Case Studies el pt

Katie's PCR Clean-up

Date: November 18, 2024

by Katie

Report on a New Chemoimmunotherapy Protocol

Editor's Note: Katie is the pen name of a patient who has just completed the PCR (Pentostatin, Cytoxan and Rituxan) protocol in a clinical trial conducted by a major cancer center. She has maintained a diary as she went through the clinical trial. Here is the story told by this patient volunteer about her experience with this chemo-immunotherapy combination.

________

Hi, I’m Katie, and I have CLL. I am 59 years old and here is my story.

Background

After a number of friends suggested I see a CLL specialist, I made an appointment and went to see Dr. Neil Kay at Mayo Clinic in Rochester, MN. I had a number of ailments this past winter including shingles, and my numbers were increasing. I had been diagnosed in April of 2024, which was just a few months after my mother had been diagnosed with CLL. The difference: she was 86, and I was 54. Then we realized that her brother, my uncle, passed away from CLL in 1980.

I must say that going to a specialist was the best thing that I did. Dr. Kay took over an hour to sit and talk with me patiently and compassionately about my history and the issues with the disease. I had a number of tests including some that contributed data to the Mayo Clinic familial database for CLL. Three days later I met again with Dr. Kay to find out the results of the tests. I preferred to wait in Rochester to get the results so that I could ask any questions directly to Dr. Kay. I found out that my bone marrow was over 90% infiltrated and that the pattern was diffuse. (My regular hematologist never told me that my initial bone marrow biopsy showed 80% infiltration and a nodular pattern when I was initially diagnosed.) Dr. Kay told me that this was probably one of the reasons that I was getting ill more frequently. I had the FISH test and found out that I had the 13q deletion, which is more favorable. I also found out that my Zap-70 was negative, so these were good signs. My immunoglobulins were very low as well. Dr. Kay’s recommendations were to begin chemo or at least start IVIg treatments immediately. We discussed Rituxan monotherapy. However, my marrow was heavily involved and I knew that Rituxan does not do as good a job in cleaning up the marrow. Combination chemo-immunotherapy was the alternative. He suggested a study at Mayo of Pentostatin, Cytoxan, and Rituxan (PCR). I had read about the side effects of Fludarabine, and really preferred not to use it.

My issue was that my hometown was not near Minnesota - and this trial was being conducted only at Mayo and Ohio State University. My husband and I decided that I would try to get into the trial at Ohio State since it was closer to my home in Pennsylvania. Dr. Kay sent all of my information to OSU along with his recommendations. I was able to get an appointment with Dr. Thomas Lin, who works with Dr. John Byrd. Both Dr. Kay and Dr. Byrd were the primary investigators for this study. I discovered that if I wanted to start the PCR treatment at OSU I needed to do it quickly; otherwise I would need to redo the BMB and blood work. For this study, these tests must be done within 30 days of treatment.

This was a very busy time for me as I returned home and had to find a new hem/onc that would work with the doctors at OSU, as well as my scheduling of the PCR treatment. I had to arrange to be in Columbus for a week for the first treatment.

Treatment

The prescription for the protocol was to be Pentostatin, Cytoxan and Rituxan at three-week intervals, repeated a total of six times. The first cycle was to be on a Monday, Wednesday and Friday with Pentostatin, Cytoxan and only 100mg of Rituxan on Monday, with the balance of the Rituxan given on Wednesday and Friday. Each of the following five treatments was completed in approximately 4 hours on the same day.

Treatment began on a Monday with blood work to insure that my numbers were okay to begin. On Sunday, the day prior to beginning the therapy, and for the next ten days I had to take Allopurinol in preparation to help my kidneys with the chemo. The pre-medications  included a bag of saline along with 10cc’s of Benadryl injected into the saline, 16 mg of Zofran for nausea, and 2 Tylenol tablets. The Benadryl caused me to have restless legs. The nurses gave me Ativan to help my legs.

