Monday, December 21, 2015


In March, I wrote a post about the importance of clinical trials. It was my hope to get the word out to as many people as possible. Before starting any course of treatment, before one single thing takes place, ask the question. Whether diagnosed for the first time or because there has been a recurrence, despite that oxygen sucking news, put on your mask and breathe deeply. Remember to ask these words:

How can I find out about ongoing clinical trials that may still need patients?

If the response is nonchalant or if you have a sense that you are being dismissed, do your own homework before determining how you will proceed. Check the online forums. Use social media. Ask in Facebook groups. Send a tweet. Ask a friend. Ask me.

Why? That's a great question and if I am to be truly honest with myself, if I am to put myself back in time and parse out my feelings and the commotion that was my life between April of 2006 and September of 2006, I likely would have bitten off the head of anyone who even hinted that I might want to look at clinical trials.

This is where the experience of those who have walked the path comes into the picture. This is where it's up to us as friends and/or advocates to see if we can find the right moment, when someone is newly diagnosed, to suggest they take a look at what might be available.

Some instances are easier than others although, sadly, it seems the worst case scenarios are those where the suggestion can and does fly right off my tongue. "My (insert relative) was just diagnosed with lung cancer and it sounds really bad. I told her I'd ask if you could give her the names of people...." Yes, that really did happen and yes, my response was immediate. "If I were in this circumstance, I would be looking for a clinical trial before anyone touched me." I went on to explain how trials must adhere to the strictest standards and starting another treatment may exclude your (insert relative) from eligibility.

To take a step back a second and jump on a soapbox, this is one area I do believe advocates at the table during trial design might make a difference. I made a difference but it was well post treatment and when I shared my experience here, I didn't fully understand the manner in which trials are designed. We may have suggestions that could be incorporated into the inclusion criteria and the endpoints that may make for a more meaningful trial. Or not..... but if we aren't included, much more widely than we are now, how will we ever know?

Now, to take a step forward and back into this discussion, what about the early stage patients? They are the ones often faced with many decisions and too much time in between tests and appointments. The perfect recipe for the internet pine box. I know most everyone diagnosed with early stage disease did what I did. Pretty much every day, there came a point where I thought, "I'll take a stroll down the What If Path for the millionth time," asking the same questions with little new information to help formulate my decisions.

It is during this time that clinical trial options can be explored. I can share right off the top of my head two things I would have done. I would have sought out trials to have a cognitive evaluation done before anything else was done to my body after my diagnosis. Again, taking the truth serum, I'm absolutely certain it would have taken some pretty persuasive language to get me to slide into a functional MRI but I do know there were trials going on back then. I know that today. No one even hinted at this in 2006. And I didn't know better, so I didn't ask.

Today, I would love definitive proof that my brain looked differently before eight sessions in an operating room under anesthesia, eight rounds of mild chemotherapy wherein I never lost my hair but I did seem to lose my brain, and eight years and counting on a drug to suppress estrogen. It would have saved countless fights with people and certainly put to rest those who persist in saying, "I didn't have chemo/cancer, what's my excuse?" They mean well. I generally laugh but then, I finally found a way of explaining the difference because yes, there is a difference between chemo brain and getting old brain or too much on your mind brain.

And by the way, what's up with those eights??? I suppose I could find one of those Magic Eight Ball things and see if it has the answer but the answers to everything medical, to everything that will advance the science of understanding and the ways to better and more effective treatments aren't in that Eight Ball, they are in the hands of the researchers. And the researchers can't conduct research without a target patient population. And so, we should be asking the question because the response might be, "Yes, there's an app for that." A research trial app(lication), followed by consent forms and a possibility to help yourself, to help others, to advance the science and develop more effective evidence based practices. Take a bow. That's damn impressive in my book.

At the San Antonio Breast Cancer symposium in 2013, findings were presented for a trial I would absolutely have joined. Truthfully, I would have jumped all over it, quite possibly without even fighting. Or blinking an eye. One of my very first questions was about tamoxifen or an aromatase inhibitor. I knew the benefits and risks of each drug but frankly, although I was pre-menopausal at diagnosis, the chemotherapy pretty much put that over the edge and then, the removal of my ovaries solidified my place in menopause. I knew I preferred the risks of the aromatase inhibitor over the tamoxifen. I did have somewhat of a choice.

At that time, in May of 2007, there were open trials where women taking an AI were given the opportunity to have treatment for bone loss using bisphosphonates, specifically, zoledronic acid infusions. During the appointment for my routine mammography that began my journey into cancer land, I had my very first bone density exam. I was already diagnosed with osteopenia. It would make perfect sense for me to do something to keep my bone strong.

Again, who even knew to ask about any sort of treatment and yet, I could have been lucky enough to be part of a clinical trial to study the use of bisphosphonates administered to early stage patients on an aromatase inhibitor. And yes, a quick search of confirms that there was indeed an open trial, recruiting at several locations including one that was close enough for me to participate.

