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

Appointment at Memorial Sloan Kettering

There is so much to say I don't know where to start and what to include in this post. 

First, I need to give a shout-out to The Corporate Angel Network. I can't say enough good things about our experience so far. I spent time on the phone last week coordinating the appointment, securing a hotel, and waiting to hear about flights. 

We got the call Thursday that they got us a flight into Terboro Airport, NJ leaving out of Columbus, OH. They arranged for a car to pick us up at the airport and drive us to our hotel into New York City. We had to pay for the trip/car but it was so nice to let an experienced driver navigate the narrow lanes, traffic jams, constant honking, and aggressive drivers. 

On Friday,March 20, 2015 we got a call that the Angel network had secured us a flight back on Tuesday morning, March 24, and a free shuttle ride back to the airport. We would only have to pay a cab to get us to the shuttle location before 7 am. The flight would return back to Columbus so we would be able to drive ourselves to the airport and leave our car. 

Meanwhile, in Dayton they wanted to  give him IV antibiotics for seven days so they had to schedule around our trip 

We arrived an hour early to the independent Flight company an hour early. It was so nice not to have to go through security, put our liquids in small bottles, and be exposed to all the people at a public airport. The pilots were so nice and made us feel welcome. The  company members, whose flight we were on with, were so gracious and hospitable to us. The flight from Columbus only took 1 hour!  We landed and our car arrived shortly and took us to our hotel, The Bently, in the upper east side of Manhattan, which is only four short blocks from the hospital. We didn't have time to go to get food at a restaurant, so we grabbed a bite at the hospital's cafeteria. The appointment was at 2:00 pm. 

The space inside the hospital was very tight, which makes sense for a prime real estate area in New York. The staff were all extremely friendly and accommodating. I also liked their policy of asking everyone to wear masks, including family members in the Cancer office waiting rooms. They also provide rubber gloves for patients who don't want to touch anything. 

We didn't have to wait long to see Dr. Stein. He wasn't anything like I thought he would be. He was short, friendly, personable, honest, and straight-forward. He asked Todd to recount his medical history from the time of diagnosis in October 2011 to present. Then he gave us the opportunity to ask questions, which I had a list of!  

I started with asking him about his opinion to do a second transplant or not. He said it doesn't matter whether to do the second transplant now or in the future. He felt that Todd would still have the same results. He asked us if we were aware of second transplant outcomes. I said yes, they weren't good. He said that's right. According to the published reports, second transplants have a success rate of 5% to 10% and he felt those numbers were generous. 

I asked if Todd would be a good candidate then for the study and he said so far everything looked good. I also asked if there would be a better study out there besides this one, and he said no.  For Todd's MDS with the IDH2 gene mutation, this was the right one. 

We asked if we could start the study here and then transfer to another closer study location and he said yes. According to his sources, Cleveland might be up and running by mid-April at best. 

I asked if the drug was working for him, could he stay on it indefinitely and he said yes. They would continue to administer it to him throughout the additional phases of the study as long as there were no complications or adverse events (AE). Todd could continue transfusions and his current medications without any restrictions. 

When I asked about how often we would need to return for testing throughout the study, his answer surprised me; it was a bit more often than I had anticipated. The first month, we would be required to be present once a week. After that, every 15 days or twice per month. Testing on days 1 and 16 the first month would be the most intense with testing lasting 10 hours each day. He advised us to be prepared to stay an extra day afterwards to have some recovery time before flying home. 

When I asked the most important question: What could we expect from the drug that would help Todd and how soon he could start it, he began by saying that they are not sure how sustainable the response would  be. They hadn't got that far along yet in the studies.  So far, they have had patients still having positive results for as long as 14 months. He was clear to say that the drug should not be considered "curative."  He said the goals he would like to achieve in Todd's case would be to get his counts high enough to get him off of transfusions and to get his white count up past the point of being neutropenic. Blast counts at this point wasn't considered a major issue, since they were already low at 3%. The good news is that the drug can create healthy neutrophils from the blast cells, because it allows them to mature. 

