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Trial underway to assess proton therapy in early breast cancer
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A clinical trial is underway to examine the use of proton therapy for patients with early-stage breast cancer.
“This study will evaluate the effectiveness and cosmetic outcome of using pencil beam scanning proton therapy for partial breast irradiation in patients with early-stage breast cancer,” Teresa Meier, MD, assistant professor in the department of radiation oncology at the University of Cincinnati, said in a press release. “Additionally, we will evaluate side effects patients experience as well as cancer recurrence rates.”
HemOnc Today spoke with Meier about what prompted this research, the timeline for results and potential implications of the findings on breast cancer outcomes.
Question: What prompted this research?
Answer : Our proton facility opened in 2016 in collaboration with Cincinnati Children’s Hospital and UC Health. At the time, I was in my last year of residency training and looking for ways to get involved in clinical research. We were opening a national trial looking at proton therapy for locally advanced breast cancer and wanted to know if there was a role for proton therapy for early-stage breast cancer, in particular for partial breast irradiation. A few facilities have looked at proton therapy for partial breast radiation, but with uniform scanning or passive scatter proton therapy. Studies of this have shown less dose going to the normal surrounding breast tissue and other organs, such as the heart and lungs. However, there was no skin sparing, and the cosmetic outcome was not as good as anticipated. Our proton facility employs newer technology, known as pencil beam scanning proton therapy, where the dose is ‘painted’ on spot-by-spot for potentially better skin sparing and cosmetic outcome. One of my mentors at the time helped me get this project started near the end of my residency, and I received a grant from a local group to help fund some of the research.
Q: How will the trial be conducted?
A: This is a phase 2, single-institution study at University of Cincinnati. We are looking to enroll 21 women aged 50 years or older who have undergone lumpectomy or breast conservation therapy for either ductal carcinoma in situ or invasive breast cancer measuring less than 3 cm. Women will need insurance approval for partial breast irradiation, which is one of the hurdles we are struggling with. Instead of our historical whole breast irradiation, which is given 5 days per week for 3 to 6 weeks, women in this study will undergo treatment twice daily for 1 week. Our primary endpoint is cosmetic outcome — we will have photographs taken of women before, during and at certain follow-up times after treatment. We will then conduct a cosmetic assessment, in which the patients fill out questionnaires and undergo cosmetic outcome grading by the treating physician and nurse.
Q: What is the anticipated timeline for results?
A: We hope to accrue the 21 women within 3 years and then follow those women for at least 2 years. We hope to have results available in about 5 years.
Q: What are the potential implications if this is proven safe and effective for these patients?
A: For partial breast irradiation, we are targeting the area of the breast tissue where the cancer was initially. Our hope is that with protons, we can decrease low-dose radiation going to the remainder of the normal breast tissue and other organs and achieve good cosmetic outcome following treatment. We also hope to minimize the long-term side effects of treatment. As imaging techniques continue to improve, we are finding more and more early-stage breast cancers, which is great, but we know this population is much more likely to die of other natural causes. So, we are trying to find ways to minimize treatment toxicities. – by Jennifer Southall
For more information:
Teresa Meier, MD, can be reached at University of Cincinnati, P.O. Box 210091, Cincinnati, OH 45221-0091; email: meierta@ucmail.uc.edu.
Disclosure: Meier reports no relevant financial disclosures.