Results from the health-related quality of life (HRQOL) analysis of the University of Pennsylvania and RTOG Foundation RadComp study indicated that both photon and proton radiation treatment options yielded similar, excellent HRQOL outcomes for women with non-metastatic breast cancer. RadComp was the first randomized study comparing proton to photon radiation for breast cancer treatment. These results were recently reported during the Plenary Session of the American Society for Radiation Oncology Annual Meeting in San Francisco, California.
“The successful completion of RadComp, the largest randomized trial comparing photon and proton therapy, is a testament to the field's commitment to comparing technologies. HRQOL is an essential endpoint, and the excellent outcomes for both arms are encouraging. While we await our primary endpoint, physicians should continue to select the appropriate modality of treatment for patients with breast cancer, taking into consideration patient- and disease-specific factors as well as regional access and cost,” stated Shannon M. MacDonald, MD, of the Southwest Florida Proton Center and the lead author of the RADCOMP manuscript.
The RadComp trial accrued 1,239 patients with non-metastatic breast cancer who were planning to undergo comprehensive nodal irradiation and assessed them to compare patient-reported body image and function, fatigue, and other HRQOL outcomes after receiving either proton radiotherapy or photon radiotherapy. HRQOL was primarily assessed using PROMIS Fatigue, Satisfaction with Breast Cosmetic Outcomes, BREAST-Q adverse effects of radiotherapy, and FACT-B. Other domains, including FACIT-TS-G and PRO-CTCAE, were also used.
At 6 months following treatment, there were no statistically significant differences between treatment arms in the PROMIS Fatigue total score, Satisfaction with Breast Cosmetic Outcomes score, BREAST-Q total score, and FACT-B trial outcome index score. For the secondary HRQOL tools, there were a few differences in favor of proton therapy in willingness to recommend treatment and to choose treatment again.
According to Drs. Alexander Lin, MD and Bonnie Ky, MD, MSCE, the current Principal Investigators of the study at the Perelman School of Medicine at the University of Pennsylvania, “This trial speaks to the tremendous multi-disciplinary collaboration across radiation oncologists, cardiologists, physicists, scientists, and most importantly, our patients. We eagerly await the primary endpoint of the RadComp trial, major cardiac events, which we will report in the future, in accordance with the study’s statistical plan.”
Research reported in this work was funded through a Patient-Centered Outcomes Research Institute (PCORI) Award (PCS-1403-12804), National Cancer Institute of the National Institutes of Health (PHR-SS-S-16-004996), National Heart, Lung, and Blood Institute of the National Institutes of Health (R01HL152707), and the David and Leslie Clarke Outcomes Research Fund, the Gant Family Foundation Fund, Alan and Louise Reed Cancer Outcomes Research Fund, and the Thalheimer Center for Cardio-Oncology at the Raymond at Ruth Perelman School of Medicine of the University of Pennsylvania.
Special Podcast Episode
Follow The NRG Oncology Podcast on Spotify, Apple Podcasts, and YouTube for a special episode interviewing Dr. Shannon MacDonald on the findings of the 2025 ASTRO Plenary Session Presentation for RadComp trial. Podcast information and playable episodes are available on the NRG website as well.
Citation
MacDonald SM, Pugh SL, Paulus R, Chauhan C, Braunstein LZ, Freedman GM, Jimenez RB, Kim JN, Thukral A, Mishra MA, Mutter RW, Wright JL, Urbanic J, Ohri N, Boggs DH, Chawla AK, Ellenberg S, Lin A, Ky B, Bekelman JE. Pragmatic Phase III Randomized Trial of Proton vs. Photon Therapy for Patients with Non-metastatic Breast Cancer Receiving Comprehensive Nodal Radiation: A Radiotherapy Comparative Effectiveness (RADCOMP) Consortium Trial: Health-Related Quality of Life Outcomes. Paper presented during the Plenary Session at the annual meeting of the American Society for Radiation Oncology. San Francisco, CA. (2025, September-October).
About RTOG Foundation
The RTOG Foundation is a nonprofit organization dedicated to improving outcomes for cancer patients through the conduct of practice changing clinical trials. RTOGF collaborates with partners from industry and federally funded programs to support its research. RTOGF is the successor of the National Cancer Institute (NCI)-funded Radiation Therapy Oncology group that was organized in 1968 as a national clinical cooperative group for the purpose of conducting multicenter radiation therapy research and clinical investigations. It was part of the NCI-funded cooperative group program and managed by the American College of Radiology (ACR) from 1971 until 2014. During that time, it activated over 500 protocols, accrued more than 110,000 patients to cooperative group studies, and published over 1,000 papers reporting the results of its findings. RTOGF has continued its close relationship with ACR to engage in clinical trial research collaborations with a variety of industry partners and participates in Federal grant-funded research through its leadership in the NCI National Clinical Trial Network group NRG Oncology. www.RTOG.org