6 MONTHS ON IBRUTINIB

I began the completion of my sixth cycle on Ibrutinib by boarding the plane to the East Coast with my husband Carl to pick up (hopefully) a three month supply, and undergo a blood test, CT scan, and bone marrow biopsy at National Institutes of Health (NIH). As someone who is immune compromised, I am aware of all the people boarding the plane, who are sniffling, sneezing, coughing, and hacking their way to their seat. Their cold could end up being my pneumonia, especially when we are breathing the same air for hours. I wear a mask and disinfect my seat to prevent me from getting sick on the plane. Why don’t they wear a mask to prevent others from catching their cold? I think it should be a health issue, just like not smoking on planes. I think I will have to write a letter…

On another note, I received my medical bracelet and dog tags from http://www.americanmedical-id.com/. Just in case of emergency, any medical team will know that I cannot be given blood thinners or it could be fatal.

The best part of our trip was seeing my cousin Sam and his girlfriend Carole, eating at Japanese and Italian restaurants, and seeing the comedy Capital Steps at the Ronald Reagan Center in D.C. The really good news is that Dr. Farooqui said I will continue to get the drug from NIH until it becomes commercially available, which means even after the last participant reaches completion of Cycle 6. And… Dr. Farooqui said I could drink my red wine again!!! Oh, mercy. Life is good!

The worst part was the bone marrow biopsy. My blood pressure was 147 over whatever when I began the procedure. When it was done, it was 119/46. Guess I was stressed… I had one uncomfortable one at M.D. Anderson in Houston, but the two others I had at NIH were a piece of cake. This one was #4. I had to be shot five times with Lidocaine, a local anesthetic that stops nerves from sending pain signals – usually it only takes one to work with me. That hurts more than the biopsy to me. I really don’t know why this procedure was different. I was wheeled out in a wheel chair, because I couldn’t walk. The PA said that this was the largest sample of bone that she has ever gotten from a patient. She has done hundreds of biopsies. Lovely… Glad I could be of service.

The next day I met with the NIH fellow Dr. O’Sullivan from Ireland, Dr. Mohammed Farooqui, Dr. Georg Aue from Germany, and Susan Soto, R.N.

My white blood count (WBC) trend is downward, which is good. I have moved in a continuous downward trend from 135,000 at peak to 53,000 (last month) to 45,000 (this visit). Goal is to normalize at 4,000 to 10,000. One of my 17p blood brothers, Dr. Matt, has normalized already. His peak was double mine. He is our poster child. This just shows how the physiology of everyone’s body is so different. I will just have to be patient.

One of the most exciting findings is that my neutrophil percentage is now 20.1. It more than doubled from the previous month of 8.5%. It has been below 9 since before I began the clinical trial. The goal is to increase to the normal of 34.0% to 71.1%. Neutrophils aid in fighting infection and disease. They are made by the bone marrow.

I have a continued reduction in lymphocyte percentages, which is good.

Kidney and liver functions are normal.

Spleen size has been reduced from 10 cm to 9 cm, which is normal.

Mineral panel is normal.

Immuniglobulin readings are normal.

Platelet count is close to normal range.

I am deficient in D3 and B12, so I get monthly B12 shots and I increased my quantity of D3 vitamins.

My CT scan indicated no changes since September 2012 in lymph nodes. There is no indication of lymph node enlargement under the arms, under the neck, or in the abdomen. Lymph nodes in neck, underarms, and abdomen are about 0.5 cm. There is a spot on my right lung that Dr. Aue confers must be evidence of benign granoloma tissue -- possible exposure to Valley Fever, which everyone who lives in Arizona for more than two years has. No worries.

I have mono-alleles, which means that the detachment is only on one arm. This is good.

I had questions about next generation sequencing – BIRC3 (which is very bad to have and confers chemotherapy resistance), SF3B1 (which is related to 11Q deletion), NOTCH (which is related to Trisomy 12). Dr. Aue said that NIH does not conduct that testing. He said it is very complex.

It is unusual that I have 17p deletion (poor prognosis) and a mutational status (good prognosis). NIH is in the process of checking my serum sample and double-checking my mutational status.

I will get bone marrow biopsy results and cytogenetics results in about three weeks. At that point I will be able to see if the cellularity in the bone marrow and the deletions in my cytogenetics have changed for the better.

Here are my side effects for CYCLE 6:

I always keep a record of ANY side effects, whether or not the minor irritations are caused by the drug or not. Only the researcher knows when the data from all the participants is collected and analyzed.

1: Nose

All month my nose has been dry. When I wake up, it is often because my air passage has been blocked by dried mucus. When I blow my nose, it is accompanied by a little blood from the tenderness of the inside of my nose. The Ohio State University recommends a bedroom humidifier. Dr. Brian Koffman recommends bactroban ointment to keep the inside of the nose moist. Dr. O’Sullivan said that I should ask my pharmacist about the availability of bactroban (Mupirocin), since it is used in hospitals to counter bacteria. I will be calling my dermatologist to see if I can get a prescription for it.

2: Hair on arms

My forearms and legs have been without hair for years. I noticed that peach hair is now growing on the arms. That is a good sign. That means that my body now has enough resources for my hair follicles.

3: Slight cramping

I have experienced slight cramping that lasts only a few seconds in my thumb, fingers, and hamstring muscles. It often happens if I hold my hands in the same position for a while, or if I move my body in an unusual position. The hamstring cramping occurred in a cold environment.

4: Gout?

Suddenly one morning at the end of the cycle it felt as though I had a cut in the crease of my middle toe under my right foot. There was no cut. I observed that it was a little swollen and tender to the touch. It began Dec. 22 and lasted for several days. My uric acid was slightly elevated in my January 4^th blood test, so this is a possibility.

5: Paronychia

The corners of the lateral nail fold on my fingers (where the skin meets the top of my nail) is tender and does not heal readily. It was diagnosed as paronychia, a splitting of the skin surrounding the nails. This often happens with patients taking chemo. Applying moisturizer on the nails is recommended. Dr. Georg Aue recommends I get rid of my nail polish, as it may cause the irritation. It is probably the acetone that is the culprit. So I will not be doing any hand modeling for commercials. LOL.

6: Traces of GI bleeding

During my annual exam, my G.P. performed a fecal occult test to determine if there were traces of GI bleeding. The test was positive. I am scheduled to have a colonoscopy in mid-January. I will have to discontinue using Ibrutinib three days before, so that I do not have a problem with internal bleeding during this procedure. As soon as there is no indication of bleeding, I will continue using Ibrutinib.

7: Hip bone soreness

For a few days I have had hipbone soreness. It is a dull aching feeling. The vital signs nurse said that several patients have reported this.

Early Sunday morning I was greeted with a headache, nausea, and dizziness. I was thankful that our plane did not leave until the afternoon, so that I could be still and let it pass. This could have been a little vertigo episode with my Meniere’s Disease. Who knows? I initially thought it meant I was allergic to the Lidocaine, but I would have thought the reaction would have been Thursday night, if that were the case.

So that’s it. Overall good news. I hope you enjoyed an insight into my leukemia journey. I want to leave you with one thought: I want Ibrutinib to be available for all leukemia patients, especially those with 17p deletion, who have no options. This beats a bone marrow transplant or heavy-duty chemotherapy any day. My side effects are minor irritations, but I certainly can live with them. I am better than I was six months ago, when I began this clinical trial. And for that I am grateful.