He was very frank with us when I asked him what his opinion was regarding Todd's prognosis. Todd's BMT doctor just danced around the issue, and we wanted to know the truth. He regretted to tell us that relapsing within the 100 day period post-bone marrow transplant was detrimental and that Todd's only real hope for a curative treatment was the transplant. I cried and said why didn't the transplant work!  Everything was ideal going into it. I said I wish we hadn't done the transplant and it only seemed to make things worse. He assured us that we did the right thing in pursuing the transplant. There was no doubt in his mind that he would have recommended the transplant too, even if it was for a family member; he would have done the same thing.   It's so frustrating and hard not to ask WHY???

I asked him what was the difference  between staying on monthly rounds of Vidaza or doing the trial drug. He said that after looking at Todd's blood work, it didn't look like the Vidaza was really working. His platelets have come up but his other counts are still down. He also asked us if we know how sustainable Vidaza is, and we acknowledged that there would likely be a point where he would no longer respond to Vidaza. He agreed. In all fairness though, I had learned that it takes 4-6 cycles of Vidaza to reap the best benefits and Todd only had 3. 

With Todd's MDS, his blast counts have never been out of control or escalated to AML (>20%), but that's not what is affecting Todd's condition. Right now it's the low blood counts, especially his low white and neutrophil counts. This puts him at such a high risk of infection. As a matter of fact, he put it bluntly that for most patients in Todd's condition, infection is the most likely cause of death. The doctors are doing what they can to prevent this scenario by giving him antibiotics and antiviral medication. Monitoring his temperature is crucial. It is often the first sign of infection. If caught early, they can treat it more effectively. 

As to the costs, we are responsible for the preliminary screening, which our insurance should cover. Once he has been deemed eligible for the study, the drug company will pay for tests and treatments associated with the trial. In addition, they will help out with travel expenses up to a certain amount. 

So far there are at least 73 patients currently on the drug officially. It is a pill taken usually once or twice a day. We will be notified what amount and dosage Todd will take. When I asked about side effects he said that there have been some. Mainly an increase in bilirubin, but no major complaints of nausea or diarrhea. Among the AEs there have been some concerns with heart and lung problems. 

This is why they run all of the baseline tests: to establish how his organs are prior to the study and if there are any significant changes that could be caused from the drug. 

We asked how soon Todd could enroll and he said it takes about a week to sign, screen, and receive eligibility status. We asked if we could start by signing the consents that day, but he said no. Apparently, you can't see the doctor and sign the consents the same day. (Might look like Coercion). He asked if we could stay another day or two so we could get everything started while we were already here. We said we thought it could be arranged if they could do everything tomorrow. So his staff began to see if they could get all the necessary tests scheduled for the next day, while I called The Corporate Angel Network to switch our flight, and the hotel to see if we could stay another night. They got everything scheduled and so did we. I called my mom and asked if she minded to stay another day-it was fine. 

Before we left the hospital they needed to do a finger stick to collect a little blood to check his counts. Then he had to have a chest X-ray to look at his Hickman catheter. This protocol has to be done since Todd's Hickman was not put-in by Memorial Sloan Kettering. They have to ensure that it was done right and looked good before they are allowed to draw blood from it. 

It was rush hour when we left. We walked back to the hotel and Todd put on his PJs and took a nap. I eventually joined him. We napped until about 9:00 pm. We were too tired to go out so we ordered a true New York style Margherita pizza and had it delivered to our room. It was delicious. We watched a bit of TV and I flushed his lines and worked on the blog. We were looking forward to sleeping in, getting a hot shower, and getting a good breakfast since we didn't need to be at the hospital until 12:00 noon. 

In closing, We were sad to hear that our hopes for a curative second transplant were confirmed: not to pursue it because the rate of success would be very low. We were encouraged that we could start the process of getting enrolled so soon. Although the drug is not considered curative, we have hope that Todd will see an improvement in his counts and hopefully have more energy, and a better quality of life. There is still so much they don't know about the sustainability of the drug, or how long it will work, but we feel this is the best option for now. There is always hope that it will work for a long time, or long enough until another cure or newer treatment becomes available. 

