 10 hours of blood draws, EKG, and another bone marrow biopsy at the Cleveland Clinic's Taussig Cancer Center.
The results at the end of just one cycle on the trial drug have been amazing! His blood counts have come up enough to go 4 weeks without needing a blood transfusion and his immune system has come up to allow him to go off antibiotics, get off the neutropenic diet, and live a little less restrictively for fear of getting an infection that could be deadly. It is also allowed the team to schedule to have his Hickman Central Catheter removed on the next visit. They have been wanting to take it out for fear of it causing an infection, but his immune system has been too low. Now, however, they feel it is strong enough to handle having the Hickman removed and having a port put in on the other side of his chest. His platelets are still under the recommended 50,000 for having this procedure done, but they will give him a unit of platelets during the procedure to help counteract any possible bleeding complications. If you have never seen someone with a port, it is a button-sized device that goes into a central vein, under the skin. So, when they need to draw blood, or give him an injection, the needle will go through the skin. Here is a brief overview of catheters and ports. He will have a catheter removed and an port put in: Port information.
Just to give you a comparison of how his counts have improved here is the 4 week difference:
4/20 4/30 5/7 5/14 5/21/15
Hemoglobin: 7.6 8.5 8.7 8.6 9.0 (low still: normal range 13.0 min.)
White: .47 .83 1.47 2.03 2.92 (low still; normal range 3.7 min.)
ANCs/Neutrophils: 00 .53 1.07 1.66 2.39 (now falls in lower end of normal)
Platelets: (1000s) 34 41 38 36 35 (Low still normal 150,000 min,)
Bilirubin(total): n/a 3.8 3.9 3.0 2.6 (want to drop; normal 0.0-1.5)
This is amazing! In just one cycle, he has seen this much improvement! You can see how he is no longer Neutropenic (when ANCs/neutrophils are .50 or lower) or no longer needs Transfusions (thresholds for Todd was 8.0 or lower). The elevated bilirubin is caused by the drug, however, you can see the numbers are dropping as his body adjusts better to the medication. The Indirect bilirubin numbers are fine and the research team is not worried about the elevated total bilirubin, as it would take his number to be 5x the normal or at 7.5 before they would adjust the dosage or make a change in his trial protocol. The only side effect of the higher bilirubin has been some jaundice, especially in his eyes.
The best news is, that the first bone marrow biopsy from Day 15, cycle 1, showed a normal range of blast cells in the bone marrow itself. There was still signs of diseased cell (ringed blasts), but the drug is helping to block the mutation to allow his blood cells to mature, leaving less blast cells in the marrow. There is also still chromosomal abnormalities found in the cytogenics results, which still show he is having the 5q deletion.
He had a second bone marrow biopsy done on Day 1, Cycle 2, but we have not received any results back from those yet. I asked the doctor if he would be considered to show a "response" or if they could say he was in remission, but she made it clear that Todd still has a way to go to ever say he would be in remission. Under the drug protocol, there are established guidelines for what constitutes a "partial response," a "complete response," or "remission." She stated that Todd would always have the diagnosis of MDS, actually relapsed MDS, that it would never go away. The only "curative" treatment was the transplant, and that failed. So, he cannot be "cured" of the disease at this time, but who is to say that there won't be a new curative treatment in the future. Research and technology are moving so fast in this field, that anything can change in a year. For example, this drug and the trials were not available a year ago!
I guess it would take not seeing any blast cells, any chromosomal deletions, and for his counts to be at a certain level before they can use the word remission. While he is not there yet, it is early in the treatment, and I feel confident that he can at least reach the level of a partial response soon.
I'm not sure if his blood counts will ever be "normal" again, but I think they can be close to it, or maybe on the low side of normal someday. In the meantime, he will still suffer from fatigue, some weakness, with a limited lifestyle or activity level, but he has already been forced to adjust to this.
I honestly feel so relieved that I don't doubt that he is getting better! While most of his counts are still below normal, we have already achieved the two main goals Dr. Stein, from Memorial Sloan Kettering Cancer Center in New York City, had in mind for Todd: to lessen his transfusions (which were 6-12 days apart) or to NOT BE transfusion dependent, and to NOT BE neutropenic. The idea that they now hope to remove his Hickman catheter and put in a port is wonderful! That means I won't have to flush his catheter lumen's every night, change his bandage and line caps once a week! He will only need to have the port flushed monthly. I'm not sure if that is something I will have to do, or whether a nurse will do it at his appointments. He will also be able to shower without covering it, and hopefully swim this summer!
