Clinical Complete Remission at 30 Months on Ibrutinib

I just returned from my quarterly visit to the National Institutes of Health (NIH) in Bethesda, Maryland, where I am in a clinical trial with the drug ibrutinib. I flew to NIH and arrived with the outside temperatures at 10 degrees. Brrrrrr. It was 70 degrees in Arizona. I brought along sinus and lung congestion that I have been fighting for a while.

I will get right to the very good news: If my bone marrow biopsy results on July 2015 are the same as the results of July 2014 (which Dr. Adrian Wiestner is optimistic about), then he declares that I am in clinical complete remission at 30 months of ibrutinib treatment. This is the best news I have had since I was diagnosed with CLL/SLL (17p deletion plus p53 mutation, a poor prognosis) August 2009. Hurrah! Hurrah!

This, however, does not mean I am cured and this is why:

A cure by definition means the end of a medical condition. A disease is incurable if there is a chance for relapse. I still have 59% damaged 17p deleted cells lurking about in my peripheral blood, according to my FISH test from last summer. When I began the clinical trial, I had 97%. So I have improved. The remarkable feature of ibrutinib is that it is not dependent upon a 17p diagnosis as being a poor prognosis. If I were undergoing chemotherapy intravenously, then the 17p-deleted cells would matter.

I never expected a clinical complete remission. I knew that 17p deleted patients were having partial remission (PR) on ibrutinib.

A remission by definition means the temporary end to the symptoms of an incurable disease or the absence of disease activity. A complete remission (CR) is the complete disappearance of all manifestations of the disease. A partial remission (PR) is the 50% or greater reduction of cancer cells.

I personally only knew of one 17p patient who had a clinical complete remission early on with ibrutinib and that was my blood brother Dr. Matthew Hils. He told me he had messy cytogenetic and 17p was not the only problem in his blood. He relapsed and passed away before he could be treated with ABT-199, another oral kinase inhibitor in a clinical trial. Matt was such a good person. All of us at NIH miss him.

In spite of the fact that I arrived at NIH with sinus and lung congestion, my blood work still managed to be normal. That was exciting news.

As a proactive patient, my next concern was a Plan B. What do I do if I relapse on ibrutinib, since the 17p deleted patients have been relapsing in about three years? Dr. Wiestner said that there would be many more options available for relapsed patients in the future. If I relapsed TODAY, Dr. Wiestner said that the options would be:

•   idelalisib: An FDA approved (July 14, 2014) PI3K inhibitor effective with p53 mutated patients, but still too costly for me, since the U.S. Congress has not passed the cancer drug parity bill. The drug company reports that the monthly cost for idelalisib is $7,200, which they report is lower that the comparable price for ibrutinib, which sells for $8,200 a month.

•   ABT-199: Currently in clinical trial

•   Half-match stem cell transplant: Remember that since I am bi-racial, I have less than a 1% chance of finding a match. He said that my brothers may be half matches and that I am still young enough for that option until I am 70. I turn 63 this month. Siblings have a 50% chance of being a half-match for each other a 25% match of not matching at all, and a 25% chance of being a perfect match.

I asked about the ROR-1 studies. He said they are still in the early phases.

This month I am driving to San Diego to have a consultation with Dr. Michael Choi, who works with Dr. Thomas Kipps at the UCSD medical research center. They are doing a clinical trial using ABT-199. My name is in the system. I just want an option available just in case.

Then Dr. Wiestner smiled and said that because I used ibrutinib as a front-line treatment, I am one of the 17p-deleted patients least likely to relapse. I paused, took a deep breath, and had the unbelievable urge to call my husband and tell him that I may be around a little longer.