MD Anderson

View of Downtown Houston from MD Anderson Room

Thursday, September 29, 2016

We flew from Cincinnati Airport to George Bush International Airport in Houston, TX on a 2 hour 29 minute flight.  We had to pay more for the direct flight out of Cincinnati, but a one-stop flight was going to take between 5-6 hours to arrive.  I knew he could not and did not need to tolerate that long of a flight and/or transfers.  Everything went according to plan.  We had no problems at any time.  Todd had a little pain on the flight, but overall, it was event-free.  Once we arrived, we used Uber to get a ride to MD Anderson.  I called Dr. Benton on the way to the ER to let him know we would be there soon. This was the plan, to go straight to the ER and have him admitted from there.  It took about 40 minutes, but our driver was able to drop us off right at the Emergency Room doors.   The ER was somewhat busy and a bit difficult to navigate with the wheelchair and all of our luggage.

It helped that I had all the registration for Todd done before we arrived.  At the time I was working on it by phone while Todd was in Soin, it was very frustrating.  I remember this process another time I had tried to get an appointment for Todd at MD Anderson in the past, before he got on AG221.  First, the doctor sets the appointment.  Then, MD Anderson calls to get all of your insurance information.  You have to be approved through a "financial clearance" department before your appointment is confirmed.  This part is the real pain.  There were some discrepancies between what our insurance company was telling us and what MD Anderson had found out.  When I called our Anthem Blue Cross and Blue Shield Plan, they said Dr. Benton and MD Anderson were both "in-network."  This meant we would not have to pay anything out-of-pocket because we  have already met our maximum out-of-pocket expenses for the year.  However, MD Anderson's financial clearance department said they had no working relationship with our provider since it was through the Affordable Care Act and not from the State of Texas.  They said they would accept our insurance, but only as an "out-of-network" provider.  We had to agree that we would pay any difference in the insurance company's maximum payment benefit and what the hospital and other providers charged.  So, for example, if the insurance company only allows for $400 for lab work, and MD Anderson charges $600, we would have to pay the difference.  This could add up!  It basically allows MD Anderson to charge whatever they want for their services, without the insurance company having the power to say that is too much or you were contracted to accept our payment of $400 as a maximum charge.  This is where the health insurance system in this country is whack!  So, yes MD Anderson is probably one of the best cancer hospitals in America, but you have to pay for the privilege to be a patient there. There is no check and balance system in place when the insurance provider cannot protest that the hospital is charging too much for services.  Who knows what our medical bills will be after this is all said and done, but how can anyone put a price on life?  I can't.  Todd's life is more valuable to me than any amount of money!

Back to the ER. It was late in the day, about 5:30 p.m., so they were anticipating one or two discharges.  They got Todd a bed in the hallway until a room opened up.  Our nurse was Jesse, and he started getting us settled in.  We had to wait for the ER Doctor, Dr. Veils, to come in and evaluate Todd and give some preliminary orders. I provided her with the medical discharge papers and recap written up by Dr. Kim the hospitalist at Soin.  This was very helpful as it gave a quick review of Todd's history with the MDS and what happened at Soin.  She questioned Todd about his family history, whether there was an any cancer in the family, what he used to do for a living, etc.  They put a pick-line in  his left arm, since they are not allowed to use his port until it is evaluated.  They drew the CBC, did a chest x-ray of the port, performed a EKG, and Dr. Veil had to do an exam of a hemorrhoid that had become enlarged due to all the diuretics they gave Todd at Soin.  While this may not seem like a big deal, it is a very dangerous situation.  Hemorrhoids can become septic in no time.  In fact, it happened to Andy, a man who was next to Todd in the transplant floor at Cleveland Clinic in 2014.  He became infected with C-diff (Clostridium difficile), a bacterial infection that causes severe diarrhea, caused from antibiotic use or spread in hospitals from lack of washing hands, etc.  People with weakened immune systems, like chemotherapy and cancer patients are more susceptible.(C. difficile, 2016).  It quickly caused sepsis and they were unable to use Lasix to drain all the fluids his body started to accumulate when his kidneys began to fail.  I am so sorry to say that Andy lost his life as a result.  He had a loving family, which I was blessed to get to know while we were there. 

They approved his port for use, but kept the pick line in his arm so they could use it for fluids and use the port the for blood draws and transfusions. 

After most of these initial tests were done, we were pleased to learn that Todd did not require any transfusions when we arrived.  The doctors at Soin only had time to give him one unit of platelets instead of two before we had to leave for our flight; we thought he might need the other unit when we got there.  The best part of the ER visit was getting to meet Dr. Benton.  He is awesome!!!  I love his bedside manner, his intelligence, and his relaxed laid-back personality! He hit us with about 7 or 8 good options.  He told us straight out that the AG881 Study was closed here too for now.  They have no slots open and won't have them for about 6 weeks.  He thought this was a good idea, but not necessarily his first option.  His first option is to use a combination therapy of chemotherapy induction to get the cancer into remission.  This could take several weeks.  There were other trial options on or off protocol that could also be used, but he wanted to see what the genetic panel and the bone marrow results showed first, if he can get them back early in the week.  He would like to do the chemotherapy with the intention of doing a second transplant.  He wants to go for the "curative" treatment.  We explained our reservations to the idea of a second transplant:  GVHD, relapse or worse, but he tried to assure us that it was the only known curative treatment available today and he thought Todd would be a good candidate.

We had to stay in the ER Room until about 1:30 a.m. when they finally had a room in the hospital for Todd.  Yes, until then, they were full!  He was admitted on the lymphoma floor, because there were none available on either of the leukemia floors.  It was very comfortable.  I had a murphy bed to sleep on and was finally able to get some sleep, even though they continued to do some tests throughout the night.  One of the weirdest things that happened is when his nurse asked what medications he was on, and could she see the bottles of medication we brought with us. She said there was no since in paying for more medication, if he already had some.   I thought she just wanted to look at the dosage and amounts, but they "confiscated" all his prescription medication!  Without asking!  Two nurses started recording the type of drug and emptied each bottle counting every pill.  We could not figure out what was going on and we were half a sleep.  The next thing I know they had packed up all his medication and made him sign a receipt saying they were giving all the medication to the pharmacy to be stored, and that if we wanted it back, we would have to take the receipt to the out-patient pharmacy and pick it up.  Really?  We had nothing to hide, but wow, were they worried about someone stealing it or patients taking it in addition to what is being prescribed?  Is this where the prescription epidemic has led us?  I later asked the nurse on the leukemia floor about his procedure.  She said they do it so a patient doesn't lose there medications and that we should have been better informed.

