April 23, 2015

A Patient's Perspective on Clinical Trials

[My speech given at the University of Calgary on April 8th. Revised for privacy reasons.]

Before my diagnosis, I just celebrated 10 years of a rewarding career in healthcare. I enjoyed educating people and encouraging them to be proactive in their health. Outside of my professional life, my husband and I were avid travellers. Around that time, I had about thirty countries under my travel belt and had plans to add many more. I picked up running at age 14, had completed a half marathon and planned to someday finish a full marathon. Eventually, we had planned to start a family. 

But plans change. My story begins in the fall of 2012, when I started noticing shoulder pain. My colleagues and I thought it was work-related. There was no reason for me to think otherwise. But the pain worsened steadily despite the usual route of therapies: physio, massage, acupuncture, in addition to prescription anti-inflammatories and analgesics. A year later, my symptoms became unbearable. I became susceptible to frequent respiratory infections, and noticed increasing shortness of breath. An MRI investigating my spine incidentally discovered the single lung nodule that would set off a cascade of tests. A month later, in December 2013 at the age of 37, a biopsy confirmed the diagnosis: stage IV lung cancer (NSCLC, adenocarcinoma). The news was devastating and shocking. How can a healthy, young female who's never smoked develop lung cancer? Well, apparently, theres a little known fact that never-smokers account for 15-20% of lung cancer patients.  But among the despair and grief that come with a cancer diagnosis, came hope. I tested positive for the EGFR mutation, which meant my first line of treatment was oral targeted therapy.  Within a week of starting gefitinib, my symptoms began to improve. Within 2 months, I was back to running on the treadmill.  I was even healthy enough to spend 2 weeks actively exploring and enjoying beautiful Iceland with my husband. This wonder drug gave me my life back. During that time, living with cancer was tolerable, almost normal except for some annoying drug side effects. Unfortunately, cancer figured its way around Iressa. About 11 months after starting gefitinib, my symptoms returned and progression/drug resistance became obvious.

When my cancer journey began, I intended on following my own advice and be proactive. Fortunately, with my health sciences background and connection with family and friends in the medical field, I wasnt afraid to ask questions, or look beyond established standards of care.  From day 1, I knew the treatment options for stage IV lung cancer were very limited.  The 5 year survival rate was grim. I remember already inquiring about clinical trials the first day I met Dr. B. So, by the time drug resistance was confirmed, I had decided that enrolling in a clinical trial was my next step. Cancer forced me to learn to live with uncertainty. I knew there was never a guarantee of a good response to any cancer treatment and that belief helped me overcome the fear of the unknown that comes with participating in clinical trials. But I also realized that qualifying for a clinical trial requires accessibility, timing, and preparation.  A Phase 3 trial on a new drug was about to open in Edmonton, possibly even in Calgary. To get the ball rolling, a new biopsy was performed in a timely manner in Calgary but because the clinical trial was actually only available in Edmonton, to our disappointment, my husband and I had to make the 6h round-trip journey to Edmonton to meet the clinical trial team and sign consent forms so the tissue sample could be released to the Cross Center, then sent to the clinical trial approved lab for mutation testing. We were reassured that things would move quickly from there. But, a week later, we found out that there was another delay because a payment was required before the sample could be transferred. Finally, 6 weeks after my biopsy, I got the call. "No, I'm sorry, you don't have the mutation to qualify for the study". All that time and effort in travel, needless delays, and subsequent anxiety, only to find out I didnt qualify. So what options, other than beginning chemo, did I have at this point?  Shortly after the rejection call, I received a follow up call from the Cross Centre. Would I be interested in enrolling in a Phase 1 study? I already have the mutation to qualify but another biopsy may be needed, this time in Edmonton.  Despite the many unknowns with Phase 1 trials, I knew this was my best chance to access a new treatment and hopefully improve my chances of long term survival. After doing my usual research on the trial drugs, I accepted the offer. Chemo can wait.  I knew finding another trial I would qualify for wouldnt be easy. But again, this meant more waiting!  Wait for another biopsy to be scheduled. Wait for results. Wait to sign papers. Wait for more tests. Wait for more progression and increasing symptoms. Wait for the unknowns. But all this waiting will be worth it if this new drug offers me more time and a better quality of life.

Things to take from my experiences:

Why are Clinical Trials & Phase 1 trials important to patients?
As you can see in my situation, Phase 1 trials offered me the chance to access a new treatment where phase 2/3 would not have accepted me. For those of us with limited or less than desirable treatment options, clinical trials offers us new hope. More clinical trials, especially phase 1 trials, means more patients can qualify for more treatment options, potentially finding something that improves quality of life, extends life, or, at least, stabilize disease progression long enough until the next accessible clinical trial or breakthrough treatment becomes available. 

Another lesson I learned from experience, in order for patients to take advantage of Clinical Trials, trials need to be accessible!

1.  According to the Addario Lung Cancer Foundation (San Francisco), 85% of patients are unaware that clinical trials are an option.  Only 3% of patients actually enroll in trials [8% in Canada]. In my opinion, patients ought to be informed that clinical trials are a treatment option before first line treatment even begins. It is a personal choice, but patients cant make that choice if they arent aware. Being informed early will also help patients plan for trials.  From personal experience, it takes strategy, research and preparation to know when and which trial to attempt to enrol in. Am I able to commit to the frequent follow ups, tests and travel time? Am I excluded because of the number or type of treatments Ive already undergone? Have I progressed too far to enrol? Do I have potential for a good response in this trial? Patients should also know that clinical trials are not meant only for patients who have run out of options. They should consider them when the right trial is available, when they qualify, when they are still physically capable, when the risk of waiting is not life-threatening, etc.

2. Of course, the time needed to get to the clinical trial site can be a significant deterrent. Having to travel 3h to access a trial is not convenient.  Given the option, I would prefer not to ask my caregiver to take a day or two off work to accompany me to Edmonton, I prefer not to be taken away from my daily routines and the comforts of home, I prefer not to be taken away from my support network of family and friends in Calgary.  I prefer to spend what spare time I have enjoying life, not traveling long distances to and from frequent appointments. 

3. Lastly, unnecessary delays in accessing a trial can be stressful enough to make us second-guess our interest in joining a trial. Cancer patients live with a sense of urgency, rightly so. Here I am with worsening symptoms, anxiously waiting for the one and only Phase 1 trial in Alberta that I tentatively qualify for to open, 5 months after obvious tumour progression began.  A cancer patients time is valuable, and a lot can happen in a few weeks or a few months.

In conclusion, if more patients are properly informed of clinical trials, and if more trials are available and accessible, more patients can enrol and help pioneer new cancer treatments. With the growing prevalence of cancer, Calgary, with its population of over 1million, and the rest of southern Alberta need better access to clinical trials, and thus more potentially life-saving opportunities closer to home.  Despite all the challenges cancer patients face, those like me still choose to take a chance on clinical trials. We stray from established standards of treatment because we believe there is something better out there; effective treatments that have yet to be discovered, ones that give us new hope for a better outcome.