Phase III trial highlights benefits of intensity modulated proton therapy for oropharyngeal cancer

Based on preliminary information from a multi-institution Part III trial led by researchers at The College of Texas MD Anderson Most cancers Middle, depth modulated proton remedy (IMPT) achieved related scientific outcomes and supplied vital affected person advantages when in comparison with conventional depth modulated radiation remedy (IMRT) as a part of chemoradiation remedy for sufferers with oropharyngeal (head and neck) most cancers.  

The outcomes have been offered at present on the 2024 American Society of Medical Oncology (ASCO) Annual Assembly by Steven Frank, M.D., professor of Radiation Oncology and govt director of the Particle Remedy Institute at The College of Texas MD Anderson Most cancers Middle.  

With a median follow-up of three years, the progression-free survival (PFS) charge was 83% and 83.5% for IMPT and IMRT, respectively, and IMPT was statistically non-inferior to IMRT. There was a major discount of malnutrition with IMPT, with 24% of sufferers sustaining their vitamin with lower than 5% weight reduction throughout remedy in contrast with 14% of these receiving IMRT. Moreover, there was a major discount of feeding-tube dependence with IMPT at 28%, in comparison with 42% with IMRT.  

The outcomes of this multi-center Part III randomized trial present proof for IMPT as a brand new standard-of-care remedy method for the administration of head and neck tumors. That is vital for sufferers because it represents a healing, de-intensified choice in comparison with conventional radiation remedy.” 

Steven Frank, M.D., professor of Radiation Oncology and govt director of the Particle Remedy Institute at The College of Texas MD Anderson Most cancers Middle

Proton remedy has each organic and bodily benefits over conventional radiation remedy utilizing photons. In contrast to photons, protons have mass and could be stopped by the human physique. This permits proton radiation to be delivered particularly to the focused space, limiting the quantity that reaches close by regular tissues. This trial represents the biggest randomized Part III trial up to now to analyze proton remedy compared to conventional radiation.  

The trial enrolled 440 sufferers at 21 websites within the U.S., with 219 receiving IMRT and 221 receiving IMPT. Sufferers have been stratified primarily based on human papillomavirus (HPV) standing, smoking standing and whether or not they had obtained induction chemotherapy. The first endpoint of the examine was the PFS charge at three years.  

“Traditionally, these form of large-scale trials to verify the advantages of proton remedy have been difficult, due partially to comparatively few sufferers gaining access to proton remedy facilities,” Frank stated.” Encouraging outcomes like these show the advantages of proton remedy and hopefully assist pave the best way for elevated entry for sufferers in want.” 

This examine was funded by grants from the Nationwide Institutes of Well being (NIH)/Nationwide Most cancers Institute (NCI) (U19CA021239, R03CA188162, R56DE025248) and Hitachi. Frank experiences proton-related grant funding by Hitachi and honoraria charges from Ion Beam Purposes S.A. (IBA). He additionally has non-proton associated well being care relationships with Boston Scientific (consulting charges), Affirmed Pharma (NIH grant), and C4 Imaging (founder, scientific advisory committee, patents/royalties, possession curiosity). A full checklist of collaborating authors and their disclosures could be discovered with the summary right here.