PLAN B AND PLAN C

Sometimes it is good to be doing activities that help me forget that I am a cancer patient – like tai chi, playing with my grandchildren, painting, and stand-up comedy. But being a patient advocate is very rewarding, and often introspective for me.

I recently returned from the Seattle Cancer Care Alliance (SCCA) to establish a Plan B and Plan C in case I (or anyone in my situation) relapses on ibrutinib, has problems with side effects, or fails to have access to the drug due to financial reasons. My Plan A has been ibrutinib (aka brand name: Imbruvica) so far.

I started on the drug to combat Chronic Lymphocytic Leukemia (CLL) in a clinical trial July 12, 2012. I obtained complete clinical remission January 2015. What most people don’t realize is that does not necessarily mean you are cured of cancer. If you are MRD-positive (minimal residual disease) like me, there are still 0.5% leukemic cells floating around in my bone marrow. That is why I take an oral cancer drug every day.

A F2F MEETING WITH A VIRTUAL FRIEND

When I entered the Seattle Cancer Care Alliance building, I stopped by one of the infusion rooms on the fifth floor to see a CLL virtual friend in the flesh … Lisa M. Weiss. Lisa had been intolerant on ibrutinib, and relapsed and was refractory to chemo. She is now on acalabruitinib. Lisa and I spent a couple hours chatting. We had talked before on the phone and she recommended the SCCA. She is a CLL patient, a patient advocate, and manages a Facebook group for women with blood cancers (CLL/SLL/NHL Cancer support for women). She is very knowledgeable and I loved talking shop with her.

We discussed how CLL is a disease of the immune system. Lisa gave me the link to a couple articles:

(1) Scientists have discovered 41 DNA changes that influence the risk of CLL (https://medicalxpress.com/news/2017-02-immune-genes-linked-common-leukaemia.html)

(2) The Center for Prevention of Progression of Blood Cancers (CPOP) research initiative at Dana Farber Cancer Institute in Boston is researching chromosome mutations in CLL patients (http://www.dana-farber.org/Research/Departments-and-Centers/Blood-Cancer-Prevention-of-Progression-Clinic.aspx).

PLANS B AND C

After my visit with Lisa, my husband and I sat down with Dr. Mazyar Shadman from Fred Hutch/SCCA to discuss the 400 pages of my medical records and to discuss my Plans B and C.  Mazyar Shadman, M.D., M.P.H is an Assistant Professor, Medical Oncology, University of Washington, and an Assistant Member, Clinical Research Division, Fred Hutchinson Cancer Research Center. He spent an hour and a half with us. He told us about the genetic research that is being done at SCCA, the CAR-T cell therapy, allogeneic bone marrow transplants (which many CLL experts see as a last resort), and the research being done by Dr. Richard James, which is funded by an NIH grant.

If a cancer patient relapses on ibrutinib, it will usually be within the first few years. Most are 17p-deleted folks like me. It has been four years and eight months for me. Dr. Shadman said that for patients like me, it has been found that the quality of response and the side effects get better with time. My worst side effect was the severe cramping in muscles in my body and my limbs. Hydration and exercise with stretching seems to have been the key for me. I have to be mindful of what I eat because of inflammation. If I give you a fist bump instead of a handshake, it is because I am immune-compromised and hands are the number one carrier of germs. I am not trying to be cool. LOL.

Here is a tidbit of information for you science nerds:

Dr. Shadman said that there are two CLL mutations in resistance that are key to patients who are taking IMBRUVICA (A.K.A. ibrutinib): (1) BTK-C481S mutation, and (2) PCG2 mutation, an enzyme mutation that makes the BTK pathway independent. The PCG2 mutation is the one he said would apply to me, if I relapse.

So what are my Plans B and C in case I either relapse on ibrutinib or do not have access to the drug? Dr. Shadman said there are many novel agents available in clinical trials. One drug that is off trial and FDA approved is venetoclax. That would be his first choice for me.

If I have disease on board, I would be pre-treated with FC (Fludarabine + Cyclophosphamide) chemotherapy before a CAR-T Cell procedure. I wrote about this trial at the University of Penn in one of my previous postings. Now remember I am chemo-resistant (17p deleted and p53 mutation), so I asked him why I would be treated with chemo. He said it is to suppress the immune system.

