I WILL NOT LOSE HEART

Scripture tells us: "... do not lose heart, but I am heart-broken. It is the unexpectedness of death that causes despair. I think of those sweet little children and caring adults in Connecticut, who lost their lives… such a senseless act of violence. I cannot imagine the pain those families must endure.

Another heartbreak happens when we are blind sighted by the sudden death of a positive person, who is feeling better than ever, who says that life is good, and hope for cancer maintenance or cure is within his reach. When I start to feel really good and a little complacent about my situation, it is then that reality shakes me to the core.

The CLL/SLL community just lost a cancer warrior. Today in Lake Stevens, Washington, was the memorial service of Randy Shirley, who was a participant in the ABT-199 clinical trial. He was 55-years-old when he died. Just like most of us on the kinase inhibitors, on Monday Randy remarked that he felt better than he had since he was diagnosed. Randy’s drug dosage was increased Tuesday. Wednesday he died. This was reported by Dr. Brian Koffman (http://bkoffman.blogspot.com/2012/12/randy-shirley-another-cll-warrior-passes.html).

There are a number of us who have volunteered in clinical trials to be participants in testing kinase inhibitors to manage CLL/SLL (Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma). The three drugs that are presently being tested are: (1) ABT-199, (2) GS-1101 (formerly known as CAL-101), and (3) Ibrutinib (formerly known as PCI-32765).

I knew Randy virtually from an interactive site about leukemia. He was an optimistic soul. He did not let leukemia own him. Randy’s motto was “Never, ever give up!” Randy was not supposed to die. The cancer treatment was working for him. So you see, the reality is that life is fragile and you can still die, even if you are upbeat and proactive.

I used to say that anyone can die walking across the street and getting hit by a truck. I don’t say that anymore, because it minimizes the daily struggle of a cancer patient.

Even though I am heart-broken, I have not lost heart and I have not lost hope. I know that a positive and warrior attitude will make my life’s journey a quality one. I will still take my chances and live my life with gusto, gratitude and love. I will not live in fear. And I will thank God for every single day I have on this earth with the people I love.

WHAT IS HOPE?

Esparanza…

“Listen to the mustn'ts, child. Listen to the don'ts. Listen to the shouldn'ts, the impossibles, the won'ts. Listen to the never haves, then listen close to me... Anything can happen, child. Anything can be.”

― Shel Silverstein

According to Merriam-Webster Dictionary, HOPE means “to desire with expectation of obtainment.” Wikipedia contributors state that “Hope is the emotional state which promotes the belief in a positive outcome related to events and circumstances in one's life. Despair is the opposite of hope.”

This weekend the 54^th Annual Meeting of the American Society of Hematology (ASH) is underway in Atlanta, Georgia. My doctors at National Institutes of Health (NIH) in Bethesda, Maryland, and M.D. Anderson in Houston are presenting their findings on the magical drug Ibrutinib (formerly PCI-32765), along with other leukemia experts from The Ohio State University. The phrases “promising,” “has the potential to improve long-term prognosis for patients,” “high response rates,” “durable remissions,” “including patients with high-risk disease (me),” “effective and safe targeted treatment option,” “manageable toxicities,” give me hope.

Let me review what chronic lymphocytic leukemia (CLL) is for those of you who asked. It is a blood cancer that causes malignant white blood cells to gather in the lymph nodes, bone marrow, blood, and other organs of the body. The cancerous cells causes organs to enlarge, bone marrow to be so impacted that it cannot produce red blood cells, lymph nodes to enlarge to the point that it impacts other organs of the body, and white blood cells increase exponentially in the bloodstream, since the malignant cells do not have the message to die.

Ibrutinib, which is the experimental drug I am taking at NIH, is an anti-cancer therapy that specifically targets an enzyme that is important to the growth of CLL. The enzyme is called Bruton’s tyrosine kinase (BTK). Ibrutinib “unhooks” the leukemia cells from the lymph nodes, bone marrow, and organs. The “unhooked” leukemia cells then flow into the blood stream causing a temporary increase in white blood count (WBC). Ibrutinib also gives the leukemic cells the message to die, so once the cells enter the blood, they essentially starve and die. An important thing to know is that unlike chemotherapy, Ibrutinib promotes the death of the malignant cells and does not harm healthy cells.

Today there is no knowledge of the long-term side effects of using the drug. Today there is no knowledge of when the drug stops working. But today for me, HOPE comes in the form of three blue capsules a day…

“I believe that imagination is stronger than knowledge. That myth is more potent than history. That dreams are more powerful than facts. That hope always triumphs over experience. That laughter is the only cure for grief. And I believe that love is stronger than death.”

― Robert Fulghum, All I Really Need to Know I Learned in Kindergarten

P.S.: Thank you Rocky and Liz for naming my granddaughter “Hope.”