I keep telling myself that miracles happen everyday!  It could happen for Todd. Thanks for your continued prayer and support. God is still in control of the big picture. 

Appointment Set & Gene Mutation Confirmed

It's been so long since I've blogged, that I forget where I left off!  Last week was so busy!  On Wednesday, March  11, 2015, I was called in to substitute teach.  When I got home, Todd told me that he had talked to the bone marrow transplant doctor in Cleveland and that they had the rest of his bone marrow biopsy results back.  The result we needed the most was the confirmation that he still had the IDH2 gene mutation, that qualified him for the AG-221 drug study.  Unfortunately, they told him that there was not enough DNA from the biopsy to complete the test!  We waited two and a half weeks to hear this!  His cytogenetics did come back showing just the one same 5q chromosomal deletion as his first biopsy post-transplant.  This was good news, but the doctor still did not think that the medication Revlimid used to treat patients with this single 5q deletion would work, because he had multiple complex deletions prior to transplant.  The problem with attempting to treat Todd's cancer with this drug right now is that it ONLY treats this one deletion.  While it could wipe this one out with constantly taking the medication, it won't prevent the other deletions/chromosomal abnormalities from coming back at any time.  This would be a waste of valuable time and somewhat counter-productive.

His BMT doctor thought it would be a good idea to see if his oncologist at Cleveland, who originally ran the DNA testing that discovered the IDH2 gene mutation, might still have a sample left of his marrow.  So, she recommended calling him to see what he suggested.  This doctor was Todd's main oncologist/hematologist prior to transplant.  We got to talk to him shortly afterwards.  He gave us recommendations of other doctors in the field that he trusted because of their experience.  One was at Northwestern in Chicago where they are conducting the trial study; another was at MD Anderson in Houston, Texas, also doing the study; and a third was a former fellow and student who now works at Memorial Sloan Kettering.  He knew of Dr. Stein and informed us that he and any other doctors assigned as the primary investigators of the study were being paid by the drug company Agios who is conducting the studies.  (This is called full disclosure).  We knew this, but in my search without a recommendation in Nashville, I called Dr. Stein's office anyway, because at least he was familiar with the drug and its results.  He told us that Dr. Stein was young and that we may want to consider a doctor who has been in the field longer, but that we should go wherever we could get in first!  Just because we sent records did not obligate to keep an appointment.  He also confirmed that it would likely be at least a month or two before the drug study would be at the Cleveland Clinic. 

When we asked about the Todd's former bone marrow samples, he said he had them in a freezer, but that whoever does the study would probably want a recent result.  He recommended our local oncologist collect a sample of peripheral blood cells to send to special lab in California to get the DNA IDH2 gene mutation results from that.  They took this sample last Thursday and I called to follow-up that they sent it to the right lab.  (Ugh...)

So, we started looking up names and phone numbers of places and doctors to call.  First, we had to confirm with the insurance company that these doctors and hospitals were in-network.  We have learned that routine blood work and other tests will not be paid for by the drug company during the study, so it is important to make sure you have coverage for the incidentals.  All three recommended doctors were in-network. 

Next, I called the doctor at Northwestern in Chicago since it was closest.  Unfortunately, the doctor would not be able to see us until April 1, 2015, which I thought was too far out.  Then, we called MD Anderson, but before we could schedule anything, they had to get our insurance information and process a request for coverage.  Since then, we have been playing phone tag, with no appointment scheduled yet. I tried to call them again today, but they refused to talk to me, stating that they had to talk to Todd first to get permission to talk to me.  We went round and round for ten minutes; I tried to hand the phone to Todd during his blood transfusion, but we can't get a signal in his ATA room and of course, the call was lost. (I had been standing in the hallway).  MD Anderson might be the #1 ranked cancer hospital or whatever, but I'm not impressed with their scheduling and staff!  Who would even want to go there after all that? 

