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...

OBSTACLE

NOUN obstacle (def) = something immaterial that stands in the way and must be circumvented or surmounted;

For example: "Lack of imagination is an obstacle to one's advancement"; "The poverty of a district is an obstacle to good education"; "The filibuster was a major obstruction to the success of their plan"; “Hurricane Sandy is an obstacle to Dr. La Verne getting her ibrutinib.”

If this wasn’t so serious, I would be laughing ‘til I cried. I not only have to fight cancer, but now Hurricane Sandy is headed right to the DC/Baltimore area, where my plane is supposed to land next week and my cancer treatment drugs need to be picked up. My last day’s supply is Thursday. Stay tuned…

Blog gadget update

I just added a new gadget to my blog called FOLLOWERS. I would love for my subscribers to use that gadget by clicking on the "Join this site" button, so that I can see who is following my blog. I have had over 1,000 people viewing my blog, but I don't know who you are unless you have posted a comment, emailed me personally, or if I have seen you in person. Thank you in advance.
-- LV

WORDS of WISDOM

I had the honor of attending Chaya Venkat’s last meeting at her house in Columbia, Maryland – that is, until she “gets her mojo back.” It was really worth my while staying longer in the East Coast after my medical appointment at NIH (National Institutes of Health).

Chaya, the chief science writer for http://updates.clltopics.org/, is a priceless patient advocate for leukemia patients with all different venues of CLL/SLL. She gives relentlessly to leukemia patients. She has been my personal virtual rock, since I was diagnosed with 17p deleted malignant B-cells that have run amuck. She has been our voice, the layman’s translator of academic medical jargon, and the inspiration for us to take control of our own health. She has been the empress of all dragon slayers, but has grown weary in the battle. Chaya has been wounded too many times with the deaths of friends. She has held thousands of hands, and touched thousands of hearts. Now her heart needs a little R&R and healing, so off to India she goes. There is not enough love and gratitude to give back to that lovely woman. I personally will be forever grateful. I pray every day that she gets her mojo back…

This blog posting is a summary of the meeting topics I found most interesting to me. I am hoping this will inform those who are caretakers, as well as those who are patients.

I. TOPIC 1: DECISIONS ABOUT YOUR CANCER TREATMENT

A. When you enter a clinical trial, be aware of the informed consent.

B. Once you make a decision, “do not look back and second guess yourself, because therein lies madness…” (a quote from Chaya)

C. The buck stops with you the patient. You won’t be handed information. Don’t take it personally. You must be your own advocate.

D. Understand that the suicide rate is the highest in the oncology field. It can’t be fun watching people die.

II. TOPIC 2: FCO vs. FCR vs. BR CHEMOTHERAPY

In summary, FCO appears to work better than FCR, and FCR appears to work better than BR for most CLL/SLL patients.

A. FCO (fludarabine + cyclophosphamide + ofatumumab)

Fludarabine (trade name “Fludara”) is a purine analog that relies on a p53-dependent mechanism for cell kill; therefore, it is not as effective for 17p deleted patients.

Cyclophosphamide is an alkylating agent.

Ofatumumab (Trade name Arzerra, older name Humax-CD20) is a fully human protein that attaches to the CD20 marker. With previously treated patients who were fludarabine refractory and Campath ineligible or refractory, ofatumumab did seem to work better than Rituxan in clinical trials. Ofatumumab hangs onto the B-cell longer.

B. FCR (fludarabine + cyclophosphamide + Rituxan)

FCR is often referred to as the “gold standard.” This frontline treatment has been used successfully for a number of years. This is not a cure, however, and most patients will relapse after seven years.

Fludarabine (trade name “Fludara”) is a purine analog that relies on a p53-dependent mechanism for cell kill; therefore, it is not as effective for 17p deleted patients.

Cyclophosphamide is an alkylating agent.

Rituxan (rituximab) is a monoclonal antibody that is often called “mouse juice,” since it is made from human protein and mouse protein. It attaches to the CD20 marker.

C. BR (bendamustine + Rituxan)

Bendamustine (Treanda) is a purine analog/alkylator hybrid agent.

Rituxan (rituximab) is a monoclonal antibody that is often called “mouse juice,” since it is made from human protein and mouse protein. It attaches to the CD20 marker.

III. TOPIC 3:  INFECTIONS

A. Bacterial infections

CLL/SLL patients get bacterial infections if they do not have enough IgG in their blood work. CLL cells cannot grow up to be healthy plasma cells. Pneumonia is caused by bacterial infections. Therapy will not help IgG. The only drug that has made IGG levels go up is Revlimid (Lenalidomide).

IgG can be replaced with IVIG ($10,000 per dose). Blood from as many as 10,000 donors could be used to make a single batch of IVIG. IVIG is a blood product that is in short supply. IgA and IgM cannot be replaced.

B. Viral infections:

T-cells work with viral infections.

C. Clinical trial eligibility:

If a patient has been exposed to Hepatitis C, he or she is not eligible to participate in most clinical trials.

D. People don’t die of CLL/SLL. They die of one or more of the following:

1. secondary cancers

2. side effects of cancer treatment

3. pneumonia

E. How to prevent infections:

1. Have your Vitamin D3 level checked by you GP. Remember that excessive Vitamin D is also toxic.

2. Chew Trident sugarless gum or any gum with XYLOTOL. It is a sugar alcohol sweetener used as a sugar substitute, and bacteria can’t eat it. It essentially starves your bacteria. Xylitol is actively beneficial for dental health, reducing tooth decay to a third in regular use, and has been shown to reduce the incidence of ear infections.

3. Get inoculated. Get a pneumonia vaccine as soon as you are diagnosed. It works for five years. The longer you wait to get this inoculation, the less chance you have of it working fully. Get a flu shot every year, even if it has less of a chance of working as the time from diagnosis goes by.

