The Miracle of How a Book Wrote Itself

 I just wrote a book titled Idea Engineering: Creative Thinking and Innovation. Yes, you are probably just as surprised as I am. The real surprise is not that I wrote a book, but how the book got written.

Because of the research I had done as a professor, I was approached by a publishing company in New York to write a book about creative thinking and innovation for engineers and technologists. They wanted me to organize some of my prior research on the topic and said the book could practically write itself. LOL. That would be a fairly easy feat B.C. (before cancer).

I paused. One of the things that happens when faced with the Grim Reaper poking at you is that you think about your bucket list and your legacy and what you will leave behind. Will anyone remember you? Will your life have counted for something good in this world? I decided to take the chance.

I said that I was not interested unless I could put my own spin on it. I wanted to add personal anecdotes so that the book could be read by people outside of the academic realm. I wanted to add some of “life according to Dr. La Verne” moments.

Privately I explained to the editor that I had been diagnosed with cancer and had entered a clinical trial. I was dealing with some side effects, but I believed that the process would be a wonderful diversion from thinking about leukemia. He was willing to take a chance.

I gathered my research and then started organizing it and rewriting it. I thank God every day that I could write this book at my pace and my way. Some days I could not do anything. I was fatigued. Some days were good and then I would have to pay for it later. Some days I could only sit for short amounts of time on the computer, because of my spinal stenosis. So some days I worked on the computer, then got up and walked around the room. Then I was horizontal in bed and read a little, then sat back down at the computer, then took a nap. The entire process was exhausting.

The interesting parts of the journey were the times I began to get the symptoms of chemo brain (Refer to my past posting). I couldn’t remember what I had done or not done on the manuscript. I know this must sound horrific to most people, but because my demented sense of humor saves me, I found it quite amusing. I would reread parts of the manuscript and say to myself, “ Wow! This is great! Did I actually write this?” Then there were days I would read what I had written and say, “This is crap! What on earth was I thinking? This doesn’t even make any sense at all!” Then I would trash it.

On a few occasions I couldn’t remember where I put my handwritten notes. “Well, you old senile bat,” I would say to myself, “Time to do something else.” Then I would meditate for a while, do something else on my list, and try again another day.

The process continued throughout all the feedback from my reviewers and the copy editors. I wish I had a fast-speed version of me. It would have made great entertainment on YouTube.com.

So now the book is being printed. It is available from Amazon.com, as well as the publisher’s website momentumpress.net. It truly is a miracle that the book got finished. Somehow it must have written itself.

Ibrutinib stopped working for Dr. Matt

George, Matt, and I began the National Institutes of Health clinical trial with ibrutinib (PCI-32765) the exact same day. We decided we are blood siblings. George and Matt will be forever my “blood bruthas.”

Ibrutinib is now called “Imbruvica” and is available to cancer patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. Soon the FDA will approve it for 17p deleted CLL/SLL cancer patients.

My last visit to NIH in Bethesda, Maryland was in October. I had hoped to meet up with George and Matt, but I did not hear back from Matt. I thought that either he was a poor communicator or something was wrong. Well, something was wrong. This is what Matt emailed to me:

Hi La Verne and George,

I’m sorry I’ve been out of touch, but I had a dramatic reversal of fortune in late September through October and was unable to communicate well. 

In summary…My June 2013 ibrutinib checkup went beautifully, with what they called a complete response to the experimental drug.  There was no sign of CLL in my bone marrow biopsy and only 2-3% of my blood cells were CLL compared with about 90% CLL when I started the NIH trial.  All was looking rosy and very positive. 

               On my 15-month checkup on 27 September 2013 things changed.  My white cell numbers were up a bit, but the NIH team was not concerned at that time.  They said they had seen some fluctuations like that and not to worry.  However, they wanted me to get another blood test sooner than the usual 3 month test, so I went to my primary care physician a couple weeks later and found that the white cells had doubled in just under two weeks. 

               The NIH team asked me to visit again on 16 and 17 October for further testing.  At this point they confirmed that the CLL had “broken through” the ibrutinub treatment and that the drug was no longer working for me.  Such a promising start turned in a total bust by mid-Oct 2013.  They suggested I return to Dr. Michael Grever and the rest of the OSU team in Columbus, OH for alternative treatment. 