SCCA has done 150 CAR-T therapies in their clinical trial. It targets CD19. Because CD19 is also found on healthy B-cells, the patient will have to have IVIG infusions every month or two, but the cancer is essentially gone from your body. It is a small price to pay.

It is in those moments when I meet with the medical team or researchers that I remember how serious immune deregulation disease is.

CAR-T CLINICAL TRIAL AT SCCA

Cyndi Stansbury entered my NIH trial with ibrutinib five months before me and relapsed in 2015. Here is a success story of the CAR-T Cell procedure:

E-mail from Bill Stansbury:

“My wife, Cynthia Stansbury, was one of the original patients in the NIH Ibrutinib trial for CLL. My wife has the 17p deletion. She was admitted into the trial in February 2012. She did well on the drug with little side effects, other that bruising easily and one bout of A Fib. In October of 2015 she began to relapse with escalating WBC. Cynthia was referred to Stanford where she was admitted into a trial for ABT-199 (Venetoclax). She was hospitalized briefly at the beginning of the trial due to tumor lysis. She relapsed off the Venetoclax after eight months showing enlarged lymph nodes on a CT scan.

It was suggested to us by the staff at Stanford that here best option was CAR-T immunotherapy.  To make a long story short, we just got back from three months in Seattle where Cynthia underwent CAR-T therapy. It was not easy by any means. She underwent three days of chemotherapy prior to the day when she was to have her cells re-infused. At that time she contracted RSV (a viral infection). She had to get over the infection before she could get her cells re-infused. That took two weeks. They then had to repeat the initial chemo then re-infuse her cells several days later. One week after re-infusion she was hospitalized for 11 days due to cytokine release syndrome. She was extremely ill during this period. About 20 days after the re-infusion, Cynthia underwent a spinal puncture, bone marrow biopsy, blood tests and PET/CT scans. There was no evidence of CLL in her blood, bone marrow or spinal fluid. Her lymph nodes showed a 40-70% reduction in size. Her FISH test showed no 17p. The care she received in Seattle was excellent. Cynthia goes back in April for a check-up.”

Cynthia was on the Emerald Team at the SCCA clinic, and Dr. Maloney oversaw the CAR-T clinical trial in which she was enrolled. Dr. Ramos was her doctor during the procedure, and follow-up will be with Dr. Shadman and Dr. Turtle. Bill and Cynthia Stansbury have graciously offered their email (billstans@msn.com) if anyone has any other questions.

IN CONCLUSION

Life goes on. I am preparing for a stand-up comedy show at the Improv this month to benefit cancer research for the Leukemia & Lymphoma Society. I am still alive and kickin’ because of cancer research. I am eternally grateful and I thank God for every beautiful day I have on this earth. I am even thankful for the crappy days. LOL.

Laughter Therapy

“The most wasted of all days is one without laughter.” – E. E. Cummings

A&K Sisters (Diane Miner and MaMa La Verne)

Laughter therapy uses the gift of humor to counter stress. It is learning how to laugh at things in your life that don’t seem funny at the time. Being diagnosed with cancer and the passage that follows is a stressful situation. I decided early on in my cancer journey that I could either use my limited energy to cry about it (which is acceptable and necessary every once in a while)… or I could heal myself and promote my wellbeing through comedy.

Even in my “horizontal days” – the days I did not have the energy to do anything – I watched comedy movie marathons lying on the sofa without guilt. I was listening to my body and it needed rest. I was listening to my mind and heart and they needed joy.

When I reached clinical complete remission January 2015, I decided I would do something out of my comfort zone. I signed up for a class on how to write jokes at out local arts center. There I was… the only female in a roomful of 20- and 30-somethings. It made me feel like I was back working with my university graduate students – something I missed terribly, since I had to leave my professorship shortly after I was diagnosed, because of the fatigue and side effects. Most of my jokes centered on my husband Carl, who I refer to as “Coach” in my act. I have been married to the man for over 40 years, so I had plenty of material.

Next session was the stand-up delivery class. I showed up and I was the only person from the joke-writing class to move on. The rest of the “students” were stand-up comedians who had performed in public before. Some were even headliners at the comedy clubs. Oh, brother! I wondered if I had made a BIG mistake. Now granted, I had lectured in front of hundreds of university students, but the students had to be there or they would flunk. LOL. This was different.

Then the leader “Creepy Guy” asked me to go up to the mic, introduce myself, and say something funny. The first thing that went through my head was that I was going to flunk this class!

