A Story Of One Woman, Lung Cancer, And Clinical Trials

I want everyone to meet Tomma Gooding Hargraves. Tomma is one of the 16% of people diagnosed with Lung Cancer that is fortunate to be a survivor. She has been able to work with the Lung Cancer Initiative of North Carolina. Together she has been given a voice, a platform, and been able to be a face for lung cancer awareness, for advocacy, for increase funding and research, and to bring the discussion out into the open. Today, Tomma will being this post with her story, and I will follow up.

“Fear the tumor, not the trial”, are the words my thoracic oncologist told me as we looked at the clinical trial he proposed to treat my Stage 3B, Non-small cell adenocarcinoma lung cancer.  I was diagnosed on November 9, 2006, with NO symptoms… I was in great physical condition.  Finding a lymph node in my neck which turned out to be lung cancer was a complete shock.  I did all my homework – checking the internet – and saw the dismal statistics on lung cancer.  My son, who is an ER doc, urged me to get to a teaching hospital where all the cutting edge treatments were… and living in North Carolina, I was blessed with having several university cancer centers close to home.  When the oncologist offered me this clinical trial, I jumped at it.  I didn’t think I had many alternatives considering…  And it was rough… not doubt about it.  Nine months of treatment which included a variety of chemo, radiation and a targeted therapy.  At that time, they weren’t testing for mutations… but I had a great reaction to Tarceva.  Since then, they have determined that I have the EGFR mutation.  Testing tissue for mutations is one of the big changes I have seen in lung cancer treatment.

I have some ups and downs… falling out of remission for a few months which involved more chemo and cyberknife for a small met in the brain… but I can celebrate this 7 year anniversary knowing I did the right thing.

But I am frustrated… frustrated by the lack of awareness of LC being the #1 cancer killer… frustrated that more women die of LC than breast cancer every year… frustrated by the lack of funding for LC, frustrated by people being afraid to participate in clinical trials which could make such a difference, and totally frustrated by the stigma of LC… it is completely unfair.

I admit that I get ugly sometimes… like why is November now called Movember for Men’s Health Awareness… what happened to the Lung Cancer Awareness month?  I refuse to shop at certain shops or stores  who have pink ribbons so big you can’t see the windows.  Do I give them my elevator speech?  You bet I do.

I am trying to put  all my passion and frustration about lung cancer awareness into positive efforts… I work with an organization in North Carolina called the Lung Cancer Initiative of NC – we have a 5K and I’ve raised probably near $20,000 over the years… I speak to primary care doctors with thoracic oncologists and surgeons about earlier and better diagnosis of LC.  I spend a lot of time talking to individuals about any kind of cancer to help them move in the right direction..  I want to do this full time but I have a job as a speech-language pathologist I need to attend to now and then…

Am I a lucky person?  You bet I am… I was in the right place at the right time with the right doctors and nurses who helped me on my journey.  Sometimes I feel guilty that I survived for 7 years when so many others haven’t.  But if I don’t use my survivorship in a positive way, what message am I giving… I am the other face of lung cancer… I survived!

One of the important things Tomma shared with me was her decision to join a clinical trial. I have been in multiple discussions as of late and a few of the topics that continues to come up is the perception, enrollment, and access of clinical trials.

What exactly is a clinical trial?

Simply, it is a scientific study that involves people. It is the final step in a long process, over many years, of research and studies that originated in a lab. For cancer, most of the treatments that are used today, originated in a clinical trial. (NCI Information here)

What is being researched or studied in a clinical trial?

Typically a clinical tail will be the standard of care + “something else.” That “something else” can = a multitude of items that fall into 4 main categories:

-drugs or methods to treat cancer (Tarceva)

-labs, imaging, genomics or other such things that can help to find and/or diagnose cancer (EGFR)

-New items that may improve our ability to prevent cancer (HPV vaccine)

-Manage symptoms or side effects from cancer and the associated treatment (lymphoma clinic, survivorship programs)

In my opinion, the biggest challenge for all of us to overcome is the perception about clinical trials. When one looks up the words clinical trials on google we see pictures of scientists, test tubes, beakers filled with different colored liquids. (images here) When one performs the similar search on bing, you actually do see a picture of a guinea pig. In addition, you see pills and syringes with long needles. (images here)

Unfortunately I believe that this is part of the problem. We as a society associate clinical trials with something that is new, unproven, or that I as a patient or loved one am going to be subjected to a treatment regimen or type of care that is not as adequate to what I would normally be treated with for my diagnosis.