Since he has he not been transfusion dependent, we haven't had to run to the local oncologist's office once or twice a week to have a CBC drawn to check his blood counts. That's a lot less running!
The first cycle of the study was a bit demanding on our schedule, having to go to Cleveland Clinic every week, and sometimes stay for 3 days, but that is behind us now. With the start of the second cycle, we only have to be there on Day 1, which we just did on May 21, and on Day 15 for a short visit! The same goes for Cycle 3. Day 1 will be a long 10-12 hour day (which will be mean a 3 day stay) and then he only has a short visit again on Day 15. After Cycle 3, he only has to go on the first day of each cycle from there on out! These days will be the long 10-12 days again, but we might be able to resume a more "normal" routine when all of these appointments are no longer necessary. All this is assuming that the drug continues to help and Todd responds positively to it, but I feel confident it will!
Todd began seeing a physical therapist finally for his shoulder stiffness and pain. It has helped some, but he still limited in using it. Our chiropractor had seen Todd before the transplant and then after, was in shock seeing how much muscle mass Todd has lost all over, but especially in his arm and shoulder. He felt that without the lack of muscle to help support the shoulder, it was making it harder for Todd to use it. Please continue to pray he will find some relief from this pain. It does inhibit his activity quite a bit and he can only take prescription pain medications, instead of any ibuprofen, and he doesn't like to take them and they don't seem to help as much as he would like. It wouldn't hurt if he could put on some weight or at least stop loosing it.
So, his next visit at the Cleveland Clinic will be June 4, 2015.
Family News
Wow, a lot has happened here too! Hannah Lewis graduates this Saturday! We've had multiple year-end award assemblies, choir concerts, etc. to attend. I have been cleaning like mad, with the help of my many good friends and family (Pam, Vicki, Darsie, Dana, Lynda, Mom)! Two of Todd's friends from work came over and painted one of the garages for him (thanks Chris and Pat).
We were able to put our house on the market for sale this past week. It is all bittersweet. We know it has to go, but we will be sad to leave it as it has been a labor of love building it, finishing it, and living in it these past 12 years. Please pray for a buyer, for financing so we can purchase a smaller home, and for the entire selling/buying/moving process.
Two praises regarding finishing my Master Degree: I was able to find a practicum at the University of Dayton in the Library/Archives department starting this fall. I have to submit a lot of paperwork to Kent State in the new few weeks to get it ready, but hopefully everything will work out so I can begin in the fall. I start my summer class and workshop next month! So, I am hoping I will be able to juggle everything once that starts. Second, I was able to get into the class I needed for the fall semester. I was originally on a wait list, but Kent State contacted me last week, offering me an opening in the class! I needed to take this class to graduate this fall, so now I can apply to graduate in December.
It's been an emotional roller coaster this past year. I crave a "normal" life whatever that is! Change has been the only consistent thing in our lives. It would be nice to be able to settle down into a mundane routine and stay in one place for awhile. With our family having to be split-up last fall, with Todd and I in Cleveland, Abby in Cincinnati, Hannah Lewis and Ellie here with my mom, and now having to move from our house into somewhere new, it is a bit traumatic for all of us. I know it does no good to worry about the timing, and wondering who will buy our house and when, or where we will move and when, but I still feel there is a sense of dread or a cloud that hangs over me. It is hard to convenience myself that it is all somehow punishment for some reason. If it is not the cancer and Todd's health, or the finances, then it is the uncertainty of "home" that seems to hang over us. For me, it is emotionally fatiguing, this roller coaster ride we find ourselves on. I just want the ride to stop, so I can get off, sit down, and rest a while. I'm still suffering from vertigo (literally), and I wonder why? Life and this world keeps spinning, and I am trying to keep upright, without falling, despite all the obstacles.
I gave the entire family this little pep talk last year about how God was going to use Dad's cancer, us going to Cleveland, Abby going to college Cincinnati, and Ellie and Hannah Lewis staying here with grandma, to GROW AND STRETCH US in ways we couldn't imagine! I had forgotten about this until someone reminded me of it recently and gave me my own pep talk in return! I know that God continues to mold us, refine us, strengthen us, give us insight, compassion, empathy, make us lean, teach us that living with less is more, help us focus on what is really important, and that home, wherever it will be, will be us together as family. But growing and stretching usually doesn't come without a bit of pain!
Thanks for your love and support. We appreciate your prayers and generosity, which continues to amaze and bless us!
Reference:
* According to the National CML Society, http://www.nationalcmlsociety.org/living-cml/response
Hematological Response is a normalization of the blood counts, particularly white blood cell counts. This is the first noticeable indicator that treatment is beginning to work, though not necessarily in the bone marrow. The response can be partial HR (reduction in white cells,but not down to normal range) or complete CHR (white blood count at or below approximately 12,000 white cells/microliter).