4. Break the habit of touching your face.

IV. TOPIC 4:  KINASE INHIBITORS and REVLIMID

A. Ibrutinib (PCI-32765):

This is the kinase inhibitor clinical trial in which I am participating. NIH says that the drug will be FDA approved in 2-3 years. Chaya believes it will be more like 5 years until it is commercially available.

A couple participants have reported iron deficiency and being anemic due to gastro intestinal bleeding. This is a micro leak in the G.I. track – essentially a small almost unnoticeable leak that adds up over time.

B. CAL-101:

24% of the participants on the kinase inhibitor trial are suffering from Grade 3-4 pneumonia, according to Chaya.

C. Revlimid (lenalidomide), a thalidomide analogue (which caused limb abnormalities in babies when used during pregnancy) has proven to be a disappointment in treating 17p deleted patients. Overall, it has caused 80% of participants to have Grade 3-4 hematologic toxicity.

V. TOPIC 5: BONE MARROW

A. Pancytopemia means that the bone marrow is dead. This occurs in late-stage CLL/SLL. Red and white cells, as well as platelets are drastically reduced.

B. The white blood cell count and ALC (absolute lymphocyte count), which is the sum of the B and T-cell counts, are not as important as the infiltration of the:

1. bone marrow

2. spleen

3. liver

4. and lymph nodes

C. These counts are important for bone marrow health:

1. red blood count (normal range 3.93-5.22 M/uL)

2. hemoglobin (normal range 11.2-15 g/dL)

3. neutrophils (normal range 34.0-71.1%)

4. platelets (normal range 173-369 K/uL)

VI. TOPIC 6: HEALTH TRIVIA

A. The basal temperature of a leukemia patient is abnormally lower than the normal person. If a healthy person’s body temperature is 98.6 degrees Fahrenheit, a leukemia patient can have a full-blown fever at 99 degrees.

Take your temperature the same time each day for 2-3 weeks and chart the results. This will be evidence to give your doctors to show your lower body temperature.

B. Dental care is very important for a CLL/SLL patient. Please inform your dentist that you are a leukemia patient. Let him or her know about your treatment and side effects.

C. Types of cytopenia:

1. anemia = a deficiency of red blood cells

2. Leukocytes, leucopenia, or neutropenia = a deficiency of white blood cells

3. thrombocytopenia = a deficiency of platelets

4. leukocytopenia = too low WBC

So these are the notes I wrote down at the meeting. These were the topics that were of particular interest to me. I hope you will find this information helpful to you.

Until my next posting … wishing you love and gratitude, because after all… we are all in this together.

SERENDIPITY

The big news is 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. This research area of the federal government is one of the most valuable resources for people like me who are left with little options. This means that the additional 17p-deleted leukemia patients, who thought they were new participants in the clinical trial, are temporarily on hold and are not allowed to be on the study until further notice. This does not include me, because I am not a new patient.

Professor Chaya Venkat, my patient advocate, met with the research director of Johnson & Johnson to try to get compassionate use of ibrutinib, since these patients will not live long enough for the drug to be FDA approved. She said she would pay her way to California to meet with the drug company stakeholders. She was denied.

It is also unclear whether untreated 17p-deleted patients (me) will be included in the initial FDA approval. The key is to get enough participants in the trial to have a decent enough sample size to warrant inclusion. Suspension of the trial is a big kick in the stomach. We are 5% of the CLL/SLL cancer population.

NIH will continue to follow patients in this trial and continue to provide the drug as long as the drug company provides the drug to NIH. NIH may continue to monitor patients after the trial.

I have written a letter to President Obama letting him know about the importance of the people who provide funding for the research. What is done here at NIH is of incredible value to patients. This is how medicine is suppose to be.

This posting is about my health update.

BLOOD WORK

The good news is that my white blood count (WBC) has dropped another 25,100, which is heading in the right direction. These are normal: electrolytes, kidney, liver, sodium, potassium, red blood count, hemoglobin (which means I am not anemic), and lungs.

These counts I need to keep an eye on:

Lactate dehydrogenase: slightly higher than normal

Uric acid: slightly higher

Platelet function: slightly lower

I have no eosinophils or basophils in my immune system.

Neutriphils are 9.5%, when they should be 34.0% to 71.1%.

BONE MARROW BIOPSY

According to Dr. Adrian Wiestner in the Hemotology Branch of the National Heart, Lung, and Blood Institute (NHLBI) of NIH, I have a very good reduction of malignant B-cells in my body and the experiment is going as expected. My bone marrow biopsy indicates lymphoid infiltration involving 20-30%, as opposed to 40-50% eight weeks earlier. Before the clinical trial, researchers knew that the drug would diminish the size of lymph nodes and eradicate the malignant cells in a patients’ blood through apoptosis (cell death). They were not sure it would help the bone marrow, in which much of the malignant cells hide out. Well, now we have a new scientific finding! It is working on the bone marrow too!

CD3 shows scattered positive T-cells. CD3 is required for T-cell activation.

CD34 protein has slightly increased to 3-5% positive. This is an important adhesion molecule and is required for T-cells to enter the lymph nodes. It facilitates cell migration.

I also have positive megakaryocytes, which are large bone marrow cells from which mature blood platelets originate.

CT SCAN

According to the CT scan, there is a decrease in adenopathy (swelling or abnormal enlargement of the lymph nodes) since June 20, 2012. In the September 7, 2012 report, there is evidence of lymphadenopathy, but the number and size of the lymph nodes on the neck have “dramatically decreased” when compared to several months prior.