Todd in his first room on the Lymphoma Floor.

Friday, September 30, 2016

His early morning CBC showed his hemoglobin at 7.7, which meant he needed 2 units of blood.  Platelets were also low, so he needed platelets too.  Someone from the Research Department came in and asked Todd to consent to allow some extra blood or marrow samples to be used for research purposes.  He has always agreed to this, even at the Cleveland Clinic.  Anything we can do to advance the effort for a cure or better treatment, we are all for!  Almost all of his tests were done in his room.  After 26 bone marrow biopsies, I finally got to watch one take place.  They took several slides of aspirate and then then they used a mini hand corkscrew-like tool to extract the small piece of marrow tissue.   They also brought a machine into the room to do his echocardiogram.  They swabbed his hemorrhoid for testing, took blood for cultures, his type and screen for transfusions, and for the multi-level genetic mutation panel. This one is much more detailed than any other he has ever had in the past.  The only test they had to take him out of the room to do was the CT scan of his spleen.  I felt bad for him.  Just after I ordered his breakfast, they said he couldn't eat because he had to drink the contrast for the scan.  He finally ate afterwards.

Speaking of breakfast, the food here has been very good for hospital food.  It is very helpful too that they provide a guest menu with prices on it so that I can order too.  It is just as reasonable to buy food here than it is going down to the cafeteria.  I have more choices and it comes up the same time Todd's food comes.  I can eat from $3-$13, depending on how much I want.  The only thing I could complain about is the lack of coffee!  At the Cleveland Clinic, the family kitchen area had free coffee, hot chocolate, and tea.  Here the coffee machine is like a vending machine where you have to pay $1.50 for a small cup of coffee.  So, luckily, they have like 4 Starbucks (or at least that is about how many I found in my limited exploration).  I have been going down in the morning and getting my $2.11 medium cup of coffee!  I prefer this delicious option to vending machine coffee! 

I have had a hard time getting a social worker to come up and see me. The sent one to me in the ER, but it was late and I really didn't have my questions ready then.  I needed to learn where to find laundry facilities, a place to shower, store food, etc.  Someone showed me the family kitchen and wrote down where I could find the hair salon and laundry.  The hair salon is for patients only and is run by volunteers.  The laundry facility is on another floor of the hospital tower and has pay-for-laundry machines.  The price is very reasonable; 75 cents per load on the washer and the dryer.  I would likely have to plan on staying there until my laundry was done though.  Things here must be different than Ohio hospitals because they all looked at me like I was crazy when I asked where I could shower.  It has always been my experience that family members were not allowed to use the patient's bathroom facilities.  Here, they are like, you can use his bathroom and shower, duh!  At the Cleveland Clinic, they had a family shower area and a free laundry room, but it only had one washer and dryer for the entire floor; sometimes, you had to wait your turn. 

Saturday, October 1, 2016

We were hoping to get the preliminary bone marrow biopsy results back.  Unfortunately, they were doing a second exam of the results and they were hesitant to release them yet.  The doctor thought there must be something questionable in the results, like calling his disease AML or blasts being at 20% or not. 

His blood counts this day were: Whites .6; Platelets 12,000; Hemoglobin 7.7.  It looks like he has become officially neutropenic with ANCs .29. Blasts in the blood were at 19%.  He received 2 units of blood and platelets. 

The doctor rounding this day, an associate of Dr. Benton, gave us a horrible shock when he came in guns blazing asking us: Why did we come here?  What treatment did we want to do? Did we come only for the AG881?- because that was closed.  We answered, well Dr. Benton gave us several options, but we didn't come just for the AG881.  He said that they would likely discharge us next week, and we would just be coming in for outpatient visits.  What???  This was news to us!  I said well he is requiring transfusions every few days, and what about his spleen?  He answered, we give transfusions outpatients and I could bring Todd in every Monday, Wednesday, and Thursday.  The spleen was still very large, about 28 centimeters, but if they could manage Todd's pain with oral pain medication, etc.  He would be fine.  He said you know you would have to stay here for at least the first round of treatment.  I said yes, we were told that yesterday by Dr. Benton.  UGH! 

I was in shock!  I told him that Dr. Benton hadn't said anything about discharging him so soon.  I'm thinking where is this doctor coming from? Why the inquisition?  I said well, we need to speak to a social worker right away because we flew in; we have no car; no place to stay and had not planned on needing all this information so soon. 

I was so relieved when Dr. Benton came in a few hours later and said that doctor didn't know the situation and wasn't really up to speed on Todd's case, that he had only been able to send him a few emails.  He had no intention of releasing Todd to outpatient care.  What a relief!  I knew that it would be so hard to drag Todd to and from the hospital several days a week in his current condition. 

He begin to discuss Todd's options again in earnest.  His first inclination was to start Todd on a chemo regimen to get his cancer into remission with the intention of having a second bone marrow transplant.  If we are agreeable to this.  We told him the first night that we weren't too excited to do the transplant after the first experience with the quick relapse and poor changes of success for a second transplant with resistant disease.   He said, he understood our hesitation then, but that now we have 15+ months of additional history of the cancer responding to treatment through the AG221 to consider.  This reveals to him more of the "biology" of the disease, that it responded well to a single-agent drug.  He feels that he would respond to a multi-agent treatment, which is what the research is all leaning towards now.  If, we still don't want to do a second transplant, we could look at therapies or trials available to him.  He called these "bridge" therapies because it would likely be another short-term fix to bridge him to the next available treatment in the future.  The main problem with going from one bridge therapy to the next is that when it would stop working, he would likely end up relapsing with the cancer progressing rapidly.  He also stated that it gets harder to put the disease in remission each time there is a relapse and the remissions would become shorter in duration.  It was his opinion that even now, after chemotherapy, the remission would likely only last 6 months or less.

If we went the transplant route, we could have it done here or at the Cleveland Clinic.  He said
that Dr. Hamilton would have to look at his list of donor options since they would not use a related donor again.  He said that she would likely recommend a full match if one was available, instead of just a half or haplo match, even though there is increasing evidence that these transplants are just as successful as full matches.  We asked about which would be best, doing the transplant here versus at the Cleveland Clinic.  Did they have different conditioning prior to transplant or different imonosuppression regimens after transplant than Cleveland?  He said that was a good question, and that it would be a good idea to bring in a bone marrow transplant doctor here as a second opinion consult to make recommendations. 

