ENDING 6-MONTH CLINICAL TRIAL and TEST RESULTS

I have mainly good news to report, along with some not-so-good news. The not-so-good news is at the end of the blog. I have been running a marathon and I have moved passed the “block wall.” I see the finish line, but I have stubbed my toe and it is broken. I now have to continue the race knowing full well that the broken toe may be my demise.

For weeks I have been waiting for different doctor’s translations of three tests – colonoscopy, bone marrow biopsy, and cytogenetics. I know enough to be dangerous. So I haven’t felt inspirational. I haven’t felt positive. I haven’t felt courageous. I have felt fatigued and introspective. That is why I had to write my blog “Letting Go” posted February 3^rd not only for you, but for me as well. I needed to remind myself that it is important to listen to my own words. Many times I have a cognitive understanding of things, but emotionally it takes a little longer to process. I like to get all the facts first, and then I process them emotionally.

The results are in and now I am ready to write this blog.

THE GOOD NEWS

Colonoscopy Biopsy

I had a colonoscopy in January because my GP detected blood in my colon. I was off Ibrutinib for three days prior to the procedure to prevent internal bleeding. The doctor did a biopsy of a small polyps that was found. Somehow the test results did not end up on the doctor’s desk for three weeks. I kept calling and almost felt like a stalker. Results finally came in… No cancer found. No more colonoscopies for 10 more years.

Clinical Trial Continuation

The NIH clinical trial I am participating in is titled “A Phase II Study of PCI-32765 for Patients With Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) Who Need Therapy and Are Older Than 65 or Have a 17p Deletion.” It states that “PCI-32765 (ibrutinib) will be given for six cycles of treatment. Those who benefit from the drug will continue to take it as long as there are no side effects and the disease does not progress. Those who do not benefit will stop treatment and have regular follow up exams.”

As I have mentioned before, I am in the 17p deletion arm of the clinical trial in which participants can be under 65. I like to tease my blood brother George and tell him that he is in the “other” category – the “elderly.” I am sure he chuckles about this as he is zooming across country on his motorcycle. LOL

The trial is non-randomized, which means that there is no placebo. Everyone gets the drug. It is an efficacy study, which means the study produced good results in a prior study (Phase 1) and this treatment provides positive results in a controlled experimental research trial. So now you know I am not as brave as you thought. I did my research.

I celebrate the fact that at the end of Cycle 6 I qualified to continue taking the experimental drug. I have my 2013 schedule in hand and am scheduled to fly back East every three months for my drug run. Hurrah! Hurrah!

Bone Marrow Biopsy

Boy, am I learning from this clinical trial! Dr. Farooqui called me on the phone to help explain how to read the bone marrow biopsy results. This is a lesson in a foreign language. Apparently I have been reading the tests incorrectly. My cellularity has remained at 40-50% during the duration of the study, which is normal for my age (just turned 61).

What I have to look for is the result of the immunohistochemical stains on the CD79a marker. This indicates the amount of CLL in the bone marrow. In the January 2013 bone marrow biopsy, the CLL comprised 15-30% of the cellular marrow. In September 2012 it was 20-30%. In February 2012 it was 40-50%. So the good news is that the amount of CLL in my bone marrow is decreasing.

THINGS TO KNOW

About Oral Cancer Treatment

In this blog posting I thought I would address certain myths about cancer treatment. First of all taking pills orally does not make them less toxic. The patient is still receiving chemicals in their body just as they would if the drug was administered through their vein.

The problem with oral injection of a drug is human nature. There is no nurse to give you the drug. Some people do not follow the instructions. They eat before the 20 minutes is up or they eat a couple hours before taking the drug, so it does not get absorbed correctly. They eat grapefruit, which nullifies the benefit of the drug. They do not take it at the same time each day. Sometimes they even forget to take it. I look at the habit of taking these pills as my lifeline.

About Leukemia Remission

Throughout this clinical trial, I have had good news for my prognosis. I have to keep reminding myself to be grateful for what I have been given. I am only human, however, and humans want more.