The CT scan indicated degenerative disease in my neck of which I was aware. Prior to beginning the clinical trial, I was going to physical therapy at The Barrow Institute in Scottsdale. The attending physician had looked at my scans and thought he had pulled the wrong medical records when I entered his office. He said that if he had just looked at the medical scans, he would have said that I was a patient who had to immediately go in for spinal surgery. He said he was surprised at how good I looked. Surprise! But this is another story for another day…

MORE GOOD NEWS

In spite of the fact that I have had some minor side effects, such as slight bruising, a little dizziness, and occasional tenderness in my mouth, I have no breathing problems, no high blood pressure, no appetite issues, no mouth ulcers. I have had a little more fatigue the past cycle (even though my blood work does not indicate a reason for the fatigue). I think I was so excited that I was feeling better that I overdid it a little.

FINAL THOUGHTS

The researchers at NIH are pleased with my progress on this experimental drug. It seems to be doing what it is supposed to do. I am about as happy as an “egg-suckin’ dog in the middle of a chicken coop” (my husband Carl’s words).

One thing I understand is that even when my WBC is normalized (between 4,000 to 10,000). I will still be immune compromised since the drug does not cure me. It simply manages the cancer. Medicines that interferes negatively with Ibrutinib are the following: anti-fungal systemic pills, anti-depression medicine, acid reflux medicine, and blood thinners (a BIG no-no).

Being immune compromised also means that I cannot ever have inoculations with live viruses, such as a live shingle shot. I also cannot be around people who have had the live virus shot for about a week to 10 days. That also includes live virus inoculations given to my grandchildren, my dog, and people at the Walgreens Pharmacy.

When you are first diagnosed, you should have a pneumonia shot, which should last about five years. A flu shot should be given every year, even though it may not help a patient who has had leukemia for a while, but it might help a little.

Since the number one cause of death for patients like me is pneumonia, the herd mentality is in place here. If you have been inoculated and protected from whatever diseases and you are in good health, flock around me, because you will protect me from the germy people. LOL.

I personally will be eternally grateful for the opportunity I have been given to participate in the NIH clinical trial with Ibrutinib (PCI-32765), regardless of whether this experimental drug helps me in the long haul or regardless of whether I continue to have access to it. I know I am helping others in the future, who can benefit from the findings of this scientific research.

RANDOM THOUGHTS

Well, it is getting close to my next visit to the National Institutes of Health on the East Coast – more tests, more drugs, and then an informative visit with Dr. Chaya Venkat, the most wonderful patient advocate for leukemia. I will be meeting with her and several others in her living room in Colombia, Maryland. This blog posting is about my random thoughts as I am getting ready for the trip.

CRAP IN MY LIFE

Cancer has a way of making me stop and reflect upon my life journey. I realize that I have gratitude for all my blessings – and I have many. I have also come to terms with the fact that I am oddly respectful of all the negative and painful events in my life that have taught me my life lessons. It wasn’t pretty, but it made me who I am today.

When something that I perceive as negative or painful happens in my life, I ask myself:

“What did that teach me? What am I supposed to learn from this in my life journey? How can I make this event transform me into a better human being? Who do I NOT want to be like?”

Do you remember the children’s song “Sticks and stones will break my bones, but words will never hurt me”? Oddly enough, it is usually the words (or lack of them) that are more painful in our adult life. As we get older, it is not the details of the event that we remember, it is how the person made us feel that lingers in our heart and often still causes pain after all these years.

As I reflect back on my life, there are people I hope will forgive me for my real or perceived bad behavior. There are others that I need to forgive – especially for their angry and cruel words directed at my family or me.

WORDS OF MY MOTHER

My mother was one of the most positive people I have ever known. She did, however, hate hospitals and hated to be alone. So one of the nights I spent with her shortly before she died, we were up all night giggling and laughing about the stories of all the guys she dated before she met my Dad. The oncology nurse barged in the room and sternly pronounced, “If I hear any more noise from you two, I will kick you out of the hospital!” My mother, answered back, “You promise?!?” The nurse then realized what she had just said to a terminally-ill cancer patient.

Sorry folks. Having a positive attitude does not cure cancer, but it certainly makes life a lot more bearable for the patient and his or her family and friends. I am not a Pollyanna, but I certainly know that a negative attitude can make you sicker, and it can make life miserable for everyone who loves you. It is such a waste of limited energy. I have learned to avoid toxic people like the plague, and my life has improved substantially.

I have been thinking lately why I am one of the few people that I know who is not on “happy pills.” One of the reasons I believe is because I have such a demented sense of humor and I can find humor even in the most dire situations. I learned that from my Mom. It is definitely a survival tool and a gift she gave me. I thank her every day for teaching me that.

WORDS OF MY FATHER

When I was a child, I was one of those who learned by observing others. My Dad said that was the Japanese part of me. It saved me a lot of pain.

In my life I witnessed the wrenching pain caused by people being cruel to each other, and I learned the importance of mercy and kindness.

In my life I witnessed people stressed out with anxiety, and I learned that I would rather choose inner peace and meditation.

In my life I witnessed the emotional damage angry people have on others and themselves, and I have learned about the importance of gentleness and self-control.

It is interesting that these are also the words of my father. I thank him everyday for teaching me kindness, inner peace, and gentleness. These were teachings from a man who fought in two wars, was wounded, and had his best Army buddy blown up next to him in the foxhole.

THE ULTIMATE REALITY

You do understand that none of us are leaving this world alive? Whether I am blessed with many more years or I die sooner than I like, that is just how it is. As I have said many times before, I am in a win-win situation. I win if I stay alive for years to enjoy my friends, children, and soon-to-be 11 grandchildren. I know where I am going if I die, so I win when that happens. So I don’t care to waste my time wallowing in the quagmire. I like to get on with my life and be grateful for every second.

I am still a work in progress. There is much to be said about a little imperfection. Some times I need to remind myself that I have many blessings in my life. Some times I need to remind myself that there are people in this world much worse off than me.

