Julia Tchou, MD, PhD, FACS is on the front lines of innovative breast cancer research. As principal investigator of a clinical study kicking off this month at Penn Medicine, Dr. Tchou and her team will test a new approach to treatment for patients with early stage breast cancer. The approach combines immunotherapy and radiation with the hope that the pairing will make patients' bodies more receptive to treatment without the use of chemotherapy.
We sat down with Dr. Tchou, breast surgeon and Director of Breast Surgery Research, to hear more about the study's origins, the research behind it, and her hope for the future of breast cancer treatment options.
Dr. Tchou, you initiated and are leading a new breast cancer research study that combines immunotherapy and radiation. How did this study come about?
I came up with the idea after reviewing a number of previously completed studies, including one in which a patient's metastatic melanoma was resistant (also known as refractory) to immunotherapy — that is, until he received radiation therapy intended for pain relief. Following radiation, and to the surprise of doctors, the melanoma tumor began responding to immunotherapy. It started shrinking.
The radiation therapy, doctors hypothesize, had changed the tumor's microenvironment, forming an immuno-stimulant that allowed immune cells to get into the tumor, making it receptive to immunotherapy. The radiation essentially converted the tumor from an unresponsive "immune desert" to an "immune oasis," full of life and therefore responsive to the immune cells.
The study we're starting this month at Penn came together as a result of our amazing team of medical, radiation, and surgical oncologists and our team scientist. We are specifically testing to see whether breast cancer tumors will melt away with one dose of immunotherapy (in this case, pembrolizumab), either alone or in combination with radiation treatment.
The previous studies you mentioned: How do they correlate to breast cancer?
We theorize that the response in breast cancer patients could be similar to the promising responses in patients with other forms of cancer. Because most breast cancer tumors don't respond to immunotherapy, any breakthroughs in this space could be groundbreaking.
Have immunotherapy and radiation been combined before?
The combination of radiation and immunotherapy has been around for some time. There are FDA-approved treatment options that combine immunotherapy and other therapy, but almost all involve the use of chemotherapy drugs. Our specific goal here is to find effective combination immunotherapy that is chemotherapy-free because, for all of its advantages, chemotherapy is toxic. It kills tumor cells but kills healthy and necessary cells, too, which is why patients experience harsh side effects during chemo, including hair loss.
The study is also innovative in that we're treating patients much earlier than in most studies, relatively soon after their diagnosis and before their immune system is exhausted. The hope is that the energized cells will almost act as a vaccine.
How is the study structured, and how long will it last?
This is a Phase 1-2 study, which means we'll be reviewing feasibility and safety as well as effectiveness. Whether this treatment ever gets FDA-approved will be determined in a larger, multi-centered study as well as a third phase, assuming the study progresses to that point.
The last time we talked to you, in 2017, you and your team were involved in a separate study testing the safety and effectiveness of CAR T immunotherapy. Where does that study stand today?
CAR T cell therapy is a form of immunotherapy that manipulates the body's own T-cells so they can act as cancer killers. Our study tested CAR T therapy on triple negative breast cancer, or TNBC. It was a pilot study that gauged safety and feasibility by injecting a limited number of CAR T into tumors into six patients.
We've moved on to a second stage of the study in which we inject CAR T cells into veins so they can travel systemically through the body. At this point we'll keep a closer eye on efficacy and impact. This is still a phase 1 study, so outcomes remain to be seen. But so far, so good.
What should a Penn patient do if they want to be part of your upcoming combination treatment study?
This is a small pilot study. It will involve about one patient per month over the course of approximately 18 months.
Like I mentioned, it will focus on patients with early stage breast cancer and can include patients from any subtype. This is a bit unusual, as the majority of clinical breast cancer research studies focus on patients with more advanced breast cancer.
There are a number of eligibility criteria, so it's important to note that not all patients who are interested will be accepted. However, we do need participants! Breast cancer patients interested in being considered for the study should ask their nurse navigator to connect them to more information.
How do you feel going into this study?
I am so excited! Excited for the process, for the possibility of a chemotherapy-free treatment combination, and also for the chance that this study could become a building block for other effective treatment combinations down the road.
My hope, big picture, is that medicine reaches a point where some or even the majority of breast cancer patients have promising treatment options that don't include chemotherapy.