I told him my main reservation about a second transplant was the unknown mortality rate within the first year or two after transplant.  I was also worried about putting him through all the toxicity of the chemo prior to transplant and then just experiencing another relapse.  He said he didn't think the morality rate would be high.  His only real concern was relapse and GVHD (Graft versus Host Disease).  He said though, that even if the transplant wasn't successful, he would still have all the other trial options available.  I was surprised, and asked if he had a high grade GVHD, wouldn't that disqualify him?  He said, no not usually.  But, I do think we would have to wait a certain about of time after transplant to become eligible for some of the studies.  However, he wasn't concerned about this.

Other treatment options included a drug that targets the P53 genetic mutation we know he has.  Although this mutation can cause additional resistance to treatment, the cells are easier to target because they are marked very specifically.  He described these cells like bank robbers with masks on who robbed a bank, but continued to wear the same mask all the time after the robbery.  It obviously would make the robber easier to catch.  See: https://www.mdanderson.org/research/departments-labs-institutes/departments-divisions/leukemia/clinical-trials.html for a list of trials offered by MD Anderson for MDS and AML.

The other recommendations went by too quickly for me to write down or look into yet.  He did say that he contacted the drug company Agios to see if Todd could start the AG881 trial any sooner.  He said they may be able to move up the next cohort to 4 weeks instead of 6, but it wasn't certain.  This still may not be soon enough for Todd.

Once the genetic mutation panel and bone marrow biopsy results are back, they will have a better opportunity to match treatment options to the specific kind of markers and mutations that Todd has tested positive for, including the JAK2 mutation I discussed in the last post. 

The good news is, we have more options here than anywhere else!  We have a great doctor and we feel very confident that we are in the right place. 

We were moved from the Lymphoma floor to one of the Leukemia Floors right after dinner about 5:45p.m.  Todd's Room and address here is as follows:

MD Anderson Cancer Hospital, c/o Todd Cade Room #G1682, 1515 Holcombe Blvd, Houston, TX 77030

 Remember not to send or bring any plants or flesh flowers as they are not allowed on the floor. 

Sunday, October 2, 2016.

Not much going on today.  Todd's counts were a bit better: Whites 1.0; Hemoglobin 9.5, and Platelets 16,000; with ANCs at .45.  Sadly, there was 23% blasts in the peripheral blood.  No transfusions were needed, however, he started having a nosebleed whenever he stood or sat up, so they went ahead and gave him platelets to help with this. 

I will blog more, when I know more.  I want to close with special thanks to those who have helped us get here financially (you know who you are).  We also want to thank all of the prayer warriors out there lifting us up to our Heavenly Father.  Also, special thanks to Dana Willet, for driving 3 hours up and 3 hours back from the Austin area to visit with us.  And to my high school friend, Kim Bird for driving 4 hours up and back from the Ft Worth area to bring me some supplies, meet Todd, and lift up our spirits.  It takes a special kind of person to drive these long distances to visit! 

References:

Mayo Clinic Staff.  June 18, 2016. "C. difficile infection." Mayo Clinic.  Web.  Retrieved from:  http://www.mayoclinic.org/diseases-conditions/c-difficile/home/ovc-20202264

CELEBRATING 25 YEAR WEDDING ANNIVERSARY AND GETTING TO NEW YORK

Today is our 25th Wedding Anniversary
September 21, 1991- 2016

PERSONAL NOTE:

It was a whirlwind courtship, but today we celebrate 25 years of a life together that has brought us many blessings and challenges. I would like to wish we could have another 25 years together, but none of us are guaranteed a tomorrow. No woman could ask for a better husband than Todd. He worked hard and has always devoted his life to God and his family. Cherishing every day and praying we have many more years together. So thankful our marriage was blessed with the greatest 3 kids we could ever hope for.

GETTING TO NEW YORK FOR TREATMENT:

Trying to get Todd to New York on a budget is proving challenging.  I’ve done it once before, and I’m going to have to do it often if he gets accepted in the trial for AG881 at Memorial Sloan Kettering (MSK). 

At first, the receptionist for Dr. Stein at MSK told me that Todd would have to come in two separate dates: one for the consult and another for the screening and by the way, Dr. Stein was only in on Mondays and Thursdays.  I told her that we had seen the doctor before in a similar situation when he was getting screened for AG221, and that we were able to have back to back appointments, one day for the consult and the next day for the screening so that we could do it all in one trip.  I explained that we were coming from Ohio and why should we have to come on two separate occasions and have to schedule 4 flights instead of 2!    This was Thursday, September 15, 2016 when she called to schedule Todd’s first appointment set for Monday, September 26, 2016.  I called back the next day and tried to convince them to let us have too appointment dates back to back.  She said she would give the message to someone on Dr. Stein’s team.  I didn’t hear back from anyone that day, nor Monday morning.  So, I called back Monday and reiterated the circumstances and said I never heard from anyone.  She said she would send out another message and have the doctor or someone on his team call me back.  His trial assistant, Emily called back later that afternoon and said of course we only needed to make one trip and that we could do everything in one day!  She said they make this exception for patients who travel long distances!  Hello?  Why didn’t the office person tell me this to begin with? 

There are still a few concerns about being able to keep the Monday morning appointment there.  First, it is at 9:40 a.m.!  That means we would have to get up very early and drive to Cincinnati or Columbus to get on a Corporate Angel Network Flight (CAN), if one is available and can get us there that early with a 45 minute drive into the city!  Corporate Angel Network cannot request a flight until 3 days prior to departure.  We can’t go up the night before because none of the corporations on the network fly on the weekend.  I won’t hear back from CAN until Thursday or Friday at the earliest to see if they are able to secure us a flight.

Second, MSK is waiting to confirm that they can add Todd to the new cohort of the trial which opens on that day, Monday, September 26.  They have been reviewing the current cohort and there can be delays if there are any concerns.  Emily is supposed to call me back and let me the status of this.

COHORT:  A group of persons or animals of the same species with a common characteristic, set of  characteristics, or exposure, who are followed for the incidence of new diseases or events as in a cohort for a prospective study. (Segen’s Medical Dictionary, 2011).

Third, getting lodging once everything is confirmed is also on hold.  I hate to book a hotel room until we get the first two confirmations.  I tried to get the social worker at MSK to work with the Hope Lodge there in New York City to reserve us a room.  However, after hearing back from the social worker today, we were informed that we would need a minimum stay of 3 days of “treatment” before we would meet the criteria for staying.  Since we only need one night this time, it’s a no go.  I did tell her that we may need to stay 3 days later, once the trial starts, but it won’t be often. 