The results at the end of just one cycle on the trial drug have been amazing! His blood counts have come up enough to go 4 weeks without needing a blood transfusion and his immune system has come up to allow him to go off antibiotics, get off the neutropenic diet, and live a little less restrictively for fear of getting an infection that could be deadly. It is also allowed the team to schedule to have his Hickman Central Catheter removed on the next visit. They have been wanting to take it out for fear of it causing an infection, but his immune system has been too low. Now, however, they feel it is strong enough to handle having the Hickman removed and having a port put in on the other side of his chest. His platelets are still under the recommended 50,000 for having this procedure done, but they will give him a unit of platelets during the procedure to help counteract any possible bleeding complications. If you have never seen someone with a port, it is a button-sized device that goes into a central vein, under the skin. So, when they need to draw blood, or give him an injection, the needle will go through the skin. Here is a brief overview of catheters and ports. He will have a catheter removed and an port put in: Port information.
Just to give you a comparison of how his counts have improved here is the 4 week difference:
4/20 4/30 5/7 5/14 5/21/15
Hemoglobin: 7.6 8.5 8.7 8.6 9.0 (low still: normal range 13.0 min.)
White: .47 .83 1.47 2.03 2.92 (low still; normal range 3.7 min.)
ANCs/Neutrophils: 00 .53 1.07 1.66 2.39 (now falls in lower end of normal)
Platelets: (1000s) 34 41 38 36 35 (Low still normal 150,000 min,)
Bilirubin(total): n/a 3.8 3.9 3.0 2.6 (want to drop; normal 0.0-1.5)
This is amazing! In just one cycle, he has seen this much improvement! You can see how he is no longer Neutropenic (when ANCs/neutrophils are .50 or lower) or no longer needs Transfusions (thresholds for Todd was 8.0 or lower). The elevated bilirubin is caused by the drug, however, you can see the numbers are dropping as his body adjusts better to the medication. The Indirect bilirubin numbers are fine and the research team is not worried about the elevated total bilirubin, as it would take his number to be 5x the normal or at 7.5 before they would adjust the dosage or make a change in his trial protocol. The only side effect of the higher bilirubin has been some jaundice, especially in his eyes.
The best news is, that the first bone marrow biopsy from Day 15, cycle 1, showed a normal range of blast cells in the bone marrow itself. There was still signs of diseased cell (ringed blasts), but the drug is helping to block the mutation to allow his blood cells to mature, leaving less blast cells in the marrow. There is also still chromosomal abnormalities found in the cytogenics results, which still show he is having the 5q deletion.
He had a second bone marrow biopsy done on Day 1, Cycle 2, but we have not received any results back from those yet. I asked the doctor if he would be considered to show a "response" or if they could say he was in remission, but she made it clear that Todd still has a way to go to ever say he would be in remission. Under the drug protocol, there are established guidelines for what constitutes a "partial response," a "complete response," or "remission." She stated that Todd would always have the diagnosis of MDS, actually relapsed MDS, that it would never go away. The only "curative" treatment was the transplant, and that failed. So, he cannot be "cured" of the disease at this time, but who is to say that there won't be a new curative treatment in the future. Research and technology are moving so fast in this field, that anything can change in a year. For example, this drug and the trials were not available a year ago!
I guess it would take not seeing any blast cells, any chromosomal deletions, and for his counts to be at a certain level before they can use the word remission. While he is not there yet, it is early in the treatment, and I feel confident that he can at least reach the level of a partial response soon.
The doctor will not categorize the results as anything but they can see that the drug has produced a "hematological response.*"
I honestly feel so relieved that I don't doubt that he is getting better! While most of his counts are still below normal, we have already achieved the two main goals Dr. Stein, from Memorial Sloan Kettering Cancer Center in New York City, had in mind for Todd: to lessen his transfusions (which were 6-12 days apart) or to NOT BE transfusion dependent, and to NOT BE neutropenic. The idea that they now hope to remove his Hickman catheter and put in a port is wonderful! That means I won't have to flush his catheter lumen's every night, change his bandage and line caps once a week! He will only need to have the port flushed monthly. I'm not sure if that is something I will have to do, or whether a nurse will do it at his appointments. He will also be able to shower without covering it, and hopefully swim this summer!
Since he has he not been transfusion dependent, we haven't had to run to the local oncologist's office once or twice a week to have a CBC drawn to check his blood counts. That's a lot less running!