While all of these calls were going on, Dr. Stein's office called and asked for a special request that Todd's pathology slides be sent to him by an express delivery service.  I told her we didn't get the results back from the biopsy confirming the DNA, but she assured us that Dr. Stein could always perform a bone marrow biopsy at the appointment.  So, I called both the local oncologist's office and Todd's BMT doctor in Cleveland to get the necessary records sent to MD Anderson and the slides to Dr. Stein. 

The next day, I called the Corporate Angel Network about arranging a flight to New York for the appointment on Monday, March 23, 2015 at Memorial Sloan Kettering with Dr. Stein.  They were able to take down all of our information and get Todd registered for a flight.  They told us that they could NOT guarantee us a flight for that day, so that we would need to have a "back-up plan."  She asked us what our back-up plan was, and I said driving I guess!  We told her we could return the same day, but she said most flights leave in the mornings, so that means we will have to get a hotel room for the night.  Since then, we talked to our pastor when he came to the house to visit, and he advised us NOT to drive into New York City.   That it was extremely difficult and parking too cost prohibitive.  Unfortunately, buying two last-minute plane tickets will also be cost prohibitive. 

The Corporate Angel Network is supposed to notify us 24-48 hours ahead of time if they were able to secure a flight for us.  I need to start working on a "back-up plan." I can call the other flying services for cancer patients and/or our pastor said he knew someone who was a pilot who may be available.  Today, our local oncologist told us that some airlines are willing to sell discounted airfares to cancer patients for appointments with some kind of doctor's note.  We could try this or just cough up the money (what's a little more debt?).  If none of that works, we hope to have a second appointment secured somewhere else.  (Looks like it won't be MD Anderson).  I'm thinking about calling back to Northwestern in Chicago and seeing someone else or just taking the April 1 appointment if it is still available.  At this point, I am going to do whatever it takes to get him in somewhere else!  And if we aren't happy with the opinion of the doctor we see next, then we will keep going until we are.

Todd's counts were not good last Thursday, March 12, but he didn't need any transfusions that day because his hemoglobin was at 8.1.  We would normally feel happy about this news, but not that day.  Todd had already felt run down and not getting a transfusion then meant having no energy until they could get blood work again on Monday, March 16.  His platelets were good, but his ANCs and white counts were "non-existent."  The nurse had me a bit scared and went to talk to the doctor about having his Hickman catheter removed (because they can be a magnet for infections), but we did not agree with this.  His Hickman looked good and he wasn't having any problems with it.  It makes transfusions and blood work so much easier on him that having to poke his arm which takes weeks to heal.  They did caution us though to take his temperature often throughout the day.  They told us that the guidelines for fevers had changed from calling with a temperature of 101.4 or higher to 99.5 or higher!  This also seemed overkill, because he had been running a low grade fever off and on.  We understand the risk of infection, but felt that running him to the hospital for a low grade fever only exposed him to more infections there than at home.  So, throughout the weekend, we took his temperature about three times per day.  If his fever went above 99.5 we waited 30 minutes and took it again.  If it went up or stayed up then we agreed we would call, but we didn't have to.  His fever did get up to 100 but only when he had been sleeping in the warm bed.  Once he got up, it went back down to under 99 degrees. 

We were due to see the doctor and have his blood work done this morning, Monday, March 16, 2015.  His hemoglobin was at 7.3 which was low enough to warrant a transfusion (<8.0).  His platelets jumped up to 70,000! But, his whites were still barely on the radar at .2. 

Here we sit, once again in the Advanced Treatment Area (ATA) of Miami Valley Hospital getting his two units of blood.   I pray it will energize him for several days.

For some reason, he is still scheduled to return to the Cleveland Clinic for treatment and to see his bone marrow transplant doctor this Friday, March 20, 2015.  I guess it is part of his monthly post-transplant check-up, but I hardly see the point, except that it will give us the opportunity to talk to his BMT doctor face-to-face and to get his breathing treatment of Pentamidine (anti-fungal) to prevent any lung infections or pneumonia.

Post script. The blood work taken last Thirsday confirmed that Todd has The IDH2 Gene mutation.  So we are good for the study!  Now we need to pray for the airfare or positive response from Corporate Angel Network