Dr Garg on a Phase 3 Study of Proton Therapy in Head and Neck Cancer

“One of the main reasons [for the survival advantage with proton therapy] was that the quality of life of patients was better.”

Madhur K. Garg, MD, MBA, MBBS, the clinical director of radiation oncology, the co-director of the Stereotactic Radiosurgery Program, and a professor of radiation oncology and otolaryngology at Montefiore Medical Center, discussed data from a non-inferiority phase 3 trial (NCT01893307) of proton therapy for the treatment of patients with head and neck cancer.

Data from the study, which was led by investigators at the University of Texas MD Anderson Cancer Center, found that proton therapy was associated with an overall survival (OS) advantage compared with standard radiation therapy, Garg began. In the trial, patients were randomly assigned to receive either conventional radiation or proton therapy, and those treated with protons achieved a longer median OS after extended follow-up, he continued. The findings represent an important development in understanding the potential clinical benefits of proton therapy, particularly in cancers where radiation can significantly affect surrounding healthy tissues, he noted.

The investigators sought to understand why patients receiving proton therapy appeared to live longer, Garg explained. Subsequent analyses pointed toward differences in quality of life (QOL) as an important potential explanation, he underscored. Patients treated with proton therapy experienced fewer treatment-related effects that could substantially interfere with daily functioning and overall well-being, he said. In particular, patients were less dependent on feeding tubes and demonstrated better swallowing function. They also experienced less dry mouth, another common and potentially debilitating consequence of radiation treatment involving the head and neck, he said.

These improvements in QOL have broader implications for patients’ ability to remain active and productive during and after treatment, Garg said. By reducing some of the toxicities associated with radiation, proton therapy may help patients maintain better overall function, which could contribute to the observed survival advantage, he noted.

The findings are particularly relevant in head and neck cancers, where radiation therapy plays a central role in treatment, Garg said. Approximately 70% to 75% of patients with head and neck cancer are expected to receive radiation therapy at some point during their treatment, either as an initial treatment or following surgery, he noted. Given the large number of patients exposed to radiation and the potential for treatment-related effects on swallowing, oral function, and QOL, approaches that can reduce these complications could have substantial clinical implications, he concluded.