               I saw the OSU team on Friday, 25 Oct 2013, and got some options for alternative treatments.  That is the day my time with ibrutinib stopped and I was no longer on the NIH trial.  We were planning to begin the new treatments at OSU soon after, but I had a series of major complications that led to three hospitalizations, two for two days each by my home and one for four days at OSU.  I retrospect all the troubles and pain were due to a Richter Transformation of my CLL into a very aggressive large-cell lymphoma.  So I turned into an even more complicated case than I could imagine.  The other thing the OSU team said is I have many more mutations than most people, making things very complex. 

               Below I have copied my latest upates to family and friends.  I’ll ask that you two distribute this to the NIH trail group as you see fit.  Ibrutinib worked well for me for quite a while, but then it stopped.  I think my case is unusual, so everyone else should stay encouraged. 

               I’m sorry I won’t be seeing you at NIH anymore.  It was great to have you in my cohort!

               As always, I wish you all the best with ibrutinib and hope all continues to trend well.  I’m taking it one day at a time, using a tremendous network of family, friends, and colleagues in Hiram and beyond.  Enjoy each day and worry about nothing but having fun! 

All my best to you both and the rest of the NIH crew,

Naturally Yours,

Matt

As I mentioned in my previous posts, Ibrutinib is a BTK inhibitor. That means it blocks a pathway used to develop leukemia cells. In Matt’s case the drug stopped working, because the leukemia found another pathway and then transformed into a very aggressive Richter’s transformation -- large-cell lymphoma. This affects about 5% of CLL/SLL patients at some time. It can appear suddenly, even to patients in remission. It has a poor prognosis with survival of five to eight months, according to the experts.

In summary Matt is at Ohio State University in another clinical trial with another experimental drug (IPI-145), an oral inhibitor of phosphoinositide-3-kinase (P13K)-delta and P13K-gamma. Matt said that the new drug is not a cure but rather a stopgap measure to get the aggressive disease under control.  

The only way he will be cured of all this is through a stem cell transplant (aka bone marrow transplant).  Unfortunately he has no matching donors in the system.  The medical team is looking into using umbilical cord stem cells or using a half match donor. No transplant can happen until the lymphoma is under control. Anyone with a fully matched donor and who has the cancer under control is in the best situation for success. Matt will be my guinea pig so that I know what to do if the same thing happens to me.

I got this news about Matt at the time I came down with an upper respiratory infection with laryngitis. I also had a severe drug-related cramp in my right ankle which tore my ligament. So I was hobbling around with a brace and cane, but the most difficult part was not talking. LOL. This is a ripe setting for a pity party. Lucky for me my friend Sally was visiting from Santa Barbara/Houston and there was no time for anything but laughter. Then Carl and I visited our friends Janis and John and the laughter continued.

Then on Thanksgiving my children and my baker’s dozen grandchildren came over to share our turkey dinner with Carl and I. That is when I was reminded again how very blessed I am for every single day.

I have kicked the pity party to the curb.

Ibrutinib is now available for MCL patients!

Ibrutinib now has a new name -- "imbruvica." It has been FDA approved to treat patients with mantle cell lymphoma (MCL) who have had at least one other treatment. 

Pat Elliot sent me these links:

http://www.onclive.com/web-exclusives/FDA-Approves-Breakthrough-Ibrutinib-for-MCL

http://www.latimes.com/science/sciencenow/la-sci-fda-treatment-imbruvica-lymphoma-20131113,0,2297063.story

http://www.nytimes.com/2013/11/14/business/drug-to-treat-blood-cancer-gains-fda-approval.html

http://news.avella.com/news/avella-chosen-as-specialty-pharmacy-partner-for-new-cancer-treatment-medication

Chemo Brain

I have always been a little on the absent-minded side. I blame that on my creative nature and my propensity to daydream.

What I did not expect to happen was a frightening fogginess that prevented me from remembering the names of a few people I have known for 30 years. I also recently had some short-term memory loss. I have had moments where it was just empty upstairs.

I talked to my GP about the problem and was given the Montreal Cognitive Assessment (MOCA) to check for dementia and cognitive impairment. The part I had the most difficulty with was the mental numeric calculations. I did not pass the MOCA test. I had to reassure the brand new GP that I honestly did have a PhD.

I kept this whole scenario from my family (all except my husband), because I didn’t want to cause them additional worry. As a university professor, my brain is my life source and this could be devastating to me.

