Managing Expectations While Maintaining Hope: Counseling Patients on Phase I Trials
Don S. Dizon and Meeyoung Lee
One of the more heart-wrenching experiences as an oncologist is to get to know someone due to their cancer diagnosis, see them through treatment only to watch them relapse, and then to treat that cancer, through multiple lines, each time, seeing it progress, sometimes after a respite or remission. Sadly, this continues to be the course that many patients will take, and I know I am not alone in experiencing some degree of despair as well. I think as oncologists we spend much of our time trying to think of options—good ones, even when they are few.
I recall treating someone for metastatic breast cancer. She had lived with the disease for years—diagnosed with bone metastases at the time of her initial diagnosis. She had progressed on multiple endocrine treatments and more recently, on two trials of chemotherapy. Her breast cancer had spread beyond her bones and now involved her liver.
Still, she looked incredible—working every day and enjoying her life. Even so, despite standard options, I had wanted to find something better, more promising. To that end, we had discussed clinical trials, specifically phase I trials. It was a delicate conversation as the idea of “first-in-human” trials was one that scared her. She wondered why I was “pushing” her to something so experimental, whether she was so “near death that that was her only option”.
I decided to chat with Meeyoung Lee about it. Although we have never met face-to-face (F2F in the social media sphere), we have exchanged so many tweets and engaged in many conversations on Twitter, that I feel like I know her and would go so far as calling her a Twiend (twitter friend). She has a long history in phase I clinical trials, and I knew she would have so much to add to this discussion.
Meeyoung, I am sure you’ve seen people with cancer come to phase I clinic with various degrees of treatment histories and also in varying degrees of health. When you see someone like this person I treated, how do you introduce phase I trials?
MYL: First off, I don’t believe anyone is ready to have a goals-of-care conversation at heart when we (as professionals) are. I think both clinicians and people with cancer may think rationally and understand the tempo of cancer progression, but acceptance of what is likely in the more immediate future is a separate issue. When they come to phase I clinic, it’s often they’ve been told that there are few or no more standard treatments available to them. Then to weave a dangling carrot of early experimental therapeutics, with its potential “promise” of efficacy becomes a difficult conversation.
When I approach patients in this situation, I review their history carefully with them and go over all the treatments they have received. We then discuss potential options including phase I clinical trials, and I make it a point to mention palliative care. If phase I clinical trials are available and the patient is accepting of this option, we discuss this more in detail.
We always discuss that any phase I clinical trial is experimental and may not produce positive outcomes in the majority of cases, although it would provide another treatment option for the patient. Undoubtedly patients have some hope or expectations that phase I clinical trials may produce positive outcomes, but if we are going to be honest, then so do clinicians.
Do you get a sense of expectations when you meet them? Or at least, what their docs have told them? I worry that I'm setting people up with too high expectations, and then setting you up unfairly.
MYL: Patients do come with expectations. Some come in with high hopes, and some with no hope but rather with an attitude of “last-ditch effort.” I try to have patients verbalize their understanding of their cancer and where they are in the course of their disease process to understand their expectations and try to meet them in the middle. Most recently, there was a patient who was so excited to be on our phase I protocol. He had such high expectations that at every visit, I had to remind him that how he is feeling may not reflect the outcome, but at the same time, I think allowing him to maintain a positive attitude is important. Indeed the outcome was poor and his disappointment was immense. However he said to me, “You were very realistic about my goals but I was just too hopeful.”
I never think that our colleagues set up unrealistic expectations for treatment outcomes and put our team in a difficult position when discussing purpose for clinical trials. Most patients are well aware of where they stand in terms of their treatments and have reasonable expectations. Most of them have had a long and honest relationships with their oncologists and come to us with their eyes wide open.
How do you manage the overall prognosis of people who have progressed like this patient? Do you think you have a responsibility to address that?
MYL: It is difficult to build a referral practice where you see people with cancer facing a relatively poor prognosis. Many of them are very scared. At our cancer institute, we try to keep open communication between the oncologists and their teams. Goals of care and prognoses don’t become our responsibility alone when they are treated on one of our trials; it is an ongoing conversation that their primary team continues to have with them too.
We know that not all patients will have positive outcomes. In fact, the majority likely will not. However, with precision studies, more targeted therapies are available. This began with the FDA approval of imatinib and other drugs like bevacizumab, BRAF inhibitors and others. These provide more hope than before.
Those of us who live in the clinical trial space have seen these unexpected outcomes once or twice and share that hope for every patient we enroll and treat.
I completely agree. When discussing goals, preferences, and options, especially with those living with cancer on an ongoing basis, it’s important to be realistic. But above all else, hope is something we should never take away. Indeed, for many, hope is a clinical trial. I think we all need to believe that.