A SELF-INDULGING MOMENT

Most of the time my blog updates are very clinical. I become the “pigmy nerd mama” that my son used to tease me about when he was in junior high school. This is because that is how I am best able to cope with the diagnosis of leukemia. My friend Nancy understands this well. I take the scientific approach and report the facts, and that has a way of removing me personally from the reality of the stupid cancer. I become the university researcher – a role I have been quite comfortable with for many years, since I left my life as a creative and art director.

The truth is that several women I personally know who have cancer have died way before their time. And moments when this happens cause me to pause and doubt my mortality… But only for a moment, because I only give myself a moment for the luxury to be self-indulgent, and have my self-pity party. And then I must move on, because life moves on.

One beautiful woman with the sweetest disposition died because she forgot to value her life more than the value of her job. She spent hours working overtime to be loyal to her company, and did not seek out cancer specialists who could have saved her, until it was too late. Her family was and probably still is very angry about this.

Another beautiful woman tried every treatment possible, until her body could take no more. She made the brave decision to stop the chemo treatments and die gracefully. I remember giving her a foot massage when she was in the hospital and we laughed about how hospital rooms should be made into spas where sick people could be pampered and powdered. I still think it is a great idea.

And then there was my beautiful friend, who was dismayed because the steroids she had to take made her gain weight and gave her a chipmunk face. “Like to shop?” I asked her. We spent the afternoon trying on all the stretchy and layered clothing that hide imperfections, and smelling different oils from India. It was a girls’ day out and we had a blast. She died the first day of my cancer treatment when I was at National Institutes of Health back East. I couldn’t figure out why she didn’t return my emails and voicemails. In all the chaos, the women in my cancer support group (including me) were not notified until a month after she died.

My friends and my family have been instrumental in supporting my journey. One of the most delightful comments I got was from my friend Laura who told me that she forgets that I have cancer, because I don’t look or act like I do. She asked me if that was a bad thing. I said “absolutely not.” Because you see for that moment in time when we talk and laugh, I am the La Verne she has always known. I am not “La Verne, who has cancer.”

But there are moments when I need the personal confirmation from friends and family that they understand the severity of the invisible face of cancer. I truly value those people in my life who share their time with me, for time is the most valuable gift anyone can give me.

P.S.: I hope this message was not too much of a downer. Sometimes when I write, it gets it all out on the table, and I can move on. The glass of red wine (which I cannot have with this clinical trial) would have really helped. I did buy a bottle of red Zinfandel to send to Dr. Keating; however. He can enjoy it for me…

P.S.S.: This is an anonymous quote about time I would like to share with you. It is a little corny, but hey, what’s new?

Have you been to the bank?

Imagine there is a bank that credits your account each morning with 86,400. It carries over no balance from day to day. Every evening it deletes whatever part of the balance you failed to use during the day. What would you do? Draw out every cent, of course!
Each of us has such a bank. Its name is TIME.
Every morning, it credits you with 86,400 seconds.
Every night it writes off, as lost, whatever of this you have failed to invest to good purpose.
It carries over no balance. It allows no overdraft.
Each day it opens a new account for you.
Each night it burns the remains of the day.
If you fail to use the day’s deposits, the loss is yours.
There is no going back.
There is no drawing against the “tomorrow”.
You must live in the present on today’s deposits.
Invest it so as to get from it the utmost in health, happiness, and success!
The clock is running.
Make the most of today.
To realize the value of ONE YEAR, ask a student who failed a grade.
To realize the value of ONE MONTH, ask a mother who gave birth to a pre-mature baby.
To realize the value of ONE WEEK, ask the editor of a weekly newspaper.
To realize the value of ONE HOUR, ask the lovers who are waiting to meet.
To realize the value of ONE MINUTE, ask a person who missed the train.
To realize the value of ONE SECOND, ask a person who just avoided an accident.
To realize the value of ONE MILLISECOND, ask the person who won a silver medal in the Olympics.
Treasure every moment that you have! And treasure it more because you shared it with someone special, special enough to spend your time.
And remember that time waits for no one.
Yesterday is history
Tomorrow is mystery
Today is a gift
That’s why it’s called the present!!

Cycle 3, Day 1

UPDATE

Just returned from National Institutes of Health (NIH) in Bethesda, Maryland. I am now beginning my Cycle 3 of my cancer treatment with the experimental drug Ibrutinib (PCI-32765).

LYMPH NODES

According to the CT scan, the largest lymph nodes under my arm pits (there were 15-20 of them) have been reduced to eight enlarged lymph nodes. I had lymph nodes in my abdomen, which are smaller now. The lymph nodes in my neck and clavicle area are also smaller. So this is moving in the right direction. I will receive the full CT scan report in about two weeks.

WHITE BLOOD COUNT (WBC)

In the past month my white blood count has decreased from 135,000 to 110,000. This is good news. Dr. Farooqui told me that the participant who has been in this study the longest has been taking the drug for 8-9 months and he still has not normalized, so don’t be disappointed if I am not. As you recall, normalization of the white blood count is between 3, 500 to 10,000.

Absolute lymphocyte count (ALC) is 104.05 K (normal is 1.18-3.74 K/uL).

BONE MARROW BIOPSY

I will receive the results of the bone marrow biopsy in about two weeks. I will post the results when I get it.

OTHER FINDINGS

My spleen is the same size.

Neutrophils are low at 5.3% (normal = 34-71.1%). Neutrophils are produced in bone marrow and are the body's primary defense against bacterial infection and physiologic stress.

Lymphocytes are 93.8% (normal = 19.3-51.7%).

Monocytes have gotten lower in the past two weeks from 1% to  0.4% (normal = 4.7-12.5%). Time for my B12 shot.