The GP ordered an MRI of my brain to check to see if I had a secondary cancer (a tumor in my brain) or large plaque burdens, which is indicative of early Alzheimer’s disease. Then my demented sense of humor took over. I thought to myself, “ Well, if I don’t have my cognitive ability, at least I have my body.” I busted out laughing when I realized that I don’t have that either with my leukemia diagnosis. Oh, life… What have you thrown my direction again?

My brain scan turned out normal with no vascular plaque buildup and no tumor. So what is the problem?!? Why was I having so many blonde moments? (Apologies to all my real blonde friends.) I thought that the impairment could be caused by stress.

When I mentioned the cognitive issues to my hemotologist/ioncologist at my appointment – almost as an afterthought – she had an answer. “La Verne, you’ve got chemo brain.” It doesn’t matter if one takes cancer drugs by vein or orally, the results are the same. This is known as PCCI (post-chemotherapy cognitive impairment) – changes in memory, concentration, and the way you think. Sometimes it is temporary. Sometimes it is long-term. Some symptoms of chemo brain are:

• Confusion

• Difficulty doing more than one thing at a time (multitasking)

• Forgetting things you normally remember (memory loss)

• Fatigue

• Difficulty finding the right word

• Difficulty calculating in your head

• Difficulty remembering or following the flow of a conversation (verbal memory)

• Difficulty recalling an image or a list of words (visual memory)

• Difficulty concentrating

• Difficulty learning new skills

• Short-term memory problems

• Taking longer and having to work harder to complete routine tasks

• Short attention span

• Mental fogginess

• Being unusually disorganized.

• Spatial ability (mentally rotating objects in space): I add this problem to the list, because engineers and technologists will be affected by this symptom in order to function at work.

Not everyone has all the symptoms.

A notable percentage of people who undergo chemotherapy experience some amount of cognitive impairment. Cancer research in the UK (http://www.cancerresearchuk.org/cancer-help/about-cancer/cancer-questions/chemo-brain) show evidence that 17 to 50 percent of women with breast cancer treatment and 47 to 69 percent of men having prostrate cancer treatment have reported chemo brain. Research has indicated that symptoms improve within a year of ending cancer treatment, but for others it is long term. Scientists are also looking into how factors such as stress contribute to cognitive impairment. Another group of researchers is examining why an increase in cytokines, which are proteins made by the body during an immune system response, are higher in people with cancer treatment. They are also researching why the highest cytokine levels are found in patients reporting thought and memory problems.

This is what I have had to do to deal with chemo brain:

• Simplify my life

• No multitasking

• Function using TO DO lists

• Put events on a calendar

• Try to get enough sleep

• Do something physical

• Keep my mind active by writing, doing puzzles, etc.

• Paint and listen to music

• Reminder notes on my iPhone

• Repeat details back to people when arranging to meet with them and write it down.

This truly was one of the hardest blogs I have written, because it has to do with my brain. I like my brain. That is the one organ that has given me opportunities to teach at the largest and best research universities. It has given me meaning to life.

I often wonder if we are faced with all our fears before we kick the bucket. I have been afraid of needles since I was four years old. Two or three doctors in a German hospital tried to hold me down for a shot, after I screamed and gasped when I saw the HUGE needle they were going to use on me. I had just been diagnosed with pneumonia. I fought them off. I remember the IMMENSE Army nurse they called into the room. She wrestled me on the hospital bed and gave me a shot in the gluteus maximus. With a leukemia diagnosis, I am poked and prodded with needles more often than I care to be. I have just learned to deal with it.

Maybe this is another life lesson I will have to learn to deal with – chemo brain. I guess I will have to rely more on my heart, since that seems to be still ticking most days. :-)

Government Shutdown, Your Health, and American Innovation

NIH 7th floor lobby

NIH clinical trial waiting room

This is where I get my chi tea latte.

Main NIH lobby and gift shop

The main National Institutes of Health campus is home to the NIH Clinical Center, which is the largest hospital in the world completely dedicated to clinical research. About 6,000 scientists work in NIH’s Intramural Research laboratories mostly on the NIH campus in Bethesda, Maryland. More than 80% of the budget of NIH goes to innovative federal grants to over 300,000 researchers at over 2,500 American universities and research institutions. Federal grants for university professors and scientists have now been put on hold.

My blood brother George contacted me and was concerned that I would have a problem with my appointment at NIH, because I was scheduled to fly in last week during the beginning of the government shutdown and 75% of the NIH is furloughed or on forced leave. That means 18,646 employees got sent home with no pay. He was worried that I would have no nurse, no medical team, or no cancer drugs.