This is a myth. People on clinical trials are treated according to treatment guidelines. The randomization or caveat that patients may get is the benefit of an additional treatment that may hopefully enhance the standard treatment.

Now, there is some potential risk that may come along with that additional treatment that is being added, such as side effects, or intensity of side effects, or additional blood work, or imaging, or other such things. But this does not equate to receiving subpar or below normal standard of care.

In all actuality, one could argue that the “care” received on a clinical trial is a bit superior to what you may normally experience during your cancer journey.


Clinical trials have to go through an Internal Review Board (IRB) with each specific facility that is going to host the clinical trial or offer it to their patients. Their sole purpose is to ensure that the rights, safety, and well being of patients on the trial are protected. I can tell you that most of the time this IRB is a lot of work to present the benefits and risks of associated clinical trials. They do a deep review and consideration, and will then give their verdict if a trial will be offered or not at the organization. The typical IRB is made up of a minimum of 5 members. One member needs to be a scientist, one needs to be a non-scientist, and one needs to be an individual not directly affiliated with that specific organization or have a family member immediately associated with that organization.

Another aspect that goes into clinical trials is the team of experts at each healthcare system that is solely focused on the patients, information, and participation in specific clinical trials. Their is usually a primary investigator (PI) that is a physician that is the champion of a particular(s) clinical trial. There is usually a research person that may also be a nurse that is responsible to education patient on the clinical trial. This person usually also works very closely with the care teams to educate them on what the clinical trials entail, what the treatment regimen is, when and how exams, tests, and treatments need to be performed. In addition, someone on the clinical trials team usually has the responsibility to work with pathology, radiology, and other clinicians to help assess which patients may be eligible for the clinical trials that are open and accepting patients at each organization.

Here is where the real beauty of clinical trials occurs, selection and continual review. I will walk you through an example of a clinical trial: RTOG 1106/ACRIN 6697 It is a randomized phase 2 trial for radiation therapy with imaging of PET-CT. (trial link here)

Selection criteria:

1. First patients must be diagnosed with 3A or 3B non-operatable Non Small Cell Lung Cancer.

2. There is a list of about 24 questions that need to be answered to see if the patients is eligible for the clinical trial. (pg 9&10)

3. Each department has to go through a rigorous process of credentialing to ensure that their treatment equipment and planning equipment are calibrated, perform, and used according to study guidelines. This consists of a separate process in which medical physicists, radiation oncologists, and dosimetrists have to use phantoms (water/plastic based models that are similar in tissue make up to humans) to go through the entire process of treating specific areas of the body, sending it in to be reviewed, and having it accepted due to their ability to hit specific targets, criteria, and %’s. Very rigorous, time consuming, and a lot of work. (pg 10)

4. Another set of 30 questions is then asked to ensure that the patient knows of the clinical trial, that they have met criteria, and other such things. (pg 11)

5. If you skip down to page 29 to 30, there is a specific section, 3.0-3.2.10 that goes through the specific criteria and eligibility that each patient has to meet in order to be enrolled and enter onto this specific clinical trial.

6. Section 4, pages 30-31 show the required evaluations, workup, and tests that need to be performed for the patients on this specific trial. (Some of this is part of the standard type of care, and some is in addition)

7. Section 6, which is about 10 pages or more long, dictates exactly how the patients treatment needs to be planned, how the patient needs to be treated, and the criteria that needs to be met according to the clinical trial. As a former dosimetrist, I can attest to the amount of work and time that is dedicated to meeting all of the criteria, and it takes more time than a normal treatment plan takes due to all of the items that need to be met.

8. Section 7 does the same thing for chemotherapy. It discusses the type of chemotherapy, the dosage, the intervals, as well as the follow up, documentation of side effects, reactions, and if there are any treatment interruptions.

