Patients Helping Patients Blog
Clinical Trials – Patients ARE Heard in the Process
Editor’s Note: After a long and resilient battle with primary peritoneal cancer, Roberta Aberle, 53, of Auroro, CO passed away on November 1, 2017 with her husband David Oine at her side. Even as she battled her own cancer, Roberta was a tireless advocate for patient care, hoping to improve the lives of others also fighting life-threatening illnesses. She will be greatly missed by all who knew her.
Bravo to Patient Empowerment Network for providing cancer patients the program series, Mythbusters on Clinical Trials. [NOTE: Segment #3 to be broadcast Sept 6th, 2017 – see program link to register concluding this blog].
Without access to this type of content, how else would patients like me know the value or merits of participating in a clinical trial? Especially a patient like me, who worked in an academic medical facility, recruiting patients for clinical trials for a different medical speciality before my cancer diagnosis. Even I did not have a fundamental understanding of the benefits for me and my diagnosis.
I did have a fundamental understanding of my dire cancer prognosis however. It was as grim as our worst fears. The best option of care presented in that initial oncology consultation was palliative and comfort care measures for my remaining months. I was deemed inoperable due to the extent and metastatic spread of my disease. Even front line chemotherapy was portrayed as uncertain for my rare cancer form, Primary Peritoneal Carcinomatosis (PPC). At least, no evidence-based medicine with a large population of survivors, longevity to discern average duration of progression free disease, let alone, studied in depth enough to provide statistics with any degree of confidence.
The topic of clinical trials was brought up by me, not my oncologist. His response, “Clinical trial enrollment and acceptance can be a lengthy process.” In the subtext, all I heard is that he thought I would be dead before I was enrolled.
However, what my Oncologist didn’t know was that death not an option for me. Not only had I underwent a total hysterectomy due to my history of uterine growths and familial risk factors, including the BRCA1 mutation and extensive extended family cancer; I had already lost one sister to early onset ovarian cancer. I aso had a second sister who had ceased treatment due to unmanageable side effects from two forms of breast cancer. I knew our family could not withstand another devastating loss to cancer. My parents are elderly and the grief from having lost one daughter with another hanging in the balance if remission would come; adding myself to the mix just seemed another cruelty to hard to deliver.
Fortunately ~ something went right for me early in the process. I was fast-tracked within ten days into a clinical trial, and my treatment started within two weeks. It was a Phase 3 clinical trial of combination therapy including a platinum-based chemo https://www.drugs.com/mtm/carboplatin.html
a second anti-neoplastic chemo
and a VEG-F inhibitor
all proven to work effectively together, but with a power boost, a new to market oral agent called a PARP inhibitor.
The beauty and greatest appeal of this particular clinical trial, and is a constant in many trials available to cancer patients today; is it fell into a Phase 3 or higher, did NOT include a placebo arm and was comprised of all known, effective agents. The purpose of the study was to identify in what frequency and dosage all worked best, not whether they would have efficacy. I knew what was being tested, which drugs were incorporated and what outcome (dose, frequency parameters defined) was expected. I was impressed at the degree of information captured, analyzed and monitored throughout my clinical trial. Never once feeling at risk of an adverse event or my identity compromised. nor, never once did I feel I did not have the power to suspend my participation if I felt any risks.
Oversight comes from many places, including national and state foundations and organizations with the 100% directive as guided by the principles set forth in the Ethical Principles and Guidelines for the Protection of Human Subjects of Research (often referred to as the Belmont Report) [https://www.hhs.gov/ohrp/]. Reviews of research are performed in accordance with the Department of Health and Human Services (HHS) regulations 45 CFR 46 (also known as the “Common Rule”) and the Food and Drug Administration (FDA) regulations 21 CFR 50 and 21 CFR 56.
I experienced an exceptional response on the clinical trial. My specific cancer marker fell from a pre-treatment high of nearly 3,000 (normal range value = 0 to 35) to 200 within the first six months. While I wish I could conclude this section saying I’ve since been cancer free or in remission. It was a short-lived response. I had disease progression the following year, but I never regret being on that clinical trial. In fact, still today, the PARP inhibitor component I was responsive to in my clinical trial, is still a core of my current treatment plan.
I can say with confidence, I am here as long as I have been by being receptive to clinical trials. That first trial, while ultimately not my cure, bought me time until the PARP inhibitor was approved by the Federal Drug Administration (FDA) for provisional production and release to patients failing 3 or more front-line treatments. As, unfortunately, following the clinical trial, after invasive surgery and debulking, intraperitoneal cancer, I had yet another round of disease progression. I also say with confidence, that first clinical trial was just my first bridge to conventional treatment and surgery.
I’ve played an informed game of leapfrog from clinical trial to conventional treatment to surgery, back to clinical trial and back into conventional treatment. Each clinical trial yielded powerful information about my responsiveness to alternative and combination therapies that proved integral to my next treatment plan.
The result being that I am here today to tell my tale. Six months is now 5 years and 6 months down the path of my cancer experience. A clinical trial was not – has not yet – provided my cure. But having these bridges to new options that were not available to me six months earlier, is not a back track record in my mind.
It still astounds me however, of the estimated 20 – 40% cancer patients who meet criteria for clinical trials, only 3-4% enroll.
I am far from considered an expert on clinical trials, have passed certification and credentialing for enrolling patients and performed data collection in my past role, but my most powerful opinion is based upon personal experience. Being afraid of being used as a guinea pig is an era far receded into the past. Today’s clinical trials are more innovative and more effective than ever. If a clinical trial buys you even 1 week or 1 month of quality time, I say it’s worth it. Even if I were a guinea pig in the process, my vote is that it would have been worthwhile. I would just have chosen to be the squeakiest among the bunch!
See us live on this topic!!
Roberta Aberle is a cancer thriver, despite her 2012 diagnosis with an advanced and aggressive type of cancer. Her cancer; primary peritoneal carcinomatosis, is very rare and lethal, giving her an extremely poor prognosis to live longer than 6 mos. Yet, 5 1/2 years later, she is an active advocate for the cause of cancer as a writer and speaker. Her articles have appeared in Conquer and Coping magazines. Her cancer blog: MyLifeline.org/RobertaAberle and social media site, Live With It on Facebook, in which she shares insights on how life looks from the eyes of cancer, has a following of thousands around the globe. Roberta’s writing appeals to not only those facing cancer or caring for a loved one with cancer; her work contains messages relevant about the need to approach each and every day with appreciation and gratitude whether you live within the fearful confines of cancer or not.