I went anyway. Wednesday, October 2nd, the NIH campus at Bethesda, Maryland looked like a ghost town. The lobby on the main floor was empty when I came in for my blood work. The café I get my chi tea latte non-fat vente was gated up, and the gift shop had no one working. I went up to the seventh floor lobby and it looked deserted. The waiting room for the clinical trials looked empty for quite a while. The only place on the entire campus that was open was the small second floor lunchroom. I was thankful that my furloughed nurse came in for my appointment and thankfully so did the medical staff.

Because I am enrolled in a clinical trial, I have the good fortune of being treated for the leukemia and having access to my drugs. Not so fortunate are those hundreds of patients finally entering the clinical trials, who are turned away every day at NIH during this government shutdown. In a week’s time there will be 200 sick patients turned away from clinical trials that could save their lives. About 30 of those patients are children with about one-third being children with cancer, according to an NIH spokesman.

This may help to make this point more poignant: 10,000 new patients enroll in clinical trials at NIH each year, because they are usually out of options. They are willing to take their chances with being a little white lab mouse and being exposed to experimental drugs and treatments, because standard medical treatments have failed. Now think about how they must feel being turned away.

I had dinner on Wednesday night with my cousin Sammy, who is an engineer working for NASA, and he just filed for unemployment. NASA has furloughed 17,451 employees leaving 549 working in the international space station and the Mission Control in Houston. HAVEN, a new robotic Mars probe is scheduled to launch November 18^th of this year at Kennedy Space Center. If the deadline is missed, the Earth and Mars will not orbit into the proper alignment again until 2016.

Oh, by the way, my white blood cell count has dropped from 29,000 to 19,000 – heading in the right directions. My platelets are a little lower than they should be, but not to worry at this point.

I am patiently waiting for FDA-approval of ibrutinib, which could save so many lives. I guess I will be waiting a little longer, since FDA just furloughed 45% of its 14,600 employees (6,620).

When I emailed my doctor when I arrived home to tell him about a side effect that I forgot to mention at our appointment, I received this email:

Day of Celebration for Dr. Matt

I have chosen to play my cancer card in the transparency of an Internet blog – accessible to anyone in the world. Was this a good decision for me or not?

There are days that this decision has cost me unnecessary stress, when desperate people believe that I can cure their loved one because I happen to have a blog on leukemia. When I explain to them that I am a cancer patient in a clinical trial, trying to share my experience with others, so that other patients can become more informed about the decisions in their life, it does not always matter. When I explain to them that YES, I have a doctoral degree – a Ph.D., not an M.D. -- so I can help with cerebral research matters, not medical matters, it does not seem to matter to them. My heart goes out to them.

This, however, is a good day. I am dedicating today as a celebration day for my blood brother Dr. Matt, who is also 17p deleted – the poor prognosis guys and gals. After one year on ibrutinib, his white blood count remains in the normal range, and his bone marrow biopsy shows no evidence of cancer. The flow cytometry blood test indicates that leukemic-type cells in the blood stream have gone from 100% to 2.4%. So he is as close to remission as he can be. He is “happier than a pig in slop” (his words). LOL. I celebrate his life!

My Dog Mac

If you are one of those people who has never had a pet or loved an animal, this is probably a posting you can skip. For all the others, especially cancer patients with pets, you will understand.

MacGregor -- or “Mac” as we fondly call him -- is my dog. He is a rescue Westie and was supposed to be unadoptable for several reasons. He was at least 10 years old, wasn’t housebroken, and apparently did not relate well to people – at least that is how the story goes. He had been left in a kennel for six months. His owners had gone to assisted living. Apparently the dog belonged to the husband, who was a banjo player. Mac wasn’t into female owners. Mac had stitches running diagonally across his belly from when he was attacked by an Australian Shepherd. He would not make eye contact. He was not a trusting dog.

I had several colleagues at the veterinary school at Purdue University. They found Mac and his longtime friend -- an 8-year-old Bichon Frise named “Buttons,” who used to belong to the wife. I agreed to “test drive” (dog sit) both dogs during the Christmas break in 2008. Buttons was definitely a lap dog and quite friendly. Mac was a grump. Carl was not too happy about the dog-sitting situation, but he could see that I was determined to care for the dogs and that was that.

First task completed… Both dogs were housebroken in two weeks – even in the freezing Indiana snow. I was a professor at Purdue University at the time. That’s the only reason I would be living in snow.