Eosinophils are low at 0.4% (normal = 0.7-5.8%).

These are very helpful in defending the body against parasites.

Eosinophil Absolute is high at 0.44 K/uL (normal = 0.04-0.36 K/uL). Eosinophils become active when you have certain allergic diseases, infections, and other medical conditions, but I do not understand why the Eosinophiils are low and the Eosinophil Absolute count is high. This is a question for my hemotologist/oncologist I see next week.

Basophils are 0 (normal = 0.1-1.2%). Basophils protect the body, killing bacteria and parasites, including external parasites such as ticks. Basophil Absolute is low at 0 (normal = 0.01-0.08 K/uL).

Beta-2-Microglobin is normal at 1.5 mg/L (normal = 0.9-1.7 mg/L).

EXPANDING OUR CLINICAL TRIAL

The last I heard from Dr. Farooqui was that he had met with the drug company on numerous occasions and the stakeholders were NOT going to expand the study. Well the good news is that the drug company changed their mind!

Originally the NIH clinical study had slots for a total of 64 participants (two cohorts -- Cohort A with 32 participants who were over the age of 65, and Cohort B with 32 participants who had 17p deletion, which trumps everything since it is a poor prognosis). The drug company agreed to add six more slots for untreated patients with 17p deletion.

Dr. Farooqui also mentioned that when the drug will get approval (probably in about two years), it will be for relapsed CLL/SLL patients. MD Anderson in Houston and NIH are the sites that are doing studies on untreated 17p deleted patients. More research will have to be done on untreated 17p deleted patients before the drug company approves the drug for them.

Cycle 2, Day 14

PERSONAL MESSAGE

It has taken me three years to finally cry. Believe me, I don’t cry easily. I was afraid to cry before, because I was worried that I would never be able to stop. Now finally something is being done to help me and I am so relieved. I am not good at doing nothing and sitting idly by. These tears are tears of hope.

My friend George asked me what it means when I wrote that I am a person of faith. I told him that I try every day to live my life so that my actions are loving and they speak louder than my words. It doesn’t always work out that way, but I keep trying. Perhaps this quote sums it up better than I can:

“Love the Lord your God with all your heart and with all your soul and with all your mind. This is the first and greatest commandment. And the second is like it: Love your neighbor as yourself.” (Matthew 22:37-39).

And what does this have to do with leukemia? Everything. My faith is my foundation. It is what keeps me grounded in this crazy world with this stupid cancer diagnosis. My faith also makes me accountable. I am reminded of the words of Mahatma Gandhi:

“I like your Christ, I do not like your Christians. Your Christians are so unlike your Christ.”

There is truth to that. So this is something I need to work on every day.

08-22-2012 BLOODWORK (Cycle 2, Day 14)

My bloodwork from August 24^th – two weeks after the 135,000 white blood cell count – shows a decrease to 114,300. This is about two weeks earlier than the average time in the study. Usually it isn’t until Cycle 3 that this occurs. This means that if all goes well, I am on the downhill slide of getting rid of the malignant B-cells that have been targeted by the Ibrutinib. In two weeks my body has gotten rid of about 20,000 B-cells. When you consider that a normal person only has 3,000 to 10,000 B-cells total in their blood, that is pretty amazing.

My lymphocyte count is still high. Lymphocytes, as you recall, are a type of white blood cell in the immune system.

My I-Bili (Indirect Bilirubin) is slightly elevated at 0.7, when it should be 0-0.6 mg/dL. This has to do with liver function.

My monocyte count is 1% and it should be between 2-8%. The low monocyte count is a side effect of illnesses of the bone marrow. This often also indicates deficiencies in vitamins such as folates and B-12. I am still getting my B-12 shot every month and taking those pink vitamins every day. Maybe that is why I at least have 1%.

My segmented Neuts are low. They are 5% when they should be 45-75%. Neutrophils are produced in bone marrow and are the body's primary defense against bacterial infection and physiologic stress.

My red blood count is normal.

My blood glucose level is normal. That is the amount of sugar present in my blood.

My platelet count is 156 (normal range 130-400). When the number of platelets is too low, that means that you will bleed easily. If it is too high, blood clots resulting in a stroke can occur.

The only side effect I have been having is a little dizziness when I wake up in the morning, look up, or move my head suddenly. I close my eyes, hang on to something, and breathe slowly. It goes away quickly, unlike my vertigo episodes. It is very minor in comparison.

ON A GOOD NOTE

Dr. Farooqui and Dr. Wiestner are having me work on an infographic illustrating how this magical drug works. This was my suggestion, mainly because I want to understand this process better, and many participants and their families also want to be better informed. It is a work in progress, because the experts are just now finding out the details of how Ibrutinib works.

Finishing Cycle 1 and on to Cycle 2

I just completed Cycle 1 of my experimental treatment at NIH and “donating” 12 tubes of blood. My white blood count has increased from 69K on Day 1 to 135K on Day 28. One more cycle of climbing – dumping those bad boys from my lymph nodes into my blood – and then I will brace myself for the decent to a normal range, which is 4,500-10,000 white blood cells per microliter (mcL).

Hemoglobin has remained steady at 13. The average for adult women is 12 to 16 gm/dL. Low hemoglobin level means a low red blood count or anemia.

Unlike normal cells, platelets do not have nucleuses. Their lifespan is only twelve days at most. The main purpose of these cells is to form blood clots. Platelets have gone from 150K on Day 1 and continued to rise to 191K. The normal range is 150K to 400K platelets per microliter (mcL), so I am headed in the right direction.

The NIH computer had issues, so I will get my full blood work numbers mailed to me by Susan Soto, the NIH nurse.