But I am not a quitter, so I slowly walked up to the mic. “Hello, I’m MaMa La Verne and I’m a virgin [long pause and confused looks on their faces] … of comedy. Everyone laughed. I was rather surprised. So I guess it was going to be okay.

I wrote my jokes for my first show and rehearsed in front of Coach. He said to me, ”Are you planning on making people laugh?”

“Well, of course,” I said.

“Well, you are going to have to turn it up a notch!” he advised.

“But most of the jokes are about YOU!” I said.

My husband responded, “I don’t care. Just make them laugh.” Coach is my inspiration and one of the finest men I know.

I had gotten to know several of the female stand-up comedians at the center. One was Diane. In our after-class conversations I shared with her my cancer diagnosis. She shared with me the death of her husband of 48 years and the cancer journey of her 20-year-old son. We bonded.

So I performed in a series of three class clowns acts at the arts center, when it struck me: Who needs laughter therapy the most? Cancer patients! So I formed a group: The A&K Sisters (Alive & Kickin’). The only problem was that I was the group.

A few months later Diane came up to me after class and was a little shaken. “The doctor says I have multiple myeloma!” I blurted out, “Oh, good! Then you can be my partner and we can do stand-up comedy for cancer survivors!” At first she looked confused. And then she gave me a big smile. She said that was the strangest response she had ever gotten.

So Diane and I have performed at the Improv for a room of about 200 cancer survivors, caregivers, and donors. We performed at the Virginia Piper Cancer Center in Scottsdale several times, and we will be performing for about 100 women in February at St. Joseph’s Hospital in Phoenix for a non-profit called Face-in-the-Mirror (http://www.faceinthemirror.org/). These pro bono stand-up comedy performances are gifts of love and gratitude for those who did not choose to go on the Big-C journey. This is our volunteer work in our soup kitchen.

MaMa La Verne: Hope is the word: Spread the laughter, heal the soul.

Diane: In the end what matters most is how well you live,

MaMa La Verne: how well you love,

Diane: how well you learn to let go,

MaMa La Verne: how much you laugh

MaMa La Verne & Diane: and how hard you kick cancer’s ass!

Pass it on…

Love & Gratitude

 Carl and I with our 14 grandbabies (half are adopted and special gifts to our family).

45 years and still counting.

This has been a very busy time of year for me, and believe me I am not complaining. I am very grateful for every day I have on this earth. I am grateful for my family and my friends. And I am VERY thankful for the medical researchers who conduct clinical trials.

Sharing my Story with Pharmacyclics

I recently returned from a visit with the Pharmacyclics folks in Sunnyvale, California.
Here I am with Wulff-Erik ("Erik") von Borcke, the President, and posing with the painting that I was commissioned to paint for their lobby "A Piece of my Heart (Part 2)."

I met with Erik for about 40 minutes and then he interviewed me in front of a crowd of about 300-400 employees for about an hour. Ibrutinib is one of their cancer drugs, so we discussed my cancer journey. What a remarkable experience for me. The employees wanted to put a human face with the drug they are manufacturing. In the audience was a recent grad of the Computer Graphics Technology Department at Purdue University, where I taught, researched and wrote grants. Small world; isn't it?

4 years and 3 months on ibrutinib

I just returned from the National Institutes of Health in Bethesda, Maryland with a medical update. After four years and three months on ibrutinib, my blood work remains good, specifically my white blood count, which is still in the normal range (8.3K).

I had the opportunity to meet two patients on the ACP-196 clinical trial, and met Nancy, a retired school teacher from Houston, who is in the same leg of the ibrutinib trial as I am, and still doing well. My blood brother George is still alive and kickin’ on ibrutinib. He started the trial the same day as me.

However, as of Thursday, Oct. 13, 2016, 17 participants in my clinical study with ibrutinib have relapsed after four to four and a half years on the drug. Most were 17pDEL, some were complex karyotypes, and all received prior treatment before ibrutinib. If ibrutinib is a frontline treatment for you (as it was for me), it may work in your favor, according to Dr. Ahn Inhye.

The good news is that there are lots of options now if you relapse that were not available when I was originally diagnosed August 2009. Clinical trials with venetoclax (an Abbvie drug) have shown amazing results. Trials combining ibrutinib and venetoclax have resulted in some MR negative results, which are associated with long-term survival. Minimal residual disease (MRD) is when a person is in remission, but there are still a small trace of leukemic cells from the bone marrow that remain, even though the patient shows no sign of disease. That’s me. It’s those little boogers that can cause a relapse.

