Preliminary data from a multi-institution Phase III trial led by researchers at The University of Texas MD Anderson Cancer Center shows that intensity modulated proton therapy (IMPT) achieved similar clinical outcomes and offered significant patient benefits when compared to traditional intensity modulated radiation therapy (IMRT) as part of chemoradiation treatment for patients with oropharyngeal (head and neck) cancer.
ts when compared to traditional intensity modulated radiation therapy (IMRT) as part of chemoradiation treatment for patients with oropharyngeal (head and neck) cancer.
Today, Steven Frank, M.D., professor of Radiation Oncology and executive director of the Particle Therapy Institute at The University of Texas MD Anderson Cancer Center, presented the results at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.
After a median follow-up of three years, the progression-free survival (PFS) rate was 83% for IMPT and 83.5% for IMRT. The study found that IMPT was statistically non-inferior to IMRT.IMRT showed a decrease in malnutrition, with only 14% of patients experiencing less than 5% weight loss during treatment, compared to 24% of patients receiving IMPT. In addition, IMPT resulted in a lower dependence on feeding tubes at 28%, compared to 42% with IMRT. The multi-center Phase III randomized trial results indicate that IMPT could be a new standard-of-care treatment for head and neck tumors. This treatment offers a curative, de-intensified option compared to traditional radiation therapy, which is significant for patients.
Proton therapy offers both physical and biological advantages when compared to traditional photon radiation therapy. Protons, unlike photons, have mass and can be effectively stopped by the body, allowing for more targeted delivery to the treatment area and reducing the impact on surrounding healthy tissues. This clinical trial is the largest of its kind, comparing proton therapy to traditional radiation, and enrolled 440 patients at 21 U.S. locations. Of these, 219 underwent IMRT and 221 received IMPT, with patient stratification based on HPV status and smoking history.
The study aimed to assess the PFS rate at three years for patients with advanced head and neck cancer, taking into account their tobacco-smoking status and whether they had undergone induction chemotherapy. Frank noted the historical challenge of conducting large-scale trials to confirm the benefits of proton therapy due to limited patient access to proton therapy centers. Encouraging results like these demonstrate the advantages of proton therapy and may lead to increased patient access in the future. The study received funding from grants from the National Institutes of Health (NIH)/National Cancer Institute (NCI) (U19CA021239, R03CA188162, R56DE025248).The author, Frank, has received grant funding from Hitachi related to proton research and has also received honoraria fees from Ion Beam Applications S.A. (IBA). In addition, Frank has health care relationships with Boston Scientific (consulting fees), Affirmed Pharma (NIH grant), and C4 Imaging (founder, scientific advisory committee, patents/royalties, ownership interest) that are unrelated to proton research.