From what I gleamed from Emily, Todd would have to start the trial with a Day -3 scenario, like he did with the AG221 trial.  This is the part where they experiment taking the medication with or without food and then do hourly blood draws for 10 hours.  I remember these days from the last trial with dread!  Talk about a long day, especially for Todd, in his current condition of severe fatigue.  After the first week, we would have to return weekly for the first month.  After the first month, appointments every two weeks for the first 4 months.  Then, just monthly appointments!  This is a much easier schedule than with the AG221 study at Cleveland where Todd had appointments for every two weeks for the first year!  That was crazy; but, you do whatever it takes!  Todd was doing so well on the drug, we hated to complain!

None of this preparation can happen fast enough. Todd continues to struggle with fatigue and lack of appetite.  The local oncologist wanted Todd to start coming in the day before transfusions to get the CBC and type and screen. This is supposed to give the blood bank a day to obtain and prepare the blood products ahead of time.  Plus, they have never liked the idea of making Todd wait for hours for the blood to get to Soin from the blood bank. 

Dr. Hamilton, in Cleveland, did not want Todd to wait 7 days to get a CBC because his hemoglobin was so low the last time they waited a week.  Arrangements were made for him to go in late Monday morning, September 19, to get the CBC and type and screen done and to have blood drawn for a special myelo-mutation panel that would identify all genetic mutations, not just the IDH-1 or IDH-2.  Dr. Hamilton wants to use this as a tool for finding any other studies that Todd would be eligible for, based on the mutations he has.

The results of the CBC were disappointing.  Less than 5 days from his last platelet and blood transfusions, his counts were so low that he needed another 2 units of blood and 1 unit platelets again!  His hemoglobin was at 7.5; platelets at 12,000; Whites at 1.1; and ANCS at 0.6.  They ordered his blood products for the transfusions set up for this morning, Tuesday, September 20, 2016 at 7:30 a.m.!  This is very early for Todd.  It took the nurses a good hour and half to get him situated in his Universal Care Room and have the blood brought in.  He didn’t have to be there until 6 or 7 pm today, but he was still there until 2:10 p.m.  It still took him about 7 hours to get the transfusions.  I’m not sure if it was really any better for him to come in two days, but I guess it was better for the hospital and staff and maybe the blood bank, I don’t know.

I think we have decided to put our house back on the market again.  A realtor came to the house and we will be in repair and clean-out mode now for some time.  Apparently, the inventory for houses in our area is low, but the turnaround time from listing to selling is averaging almost 300 days according to her graph report. I can’t imagine keeping everything “show-ready” for up to 10 months!  The whole prospect feels every inch of me with apprehension, but I’m doing it for Todd’s peace of mind.  Less stress in keeping up our big house and its expenses.  He worries about the future and my ability to keep everything up on my own.  Goodwill, Beavercreek Bargains, Plato’s Closet, here we come!  I know it needs done; I just don’t have the mental or physical energy and the heart to do what it takes.  I can’t give in to sentiment.  Even more depressing is finding somewhere to move that isn’t a major wreck.  God Help Us!  I mean that sincerely and earnestly. 

NEW DEVELOPMENTS:

This news is crazy, so hang on.  I received a call late yesterday from Emily, Dr. Stein’s trial assistant at MSK.  The meeting that the trial study team was supposed to have with the drug company on Monday, September 19, was unexpectedly postponed for a week with no explanation.  It just wasn’t the meeting at MKS that was postponed, but the meetings at the other four U.S. trial study locations too. 

The meeting was supposed to cover the results of the first cohort of the Phase I trial of AG881, which was a dose expansion phase, defined as “A progressive increase in the strength of any treatment (e.g. a drug or radiation dose), to improve its tolerability to maximize it effect.”  (Free Dictionary 2009).

This is when they give different patients different amounts of the drug: 50 mg, 100 mg, 200 mg, 400 mg, and 600 mg until the maximum tolerated dose is established.

MAXIMUM TOLERATED DOSE:The highest drug dose that can be given without causing adverse side effects in most recipients.  (Segan’s Medical Dictionary, 2011).

The second cohort of a Phase I, is usually a patient expansion.  We are hoping to get Todd a slot in this part of the trial.  Now everything is on HOLD!  The appointment for Monday, September 26, 2016 with Dr. Stein has been cancelled too.  We are hoping to go instead on Thursday, September 29, 2016, IF the news and instructions from the drug company from the rescheduled meeting that Monday allows new enrollees. 

I guess speculating doesn’t do much good, but I can't help it. This could be good news or bad news.  They could have reached the maximum tolerated dose and have decided to go on to Phase II.  This would be good news since Todd would not have to be exposed to dangerously high dosages, but it could take weeks or maybe months to get the new Phase up and running.  The worst case scenario would be that the drug didn’t work at any dose for the initial set of patients, but this would be highly unusual.  The best news would be that they just needed to reschedule the meetings for a week and the drug company will call the Trial Centers/Hospitals and let them start pre-screening for an additional number of new patients for the next cohort or Phase. 

The problem for Todd is time.  He needs to get on a treatment soon.  The two-week “wash-out” period of being drug-free in preparation of starting a trial will end tomorrow, Thursday, September 22.  Even though I feel desperate to get him on some kind of treatment, we can’t jeopardize ruining this wash-out period and not being ready when next trial slot opens up. 

So, we wait.  Wait to hear from Dr. Stein's team and continue to get Todd any transfusions whenever he needs them.  Prayers for the situation to be resolved and settled would be appreciated, as well as for protection for Todd against getting an infection or virus.  

References:

cohort. (n.d.) Segen's Medical Dictionary. (2011). Retrieved September 21 2016 from http://medical-dictionary.thefreedictionary.com/cohort

dose escalation. (n.d.) Medical Dictionary. (2009). Retrieved September 21 2016 from http://medical-dictionary.thefreedictionary.com/dose+escalation

maximum tolerable dose. (n.d.) Segen's Medical Dictionary. (2011). Retrieved September 21 2016 from http://medical-dictionary.thefreedictionary.com/maximum+tolerable+dose

COUNTS DROP FOR UNKNOWN REASONS; TRANFUSION NEEDED JULY 21, 2016

I hate that I tend to blog only when there is a major change in Todd’s condition, but when he is feeling well, we are busy trying to enjoy life!  Unfortunately, it has been since May since I have provided and update, and once again the news warrants the update.

Todd’s condition on the trial drug AG-221 (Agios/Celgene) has been stable.  He hit end of the one year anniversary being on the medication on March 23, 2016.  He had a bit of allergy symptoms in early spring April/May 2016, with a runny nose, sneezing, cough, etc.  We attributed this to the fact that the grass was being mowed often and the spring was wet. 