I have another unrelated issue I am taking care of that has to do with my immune system. My GP said that recent bloodwork indicated I tested positive in three blood tests: (1) anti-nuclear antibody (ANA) test, (2) rheumatoid arthritis (RA) test, and Sjogren Syndrome. The important thing to remember is that any of these tests can be a false positive, so I will not worry about it until I find out otherwise.

The ANA test reveals the abnormality of autoantibodies attacking the body’s own cells, which may indicate the diagnosis of lupus. Further testing is needed. The RA test checks for autoimmune disease of the joints. I have an appointment with a specialist in December. Sjogren Syndrome is an inflammatory disease affecting the immune system and tear and salivary glands – hence dry eyes and dry mouth issues.

So now I am trying to get my short-term memory cells to communicate with each other, because I am performing in two stand-up comedy routines next weekend. As the Alive & Kickin’ (A&K Sisters), my stand-up partner Diane Miner and I will be opening for the Decoding Annie Parker movie and book signing in Scottsdale on Saturday. It is about the discovery of the breast cancer gene.

On Sunday in Tempe I will be doing a stand-up comedy act as MaMa La Verne at the IMPROV, along with other comics, to benefit the Leukemia & Lymphoma Society.

So there it is. Life is unexpected and concerning, yet joyful. Hope is the word: Spread the laughter, heal the soul.

In the end what matters most is how well you lived,

how well you loved,

how well you learned to let go,

how much you laughed

and how hard you kicked cancer’s ass!

IMBRUVICA is still doing its thing

 Mountain Winery, Saratoga, California

LLS donor development friends:

Gail Sperling, Carson Jacobi, Sharon Ladin, and me

What an incredible past few weeks it has been! 

I flew to a vineyard in northern California to talk to some pharma sales reps about oral cancer drugs. It was important for them to talk to a real live human who is alive because of the novel cancer treatments they are selling to medical doctors. They had lots of questions. I looked in the audience and saw such wonderful smiles. They filled my bucket, as my granddaughter says.

Then my husband Carl and I flew to Bethesda, Maryland for my medical testing and I met my new doctor. More about that in a minute.

Then we had out-of-town family/friends fly in from Santa Barbara and Houston to celebrate my daughter-in-law’s birthday. Yes, you heard me right. They flew into Phoenix during our heat wave. I told them it was like flying into Toronto, Canada during a snow blizzard. They must love us a lot. LOL.

Then I gave a talk to the national Leukemia & Lymphoma Society (LLS) donor development staff at the Renaissance Hotel in Phoenix. My talk was about my diagnosis, how I got involved with LLS, how LLS helped me, and my message to donors. I threw in some of my stand-up comedy, which was unexpected to them. I got a standing ovation. I was deeply touched.

So getting back to my leukemia update:

I met Dr. Ahn Inhye again at NIH. She is now the doctor I will see when I go to NIH for testing. I met her originally at the beginning of my clinical trial journey. She is short like me and Asian and I could actually look her in the eye. LOL.

Two years ago (July 2014) medical tests indicated that I had 23% leukemic cells in my blood. One year later (July 2015) I had 3.8% leukemic cells in my blood. I was thrilled to know that this visit to the NIH I did not have to have a bone marrow biopsy, because the one I had July 2015 showed a normal bone marrow biopsy. I was hoping that my flow cytometry test would come back showing I had reached MRD (minimal residual disease) negative. MRD negative disease in CLL is not “no disease” but an incredibly low level that is below the detection cut-off of 0.01%.

The flow cytometry test results came back a week after I got back to Arizona indicating 3.2% leukemia B-cells in my blood. Good results, but not the kind of results that would have “knocked my socks off,” that I say to my students.

I wondered if anyone in the clinical study had reached MRD negativity. I found out there were two participants. The majority of participants did not reach MRD negativity, but continue to respond on low level of detectable disease. So this is my case. The doctor considers 3.2% a low burden of disease, and interprets this result as a very good response since I have been on IMBRUVICA (a.k.a. ibrutinib, PCI-32765) for four years now.

Happiness doesn’t come as a result of getting something we don’t have, but rather of recognizing and being grateful for what we do have.