The first cycle of the study was a bit demanding on our schedule, having to go to Cleveland Clinic every week, and sometimes stay for 3 days, but that is behind us now. With the start of the second cycle, we only have to be there on Day 1, which we just did on May 21, and on Day 15 for a short visit! The same goes for Cycle 3. Day 1 will be a long 10-12 hour day (which will be mean a 3 day stay) and then he only has a short visit again on Day 15. After Cycle 3, he only has to go on the first day of each cycle from there on out! These days will be the long 10-12 days again, but we might be able to resume a more "normal" routine when all of these appointments are no longer necessary. All this is assuming that the drug continues to help and Todd responds positively to it, but I feel confident it will!
Todd began seeing a physical therapist finally for his shoulder stiffness and pain. It has helped some, but he still limited in using it. Our chiropractor had seen Todd before the transplant and then after, was in shock seeing how much muscle mass Todd has lost all over, but especially in his arm and shoulder. He felt that without the lack of muscle to help support the shoulder, it was making it harder for Todd to use it. Please continue to pray he will find some relief from this pain. It does inhibit his activity quite a bit and he can only take prescription pain medications, instead of any ibuprofen, and he doesn't like to take them and they don't seem to help as much as he would like. It wouldn't hurt if he could put on some weight or at least stop loosing it.
So, his next visit at the Cleveland Clinic will be June 4, 2015.
Family News
Wow, a lot has happened here too! Hannah Lewis graduates this Saturday! We've had multiple year-end award assemblies, choir concerts, etc. to attend. I have been cleaning like mad, with the help of my many good friends and family (Pam, Vicki, Darsie, Dana, Lynda, Mom)! Two of Todd's friends from work came over and painted one of the garages for him (thanks Chris and Pat).
We were able to put our house on the market for sale this past week. It is all bittersweet. We know it has to go, but we will be sad to leave it as it has been a labor of love building it, finishing it, and living in it these past 12 years. Please pray for a buyer, for financing so we can purchase a smaller home, and for the entire selling/buying/moving process.
Two praises regarding finishing my Master Degree: I was able to find a practicum at the University of Dayton in the Library/Archives department starting this fall. I have to submit a lot of paperwork to Kent State in the new few weeks to get it ready, but hopefully everything will work out so I can begin in the fall. I start my summer class and workshop next month! So, I am hoping I will be able to juggle everything once that starts. Second, I was able to get into the class I needed for the fall semester. I was originally on a wait list, but Kent State contacted me last week, offering me an opening in the class! I needed to take this class to graduate this fall, so now I can apply to graduate in December.
It's been an emotional roller coaster this past year. I crave a "normal" life whatever that is! Change has been the only consistent thing in our lives. It would be nice to be able to settle down into a mundane routine and stay in one place for awhile. With our family having to be split-up last fall, with Todd and I in Cleveland, Abby in Cincinnati, Hannah Lewis and Ellie here with my mom, and now having to move from our house into somewhere new, it is a bit traumatic for all of us. I know it does no good to worry about the timing, and wondering who will buy our house and when, or where we will move and when, but I still feel there is a sense of dread or a cloud that hangs over me. It is hard to convenience myself that it is all somehow punishment for some reason. If it is not the cancer and Todd's health, or the finances, then it is the uncertainty of "home" that seems to hang over us. For me, it is emotionally fatiguing, this roller coaster ride we find ourselves on. I just want the ride to stop, so I can get off, sit down, and rest a while. I'm still suffering from vertigo (literally), and I wonder why? Life and this world keeps spinning, and I am trying to keep upright, without falling, despite all the obstacles.
I gave the entire family this little pep talk last year about how God was going to use Dad's cancer, us going to Cleveland, Abby going to college Cincinnati, and Ellie and Hannah Lewis staying here with grandma, to GROW AND STRETCH US in ways we couldn't imagine! I had forgotten about this until someone reminded me of it recently and gave me my own pep talk in return! I know that God continues to mold us, refine us, strengthen us, give us insight, compassion, empathy, make us lean, teach us that living with less is more, help us focus on what is really important, and that home, wherever it will be, will be us together as family. But growing and stretching usually doesn't come without a bit of pain!
Thanks for your love and support. We appreciate your prayers and generosity, which continues to amaze and bless us!
Reference:
* According to the National CML Society, http://www.nationalcmlsociety.org/living-cml/response
Hematological Response is a normalization of the blood counts, particularly white blood cell counts. This is the first noticeable indicator that treatment is beginning to work, though not necessarily in the bone marrow. The response can be partial HR (reduction in white cells,but not down to normal range) or complete CHR (white blood count at or below approximately 12,000 white cells/microliter).
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