BEGINNING CYCLE 6: I HAVE NOTHING TO COMPLAIN ABOUT

My “drug run” was successful. Just got back from National Institutes of Health (NIH) in Bethesda, Maryland at midnight. Couldn’t get a direct flight back to Phoenix, so I had to fly to Las Vegas and then wait for a connection to Phoenix. Never-the-less, it was worth it. The experimental drug Ibrutinib (PCI-32765) has caused my white blood count (WBC) to continue a downward trend to 53,000, which is the WBC I was at exactly two years ago. This is a very good thing. This makes me feel like I have been gifted those two years. One of my clinical brothers (Matt) has actually normalized, and his WBC is now in the high normal range. I am so happy for him.

I met more participants in the trial on Friday and we exchanged lots of information about our progress on the drug. Many of us don’t shake hands. Many of us have even moved past the Obama knuckle bumping. We decided for health reasons that we will do elbow bumping when we greet and leave each other. I – on the other hand – carry antibiotic gel with me, just in case I need to touch someone’s hand. I’ve still got my mother’s European need for human contact in me.

OUR COMPROMISED IMMUNE SYSTEMS

One of the clinical trial participants continues to have Immunoglobin infusions (IVIG), even when her numbers are above the recommended number to receive infusions, in order to prevent bouts of pneumonia. Her WBC is almost in the normal range and she has been taking Ibrutinib three months longer than me. Even though we have been getting positive results from Ibrutinib, our compromised immune systems will probably always be susceptible to viral and bacterial infections, so extra care must be taken so that a common cold does not transform into deadly pneumonia that lands us in the hospital.

Saline solutions and a room humidifier (Honeywell was recommended by a participant) are helpful to prevent the bloody noses and/or the breathing problems. No Neti Pots, according to some of the participants, because the nostrils are a direct passageway to the brain. Not using distilled water, or not properly cleaning the Neti Pot can cause death through brain infections. See

http://well.blogs.nytimes.com/2012/09/03/rare-infection-prompts-neti-pot-warning/

http://www.forbes.com/sites/daviddisalvo/2012/08/27/how-not-to-die-using-a-neti-pot/

DRUG COMPANY DISCUSSION

NIH had a discussion with the drug company, based on the ordeal we all went through with cancelled flights to the East Coast due to Hurricane Sandy. They gave us extra pills to tide us over in case of another weather crisis. We are all thrilled.

SIDE EFFECTS

My side effects this month have been nothing to write about. I have just noticed that it takes longer for me to heal from even a mild scratch. I still get slight stiffness or cramping in my hamstring muscles and my thumbs, especially if I am exposed to cold or hold a position too long. Because the drug often causes internal bleeding, I am not surprised that blood was found in my colon, so off to the colonoscopy doctor I go. What a pain in the butt! LOL.

I have gotten over my fear of needles and am no longer as ticklish as I have always been. When you are poked and prodded so many times, it becomes your new normal.

BLOOD TEST

• My morphology report indicates that I have giant thrombocytes (platelets). According to the experts, this could be fragments from the CLL cells, and should be of no concern.

• I also have a rare teardrop-shaped red blood cells, which is a technicality, and have more than likely been caused my the CLL cells.

• I have mild hypochromasia, which means I have a mild anemic condition due to a deficiency of hemoglobin in the red blood cells.

• My LDH is normal, which is great.

• My kidneys and liver are normal.

• My GP discovered that I am Vitamin D3 deficient, so I have increased my Vitamin D3.

• My local oncologist/hematologist continues to give me monthly B12 shots, since I was diagnosed B12 deficient when I first was diagnosed with leukemia.

AND IN SUMMARY

The research team met with me and were pleased that I wrote a letter to President Obama about the value of the NIH funding. NIH and this clinical trial has been my lifeline. So I have absolutely nothing to complain about.

Reposting of Dr. Brian Koffman's post on Ibrutinib Creators

Thank you, Dr. Brian, for this wonderful post about the inventors of our miracle drug.

Now a Word from the Creators:
The Team who Designed and Synthesized the Molecule now called Ibrutinib

http://bkoffman.blogspot.com/2012/11/now-word-from-creators-team-who.html

MORE LEUKEMIA RESEARCH TO SMILE ABOUT

Well  Thanksgiving is over, but my gratitude is not. I am grateful for my family, my friends, my online CLL friends, and the amazing researchers and staff at the National Institutes of Health. How very blessed I am to have the opportunity of being in the NIH ibrutinib clinical trial. I am grateful to have my 15 minutes of fame on this earth by being a participant.

Dr. Mohammed Farooqui will be presenting some of his findings from our clinical trial at the American Society of Hematology in Atlanta, Georgia in December 8-11. One of his findings is that platelet function does not seem to be affected negatively for participants on the experimental drug ibrutinib.

