Happy Day! FDA approves Imbruvica!

Monday, July 28, 2014 was a wonderful day! Our granddaughter was over at our house having a sleepover. She was born a year after I was diagnosed with leukemia. My son and his wife named her “Hope” to give me hope.

A few days ago on July 25, 2014 the news came in that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended ibrutinib (a.k.a. PCI-32765, brand name Imbruvica) for those with relapsed or refractory mantle cell lymphoma (MCL), CLL patients with one prior therapy, and [TRUMPETS, PLEASE] first-line use for those with 17p deletion or TP53 mutation who are not suitable for intravenous chemotherapy.

That was Europe. But in the U.S. the F.D.A. (U.S, Food and Drug Administration) approved the drug for MCL (November 2013), and those patients with prior CLL treatment (February 2014), but not for those with 17p deletion.

August 2009 I was diagnosed with CLL (a leukemia which is also a type of non-Hodgkin lymphoma) with deletion 17p (del17p) and TP53 mutation. Event though CLL is a chronic disease, I realized I had drawn the bad card… two to three years median predicted survival. The deletion and mutation status is linked with treatment-resistant and aggressive cancer. Loss of the key gene TP53 means the loss of triggering DNA repair or cell death in order to control the presence of abnormal tumors in the body.

Three years after diagnosis I was accepted in a clinical trial at the National Institutes of Health (NIH). Five years after diagnosis I am still here on this earth happily living on borrowed time. I really wanted other patients who did not get into a clinical trial to have the same blessings I have had.

Monday, July 28^th Pat Elliott (a.k.a. CML social media queen) sent me the F.D.A. (U.S. Food and Drug Administration) news release that the FDA expanded the use of Imbruvica for those CLL patients who carry a deletion in chromosome 17. Good news, indeed. That means that all cancer patients with this diagnosis can be prescribed Imbruvica.

What a happy day!

GOOD NEWS! Two years on Ibrutinib

I just flew in from the National Institutes of Health. It is my two-year anniversary participating in the clinical trial with the oral cancer treatment ibrutinib (a.k.a. PCI-32765, Imbruvica). Ibrutinib targets Bruton’s tyrosine kinase (BTK), which is a protein that is necessary for CLL cancer cells to survive. The BTK protein was first identified by scientists four years ago. Ibrutinib is the first BTK inhibitor.

I have good news. Pharmacyclics (the manufacturer of the drug) has decided to increase the length of the NIH clinical trial for the 87 participants. It makes good sense to them to follow us and track our progress on ibrutinib. What this means is that as long as I am willing to fly to Bethesda, Maryland every three months, I will have access to the drug for as long as it continues to work on my body. I am really blessed.

On a personal level, my white blood count has improved since my last visit three months ago. The leukemia pill is not only slowing, but also reversing the cancer in my body. I still have not normalized, but I am getting closer. I am doing well. I am still alive, and that is a good thing. 

The majority of frontline patients treated with ibrutinib have done well. Studies are being conducted to see if ibrutinib is better than chemotherapy in the frontline setting. The longer a patient uses ibrutinib, the better the immune system appears to work. In the Ohio State clinical trials only 15 percent of about 250 participants have stopped using ibrutinib because they have become resistant to it.

RESISTANCE TO IBRUTINIB AND POSSIBILITIES

Ibrutinib binds to the BTK protein at Cysteine 481, which is a specific location. When a person becomes resistant, the clever cancer cell figures out a way to change the cysteine to serine, resulting in ibrutinib having a more difficult time binding to the protein and thereby shutting it down.

The cancer has progressed in more than half of the patients with 17p deletion, who have been treated with ibrutinib, so I count my blessings every day. The 17p deleted population still need new agents to use if they relapse on ibrutinib. A number of possibilities are in the works (See Figure 1).

Figure 1

I am also following the research of a new drug GDC-0853 developed by Genentech. It is being tested in a Phase I clinical trial in patients with relapsed or refractory B-cell Non-Hodgkin’s Lymphoma and Chronic Lymphocytic Leukemia. GDC-0853 is supposed to get around the Cysteine 481 protein mutation and still work as a BTK inhibitor. The recruiting locations of the clinical trial are California, Missouri, Ohio, Oregon, Tennessee, Washington, and Australia.

Gratitude & Love,

Dr. La Verne

My 15 truths about cancer -- Cells Behaving Badly

“And ye shall know the truth, and the truth shall make you free.”

(John 8:32)

So it is one of the worst days of your life. You have been diagnosed with the big “C” or someone you love has been diagnosed with cancer. These are my 15 truths (with a lowercase “t”) about what I have learned in my journey with leukemia. I hope it gives you a new paradigm shift.

First let me clarify what I mean by TRUTH. What is the difference between the truth (with a lowercase “t”) and the Truth (with a capital “T”)? The truth with a lowercase “t” is according to man. It is relative. It is subjective. The Truth with a capital “T” is according to God. It is absolute. It is unchanging and true in all situations.

My 15 truths:

1. Cancer will dramatically change your life for the worst or for the better (and sometimes both) depending on your perspective. There is a transformative effect of suffering from an illness at a time when everyone else is pursuing happiness that seems so unfair. Only you have the control of your attitude. Do not let cancer steal whatever life you have left.

2. Each person's journey is different. Most people carry precancerous cells in their body. These cells often do not grow into cancer, because they are kept in control by a number of mechanisms that keep them playing nicely with other cells. If the precancerous cells are so damaged that they cannot cooperate, they usually repair themselves or atrophy and die.

     It just takes one bad boy. It can happen to anyone. The miracle is that it does not happen more often. The cell that decides to become anti-social develops a pattern of bad behavior. He divides whenever he pleases instead of waiting for signals from other cells. Other cells become crowded out.  The bad boys move to places they should not be, develop their own mutations, and stop listening to signals that they must die.