He felt well enough to visit his brother Ted in St. Petersburg in mid-June, but he was still suffering from allergy symptoms.  He saw his Bone Marrow Transplant Doctor at Cleveland Clinic every month on Day 1 of his drug cycle, and continued to get blood work drawn locally on his Day 15.  The doctor gave him the “thumbs-up” on his June 13 visit to fly to Florida and back for the short visit. He came back still feeling symptomatic, mostly still suffering from a lingering cough. 

He was feeling somewhat tired, but was able to get around most of the day just fine, but with a nap (it isn’t unusual for him to need a nap). We had missed a family reunion in Tennessee in June and wanted to go down to visit the weekend of July 4.  I haven't had a vacation in over two years! He had blood work drawn before we went on Day 15 of Cycle 16, which was June 29, 2016.  Since it was drawn at a local lab, he didn’t get the results until we were driving down to Tennessee on July 1.  All of his counts had dropped.  This was the first time in many months that there had been a significant, noticeable drop in counts.  His Hemoglobin was down to 9.0, white counts to 3.2, ANCs at 2.5, and platelets at 65,000.  Just to give you some perspective, his Hemoglobin had been running in the 10s and 11s, Whites and ANCs in the 4s, and platelets as high as 75,000. 

This was a shock to us; this meant he was only 1 point  away (<8.0) from needing a blood transfusion!  He hasn’t needed a transfusion since he was sick with the pneumonia and cold last October 2015.  Even though his counts had starting dropping slightly before this, we were not concerned, because we all understand that there is often some slight variation from visit to visit and from one lab (Cleveland Clinic) to another (Local Compunet). So, we attributed the slight differences in the differences in labs.

We tried to make the most of our trip to Tennessee, however, we quickly noticed that Todd was getting tired very easy.  When we returned, he didn’t seem well rested and still had that nagging cough.  So I ended up emailing his trial nurse at Cleveland (so did he!) the next morning to let her know.  Todd’s trial appointment was already set for the upcoming Wednesday, July 13, 2016 for Day 1 of Cycle 17.  So, they set-up at Chest CT in addition to his bi-monthly bone marrow biopsy, Pentamidine breathing treatment, EKG, and Echo cardiogram.  

The doctor had asked extensively about his cough and some tightness he was having in his foot/ankle before she gave us the news about the low blood counts.  We both felt something was wrong, and knowing her well, felt she didn’t want to give us the bad news. Then she let the bomb drop; the blood work for that day was back and his hemoglobin had dropped even more:  Hemoglobin down to 8.1, Whites #, ANCs #, and Platelets.   Basically, the initial view of the CT scan looked fine, and she didn’t have any idea why the counts were dropping.  We discussed having Todd tested for CMV or Cytomeglavirus which can affect post-transplant and immune-compromised patients, but she was hesitant to this.  I knew why.  She wanted to wait to see what the results of his bone marrow biopsy were.  If the blast counts, were up, we would have our answer.  This scared us; the trial drug has been working so well!  She said that it was possible that he was sick with a virus, and that the only time his counts had dropped like this (on the trial drug) was last October when he had the cold and pneumonia.  So, the possibility that he was sick, was a good one.  We left a little deflated. 

They don’t transfuse Todd until his hemoglobin drops below 8 and it was already late when we got done with all his appointments.  There was no treatment appointment made to give him a transfusion while he was there.  We would have to follow-up with his local oncologist. We didn’t end up getting home from Cleveland that night until after 11:00 p.m.

So, the next day, Thursday, he was still very tired.  His trial nurse called in blood work orders to his local oncologist and he went in on Friday, July 15, 2016.  We also asked if they would go ahead and have the blood drawn for the CMV test.

Before I go on, I have to tell you about our ObamaCare health insurance nightmare.  We received a letter from our Healthcare provider, In Health Mutual, an Ohio PPO created after the Affordable Care Act was passed in June saying that they were going bankrupt and that if we didn’t want to lose our tax credit/subsidy we had to select a new health care provider by July 1, 2016!  So, Todd had to go back onto the Government Healthcare Marketplace website and try to find insurance that the Cleveland Clinic and his doctor accepted. He found one: An Anthem BC/BS Silver PPO program, which he selected.  We paid for the new premium for the Anthem and had the information for the new insurance before Todd’s appointment at Cleveland Clinic on July 13, 2016, only to find out that IN Health Mutual withdrew almost $1,000 from our checking for the July premium-even though we switched healthcare companies!  We spent hours trying to get it corrected and to get our money back.  The input operator at the Marketplace also accidentally cancelled our Dental Insurance, so, we had to cancel Todd and Abby’s dentist appointments for that week and try to get our Dental re-instated!

Here’s the kicker, we realized when Todd went into see the local oncologist’s PA to have more blood work on July 15, that they didn’t accept our new insurance!  Basically, we would have to pay that bill out-of-network!  This is already in addition starting over on our yearly deductibles half-way through the year, when we had already met our deductibles on the prior In Health Insurance!  

Now, back to Todd.  The blood work came out about the same, Hemoglobin was still at 8.1 and the platelets had gone up slightly, but the PA decided that Todd could wait to have a transfusion and sent him home.  I called the trial nurse that day and asked if the preliminary bone marrow results were back; that it would ease our minds to know the results.  She sent him the results and Thank God, the blasts were still only at 1%!  This was great news!  The cancer had not been ratcheting up, but something unknown then was causing the drop in counts. 

By Tuesday, July 19, 2016, Todd was still very tired and his cough still persisted.  The trial nurse sent orders to the lab, but no one there was certified to take blood from his port, only from his arm and by this time, his arm was getting bruised.  I knew we needed to have his blood drawn again, and something needed to be done about getting him a new hematologist/oncologist locally.  So, I started calling.  First, to the new insurance company, Anthem.  They gave me 2 or 3 names, but only two were actually hematologists.  I also asked about what hospitals in the area were covered because he had always gone to Miami Valley Hospital in Dayton for all of his transfusions.  I found out that Miami Valley was no longer on our list!  Only the Kettering Medical Network of hospitals.  I was upset at first, not sure if any other hospital had their own blood bank nearby.  I also asked Anthem if Cleveland Clinic and Dr. Hamilton was covered and she said no!  I wanted to throw-up in my trash can I was so upset! So, I called the Government Healthcare Marketplace back and they said both were listed as providers! 