I had my first real symptom on Day 27 – a massive leg cramp in my left Tibialis anterior. I had never had a leg cramp there. I was suddenly woken in the middle of the night and did not know which way to pull or push my foot. I finally figured out I needed to push it like I was pointing my toes in ballet. I did my Lamaze breathing and massaged the muscle until the cramp went away. It seemed like it took forever. The doctor did not know if it was caused by the drug or my overdoing it at the gym on the cycle. One teaspoon of mustard is supposed to help, along with eating my bananas for potassium and replenishing my electrolytes. Mercy!

One of my Ibrutinib colleagues suggested a book for me to read called The Emperor of All Maladies: A Biography of Cancer, (2010). It was written by a physician named Siddhartha Mukherjee. I believe I will put it on my wish list. Still reading the bio of Steve Jobs, along with a couple more books on my night stand.

Just started Cycle 2…

How a BTK inhibitor works

In the average healthy adult between 50 and 70 billion cells die each day due to apoptosis (cell death). B-cells, which are lymphocytes, are part of the immune system. When a person gets a cold, these white blood cells increase, attack the germs, and when they have done their job, they die. All it takes is a mistake in one cell that leads to the cloning of white blood cells that do not die. It is just bad luck.

There has been a decade of scientific research supporting the importance of the B-cell receptor signaling pathway in rapidly out-of-control growing B-cells (leukemia). Dr. Michael Keating from Houston’s M.D. Anderson was the first physician to tell Carl and I about the new drug PCI-32765, which was later named “Ibrutinib.” I remember the excitement in his voice when he showed us photos of before and after lymph nodes, and exclaimed, “This is what you need!”

The proteins in my leukemic white blood cells prevent cell death, so they continue to proliferate in my blood, my lymph nodes, and my organs. Because, quite frankly, blood runs through every organ of your body. The white blood cells crowd out healthy red blood cells and platelets and enlarge lymph nodes, which often affect blood circulation. With a weakened immune system, there is constant worry about getting infections.

BTK is an essential kinase (a type of enzyme) in the signaling pathway downstream of the B-cell receptor. The pathway in which BTK is involved turns several protein enzymes that prevent cell death either on or off.

Scientists are hoping that Ibrutinib, which is a BTK inhibitor, will target the pathway and not affect other organs or tissues of the body. When Ibrutinib molecules target and irreversibly bind to the kinase, it will do so for as long as 24 hours, which means I have to take the drug every day until it stops working.

When Ibrutinib is ingested in the body, the leukemic white blood cells in the lymph nodes dump into the blood stream. This causes a temporary increase in white blood count (WBC) for about two months. When the drug blocks BTK, it induces cell death in white blood cells that refuse to die and the cells leave the body.

That, my friend, is how it is theoretically supposed to work.

Since I am experiencing the mutation in which the short arm of chromosome 17, where the gene for p53 resides, is deleted, my B-cells are free of the tumor suppressor. This is not good, and is a poor prognosis. This is what some of my doctors have termed “a true death sentence.”

However, I beg to differ… I do not believe I have been given a death sentence. I believe Ibrutinib has just given me a life sentence.

Update and future clinical studies

Day 10, Saturday, July 21 I woke up with a runny nose. It only lasted one day and turned into a sore throat, which lasted for a few days. The physician at NIH said it looked like I had a cold. For the past week I have had no runny nose, no sore throat, but lots of coughing. Thursday, August 2^nd I coughed up a small amount of what appeared to be dark red blood. Considering the fact that internal bleeding is one of the side effects of Ibrutinib, I got a little concerned.

Well the good news is that I am not bleeding internally and I do not have pneumonia. But I do have bronchitis – a cold that seems to have worked it’s way to my lungs. So an antibiotic is in order. It’s funny how one gets overly cautious about the toxic combination of drugs, so I would not take the antibiotic until I got the okay from Dr. Farooqui. I can’t take aspirin or Ibiprofin anymore because of it’s blood thinning abilities. No more red wine for La Verne either (BOO! HOO!), until the researchers figure out the issues of alcohol and the experimental drug.

I also wanted to mention that it was announced August 1^st that three additional Ibrutinib Phase 3 clinical trials at undisclosed locations will soon be posted -- two are for CLL/SLL and one is for mantle cell lymphoma (MCL). Pharmacyclics and Janssen (two drug companies) will begin to invite participants into the clinical trials any day. The California-based Pharmacyclics is a biopharmaceutical company developing and commercializing innovative small-molecule drugs for treating cancer and diseases related to the immune system. The New Jersey-based Janssen is a pharmaceutical company of Johnson & Johnson that provides medicines ranging from ADHD to mental health to neurologics to pain management. Jenssen immediately saw the potential of Ibrutinib and paid Pharmacyclics $150 million upfront for a worldwide collaboration. In total Pharmacyclics will potentially receive $975 million for collaborating with Jenssen on the experimental drug I am taking. Hmmm… Who says it’s not all about the money?

The three studies will include the following:

1. A random study of the combination of Bendamustine/Rituximab plus Ibrutinib in comparison to Bendamustine/Rituximab plus a placebo in relapsed or refractory CLL/SLL patients. What this means is that participants sign up for the clinical study and have a 50:50 chance of getting Ibrutinib or the placebo. Bendamustine (tradename Treanda) is a nitrogen mustard used in treating CLL and lymphomas. Rituximab is a chimeric monoclonal antibody, which was FDA-approved in 1997. A placebo is a simulated treatment for a disease intended to deceive the recipient.

2. A frontline study of Ibrutinib alone compared to a comparator (Waiting to find out what this will be) in elderly CLL/SLL patients. Again, as a participant, it is the luck of the draw whether you get Ibrutinib or not. Also, please note that “elderly” means you are 65 or older. Most of the participants in my study are fuming at the use of the term “elderly,” so my doctor calls them the “other” cohort. LOL.