Oral Cancer Drug Access for Medicare Patients

  L: Mary Catherine Moffett, MIDDLE: me, R: Thea Zajac

PHOENIX, ARIZONA

Monday, June 27, 2016 I had the pleasure of meeting with Mary Catherine Moffett, Advocacy Director of the national Leukemia & Lymphoma Society (LLS), and Thea Zajac, LLS Director of Government Affairs. The discussion focused on Medicare cancer patients’ access to oral cancer drugs.

Members of the national LLS and I are going to share stories of Medicare and non-Medicare patients who received access to oral cancer drugs through their insurance and others who have not with U.S. Congress members.

Please email your stories to me at DrLVHarris@gmail.com and use the subject line: ORAL CANCER DRUG ADVOCACY. I have a September 1 deadline. These stories will be sent to Washington, DC.

Please include the following in your e-mail stories:

• Name, age, gender

• Name of cancer

• Are you on Medicare? If not, what insurance?

• What is your prescription insurance? Secondary insurance?

• Have you tried to get your oral cancer drug covered by your insurance company? What is your co-pay? Is it affordable to you?

• What is your experience? How is this financial burden changed the quality of your life?

It is remarkable all the breakthrough cancer treatments that have been FDA-approved and tested in clinical trials for leukemia and lymphoma patients the past several years. That is what medical innovation is all about. My hat goes off to all those dedicated medical researchers, who persevere and do not give up on finding a cure. I am also forever grateful to the stakeholders and organizations providing funds to make these innovations possible.

Love and gratitude from the lab rat – me. As many of you know, I am here only because I became B22 in a clinical trial with an experimental drug for patients with a very poor prognosis. So the oral cancer drug is working and I have access to it through my clinical trial, because I am being observed for any long-term effects. Originally I was supposed to have access to the drug as long as it worked for me -- until I relapsed. I breathed a big sigh of relief. That is, until last April when I had to sign a revised contract stating that at any time without any reason I could be pulled from the study. Be still my heart… on to Plan B and Plan C.

But before I do, let me explain the costs of newly FDA-approved drugs. Many are $100 a pill and if a patient is prescribed three a day… You get the picture… over $100,000 a year -- $109,500 to be precise. Because of the poor prognosis cancer diagnosis, and having to search the United States for a cancer expert, I had to leave my university career before I was able to qualify for retirement benefits.

The Leukemia & Lymphoma Society (LLS) has been instrumental in pushing legislation through the states for affordable access to oral cancer treatment by promoting that insurance plans not require patients to pay more out-of-pocket for cancer medications based on how those drugs are administered. As of today, 40 states and DC have passed these state laws. Many of the drug companies are generous in their ability to help subsidize the cost of expensive Tier 1 drugs for patients with insurance other than Medicare.

So Medicare has become an insurance challenge. It is a federal program. And unfortunately, the majority of leukemia and lymphoma patients are on Medicare.

Two years ago, a number of us from Arizona’s LLS met seven members of Congress face-to-face to discuss passing a bill so that oral cancer treatment would be treated the same as intravenous cancer treatment. Why shouldn’t it be? After all, cancer treatment is cancer treatment. LLS hired a research firm to confirm that the medical costs of treating a patient on an oral cancer drug as opposed to one who did not have access and became ill is about $2 more. The lobbyists backed away and the bill had no one opposing it. We encouraged the lawmakers to sponsor the bill and get it through Congress since it had no opponents. The bill just sat there gathering dust.

Today there is a bill in Congress that expires in December. It is called the Medicare Part D Beneficiary Appeals Fairness Act (HR2624 and it’s Senate companion S1488). It allows a cancer patient to negotiate a Top Tier drug to be more affordable.  It is not exactly what I wanted, but it is a start. It is sponsored by Senator Bill Nelson (FLA). Kudos to Rep. Raul Grijalva (Arizona District 3) for being the only Arizona co-sponsor. LLS is going to re-introduce the bill to Congress in January. All I hope is that cancer patients in the future will be able to benefit from this, and that politicians remember that they work for us.

So here is one of our plans. Several of us at LLS are going to have to pound the pavement AGAIN and begin in Arizona to get the ears of Senators Jeff Flake and John McCain, and Representatives, such as Ann Kirkpatrick (Az-1) and Kirsten Synema (Az-9).

I am in contact with several national insurance assistance experts and will be reporting on what I find out that benefits Medicare patients, who will be or are presently taking oral cancer drugs. That will be another blog.

We need your stories in order to get this bill through the system. Let’s “get’er done!”