AACR Conference 2023

The American Association for Cancer Research (AACR) annual conference is in my back yard this year at the the Orange County Convention Center. It started last week, has continued over the weekend and will conclude Wednesday morning. The website for this meeting is extremely robust and you can view all of that here. While I’m still trying to figure out how to navigate all of the offerings and details and exhibits and people (as well as fit attendance into our busy soccer weekends), I wanted to highlight that I was asked to speak on a panel occurring this morning, as you can see below …

As we prepared for this panel, I have been extremely impressed by each of the doctors I’ve interacted with and how careful they’ve been to include the patient perspective in each of our discussions. I’ve also had some time to think carefully about clinical trials and what I might share with the audience of researchers and clinicians today. Since my own de novo Stage IV Metastatic Breast Cancer (MBC) diagnosis in 2017, I have been offered multiple trials, participated in multiple trials and pursued potential participation in multiple trials. While I’ve not yet experienced a medication in a trial yet, I have some thoughts about clinical trials generally that I want to share with all of you.

First, clinical trials do not always involve taking medication. Each of the trials I’ve participated in thus far have been about trying different diagnostic testing or developing better ways of interpreting bloodwork. For example, one of the trials involved taking and examining my bloodwork before, during and at multiple intervals after I underwent stereotactic body radiotherapy (SBRT) in early 2021 for the pesky met in my pelvis (you can read more about that here (Part I) here (Part II) and here (Part III) . The investigators hope to be able to anticipate progression by examining and tracking various elements in the bloodwork, perhaps either limiting or eliminating the need for regular scans that involve radiation. We’re not at this place yet, but some of the ideas and potential ways to interpret changes in bloodwork are really exciting.

Second, clinical trials are not always easy for patients. When I was recruited for the trial I referenced above, I was told that the extra bloodwork necessary would be scheduled such that I wouldn’t have any extra appointments. I could probably write a long series of blogs on how that didn’t happen, how I had to fight tooth and nail to get that to happen, how communication was extremely poor, how I often wanted to drop out and overall how frustrating it was. Other patients experience similar frustrations and this is why ensuring that patients are involved in the design and implantation of clinical trials is so important. As a lawyer, I really do understand the need for regulations to protect patient safety and to ensure that data is collected in such a way to limit bias and other issues; at this same time, clinical trials need to be accessible to patients and not create more work for those of us who are already overloaded with interactions with the medical system if that’s possible and especially if that is promised an enrollment.

Third, clinical trials are not just a last resort option. Even though I haven’t yet participated in a clinical trial that involved taking medication, that’s not for lack of examining possibilities each time I’ve had progression. Each clinical trial is unique and has many different criteria for participating; at the same time, one element seen frequently is a restriction on how many lines of treatment a patient has been prescribed. As I am on my 5th line of treatment since my diagnosis in 2017 (including two different lines of IV chemotherapy), I’m approaching the dreaded “heavily pretreated” designation, which may mean I would be excluded from many clinical trials. Considering clinical trials early and often is key so that patents are able to participate and precious data can be collected. There are more and more trials that include those of us who are heavily pretreated or nearing that status, but the point I want to make here is that it’s never too early to consider a trial and there can be a potential issue if a patient waits too long to consider a trial.

Fourth, not all patients are offered clinical trials. Some of the trials I’ve participated in have been suggested by my medical team and some have been those I’ve sought out. Since we know that approximately 80% of MBC patients are treated in the community setting (meaning not at an institution that is focused on research), many of us aren’t at a location that offers many trials. Additionally, the BECOME survey demonstrated that black and brown patients are offered clinical trials far less often than white patients. We have a long way to go here to ensure that all patients are given the opportunity to participate in research and I’m hopeful that some of the lessons of the pandemic, which created more access to trials, will stick around.

Fifth, one of the points of the panel I’m participating in is about endpoints of trials. While this can be a complicated subject, here’s a cliff’s notes version as I understand it. When a trial is designed, it has to have: 1) goals (sometimes an answer to a specific question); and 2) times to evaluate if the goals are met (a/k/a endpoints). Two different endpoints that often show up in clinical trials for MBC are Progression Free Survival (PFS) and Overall Survival (OS). The first examines how many patients haven’t experienced progression of the cancer in their body by a specific date and the latter examines how many patients are still alive at a specific date. One of the frustrating things about research (for everyone, but particularly patients) is the time that it can take for a concept to be developed until that same concept becomes medication available to patients. While OS data can take time to gather since we are living longer and longer with MBC, it is truly the best way to determine both safety and efficacy of a particular medication.

Sixth and finally, one of the major points that I want to make by my participation in this panel is this: how the medical team behaves towards a patient in a trial can create an environment where the patient feels excited and part of the process or can alienate the patient. In all the trials I’ve participated in, I’ve never met anyone other than the non-medical staff to explain paperwork or perhaps nurses actually drawing blood or the techs administering the scans. At no time in the trials I’ve participated in has anyone sat down with me and cast a vision for the reason the trials were occurring. At no time in any of the trials I’ve participated in was it ever communicated that my participation was vital to the work that was being done except in a general or offhand way.

I see a huge missed opportunity here and I strongly believe that if patients feel as though they are part of the team, participation in the short and long term would improve significantly.

I worked hard to participate in the trials I’ve signed up for. It wasn’t easy to fit it all into a busy life and all of the other treatments I was undergoing. I wanted to participate and I knew from the beginning how important it would be to get to the answers the researchers needed. I am acutely aware (and am told often) that I am not an ordinary patient — when something important becomes difficult, my instinct is to double down, to fight. I know other patients who gave up, who dropped out because participation became too hard, too much. I don’t blame any patient who chose to reduce the stress in their lives by opting out of a difficult trial, my inclination towards stubbornness doesn’t always serve me well.

We can all do better. The doctors and researchers and health care workers bring their expertise to the table, but without patients, clinical trials can’t happen. If the medical team truly considers patients as their partners in research, works to cast the vision of why a trial is important, carefully considers all aspects of the impact on patients who want to participate, I truly believe that many of the roadblocks that prevent patients from participating would simply melt away.

One last word about clinical trials. As many of you are aware, a dear friend of mine, Amanda Raffenaud, died on April 3, 2023 after living with MBC since 2018. I attended her Celebration of Life this past weekend as the AACR conference was getting underway and I’ll write more about that soon. I bring this up because Amanda died from MBC in part because she ran out of workable options. When she got to the end of the available treatments, she had little choice other than to enter hospice as the cancer overwhelmed her body. For me, advocacy, participating in clinical trials and contributing to research is not just to extend my own life, but also for Amanda and so many others who will lose their lives to MBC without more treatment options.