As a long time survivor of ovarian cancer, I thought I’d been through it all on this 20-year saga. Lots or recurrences, lots of surgery, ugly chemo, just about everything medicine has come up with to keep my disease at bay. In fact, I wondered when my cancer would outrun the medical treatments, eventually doing me in.
In January, 2006, I was not really surprised when I presented with seven new tumors after intensive Tamoxifin/Progestrone treatments, just disappointed. And the position of three of the tumors on the liver was particularly nasty news.
After exploring all treatments available to me, including going abroad for treatment, my husband and I met with my gynecologic oncologist to schedule surgery one more time, surgery that would surely involve a liver resection. Fortunately, my oncologist was not so anxious to pursue the obvious. After eight surgeries, he was bothered that we had not affected the chemistry of the disease, just cut out tumors after the fact. He suggested that we consider clinical trials, a course heretofore unknown to me.
Conventional wisdom suggested that clinical trials were a “last chance” for desperate people, one step ahead of voodoo. I could not imagine that they would be safe, effective or even useful to me in any way. I resisted until he asked that I visit at least one of the clinics (not associated with his practice) and discuss options with other oncologists who specialize in clinical research. What I found out was amazing . . . and a bit of a miracle.
The research side of oncology was significantly different from my experiences with oncology over the last two decades. The first difference was purpose; the intention of a trial is to evaluate potential modalities and treating patients is the process by which evaluation is achieved, a subtle but important difference. This led me to a more analytical assessment of the process, including the reputation of the clinic and the pharmaceutical company, and second opinions about the methodology.
After comprehensive testing, I was informed that I qualified for several trials and, based on numerous factors, I settled on one: a study of monoclonal antibodies called APOMAB. There are many monoclonal antibody studies; this one was testing the ability to induce apoptosis, or “programmed cell death,” through the use of human antibodies. According to the research study, although our bodies are naturally engineered with “apoptotic pathways” to eliminate malignancies, the mutations that occur with cancer frequently disable this natural defense mechanism. The reengineered antibodies, designed to target only cancer cells, would theoretically reignite my cancer cells’ ability and desire to self destruct.
Finally, not without trepidation, I began the trial.
In spite of my commitment to enter the trial, several concerns remained. Would the trial compromise my options for traditional treatment; in other words, would surgery still be an option if the disease progressed or would we be too late? What about side effects? After all, I was in the second group of humans to get the drug. Would I be worse off than when I started? To quell my fears, I was assured that, even though entering early in the trial process, the nature of the drug was well understood and somewhat predictable. And the window would still be open if we decided it was best to change course. I could leave the study at any time I chose.
During my four months in the trial, I was monitored more closely than during any other treatment I had had before. At several points in the trial, I had a PET and/or CT scans and countless labs to assess my reaction to the drug and monitor biological changes. I felt safe being scrutinized by a whole new group of researchers investigating future cancer treatments. And nothing horrible happened. In fact, just the opposite occurred.
After two months in the trial, my tumors began to shrink and several were no longer visible on scans. Follow up scans gave us better and better news. For the first time in 20 years, we had evidence that we had biologically changed the disease progression. By the end of trial, my remaining tumors appeared necrotic, with “no evidence of metabolic activity.”
Beyond the medical benefit, my experience was very positive. The relationship with the treatment staff of nurses, pharmacist, and doctors, was one of respect, compassion and care. My research oncologist conferred regularly with my personal gynecologic oncologist, so I felt covered on all sides. And, my treatments were very easy to tolerate. Not all participants in the trial had the same response. This study was being conducted on metastatic tumors of different cancers and some cancers progressed. It should also be noted that not all trials and not all clinics are the same. There may be different cost issues and different approaches to treatment. In my case, all the costs were covered but this is not the case for every trial. There are risks associated with clinical trials: the drugs are new and may not work or may create more problems; results are not always predictable.
I believe that clinical trials are important for several reasons. Not only have we learned a lot about my disease in this trial, but medical science knows more about possible treatments for ovarian cancer. They may not be for everyone and certainly do not benefit all, but I believe they are an opportunity and a vital resource for many of us.
For me, it was a miracle.