     Each cancer is different depending upon a patient’s individual genome (body chemistry). That is why there are different responses to the same cancer treatment for the same cancer diagnosis.

3. You will reassess your priorities. A cancer diagnosis will make you realize what is really important in this life. For me it is the relationships in my life (both spiritual and personal), creating my art, my writing, and my small contribution to making the world a better place. Think about all the stuff (material and financial) you have been collecting all these years. You can’t take it with you.

4. You will see your own mortality. A cancer diagnosis will make you stare at God at close range. Having a diagnosis of cancer makes the reality of death more clear. This is inevitable. The reality is that our physical bodies are all going to die at some point. This is not something to be feared. We will just walk into another room. I believe our spirit lives on forever.

5. Learn to live in the here and now. It is amazing how it takes being diagnosed with cancer to make us embrace the beauty of today. We can clutch the past so tightly that we leave no room for today. Or we can live in the future of what ifs -- not realizing that tomorrow does not exist yet.

6. Family and friends that connect with you do it out of love and caring. These people become your support and the joys of your life. You will find out who really cares. Do not constantly barrage them with your illness. Do not let the cancer define you. It will wear them out. Remember that they have a life that deserves to be discussed and lived.

7. Do not surround yourself with toxic or selfish people. Avoid family members and friends like the plague who make you feel worse than you did before you communicated with them. Also understand that family members and friends who disconnect with you do it out of fear of their own mortality or because you are no longer useful to them. Forgive them and move on.

8. It is important to be a proactive patient and educate yourself. Research. Find support groups. Ask questions. Take control of your life! You will come to realize that physicians often have to rely on educated guesses because they do not know all the answers. We are just at the cusp of understanding cytogenetics and DNA.

9. GET A SECOND OPINION or third or fourth. Surround yourself with experts, not just generalists. Explore your options. What is the standard therapy? Is there a clinical trial you could participate in? What other possibilities are available for you?

10. Do not let statistics freak you out! When you read about statistics please understand that it is a mathematical science based on the number crunching of data. It does not mean YOU.  In order to have the numerical results, there is often the presence of outliers that do not fit into the sample mean. You may be an outlier.

11. Your body will change during treatment. You may have cognitive impairment from the treatment. You may have fatigue, pain, or limitations in your daily life. Take care of your body. Adjust to a new normal with no guilt.

12. Prepare to have psychological and social stressors that you should not ignore. Even if you are a well-grounded person you will have your moments. Your psychological wellness affects the health of your body. Be kind to yourself. Understand that the dark cloud may quietly hover over your head, even when you are in remission, because of the fear of the return of those bad boys.

13. Financial stress may become an unfortunate part of your life, which may include fighting with insurance companies or experiencing reduced employment or no income. Take care of your energy level so that you have enough energy left over to live as well as you can with the diagnosis.

14. Laugh when the spirit moves you. Laughter improves our well-being. Don’t take yourself or life too seriously. Remind yourself of funny moments in your life. Hang around people who make you laugh. Go to the Improv or to see comedies. Try to find humor in bad situations. I understand that sometimes life just sucks. But it helps me to find demented humor in the soap opera of life. LOL.

15. Wake up every morning full of love and gratitude. Meditate, pray, and count your blessings. Surround yourself with people and activities that make your life a joyful one. Don’t overlook the simple things in life that give you happiness – like a beautiful sunrise or a grandchild’s laughter or a puppy sitting on your feet.

So there you have it – my 15 truths about cancer. This is how I personally have been able to not only survive on my journey, but also joyfully live.

Fair Access to Cancer Treatment (FACT) Act (HB2078) becomes law in Arizona

The signing of the Fair Access to Cancer Treatment Act

 Pat Elliott, Governor Jan Brewer, Dr. La Verne

Jim Brewer (LLS), Pat Elliott, Dr. La Verne, Sen. Anna Tovar

July 1, 2014 the Arizona House Bill 2078, known as the Fair Access to Cancer Treatment (FACT) Act, was signed into law at a ceremonial signing at Virginia G. Piper Cancer Center at Scottsdale Healthcare Shea Medical Center. The bill passed by unanimous vote within one year. My only disappointment is that I wanted it to be effective January 1, 2015. The law becomes effective January 1, 2016.

There were no oral cancer treatments 14 years ago, so the law needed to be updated to fit today’s innovative medical treatments. Drugs administered orally for cancer treatment should be covered by insurance the same as drugs administered intravenously. HB2078 offers fair and equal coverage for patients with orally-administered cancer treatments for patients in Arizona who are covered by health care insurance entities, such as disability insurers, health care services organizations, and hospital, medical, optometric service corporations (HMDO). For some patients the oral cancer treatment is their only option and not having access because of the high out-of-pocket costs means they will not survive.

Gratitude goes to the Fair Access to Cancer Treatment Coalition of 21 organizations consisting of nonprofits, cancer centers, professional organizations, etc.) spearheaded by the Arizona Chapter of the Leukemia & Lymphoma Society (LLS). Thank you Jim Brewer, Executive Director of LLS, and Shayna Diamond, patient access and education manager. Gratitude also goes to Rep. Heather Carter (District 15) who sponsored the bill after it was passed to her by Senator Adam Driggs (District 28). Gratitude goes to Senator Anna Tovar (District 19) for her role on the LLS Board and the State Legislature. And lots of love and gratitude to the patient advocates who joined me in giving testimony to the Legislature, as well as those who used social media to expose the inequity (i.e. Pat Elliott).

Thank you Governor Jan Brewer for signing this bill into law.  Regardless of what your political beliefs may be, this is one of the most life-changing Arizona bills that was signed by Governor Brewer for cancer patients.