As time went on, I noticed that Mac began to quietly growl under his breath at Buttons, when Buttons would jump in my lap. Mac would then scoot closer and closer to me on the sofa. He still was not making eye contact or letting anyone touch his ears or belly.

By the time Carl and I went to our Midyear Conference in California in January, I decided that I wanted to adopt both dogs. Carl was still not over losing our Corgie Sophie and said, “No.” So I negotiated for one dog instead of two. He said I tricked him. LOL. “Which one do you want?” Carl asked. “I want the Westie,” I said. He looked surprised. “That ugly, grumpy dog with the stitches and bloody ears?! No one would want him!” “Exactly!” I said. “That is why I want him,” I replied. And that was that.

Buttons went off to a great home in Chicago to live with the father and sister of my friend Judy. He is happy as pie.

When I was diagnosed with leukemia, I was very fatigued. I remember lying on my back on the sofa and not feeling well. When I woke up, Mac had climbed up on the sofa and was lying on me with his belly touching my torso and his head under my chin. Ever since then he followed me everywhere. I could not even go to the bathroom without him waiting outside the door. We were friends for life. And that was that.

Last Monday Carl and I were packing and getting ready for our vacation in the White Mountains. Part of the ritual was dropping Mac off at the vet’s boarding facility Monday late afternoon. The alarm was set for 5 a.m. on Tuesday, so that Carl could make his golf tee time. The fishing poles and gear were ready for some trout catching.

I woke up suddenly at 4 a.m. with a bad feeling in the pit of my stomach. For some reason, I started to cry. I was worried about Mac. I asked Carl if he would be terribly upset if I did not go, because I had to get my dog. This was not like me. Carl was surprisingly understanding, even though he probably thought it was strange.

I waited for the vet’s door to open, and I asked to take Mac out of boarding. They looked a little surprised at my request. I wanted the vet to take a look at him. The vet felt a lump in his belly. The x-rays showed that Mac had recently swallowed 50 stones (30 in his belly and the rest in his intestines). The vet said he was too old for surgery. The only chance he had was to get rid of the stones. I spent the last three days and nights helping him expel the stones from both ends. We were exhausted.

By Thursday the last one came out. Mac was a tough dog, but the ordeal was too much for his old body. I wrapped him in a towel and rocked him. Mac passed away on Friday with me petting his beautiful head and body. Such a truly loyal and faithful friend. May you rest in peace, you old grumpy sweet boy. I will forever be grateful for all the love and happiness you brought to my life. You will be missed more than you know.

Love & Gratitude,

Your MaMa

One year on ibrutinib

Carl and I recently returned from NIH on the East Coast. The highlight is always being able to have dinner with my cousin Sam. This time we managed to also squeeze in a pancake breakfast. He works for NASA and has decided to retire in a year or two to Arizona. Sam, Carl, and I are very close, so it will be wonderful having more family close by. The three of us took some time to go to the Hungarian Festival for a little R&R. We saw George at the hotel (one of my blood brothers, who started the trial the same day). We missed seeing Matt. :-(

I cannot believe it has been a year since I entered the clinical trial with the experimental drug ibrutinib. My visit to NIH began with donating 17 viles of blood to Count Dracula, the lab technician. The good news is that my white blood count has decreased from 35,000 to a little over 29,000 (approximately 4,000 to 10,000 is normal). This is where I was five months after I was diagnosed. I am moving slowly, but headed in the right direction. I would be thrilled to be normalized.

I was then pumped full of radioactive juice so that my insides could be viewed by the medical team. My lymph nodes have not increased and I have remained the same since last January. This is also good news.

If you recall, last time I had a bone marrow biopsy I was wheeled off in a wheel chair. I could not walk due to the fact that I was stabbed five times with the Lidocaine, because my nerves kept feeling the needle. My bone marrow biopsy went better this time. Thank God for that one. I walked off the operating table on my own. I will not get the results of the bone marrow biopsy for several weeks. As soon as I do, I will post the results.

There are only a few side effects I reported.

1. The first is that the fatigue has returned the past few months. Rats! Sometimes the fatigue is more like complete exhaustion. Yesterday I took a 4.5 hour nap. I am hoping this will ease up. The medical team said they may have to take me off the drug for several months, if this continues. This freaks me out a little. I am keeping a journal for them.

2. The second side effect is my brittle nails. I have always worked with my hands, so I never had the luxury of having girlie–girl nails, so that is not a big thing for me. It is just a little annoying. The doctors suggested I take biotin.