I called Dr. Amanda Laubenthal of Cancer Specialist of Greater Dayton.  They were very nice and I began to relax. They had an office in Beavercreek near Soin Medical Center, just minutes from our house.  The doctor was willing to see him right away, but they needed his medical records (at least his recent reports).  So, I called his trial nurse and Cleveland and she was able to send them electronically before we got off the phone!  She also told me that the CMV test had come back negative.  So, one more thing we could rule out!  Dr. Laubenthal’s office contacted Todd and he had an appointment to see the doctor and get blood work for Wednesday afternoon, July 20, 2016.  I was so relieved!  I didn’t get to go with him to the appointment that day because I had to work, but he liked the doctor and the blood work showed that his hemoglobin had dropped to 7.5, whites to 2.2, ANCs to 1.7, and platelets to 66,000.

At first he told me over the phone that he wasn’t going to get a transfusion even though his hemoglobin was under 8.0.  He was just going to “monitor himself” and get blood work next Wednesday!  I was livid!  I tried to convince him that he would likely feel worse and that come the weekend, he wouldn’t be able to get a transfusion and would have to wait until the following Monday to get in.  I didn’t understand why he was so opposed to getting transfused.  He told me he was going to go to SAMS Club to pick up some things we needed.  In about half an hour later, he texted me and said he was going to go back to the Dr. Office/hospital to get “type and screened” for a transfusion.  They had just closed the office, but lucky for him they let him come in and by 5:00 p.m. they had set up an appointment for a transfusion of 2 units of blood at Soin Medical Center for the next morning, July 21, 2016. I’m not entirely sure what made him change his mind so quickly, but if I had to guess, I would say that once he got to SAMS Club and had to walk so much, he realized how exhausted he was and that he had better go get the transfusion!  I knew he was stubborn, but… Anyway, I was just grateful that he changed his mind.

I had to work the next day, but I took a long lunch to go check on him during the transfusion.  I told Todd to make sure the blood they gave him for the transfusion was “Irradiated and Leucocyte-reduced, and CMV negative.”  He asked, and they assured him the first unit they were giving him was.  When I got there, they were just finishing the first unit of blood and getting ready for the second unit.  While they were getting it ready, I asked if it was Irradiated, Leukocyte-reduced, and CMV Negative, but they couldn’t find it labeled anywhere on this unit that it was CMV Negative.  So, I asked them to wait and ask someone.  This is a bit technical, but basically, people who have caught CMV (the virus that can cause Herpes) produce antibodies to fight against it.  Once you have been exposed to CMV, it can stay in your system forever, even if it stays dormant.  So, if the antibodies are present in the blood, then they know the donor has been exposed to the CMV.  We had just confirmed that Todd didn’t have CMV, nor did we want him to get it, so I wanted to be careful.  Most of the time, if the blood is irradiated it kills most germs or viruses.  In addition, if it is leukocyte-reduced, it means that they have tried to take out most of the white blood cells, where viruses like CMV reside.  This is likely good enough, but I knew that since they were able to screen for it now, and since the first unit was CMV negative, why shouldn’t the second unit of blood be?

So, they halted the transfusion and waited from word from the blood bank and the local oncologist.  Meanwhile, I called Dr. Hamilton, his Bone marrow transplant Doctor in Cleveland and his trial nurse to ask.  I got patched through to Dr. Hamilton and she said it would likely be ok, however, Dr. Laubenthal said No, just order new unit of blood that was marked CMV negative.  So, luckily Soin had more blood on stand-by and Todd only had to wait another 30 minutes for them to get the second unit of blood and start the transfusion back up.

I was glad though that I had a chance to talk to Dr. Hamilton, who said she was at a loss for what was causing the drop in counts since the bone marrow blast counts were low and the CMV test came back negative.  They were trying to come up with other possibilities and decided that he should be tested for RSV.  So, they contacted Dr. Laubenthal's office and had the nurses collect a sample (through the nose) while he was there.  The transfusion was long as usual, but helpful.  

I know medicine is a process of elimination, but it can be frustrating not knowing what is causing the drop in counts, even though all the tests for various viruses having been coming back negative, which is good.  The alternative of it not being an illness or virus of some sort, is too upsetting to contemplate at this point.  

He is scheduled to have blood work done for his Day 15, Cycle 17 done on Wednesday, July 27, 2016.  So, we are going to see how much this transfusion helped, get the results back from the RSV swab, and go from there.

We appreciate your prayers and support as always.


WANT MORE INFORMATION:
Cytomeglaviru (CMV)s: http://www.mayoclinic.org/diseases-conditions/cmv/basics/definition/con-20029514

RSV:
https://www.cdc.gov/rsv/
http://www.mayoclinic.org/diseases-conditions/cmv/basics/definition/con-20029514

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:

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.

January 2016 Begins Month 11 of Trial Drug AG221

It is hard to believe that as of this Wednesday, Todd will begin his 11th month on trial drug AG221. I was reading a news update on the drug (link here:  http://www.nasdaq.com/press-release/agios-announces-data-from-ongoing-phase-12-trial-of-ag221-showing-durable-responses-in-patients-20151206-00039 ).  It looks like they are continuing with additional trials this year for MDS patients in addition to AML patients.  It looks like Todd is not the only one seeing some improvement. When you read the article Todd is one of the MDS patients having a response to the drug. 

As we read the article, we were able to reflect on where he was a year ago! He was so weak and transfusion dependent. I was frustrated with the current rounds of chemotherapy (Vidaza). It is amazing that we know so much more about AG221 now than we did last year!  

I'm so grateful to Dr Etyan Stein for his work on getting this trial information in the news and Agios for putting his presentation online where I was able to watch it and encourage Todd to go on it and fly to New York to see Dr. Stein at Sloan-Memorial Hospital in New York City. 

Todd's last appointment in December went well. His blood counts and his MDS are holding steady. For those of you who are interested in CBC counts for comparison: White: 4.02; Hemoglobin: 10.9; ANCS: 3.42; and Platelets: 51,000.  His Bilirubin remains higher than normal, but still within the study limits. We did get his last bone marrow biopsy results back and they showed a 1% increase, resulting in a 3% total blast count. We aren't upset about this because this is essentially not enough of an increase to make a difference. They always have to allow for a small percentage of error or for slight variations as counts and bone marrow samples differ. The good news was that his cytogenetic report from that biopsy did not show any additional chromosomal abnormalities. 

