ALK Positive Clinical Trials and Interview with multi-clinical ALK trial participant, Hazel Senz
Member Hazel Senz from Golden, CO shares her experiences from participating in multiple ALK clinical trials and how they have affected the course of her disease.
Hazel Senz has been adjusting to the “new normal” of ALK-positive NSCLC for 6 years. She is out living life in Golden, Colorado, experimenting with new ways to enjoy her hobbies of skiing, snowshoeing, and hiking. Hazel has enrolled in several clinical trials, including two trials that tested innovative treatments. We had the great pleasure of interviewing Hazel and asking about her experiences in clinical trials for ALK-positive lung cancer.
“Participating in clinical trials gives me hope. Hope for new and better treatment options so that research can be one step ahead of me. Hope that research will continue to prolong our lives. Today’s clinical trials are tomorrow’s cure.”
-Hazel Senz
Hazel, thank you for agreeing to share your story with us today. Let’s start with some background. What were your first symptoms of lung cancer, and how were you diagnosed?
I never had any symptoms, no cough or shortness of breath. I had a CT scan of my abdomen because I had a UTI and had blood in my urine. My urologist called me and said, “Your bladder and kidneys look great, but you have a large solid mass in your left lower lobe and you should get it looked at.” As it turned out, the abdominal scan just barely reached the lower part of my lungs, revealing the solid mass. The mass was the size of a lime and I had no idea it was there; growing and making itself at home in my lung for who knows how long. That very next day, I had a chest CT which confirmed the large mass in my lung and a needle biopsy confirmed it was adenocarcinoma of the lungs. It was stage IV because of involvement of both lungs and some lymph nodes. When my biomarker testing came back, the doctor I was working with had tears in her eyes. She was jumping up and down holding the results saying, “This changes everything!” With the ALK mutation, I was now eligible for targeted therapy. Who knew that if you have lungs, you can get lung cancer regardless of your smoking history and/or physical condition? I certainly didn’t know, but I found out that I was not alone and there were many other people in the same boat.
Who was the first person to suggest that you might be eligible for a clinical trial? What did the enrollment process entail?
My oncologist, Dr. Robert Doebele at University of Colorado, was the first person to suggest a clinical trial. At the very beginning, the trials I was enrolled in were observational trials, not treatment trials. The researchers wanted to collect blood and tissue samples and store them in a biobank for future studies. To me, these were “no brainer” studies. Why wouldn’t I want the research staff to have access to my blood and/or tissue for their future research?
My first treatment for ALK lung cancer was the clinical trial: A Randomized Phase II Study Assessing the Efficacy of Local Consolidative Therapy for Non-Small Cell Lung Cancer (NSCLC) Patients with Oligometastatic Disease. Basically, this study was to determine whether or not having Local Consolidative Therapy (LCT) would help control NSCLC. The hope was that if they were to irradiate (kill) the high concentration of cancer cells in the primary tumor, it might keep those cells from breaking off and migrating somewhere else. I was randomized to get radiation therapy to my primary tumor after I had been on Crizotinib for four months. The results of the study were so good that they stopped the trial earlier than expected.
Next, I enrolled in another treatment trial titled: An Open-Label, Multicenter, Global Phase 2 Basket Study of Entrectinib for the Treatment of Patients with Locally Advanced or Metastatic Solid Tumors that Harbor NTRK1/2/3, ROS1, or ALK Gene Arrangements. I was offered enrollment into this study because I had progression in the brain after two years on Crizotinib. I could have gone onto the next FDA-approved ALK inhibitor, but I decided to try the trial drug, Entrectinib. I knew that I could jump off the trial anytime if I felt it wasn’t in my best interest and start taking the next standard of care drug.
For both treatment trials, the enrollment process was similar. The first thing that happens is the investigator and/or study coordinator makes sure that you meet the study inclusion/exclusion criteria. If you qualify, they introduce the study to you and give you an overview of the purpose, treatments and possible side effects. They review the informed consent and you sign the consent. Once you sign the consent, you get randomized and begin study procedures.
Did you have any negative reactions in your clinical trials?
The radiation study I was in was a breeze. I had four radiation treatments over a couple of weeks. All went well until four months later when I developed radiation pneumonitis. They had told me that this was a possible side effect of the radiation. The pneumonitis was treated with steroids and cleared up after about six weeks.
The Entrectinib study was brutal. At the beginning, the study drug made me feel really foggy. It always felt like I had too much Nyquil the night before, but the mental fogginess would last all day. Also, I had pretty severe leg pain most of the time. A few months later, I started having leg tremors. Right when I was about to quit the trial, an MRI of my brain showed progression, so I had to go off the study anyway.
Do you regret your decision to enroll in the Entrectinib trial?
I don’t regret my decision to enroll because I felt like I had to give the Entrectinib a chance. Clinical trials are only available for enrollment for a limited time. Sometimes, the trial drug ends up being as good if not better than the next standard of care, FDA approved drug. I knew that the FDA-approved drug would always be there for me if I wanted to take it, but the study drug would not. Because folks like me with ALK- positive NSCLC enrolled, they were able to determine that Entrectinib did not work well for ALK-positive lung cancer. After the Entrectinib trial, I started Alectinib, which has worked very well for me.
What motivated you to participate in these clinical trials?
I will always be motivated to participate in clinical trials because I know the importance of obtaining data to ensure FDA-approved drugs are safe and have solid evidence regarding their effectiveness. Clinical trials also offer another treatment option. Who’s to say that the standard of care treatment would even work for me? At the least, the clinical trial would give me one more option that wasn’t there before.
In your opinion, what is the best thing about being involved in a clinical trial?
When you are in a clinical trial, most of the time, the study visits occur more frequently than the usual visit schedule. Also, during the trial, scans, bloodwork and other tests are scheduled more often. You are monitored more closely when you are on a trial.
What is the biggest disadvantage of being in a clinical trial?
I think the biggest disadvantage of being in a clinical trial is the possibility of the unknown side effects.
Do you think your participation in clinical trials has changed the course of your disease?
I really feel that my participation in the radiation trial changed the course of my disease. I believe it allowed me to stay on Crizotinib longer than I would have had I not had radiation to my primary tumor.
What would you like the ALK-positive lung cancer community to know about clinical trials?
I wish people wouldn’t feel that they are “guinea pigs” in clinical trials. Clinical trials help everyone. All these amazing ALK inhibitors that are currently in use had to go through the clinical trial process. Because people enrolled in trials, we were able to find out how effective these drugs are. A lot of them got fast tracked through the FDA so people could quickly receive the benefits of these targeted therapies. Without these targeted therapies, we’d all be on the same chemo cocktail regardless of the results of our gene testing.
Our theme for this newsletter is "Adjusting to the New Normal". As someone who has been living with ALK lung cancer for many years, what strategies have you used to adjust to your new normal?
In the beginning, I struggled because I was told my prognosis was about 2 years. I made some life decisions based on that prognosis, then I survived much longer! I had to adjust to the idea that my prognosis is completely unknown. I wish I had known that from the start. Over time, I feel that it’s been a series of trial and error strategies to adjust to the new normal. It’s been hardest to get used to a new normal of physical activity, since I have always been an active person. At first, I always measured my life’s success on the “before cancer” me. I’ve since adjusted that metric to be based on the “new me”. I’m happy that I can go for a long hike, even if I’m not as fast as I used to be. I am still out living life and not letting cancer define me.
AUTHOR: Ellee Urban