Initially, they gave me 100 milligrams of Rituxan over four hours. An hour and a half later fever, chills and back pain caused them to stop the Rituxan. I received 2 doses of Demerol within a few minutes. Half an hour later, the nurses slowly began the Rituxan again. Once that was completed, I received Pentostatin and then Cytoxan. That night and the next day I had the chills and a very bad headache with some nausea. On Wednesday and Friday, I received Rituxan only. I had the same problems with the Rituxan on Wednesday, but by Friday, it was not a problem.

On Wednesday, my husband, who had never given an injection before this, started giving me Neupogen injections, which continued for ten days. This would increase my absolute neutrophil count. I was given a prescription for Zofran, which helped my nausea. I received prophylactic prescriptions for Acyclovir, an anti-viral, and Dapsone, an anti-bacterial. I would have to take these for up to a year.

My next chemo treatment, which had been scheduled for twenty-one days after the first one, was delayed because of a hospital stay. I experienced shortness of breath. Diagnosing the reason for it took a while. After I spent a week in the hospital, and they discovered that the anti-bacterial, Dapsone, had the side effect of increasing methemoglobin, which impairs the oxygen carrying capacity of the blood. The minute I stopped it, my shortness of breath was much better. It was very scary because I could not speak a sentence without having breathing problems. In the place of Dapsone, I now go into outpatient treatment to receive a monthly dose of Pentamadine that is administered via a nebulizer in a special negative pressure room..

On my next trip to Columbus for the chemotherapy, they found that my neutrophils were too low to have the treatment. We returned the following week after a couple of additional Neupogen shots. After this, I must say that the remainder of the treatments were uneventful. The restless legs continued each time with the injection of the Benadryl, and were immediately relieved by the addition of the Ativan, which helped me doze through most of the treatment. The week after each treatment was difficult, with fatigue, body aches and nausea. These seemed to become more severe with each treatment and it took longer to feel better. The fatigue has continued, but I must admit that my blood work numbers really came down.

I did have thinning hair, but I cut my hair short, only used Nioxin shampoo and conditioner, and a wide comb. I had issues with constipation due to the drugs and lack of fruits and vegetables. I took bisacodyl and stool softeners to help with this problem.

Recovery from the last treatment took longer than usual. I ended up back in the hospital with shortness of breath. This time I was in only for a few days, and received other tests as an outpatient. The doctors determined that I now had asthma. This problem was very difficult to correct. I first received one bronchodilator, and then a second one, and finally five days of steroids to stop the bronchial spasms. This issue took over a month to resolve itself. I stayed inside most of the time because we did not know if the pollen, molds or humidity caused the asthma.

Additionally, during the treatments, I stayed on a neutropenic diet and only ate foods from Whole Foods because I felt that I was much safer. We did not go out into public places except to get my blood work done twice a week. I had friends visit me at home. I think that my being careful was beneficial to my well being. Many people say that this is unnecessary, but I felt that it was important for me to stay healthy since my counts were so very low.

Numbers

Two months after my last chemotherapy, I went back to Ohio State for a bone marrow biopsy and blood work. The following week I was back again to hear the results. I knew from my blood tests that the chemo had done a good job but the state of my bone marrow was critical to my recovery. The doctor’s news was that they did not find any CLL cells under the microscope in my bone marrow but the flow cytometry did show less than one-half percent CLL cells remaining in the marrow. The doctor called this a clinically complete response (CR). He did not have a PCR test done. He told me that I would probably test as PCR positive right then. Although my response was not PCR negative, I still feel that the Pentostatin-Cytoxan-Rituxan protocol is a good one. As I look back on it, I feel it was not that difficult. I am happy that I did not use Fludarabine because of the many issues with that drug. Additionally, I am very pleased that I went to a CLL consortium center. To me, that was the most important aspect of all of this. I feel strongly that it made a difference working with the the doctors there and participating in a study for which they were the lead investigators. They will continue to monitor my bloodwork for the next five years.

Katie's CBC Results

CBC Results	5/19/04	8/22/04
WBC	160.2	3.8
Absolute Lymphocytes	152.2	0.42
Absolute Neutrophils	6.4	3.15
Platelets	134	199
Hemoglobin	11.9	13.4
Hematocrit	36.3	39.3

I hope that this helps you to look at different options other than the “gold Standard”, RFC. Be well!