Friday, August 29, 2014

Good news, bad news, and life in the big city

It has taken me a good month to process the results of my bone marrow biopsy, my FISH test, the clinical trial letter I received, and information on the length of time ibrutinib works for 17p deleted folks. Sometimes I am intentionally slow at assimilating information because I need time to process it so that I do not panic.

Remember that at initial diagnosis and therapy, I had the 17p deletion. I was treatment naïve before being a participant in the ibrutinib trial. Patients have a 5 to 10 percent chance of having a 17p deletion at initial therapy, but the frequency increases to 20 to 25 percent in relapsed populations.

Let’s start out with the results of my tests from my two-year clinical trial checkup at the National Institutes of Health.

GOOD NEWS
• I still have evidence of leukemia in the flow cytometry; however, the presence of abnormal leukemic cells in my blood has been reduced since January 2014 from 86.4 percent to 59 percent. Slow, but continued improvement.

• There is no visible evidence of leukemia in my bone marrow, which is where the leukemic cells are produced. Ibrutinib works for 24 hours, which is why the pills must be taken every day. Apparently I am being a compliant patient.

• I am not in remission after two years on ibrutinib, but my white blood cell count is heading in the right direction.

• My myeloid and erythroid maturation is progressive. Translation: My white blood cells and my red blood cells are maturing. This is what we want to see, since I previously had many immature cells that never matured.

IBRUTINIB FAILURE RATE OF 17p DELETED PARTICIPANTS
Here are the facts I found in the latest research: The risk of failure on ibrutinib has been documented to be higher with patients having 17p deletion, and achieving a complete remission is significantly lower with the loss of chromosome 17.

Dr. Michael Keating also mentioned in his newsletter that a British clinical trial showed that patients with less than 20 percent of 17p deleted cells, experienced a more favorable treatment outcome compared to those with a higher percentage of abnormal cells. My numbers are way above those percentages; however, I hope to be an outlier.

So what do you do with these “bad” stats? I try to connect to others and find out possibilities. I have to keep reminding myself, "Remember that these are just statistics. It does not mean it has to be you."

One of the bloggers I follow is Dave Eckberg, M.D., who is a medical doctor and a Vietnam vet exposed to Agent Orange. He is my blood brother and has CLL/SLL and has developed 17p deletion.

I decided to read his blog from the beginning to end, and I came across a post from nine months ago that concerned me. Dr. Dave posted a blog about the ibrutinib failure rate in the 17p deletion patients after 30 to 48 months on the drug and was also concerned. And of course as I am reading it, I am thinking, “Oh, my! I am on month 25!”

So rather than let my imagination go wild, I contacted Dr. Dave to find out an update. He had an upcoming appointment this summer with Dr. Michael Keating, his CLL specialist in Houston at M.D. Anderson, and was going to ask him about the percentage of patients failing the drug. He was told 10 percent.

I also contacted another blood brother, Brian Koffman, M.D. He is a medical doctor and a CLL/SLL patient who has developed 17p deletion. He said that the majority of frontline (those who have ibrutinib as the first cancer treatment) 17p patients do great, but the success is not as high as those with relapsed disease. Progressive-free survival (PFS) is around 60 percent for 17p-deleted participants on ibrutinib at three years, according to recent research published.

Dr. Adrian Wiestner, my NIH physician, said because my treatment- naïve body has not been damaged by any prior toxic chemotherapy treatments, which destroy the healthy cells, he feels better about my survival chances.

The bottom line is that we don’t have the answers yet. Being a proactive patient, I have to prepare myself for the worst-case scenario. If ibrutinib fails me at some point, there are several clinical trials on the horizon with various therapies that could be my Plan B or Plan C. There is hope. In the future there will be options. Today the possibilities are so much better for those diagnosed with the poor prognosis than they were five years ago. So life is good.

ANOTHER BUMMER: THE CLINICAL TRIAL LETTER
Those involved in research understand that clinical trial researchers inform participants if there is a death that may be caused by the experimental drug. Participants are given a choice to voluntarily remain on the trial or leave. I received such a letter from the NIH.

Since February 2009, 6,000 human patients have been treated with ibrutinib in a commercial setting, and over 2,800 human patients clinical setting in a clinical setting. June 14, 2014 one of the NIH trial participants died suddenly from sudden cardiac death and all the clinical trial participants were notified. One of the side effects of taking the drug has been documented to be abnormal heart beats (atrial fibrillation). If any of us have had hypertension and arrhythmia in the past, we are to be particularly sensitive to any shortness of breath, rapid heartbeats, chest pain, dizziness, or lightheadedness, and we are to seek medical attention and notify NIH.

I had an EKG test performed and it came back normal. I had hypertension years ago, but a couple years prior to being admitted into the trial my blood pressure dropped to the point that I was taken off the blood pressure medicine. I have been taking my blood pressure on a daily basis. Some days it is higher than normal, but most readings are in the normal range.

I often deal with the “what-if” potential crisis by removing myself emotionally and putting on the hat of the researcher, or relying on my demented sense of humor. After reading the letter, I told my husband that the silver lining is that if I did die from sudden cardiac arrest, at least it will be a fast death, and that I better not leave the house without clean underwear. He did not think that was funny. LOL.