Ibrutinib can normalize your bloodwork, and that would be a gift. Some in our study have normalized and I celebrate for them.

Many have said they have prayed for my remission. What most people do not realize is that when a leukemia patient is in remission, it does not mean that the cancer is gone. It means that you have a normal life for 18 months, three years, five years, 10 years or more, but the cancer will return.

Experts don’t know when and if Ibrutinib will stop working for patients. Perhaps there will be other options when and if this happens. Perhaps by then there will be a cure. We can only hope, and continue to support the funding of research.

I have shifted to a paradigm of survivorship. I understand this drug is not a cure, but I am hopeful that it will control my disease and I can have a quality of life.

FISH Test

I am learning every day. One of the first tests I learned about is the FISH (fluorescence in situ hybridization) test, which is a cytogenetic test used to examine DNA on chromosomes. For those of you who glaze over when I use my technical jargon, skip over the next three paragraphs.

I read my FISH test from a year ago (January 26, 2012) and the FISH test showed evidence of the loss of one copy of p53 (17p13.1) in 97% of the 500 WBC nuclei examined, as well as a second abnormal cell population of 13q34 in 92.8%.

Today there are still large abnormal clones. The probes identified a deletion of one copy of TP53 in 242 (86.4%) of 280 nuclei scored, and a gain of one copy (trisonomy) of 13q34 in all (100%) of the 249 nuclei scored. There is no evidence of trisomy 12, any other deletion, or other chromosome abnormality of the ATM gene.

Gene sequencing was not done at this time, because it is three times more expensive, so there are a couple findings that I am tagging as “most likely.” I am most likely one of the 81% who have 17p deletion and deletion of TP53 (tumor-suppressor gene). I most likely have monoalletic inactivation of TP53, which means I have a single deletion without a mutation on the remaining allele. Bialletic inactivation (having a deletion on both alleles) is worse than monoalletic inactivation.

The test interpretation states that “these results are essentially the same as a year ago.” A 6% change is not that much of a difference in the cytogenetic world. I would have liked to see a decrease, but no progression of the chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) in my world is good news.

THE NOT-SO-GOOD NEWS

I remember when I was in science class in my childhood and my teacher discussed that some day we will be able to have genetic tests to reveal our tendencies toward the diseases we may have to face in our lifetime. She asked us how many would want to know. There was a great deal of hesitation in the room. I raised my hand.

Well the future is here. When you want to know the truth, you need to be prepared that it may not be what you really want to hear. If you can’t handle it, then be an ostrich and stick your head in the sand. I am not good at that.

The NIH laboratory researchers examined my megakaryoctes. These are the bone marrow cells responsible for the production of platelets, which are used for blood clotting.

What I learned from my conversation with Dr. Farooqui is that trisonomy 13 is not usually seen in CLL/SLL patients. What that means is that instead of a deletion of the 13q34, which is commonly found in CLL/SLL patients, I have an addition of the 13q34. The staining indicated the amount is very low, and he assured me that it is of no concern today. I do not need treatment on this now.

But my inquiring mind wants to know what this infers. Apparently trisonomy 13 is found in myelodysplastic syndrome (MDS). This disorder means that the bone marrow is not producing cells correctly. These immature stem cells that accumulate in the bone marrow die prematurely and are called “blasts.” If a person has 10-19% blasts, he is categorized as a high-risk MDS patient. If a person has 20% or more of the blasts, he is categorized as having acute myeloid leukemia (AML), which is another type of cancer. So the optional bone marrow biopsy I was supposed to have this summer is now medically required, so the medical team can keep the potential for this secondary cancer in check. Not what I was hoping to hear. Now you know why I needed to get my mind right…

FINAL THOUGHT

I need to focus on what is, not what might be. I leave you with this quote:

“(S)He is a wise (wo)man who does not grieve for the things which (s)he has not, but rejoices for those which (s)he has.” — Epictetus