Early in December, I did have a candid conversation with his Bone Marrow Transplant Doctor about the new research about the TP53 genetic mutation.  This mutation is acquired and is usually what causes the cancer or disease.  There has been some studies trying to determine whether patients with this TP53 mutation, don't respond well to transplants or are more resistant to therapy.  She discussed how the TET2 mutation also is being studied in relation to patients who end up with a "poor prognosis" or at higher risk.  I had learned about the TP53 mutation after reading a friend's blog about her son with Leukemia, who had relapsed after a bone marrow transplant, who is now relying on an alternative trial treatment that using T-cells.  (Craun, November 2015). And, when reading the last issue of the MDS newsletter, there was an article about TP53 and its connection to a patient's prognosis who has this mutation. (MDS News, Fall 2015). I asked Todd's doctor if Todd had this mutation, and she knew the answer immediately: Yes, he did.  If this research proves true, it would answer the nagging question of why Todd's bone marrow transplant failed.  It would also be helpful in the decision to have a second transplant someday; if the evidence shows this mutation inhibits a successful transplant, we would likely eliminate that option in the future.

I'm so thankful that he has not suffered any of the severe adverse events or reactions to the drug. Even though he has suffered terrible nausea and high liver function counts, it has been tolerable. 

I'm a bit disappointed that he has to have another bone marrow biopsy AGAIN this visit. The other tests are less invasive and they don't bother him as much. Hopefully, after he has been on the trial drug for 12 months, they will lessen the frequency of biopsies, although I have no assurance of this.  We were assured though that at after 12 months, his trial study appointments at the Cleveland Clinic would change in frequency from every two weeks to only once a month!  This will be great!

We said goodbye to Ashley, his primary trial nurse, who is leaving the program to take a nursing job back on the Leukemia floor.  We will miss her, as she was there for us from the beginning and whenever we needed answers.  We are confident that we will be in good hands with her replacement, Sam, who has been on the trial study team from the beginning too. 

So, Todd will have a full run of tests this Wednesday, as he plugs along on AG221.  We are curious to see how our new insurance, through the Affordable Care Act, works for us this year. The main focus now is to get him through Winter without getting sick.  We haven't done much socially, and fear vacation travel at this point, but it would be nice to get away for a little bit over spring break. 

 A few concerns and prayer requests:

First, like I stated in the last post in December, we received paperwork from the Social Security Disability Board asking for detailed information in their review of his continued approval for benefits, which is beyond comprehension to me!  I filled out about 10 pages of appointments, treatments, hospitalizations, transfusions, medications, etc. only to receive a second request form (8 pages) last week asking us to describe his daily functions in detail!  I can't imagine how anyone could look at these papers and not determine his continued need.  His health is so precarious, dependent on stable blood counts and staying completely healthy.  We learned how quickly he health could change in October 2015 when he was hospitalized for a cold and pneumonia for 13 days!  As this is our only source of income right now, we are desperate that it continues.  I don't understand how he was a productive citizen and paid the maximum into the system for years, and then we he needs it, they have to challenge it! 

Second, speaking of income, I still haven't found a full time job.  I graduated with my MLIS in December 2015, only to be let down by what little value these credentials are in obtaining a position.  I apply weekly for jobs, and try to do something productive everyday in the job search.  I have several applications pending at UD right now, but everything else I have applied for has not produced any offers.  I am also actively seeking volunteer experience and trying to schedule to attend several professional organizational meetings, but these have also been in limbo.  If you know of anyone who is hiring, even outside the field, please let me know!  I have applied for positions outside of field, and one of those applications is still pending.  It is not always what you know but rather who you know that helps land that job!

We took the house off the market for the holidays, as we needed a break from showing it and our listing had been on the market too long for serious offers.  We will likely put it back on the market in early March. 

We appreciate all those who have sent Christmas cards, money, and gift cards, especially Beau Townsend Ford's Employee Christmas Club Fund and that of our friends and neighbors. 

Right now, we are just trying to appreciate Todd's stability and giving God the praise for the blessings we have daily! 


References:

Craun, Gina. November 24, 2015). Windshield Wipers. Cainan Craun. Caring Bridge. Blog.  Retrieved from: http://www.caringbridge.org/visit/cainancraun/journal/view/id/56549676a589b45a417219e8

Prognostic Impact of TP53 Mutations. MDS News, Fall 2015,Vol. 21, Issue 2. page 11.  Retrieved from: http://mds-foundation.org/wp-content/uploads/manual/2015fallnewsletter.pdf

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

Seeing Early Results within 5 Days of Starting Trial Drug

Todd holds up the AG-221 Trial Study Drug

We are so excited that Todd finally got to start the Trial Drug AG-221 on Monday, April 20, 2015, at the Cleveland Clinic. We had to be there from Sunday night April 19, through Thursday morning, April 23.  My mom graciously stayed with the kids.  Monday was a long day, beginning with testing at 7:15 a.m.  He took the first dose of the drug:  200 mg or 2- 100 mg tablets with food  around 9:00 a.m. with hourly tests of EKGs and blood draws for 10 hours beginning shortly after.  His blood counts were low that day with his hemoglobin at 7.6; whites .47; platelets 34,000; and ANCs/neutrophils too low to count.  So, once they checked the protocol to make sure it was alright to give him blood during the testing, they ordered him two units of blood to be transfused while he was there.  We finished that day around 7:00 p.m.

The next morning, Tuesday, April 21, we had to be there around 8:30 a.m. for lab work and testing.  No drug was given this day.  The protocol called for one dose on Day -3, which was Monday, then to do testing and evaluations for the next 72 hours.  So, we had to go back Wednesday for another easy day of morning testing and no medication.  Thursday, April 22, 2015 (my mom's birthday!) was considered the official first day or Day 1 of the trial drug.  It too was a relatively easy day.  We were able to finish up early and head home.  For all the months and preparation leading up to beginning the trial, three out of the four days we were relatively uneventful!

Overall, we are pleased with how everything went at Cleveland Clinic.  Todd got to see his bone marrow transplant doctor on Monday and Thursday.  I love the research nurses Ashley, Samantha, and Chad.  They were very good to us.  The Cleveland Clinic was able to fund our hotel stay for this initial visit at a nearby hotel between downtown Cleveland and the Clinic; mainly because we were on the waiting list for the Hope Lodge, but were unable to get in.   We were able to submit travel expenses including Todd's meals and gas/mileage for reimbursement.  On all other trips, we have to pay for our hotel stay, unless a room becomes available at the Hope Lodge, but we can submit those expenses also.  God continues to provide for us!