3. The third side effect is sort of a silver lining one. My hair has changed texture. It used to be straight with no body. Now it has curl and body. I can’t wear a bob cut without using a flat iron! Amazing! Apparently, I am not the only one who has this side effect. I am not complaining about this one. LOL.

I have also signed up for another clinical study to help Dr. Richard Childs and Dr. Adrian Wiestner at NIH. This just involves donating my blood, bone marrow, tissue, etc. for further genetic research. This will help me get more scientific information to help me understand my situation.

I just got through reading Dr. Wiestner’s paper on the clinical study that was presented at a conference and found out that two people in our trial have died, but thankfully not from the experimental cancer treatment. Looks like they had problems with infections. I can’t let things like that get me down. I don’t have time to wallow in the mire and waste my time belly-aching.

My family and friends keep me excited about living. My son-in-law Steve is in Africa now and will be bringing home Ian, a new son. He just turned two years old and he is blind. I am excited about meeting him.

My son Rocky just completed another marathon in Portland. That makes two marathons in four weeks. Crazy! My daughter-in-law Elizabeth, who is five months pregnant, walked a total of eight miles to meet him at his milestones. What animals! It puts a smile on my face.

Love and Gratitude to my marathon runners and Man-of-the-Year

I need to take the time to send a ton of love and gratitude to three young men in my life: my son Rocky, and his childhood friends Tyler Breskin and Adrian Gastelum. They did a ton of fundraising for leukemia and lymphoma research the past few months. 

Rocky and Tyler ran the San Diego Rock’n’Roll Marathon on Team La Verne, and were third place and eleventh place respectively in the United States in fundraising. Rocky and Tyler dedicated their efforts in honor of me.

Adrian just got second place last night for Phoenix Man-of-the Year raising funding for research. Adrian dedicated his fundraising in honor of his brother, who died of leukemia, and me. Wonderful, wonderful men.

Tyler and Rocky at the finish line.

Adrian

MY LIFE since diagnosis

This is a concept map of my life since I was diagnosed with high-risk leukemia a few years ago. Each cancer patient faces emotional, physical, and financial tolls, as well as trying to cognitively put their hands around what is happening to their body and what can be done.  In my case, there were no real successful options, until I entered a clinical study.

I now have a cognitive understanding of the cancer. I am dealing with the physical and emotional toll. I believe the financial toll is manageable for now. After 2 1/2 years of weekly depreciating insurance interviews and filling out questionnaires and providing evidence of disease, I thought I could get on with my life. But now I have been randomly selected (LUCKY ME) to participate in another detailed insurance questionnaire about my medical condition. Here we go again...

And now I find out that the drug that is working for me will probably cost $150,000 per year... I am so happy I have a demented sense of humor!

                                                                   -- Dr. La Verne

Dr. Sharman's Post: How expensive are new drugs?

I just got through reading Dr. Sharman's blog post and wanted to share it with you. It is a continuation of my conversation about the out-of-control costs of cancer drugs. I will let his words speak to you...

http://www.cll-nhl.com/2013/05/how-expensive-are-new-drugs.html?utm_source=feedburner&utm_medium=email&utm_campaign=Feed%3A+DrSharmansCllNhlBlog+%28Dr.+Sharman%26%2339%3Bs+CLL+%26amp%3B+NHL+Blog%29

Paying to Survive: The Cost of Leukemia Drugs

My husband Carl and I have worked hard all of our lives. We both went to college, earned a living, raised a family, contributed to society, and hoped to leave the world a better place because we were here. Cancer reared its ugly head when we least expected it, and it took a financial and emotional toll on us. Becoming a proactive patient has helped me to personally deal with my diagnosis of 17p deleted leukemia.

As you all know, I have just completed nine months in a clinical trial with an experimental drug Ibrutinib, which will not cure the leukemia, but seems to be keeping it at bay, until a cure can be found. Hurrah! It looks like the FDA will approve of the drug in a year or so. This will be my lifeline and has changed my chances for survival. Hurrah! Now the next obstacle in our lives… How much am I going to have to pay to survive?

Here is a quote from the Blood Journal Report, which was prepublished April 25, 2013:

“Of the 12 drugs approved by the FDA for various cancer indications in 2012, 11 were priced above $100,000 per year. Cancer drug prices have almost doubled from a decade ago, from an average of $5,000 per month to more than $10,000 per month.”