3. A study outside of the United States for patients with relapsed or refractory mantle cell lymphoma (MCL), who have received at least one prior chemotherapy regimen. The participants will be randomized and will receive either Ibrutinib or Temsirolimus. Temsirolimus is an intravenous drug for the treatment of renal cell carcinoma (kidney cancer).

Click for the full article:

http://files.shareholder.com/downloads/PCYC/1987224025x0x587541/287a7482-75f0-4e60-881d-a8b7ede67e58/PCYC_News_2012_8_1_General.pdf

I thank God every day that I was able to get into a clinical trial in which every participant received the drug Ibrutinib. I celebrate each day. I will be forever grateful for this opportunity regardless of the outcome.

“(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

2-week update on Ibrutinib (PCI-32765)

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GOOD NEWS!

Just flew back from NIH. The drug is working!!!

This time only six vials of blood were taken. I always make sure I am hydrated 24 hours before getting my blood drawn, and I make sure to keep my arms warm. This helps, since I have crooked veins and am a hard stick. I am getting used to having my blood drawn, and now I can look at the process of the technician filling the vials. Still have to close my eyes and meditate when I get the needle; however.

My white blood count (WBC) has escalated to 101,000, but that shows that the cancer cells are leaving my lymph nodes and are dumping into my blood. Hopefully, after two months of escalating, the WBC will begin to decrease to a normal range (3,000 to 10,000).

My hemoglobin has slightly decreased to 13 and may decrease more on this drug before it increases. Normal levels for an adult is between 12 to 18 grams per 100 milliliters of blood. Dehydration and lung cancer can cause levels to be above normal. Anemia, kidney, and liver disease can cause levels to drop below 12. If it decreases to 8 then I will need a transfusion. If I was in my 70s, had heart disease, and shortness of breath, then I would get a transfusion right away. But I am not, so no worries.

LDH (lactate dyhydrogenase, which is an enzyme in red blood cells) increased slightly, but no worries at this point. It is a marker for hemolysis (rupturing of hemoglobin in surrounding tissues) and myocardial infarction (heart attack), so the medical team will need to watch this. 

I am having a Beta 2 microglobulin value decrease already, which is good. It is still high at 2.1 (previously was 2.2) and the normal range is 0.9-1.7 mg/L. These are markers for the activation of the cellular immune system, as well as a tumor marker in certain hematologic malignancies.

My platelets are increasing and aggregating in the normal range, which means my platelet function is normal. This is good.

My neutrophils are low at 5.1 (normal range: 34.0-71.1%). A neutrophil is a type of mature (developed) white blood cell that is present in the blood. White blood cells help protect the body against diseases and fight infections.

My eosinophils are low at 0.0 (normal range: 0.7-5.8%). They are also a type of white blood cell that helps protect the body against diseases and fight infections.

My basophils are low at 0.0 (normal range: 0.1-1.2%). are a type of white blood cell that are involved in inflammatory reactions in your body, especially those related to allergies and asthma.

My monocytes are low at 0.7 (normal range: 4.7-12.5%). These are white blood cells made in the blood marrow. They attack any foreign material, such as a bacteria or virus, and consume it so that it cannot hurt the body. They preserve an antigen, so that the body will be able to recognize the foreign material in the future.

SIDE EFFECTS and BENEFITS

No major side effects after two weeks. Physical symptoms are improving. Dr. Farooqui said that other patients have experienced canker sores, rashes, severe leg cramps, bleeding, heart palpitations, and shortness of breath. So far, so good for me, but I am only two weeks out from the initial treatment, so it remains to be seen.

I mentioned to Dr. Farooqui that occasionally I would experience painful joints and muscles when I got up from sitting for a while. Since I have been on Ibrutinib, I have not had any pain. Dr. Farooqui said that the drug was has potential effects for patients with autoimmune arthritis, so I get an extra benefit.

My fatigue has been improving. I can’t believe I don’t need a 3- to 4-hour afternoon nap every day in order to function. I hope this continues. I am still sleeping longer at night than my normal pre-cancer life, but I figure my body needs it to heal itself.

I have been fighting a respiratory infection (the common cold) and I can’t believe what a baby I am about it. I really don’t like the feeling of not being able to breathe fully. My ribs are sore from sneezing and coughing. I cannot take an aspirin or any type of blood thinner while on Ibrutinib, so I have resorted to gargling with salt water for fear of taking something that will cause internal bleeding. I have also had to be careful about laughing too much when I have a cold, because it makes me cough. Carl (my little worry wart) is worried that I am going to bleed internally from one of my MaMa La Verne sneezes and he has been hovering around me like a protective eagle. I believe it must be harder on the caregiver than the patient at times. I believe I will be just fine.

FUTURE TRIPS TO NIH

I will be taking a number of trips to NIH this summer and fall. I will be flying in the night before the blood work and meeting with the medical team, and flying out that evening, unless I need a transfusion. The plane ride home is uncomfortable and long (since I have been up since 3:00 am AZ time for blood work), and I am exhausted when I get home. I will have to consider whether to spend another $200 on another night at the hotel. The good thing is that my cousin Sammy has dinner with me when I arrive, and that is a wonderful bonus.

The January trip is a longer one with a number of medical procedures. Carl and I will be staying by the metro so we can get around DC. Since we are spending all our vacation money and savings on these medical trips, DC will have to be our vacation destination for the next couple of years. I am okay with that.

IMPORTANT NOTE

When my WBC drops to the normal range, this will not mean that I am cured of cancer, because if I stop taking the Ibrutinib (PCI-32765), within a week my WBC will begin to escalate, according to what has happened to prior patients. What I am hoping for is that my cancer will be manageable and it will buy me some time. Researchers do not know if eventually the cancer cells will be intelligent enough to figure out another pathway, just as Gleevac has done after 10 years. If so, there are at least two other kinase inhibitors in the works. I will deal with that when the time comes. What a lovely word… “time.”