My doctor didn't suggest this this and I was still on that steep learning curve. I so clearly recall telling my oncologist, "I'll deal with a broken bone over a recurrence," as he was writing the prescription for my femara. The thought of looking for a clinical trial wasn't even in my vocabulary. And yet, there it was. And I was eligible. And because I wasn't a savvy patient, and I had no one to suggest looking at trials, I missed an opportunity.

Two years ago, findings were presented at San Antonio regarding an unexpected benefit of bisphosphonate treatment. It seemed to help prevent bone metastasis in a particular sub-set of patients. I decided it was time to address my osteopenia. I asked a few oncologists their feelings and given the fact that the osteopenia was worsening with every bone density test, there was a medical reason for me to seek treatment. In the scheme of things, it wasn't a broken bone that concerned me, but any edge to prevent a bone metastasis? I'm there. I wish I knew about that trial.

Instead of getting the treatment, I had a brawl with my oncologist's office, first. Then, I got the zoledronic acid infusion, and then I learned there were other studies that should have been shared with me to avoid a three week fever. In April, at my annual follow up, it was determined that I would be given denosumab for my second treatment. That fever made me a failure. I failed on the first medication so I was eligible for denosumab.

(Yes, I would like you to re-read that last thought because it's highly insulting to patients to say we failed on a drug. Did we fail, or is it more appropriate to say the drug failed the patient? A different post for another day. Along with this step therapy nonsense and the inability for a doctor to choose the right treatment for the right patient. Somehow, pharmacy benefit managers get to make those decisions and THAT is a rant that is recent and ongoing.)

Fast forward to San Antonio 2015. A few weeks ago, findings were presented for a trial I would absolutely have joined. Truthfully, I would have jumped all over it. I've always wanted to go to Vienna and this would have given me reason to travel to Austria. I suppose I'd have a bit of an issue here since I would have actually had to choose between the two trials. I couldn't absolutely have joined each of them. Although, I wonder if there was better communication if one or the other trial might have considered adding a third arm to compare bisphosphonates, denosumab or nothing.

Jokes aside,  Dr. Michael Gnant explains the trial in these three videos. I've provided the quick version, the mid version and the hard core science version. It's been written up in the AACR SABCS news release, MedPage Today (complete with video) and Medscape and I'm sure in many other places, too.

The trial was to determine the effectiveness in using denosumab to prevent fractures in patients on aromatase inhibitors. The results are so impressive they will be "unblinding" the trial.

This is important for those who resist clinical trial participation because they are hung up on the idea of "not getting the real drug." Here's why. The results were so remarkable, the effects were so beneficial, it was felt to be unethical NOT to unblind the trial. So there you have it. If you are on the placebo of the next big thing, chances are it will become obvious something is happening and you won't be on a placebo for long after the realization is made. In this case, patients will choose if they wish to be unblinded, they will learn if they were on the placebo and if so, they will be treated with the real drug. Me? I will be fighting with my health insurance company in April for my next treatment.  Clinical Trial: WINNER! AnneMarie/Health Insurer: Fight.

And then, there's the secondary benefit in post-menopausal women. Again, it would seem there is a benefit in disease free survival. Overall survival will take longer to determine and I'm sure the women will be followed. In the video, Dr. Gnant notes that bone treatment is more effective than aromatase inhibitors, tamoxifen or chemotherapy at preventing recurrence.

Looking at everything and drilling it down to get back to what's most important: Clinical trial participation, here's the thing. There are desperation, out of options, Hail Mary pass trials and there are trials to address quality of life or prevention of new cancers. However, in between the two, exist thousands and thousands of trials. We shouldn't be looking at clinical trials as the place to go when all else has failed. Nor should we be looking at trials after the damage from primary treatment has already become something that may be adversely impacting our daily lives. We should be looking into that vast space in between. That's where the advances are happening, that's where the exciting findings are being made, that's where the future of precision medicine lies.

Step up, check them out and if you are eligible, get serious about joining.

And now, let's go to the tale of the (video) tapes....

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  1. Thank you for sharing this. I was looking for the notes to the research as my oncologist is recommending the AI plus denosumab path for me. He mentioned that the latest research is showing that combination as more effective. For me, it is actually a no-brainer ... I have already failed on tamoxifen, and have osteopenia - so the bone builder is important. Just hoping my insurance doesn't baulk at it!

    1. Happy I was able to help. I was looking for something a few weeks ago and was thankful another blog buddy had posted what I was searching for.

      You may have to "fail first" on zoledronic acid (bisphosphonate) but even if that's the decision of the insurance company (which frankly, WILL piss me off because I do believe decisions like this belong in the hands of the doctors and the patients with the insurance company playing far less of a role in this process), zoledronic acid was shown to have similar effects and they were not tested "against" each other to see if one is better than the other.

      I'd like to know what happens!



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