If the cost of Ibrutinib follows in suit with today’s cost of Imatinib, more commonly known as Gleevac, which is a drug for chronic myeloid leukemia, the drug company will probably price it about $100,000 per year. Hmmm… My husband is retired. I am not working now. I don’t believe we have an extra $100,000 per year laying around to pay for my survival. I wonder if my insurance will help me pay for this? We are not alone in this situation. I guess we will cross that road when we get there.

All I can say is “Thank God for compassionate and sensible physicians.” Dr. Hagop Kantarjian from M.D. Anderson in Houston is taking the lead with a paper in the Blood Journal Report:

“The Price of Drugs for Chronic Myeloid Leukemia (CML); A Reflection of the Unsustainable Prices of Cancer Drugs: From the Perspective of a Large Group of CML Experts.”

Dr. Kantarjian states:

“As a group of more than 100 experts in chronic myeloid leukemia (CML), we draw attention to the high prices of cancer drugs, with the particular focus on the prices of approved tyrosine kinase inhibitors for the treatment of CML. This editorial addresses the multiple factors involved in cancer drug pricing, their impact on individual patients and healthcare policies, and argues for the need to lower the prices of cancer drugs to allow more patients to afford them and to maintain sound long-term healthcare policies.”

Blood Journal Report full article:

http://bloodjournal.hematologylibrary.org/content/early/2013/04/23/blood-2013-03-490003.full.pdf

The New York Times article, published April 25, 2013, states that physicians in more than 15 countries on more than five continents have joined together to suggest “… that charging high prices for a medicine needed to keep someone alive is profiteering, akin to jacking up the prices of essential goods after a natural disaster.”

New York Times full article

http://www.nytimes.com/2013/04/26/business/cancer-physicians-attack-high-drug-costs.html?_r=1

Stay tuned for the next adventure of “Dr. La Verne’s Awesome Adventure: Slaying the Leukemia Dragon.”

Dedicated to Dr. Mohammed Farooqui

This painting is on display at Banner Hospital for the next few months. When it is returned to me, I will give it to Dr. Farooqui as a gift of appreciation.

Novel Antibody Directed at Chronic Lymphocytic Leukemia

By Anna Azvolinsky, PhD¹ | April 3, 2013

¹Freelance Science Writer and Cancer Network Contributor.

Researchers have identified a novel monoclonal antibody directly targeted against a receptor found in abundance on chronic lymphocytic leukemia (CLL) cells, but not normal B cells. The humanized antibody can directly kill CLL cells, according to Thomas Kipps, MD, PhD, professor of medicine and deputy director for research at the University of California, San Diego Moores Cancer Center, and colleagues. The results of the study are published in the online edition of Proceedings of the National Academy of Sciences.

In contrast to normal B cells, CLL cells express a high level of CD44, a cell-surface glycoprotein receptor. CD44 is thought to mediate one of the important survival signals for leukemia cells. CLL cells receive survival signals from its tumor environment, including cells that are present in the lymph nodes and the bone marrow of CLL patients. Previous work from Kipps and colleagues has shown that CLL cells can undergo drug-induced or spontaneous cell death when removed from a patient and cultured in the laboratory. Because the RG7356 antibody induces cell death of the CLL cells by binding to CD44, the drug is a potential new therapy for treatment of at least a subset of CLL patients.

Ibrutinib on a Fast Tract for FDA Approval for 17p Deleted Patients

EXTRA! EXTRA!

April 8, 2013 it was announced that the FDA granted breakthrough therapy designation for ibrutinib (Janssen and Pharmacyclics) as a monotherapy for patients with CLL/SLL (chronic lymphocytic leukemia or small lymphocytic lymphoma) with deletion of the short arm of chromosome 17. This genetic mutation is associated with poor prognosis and is one of the worst prognostic factors in patients with CLL. This is what I have.

This is the third breakthrough designation the FDA granted for ibrutinib an investigational Bruton’s tyrosine kinase inhibitor. One was as a monotherapy for previously treated patients with relapsed or refractory mantle cell lymphoma, and the other was as a monotherapy for patients with Waldenström’s macroglobulinemia.

The breakthrough therapy designation was created in 2012. It enables the development and review of drugs shown in preclinical studies to offer potentially substantial improvements over existing therapies for patients with serious or life-threatening diseases to be expedited.

Patients like me with 17p deletion generally do not respond well to chemoimmunotherapy, and are limited on their treatment options. In my case, because I am bi-racial, I have less than a 1% chance of finding a bone marrow donor match. Ibrutinib has the potential to improve the outcome in this serious and life-threatening disease, and is much less risky than a bone marrow transplant.