To get all there is out of living, we must employ our time wisely, never being in too much of a hurry to stop and sip life, but never losing our sense of the enormous value of a minute. -- Robert Updegraff

Cycle 1 of NIH Ibrutinib (PCI-32765) clinical trial

07-17-2012 Leukemia Update

La Verne Abe Harris, Ph.D.

If any of you have read the novel by Mary Shelley (1818) or watched the horror film Frankenstein (1931) with Boris Karloff, you are well acquainted with the most famous line of the story, “It’s alive! It’s alive! It’s alive!” (http://www.youtube.com/watch?v=xos2MnVxe-c). That is how I felt after returning from the National Institutes of Health (NIH) in Bethesda, Maryland this week. LOL.

The day after Carl and I arrived, I had my blood work done (12 tubes of blood) and a meeting with Dr. Mohamed Farooqui, Dr. Saba (a research fellow), and a medical student. The only meds I am on prior to the clinical study are herbal supplements, which have been approved by Dr. Farooqui.

Cycle 1, Day 1: July 12, 2012

I had a rough night on Wednesday, July 11. I am not sure if it was nerves or that I was being tested again. I went to bed with the start of vertigo, which entails dizziness and nausea. It lasted off and on all night long. I did get a little sleep. Luckily it was not the full-blown vertigo I have had before from Meniere’s Disease, which feels like seasickness lasting eight hours. Carl was concerned that my lymph node biopsy would be cancelled. It was not, since I was able to hold myself together for the procedure. That is, until the nurse asked me to sit up from the surgical bed and I was visibly dizzy. They wheeled me into the hospital on a bed and I felt pretty pampered. I got through the lymph node biopsy in my right under arm with local anesthesia and a discussion of politics with Dr. Chang’s team. He said I would probably be in pain afterwards, but I was not and did not even need a Tylenol. I did not have pain during the procedure, which he found unusual.

Carl was my drug dealer for the day and picked up the following prescriptions:

Acyclovir (800 mg, 2X/day) to prevent Zoster infections (shingles) in the middle of the study.

Allopurinol (300 mg, 1X/day) for 14 days to prevent tumor lysis syndrome (TLS).

When a person with leukemia is treated with chemotherapy, the content of CLL cells is destroyed and the toxic content of the cells go into your blood and can hurt your liver and kidney. Alloprurinol is a drug that is used to prevent this from happening. Ibrutinib (PCI-32765) is not known to give leukemia patients TLS; however, allopurinol is given as a precautionary measure.

Ibrutinib (PCI-32765): Take three tablets a day (420 mg total) alone (so that it can be properly absorbed) for as long as it works. This drug has been tested in clinical trials for only 11 months. Ibrutinib, a kinase inhibitor, disrupts the signaling pathways of B-cells and pushes them out of swollen lymph nodes, and hiding places in the spleen, etc. Scientists do not know the adverse effects of long-term usage.

I need to return to NIH every two weeks this summer, then every month, and then every three months after the first of the year. No naprocin or aspirin. No alcohol intake the first month because it may raise the concentration of the drug in my liver.

I took the first treatment Thursday with no side effects. I did manage to sleep three hours in the afternoon, but I think that was warranted after all my body had been through.

Cycle 1, Day 2: July 13, 2012

Eight tubes of blood were taken from me. After one day, my white blood count (WBC) increased 1,000, which is less than expected. My platelets were decreased 27K, which was expected. Every patient is different.

My second lymph node biopsy was done by Dr. Brad Wood. Six samples were taken from the same node under my right arm. One sample will be sent off in formalin and the other five will be taken in saline. They will be studying the tissue samples separately.

Side effects:

1. Five people in the study have had bleeding of the brain resulting in one death. These participants were on a blood thinner called Coumadin. My patient advocate Dr. Chaya Venkat advises eliminating blood thinners, such as fish oil from my herbal supplements.

2. Because of the potential side effect of internal bleeding, I need to watch out for excessive bruising and rashes. Bruising may mean my platelet count is too low.

3. Rashes may indicate I am allergic to the experimental drug. Benedril should help with the rash temporarily.

4. Participants have also complained of muscle and joint pain and diarrhea.

5. Dr. Farooqui warned me that several patients have had a strong reaction to mosquito bites. That is not new to me, since my mother always said I had “sweet blood” when the mosquitoes attacked me. Glad I am not in Houston. I will heed the warning.

6. Leg cramps are another side effect. Dr. Farooqui said to take electrolytes, water, massage the legs, and take one teaspoon of mustard. I asked him if Dijon mustard counted. He chuckled.

Emergency situations:

1. If I begin to suffer extreme fatigue or have lots of bruising, it is an indication that my platelets may be low (<100K) and my hemoglobin levels may be too low (<11.0). It may also indicate internal bleeding. I may need a transfusion at this point and I am supposed to go to the hospital immediately.

2. If my neutrophils are less than 500 (0.5), then I am at risk. This usually comes with a fever and is a medical emergency.

3. Evidence of a rash may indicate that I am allergic to Ibrutinib.

In Conclusion

I am B22 (the second cohort of 17p deleted patients), and No. 41 overall (out of 64). Two of the Ibrutinib clinical studies in the U.S. have closed, and the NIH study will close this fall. I consider myself lucky.

All we have in this thing called life is what happens in the here-and-now. Being stuck living in the past or living in the future is a waste of your beautiful life.

We have to determine what risks in life we are willing to take, and weigh the benefits to the losses. This also applies to the people in our lives. Dump the toxic people and surround yourself with people who make you happy.

Dr. Brian Koffman, who is a medical doctor with leukemia, says, “ There is a cost to doing anything. There is also a cost to doing nothing.”