His abstract can be found at this link:
https://ash.confex.com/ash/2012/webprogram/Paper50250.html

My friend Michael Novak also alerted me to a new finding in the leukemia world. Dr. Robert Weinkove is a Clinical Research Fellow at the Malaghan Institute of Medical Research in New Zealand. His research focuses on vaccinating leukemia patients through stimulating the activity of an immune cell called invariant natural killer T (iNKT). This is another targeted immune therapy.

Here is the link, if you would like to read the entire article:
http://www.malaghan.org.nz/news-and-events/boosting-immune-responses-against-leukaemia/
http://sciencealert.com.au/news-nz/20122011-23865-2.html

We are at the brink of discovery. The maintenance of leukemia for high-risk patients, and perhaps even the cure are right around the corner.

I am headed out to Bethesda, Maryland next week. I will be posting the results of my tests after I return.

HAPPY DANCE TIME AGAIN

Boy, did I have a wonderful trip to National Institutes of Health in spite of the scare that my flight could have been cancelled because of Hurricane Sandy. George and Matt (my PCI brothers), who began the clinical trial on the same day as me, both made it to NIH, and that made me very happy. I had dinner with my cousin Sammy, who works at NASA, had two non-stop flights, sat in the window seat each flight, read half of my book, slept on the plane on my way home, chatted and laughed with my wonderful OP7 (Outpatient Floor 7) friends, had my Chi Tea latte non-fat vente… Who could ask for anything more?

I delivered a copy of the letter I sent to President Obama about NIH and the request for continued funding to the NIH research staff. This is the way medical care should be done. I am forever grateful and I cannot say it enough.

One issue that needed to be addressed was the Hurricane Sandy and flight cancellation situation. We discussed this with the research nurse and found out that according to the drug company, Ibrutinib cannot be shipped to us, if a disaster happens again. It must be picked up in person. This is not very logical to me. If another disaster happens, it seems like we should be able to get local outpatient blood work that could be expedited and faxed to NIH. Then if our neutrophils are high enough, we should qualify for the next supply of the drug. NIH is talking with the drug company again about this. Sounds like the drug company needs a Plan B.

In a prior post I mentioned that as of October 4, 2012 the clinical trial at National Institutes of Health in Bethesda, Maryland (NCT01500733) has been suspended and is currently under review. I emailed those who asked what this implies. I will repeat it again. What this means is that existing participants are not affected. New participants waiting to start the drug may have a little delay. This is normal procedure in reviewing a clinical trial at NIH.

THE GOOD NEWS!

My white blood cell count has continued to go down from 84,500 to 68,170 (another 16,330). I am now beginning Cycle 5 of Ibrutinib. Everything is headed in the right direction. Everyone I have talked to at the trial is responding well or at least maintaining. We are the happy people sitting in the OP7 lobby.

SIDE EFFECTS FOR CYCLE 4

These are my side effects for Cycle 4, which may or may not have been caused by the drug:

• At the beginning of Cycle 4 (October 7) I returned home from a grueling 7½ hour flight from Baltimore. My left side, my left waist and my left back were so sore it almost took my breath away. It felt like a constant cramp that lasted three days. I had difficulty sleeping for a few nights and started getting concerned that I was bleeding internally or something was wrong with my kidney, and of course, none of that was true. It was my muscles that were hurting – perhaps from my cramped position on the plane ride home. I treated myself to a one-hour massage from an oncology nurse at the hospital. I have been fine since.

• About five days into Cycle 4 I ate a couple tangerines and a tomato (apparently too much acid) and the inside of my mouth paid for it. I got two blisters on the bottom of my tongue and the inside of my entire mouth (including inside lips) is very tender and sensitive. I could hardly brush my teeth without it feeling like my gums were bleeding (which they did not). This lasted about five days.

• Three-fourths of the way through Cycle 4 I noticed a red neck rash. Part of it was shaped like a perfect triangle. I also have Rosacea, so perhaps it was that. It was gone by the second day.

• Had a running nose and sneezing that lasted two days.

• At the end of Cycle 4 after arriving in hotel, I noticed the top of my left hand was covered with little numerous tiny pinhead-sized purple or red spots, which are flush with the surface of the skin. These are called Petechiae and are tiny hemorrhages within the dermal or submucosal layers. They went away after two days.

Believe me, I can live with these minor irritations.

BLOOD WORK

• I am still without monocytes, eosinophils, and basophils, but that seems par for the course.

• My LDH (lactate dehydrogenase) is 250, which is higher than normal, which is (113-226).

HOPE

This miracle drug -- Ibrutinib – has given all of us hope. So much research in targeted therapy is underway. The next step is to get access to the drug after the trial is over.

HAPPY DANCE

I got my airline ticket to NIH! Doing the HAPPY DANCE!!!

I will post when I return...