A Phase II global study of ibrutinib in patients with CLL deletion 17p, will be available this year and Pharmacyclics plans to enroll 111 patients worldwide. The study called “RESONATE™ -17” is a single-arm, open-label, multi-center trial using ibrutinib as a monotherapy in previously-treated patients who have deletion 17p, who did not respond or who relapsed (a high unmet need population). The purpose of the study will be to determine overall response rate.

Those of you following my blog know that I have just completed my 9-month milestone as “a little white laboratory mouse” in the clinical trial with ibrutinib. Dr. Adrian Wiestner, M.D., PhD, of the National Institutes of Health is the lead investigator in the clinical study. Dr. Wiestner just presented the findings from this clinical trial at the American Association for Cancer Research (AACR) in Washington, D.C. Here is an excerpt from Pharmacyclics’ press release from April 8, 2013. Please note that this is a fast track to FDA approval, and applies to 17p deleted CLL/SLL patients like me. :-)

Phase II Ibrutinib Monotherapy Study Shows CLL Patients Achieved Rapid and Sustainable Disease Control Irrespective of Age or High Risk Prognostic Factor

SUNNYVALE, Calif., April 8, 2013 /PRNewswire/ -- Pharmacyclics, Inc. (Nasdaq: PCYC) today announced results from a Phase II trial of the investigational oral agent ibrutinib which demonstrated rapid and sustained disease control as a monotherapy in untreated, relapsed and refractory chronic lymphocytic leukemia (CLL) patients, irrespective of characteristics that predict poor outcomes to chemoimmunotherapy.

This study was discussed at today's American Association for Cancer Research (AACR) annual meeting in Washington, DC together in addition to 8 other presentations covering advances in clinical and pre-clinical research with ibrutinib. The Phase II study, which was sponsored by the National Heart, Lung and Blood Institute, included an analysis of two CLL patient cohorts: the elderly, above 65 years of age, (n=24, of which 8 were treatment naive) and the high risk genetic group with a deletion of chromosome 17p (del 17p) (n=29, of which 15 were treatment naive). Many elderly patients with CLL are unable to tolerate aggressive therapies. Patients with deletion of chromosome 17p typically are poor responders to chemoimmunotherapy and have limited treatment options with no standard of care defined. Of all CLL patients enrolled in this trial, 72% had been characterized as Rai stage 3-4, indicating an advance stage, high-risk patient population.

The results of the study were presented by lead investigator Adrian Wiestner, M.D., PhD, Hematology Branch, NHLBI, National Institutes of Health. "Ibrutinib was highly efficacious as a single agent in patients with untreated, relapsed and unresponsive CLL, irrespective of their del 17p status," Dr. Wiestner said. "Responses in this study appear to be durable, and results indicate the drug is effective against the disease in lymph nodes, spleen and bone marrow. This is important because existing therapies often fail to effectively eliminate cancer cells in these tissue sites. Targeted therapy for CLL is becoming a reality, and this new approach may greatly improve the lives of patients with this disease."

The study also evaluated in vivo effects of ibrutinib using blood and tissue samples collected before and during treatment. Ibrutinib demonstrated rapid and sustained disease control in blood, lymph nodes, spleen and bone marrow. After 6 months, 95 percent of patients experienced a reduction in lymph node size and all showed reduction in spleen enlargement, with a median reduction of 55 percent. In 26 patients, for whom a bone marrow biopsy was done, tumor infiltration decreased by 82 percent.

The Progression Free Survival probability for these patients at 12 months was estimated to be 94 percent. Most adverse events were mild and manageable and included diarrhea, fatigue and rash, severe events occurred in less than 13 percent of patients. 

"We are very pleased with the continued research that is being demonstrated at AACR across 9 different presentations. These advances show the potential breadth of the ibrutinib program and provide further opportunities for us to pursue. We are grateful for the continued support of our collaborators, investigators, patients and shareholders," said Bob Duggan, CEO and chairman of the board.

Ibrutinib has been designated as a FDA Breakthrough Therapy in CLL patients with deletion 17p, based on data from completed Phase I/II clinical studies, where ibrutinib as a monotherapy was used to treat patients with this disease. Ibrutinib has the potential to improve the outcome in this serious and life-threatening disease, and may provide a substantial improvement over existing therapies for this indication.