9. Section 11 discusses the pretreatment evaluation and workup that needs to be done on each patient. There is also a section that highlights the workup that needs to be done during treatment, and in addition, the workup, imaging, and labs that need to be done after treatment is completed. It also discusses the intervals and follow up in which a patient needs to see and meet with their care team(s).

This is all important because this is some of the additional attention to detail and care that patients on clinical trials receive versus patients that are NOT on clinical trials. It is not to say that there is a 1:1 correlation that if you are on a clinical trial that you get more attention from clinical teams than if you are not on a clinical trial. However, in my experience, I have seen first hand that patients on clinical trials do have access to more of the tools, resources, and team that is surrounding their care versus the patients that are not on clinical trials. This may not be directly related the trials, but an outcome of patients having more touches with clinicians and care teams, on a scheduled, and more routine basis, versus patients that do not enroll on clinical trials.

In doing a literature search to see if there is any real clinical data to show that patients enrolled on clinical trials fair better than patients on standard treatment I could not find anything that was concrete. The exception was in pediatrics, where there is clinical data to show that 80% of pediatric patients on clinical trials  outperform patients that are not enrolled on a clinical trial. 

Which leads to one more thing to be educated on in regards to clinical trials. Populations. In order to show a clinical benefit with a new drug or treatment you need to compare it with a controlled population. The only way to see if there is an advantage is to compare the controlled population with treated population, and compare this on a population level. The smaller the difference, the greater the difficulty to detect the change, and the more patients that are needed to detect it.

This is where we have been for over 40 years since Nixon’s declaration of a  “War on Cancer.”

However, we are in the midst of a revolutionary change. We are moving from population care models to personalized medicine, which is being directed at a molecular level. (DNA, cellular)

In Tomma’s description she said she has now been found to have the biomarker EGFR. In Breast cancer their are other types of markers such as ER, PR, HER2Nu. In Melanoma there is BRAF. Most of these markers are still have a long way to come, but are directionally correct, and in the right populations of people, just like Tomma, are very beneficial and life saving.

There is a new clinical trial underway that shows what the future of clinical trials, treatment, and personalized medicine is headed. It is called, I-SPY2 Trial. It sat ands for a mouthful: Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging And moLecular Analysis 2. Glad they shortened it.

Simplified, this study is looking at women diagnosed with advanced breast cancer to see if adding an investigation drug to the standard chemotherapy treatment before surgery is beneficial or not.

Its actually a very clever way to do clinical research and may have the ability to impact more patients diagnosed with cancer, in a much faster and accelerated manner than most clinical trials.

By using biomarkers that show a specific genetic signature for each patient and their specific cancer, you can the compare how patients are performing with various types of new drugs that are combined with standard chemotherapy. You can then see which patients have a good response, which patients do not have any response, and which patients may have additional side effects. As you being to move forward, the knowledge will begin to shape and change future treatments for new patients enrolling on the trial.

This will be the future of cancer care. Treating each patient, based on their specific genetic makeup of their cancer, and being able to target it most effectively with the right combination of treatments to get the best possible outcomes.

It is a story in which we can all win in the future. A story that clinical trials are not something to fear. A story in which you have access to new types of treatment that may benefit you and your story. A story in which you have a focused team that surrounds you, cares for you, and you know are held to a rigorous and routinely monitored set of criteria about your care. A story that allows you to be a part of the future of cancer care, and to have a hand in impacting and improving the care and outcomes of other people that will be in your same shoes in the future.

A story in which you get to help set the course of the future. A future in which we are not treated all the same, or according to some population based models, but that we are seen, discussed, and treated as the unique and special individuals that we all in the world.

Clinical trials allow us to participate in the story of us, the story of how each cancer supports and impacts every other persons cancer, and together we are all stronger.

Tomma inspires me. My father, his pancreatic cancer, and his passing inspires me. My passion for cancer and impact inspires.

What will your story be?

As always, you can feel free to contact me at: CANCERGEEK@GMAIL.COM

#PtExp #PX #cancer #hcldr #hccosts #hcsm #stories #storytelling #lcsm #bcsm #LCAM2013 #clinicaltrials
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