While we were there, we visited our friend Rick, from the Transplant Floor.  He had been admitted to the Leukemia floor trying to fight his relapsed AML since March.  The chemo has taken the toll on him.  His hands and feet were peeling and yellow from jaundice.  He wasn't as responsive like normal. He has a bowel blockage and hasn't been able to eat solid foods; unfortunately, he can't control his bowels at all, they believe that is also a side-effect of the additional chemo.  He has to have platelets and blood transfusions every day!  They are also giving him potassium for his brain.
As a follow-up, I talked his wife on Wednesday, April 29, and they were in the process of moving him to hospice closer to home.  The doctor said he may have 2 weeks to 2 months to live.  He has 50% blast cells in his blood stream, and does not have the same gene mutation Todd does, which makes him ineligible for AG221 drug study.  Please pray for him in his last days and for his family as they go through this difficult time.  

Todd had to have routine blood work done on the following Monday, April 27, 2015.  We were afraid he was going to need a transfusion, because he had been feeling fatigued the day before and spent most of the day in the bed resting.  To our surprise, his numbers were good!  He needed no transfusion since his hemoglobin count was at 8.8. His white count went up to 1.0 which hasn't been that high in weeks or months! His neutrophils were still low at .700, but at least he was above the neutropenia threshold of .500 and his platelets were at 60,000! We were praising God for these very early results. He had only taken 5 doses of the trial drug by this day and we want to believe that the increase was the result of the medication beginning to work.

The weekend we got back home, we started working on the house again, trying to get it ready to sell.  We both worked a little too hard and too much, but not without help.  That day, I had my good friend Dana come over and she went to work on helping clean out my bedroom closet, so it didn't look cramped or cluttered.  We got a lot done! Monday, I spent finishing cleaning the closet and taping up boxes and moving them out to the garage with the help of my good friend Darsie.  Tuesday, we were blessed with the help of our great friends Chris and Lynda; the guys worked outside in the yard and Lynda and I cleaned and straightened up the Piano Room and Dining Room.  We got so much done! 

In addition to working on the house, we have been selling our furniture and other items as we go.  I take photos and then we post the items online and usually spend the next day or two taking emails, texts, calls, and arranging pick-up times.  This has been a good strategy, since we are getting things removed now before showing the house and before I attempt a garage sale (which is so much work in relation to how little people are willing to pay). 

By Wednesday we needed a break! We had to pack for our trip to The Cleveland Clinic, but at least I was able to help Ellie pack up some keepsakes in her room before leaving late that night.   Thanks to Todd's mom Ann and our former neighbors Joni and Raymond, for all the boxes and packing materials!

We arrived around in Cleveland around 11 pm last night and hit the bed, since we had to be at the hospital the this morning, Thursday, April 30 before 7:30 a.m.  The day's appointments went well.  Todd saw his doctor and the research nurses got busy asking their questions, doing the EKG and blood work for the trial study.  He was scheduled to have a transfusion today if his hemoglobin was below 8.5, but we learned that it was at exactly 8.5, so everyone was in agreement that since Todd was feeling pretty good, they were going to hold off on transfusing him for today.  The rest of his numbers were down slightly, his whites went down to .830; his platelets down to 41,000; and the nurse contacted us later with the other numbers, namely his neutrophils, which have dropped to .530 making his nearly neutropenic again.

What's Next?
He is scheduled for routine blood work every Monday at the local oncologist's office, so we will see how his counts are on Monday, May 4, 2015.  If he needs transfused, the local oncologist will make arrangements for him at Miami Valley  Hospital before his next appointment at the Cleveland Clinic on Thursday, May 7, 2015.  This is going to be another long day of tests, because it is Day 15, or about the half-way point of the Cycle 1 of his drug trial.  In addition to hourly blood draws for 10 hours, he will have EKGs, and a bone marrow biopsy (his 15th? I think, he has had so many, I have lost count). They have also scheduled a treatment appointment for transfusion, if he hasn't had one by then and needs one. The protocol of taking the drug with food will also change at this point.  Instead, he will have to fast for 2 hours before taking his scheduled dose at 9:00 a.m. and then wait for 1 hour after taking it before he can eat.

The only concern so far is his bilirubin levels, which were elevated, however, even this is expected in the beginning.  The research nurse assured me that these levels typically come down as time goes on.  They are not concerned about these levels because his liver numbers and the direct bilirubin numbers both looked good.  They only thing that I noticed today, was a slight yellowing in the corners of his eyes; the nurse agreed that there was a slight bit of yellowing, but that this is a known side-effect of the drug.  If it gets too high, they will interrupt the dose or decrease it, but that his current levels are no where near needing any of those adjustments now.

On a personal note, we will continue to work on getting our house ready to sell.  Which means, I will be enlisting another round of volunteers to help me inside get things de-cluttered and cleaned for showing.  Todd won't need much more help outdoors, but mainly indoors, with a bit of painting projects, changing light bulbs inside and outside (some days I don't want him on a ladder), and repairing a bit of drywall.  Tomorrow, I'm going to help our oldest daughter Abby finish moving things out of her dorm room.  I can't believe she is done with her Freshman Year of college already!  I need to work on preparing a graduation party for Hannah Lewis, including buying decorations, ordering food, etc.  Ellie's last club volleyball tournament is this Saturday: yahoo!  And track season should be ending soon too.

Please pray: 

• That we can get our house on the market in about two weeks.  The market is still hot and we can't really buy or write a contract on anything til we have ours sold.
• That Abby and Hannah Lewis find jobs soon.
• That I can get get the majority of packing and selling done before I start summer classes in June.  I also have to turn in my application for a fall practicum by June 6 or so, and I don't have one lined up yet.  If I can't do this, I won't be able to graduate by the end of the year. 
• Continued improvement of Todd's health and stamina; namely, that the drug will begin to help his counts go up and the need for transfusions go down.
• Family issues and dynamics as we continue to undergo weekly family counseling
• That the transition of moving to go smoothly.  That God would open and close doors: find the right buyer for our house and the right house for us to buy.  We have been struggling to find  a house that isn't too big or too small that will give us enough financial breathing room while Todd is on disability and I finish my degree.  The physical demands of moving and the emotions of giving up our home and most of our belongings is traumatic, even though we understand they are just material.  This is the only home Ellie has really known and both of her siblings will be gone at college this fall; all this will be a big adjustment for her. 

As you can tell, there is just so much uncertainty in our future.  We are doing our best to take things a day at a time, but with such upheavals and the constant concern for Todd's health, me and the kids are feeling a bit anxious and emotional. (Not Todd, he is in a different place than we are!). We understand the wisdom of asking God to give us just what we need for that day, and not to worry or be anxious about everything else, but we need reminded!  We also understand that we need to take these feelings to God through prayer and that he will supply all of our needs.  Please pray with us.

As always, we appreciate your love and outpouring of concern and support.  It means so much, to see our friends and family helping us through all of this day by day.