In a national study led by Yale Cancer Center, transoral robotic surgery followed by low-dose radiation without chemotherapy led to increased survival rates and a more favorable quality of life compared to usual high-dose radiation with chemotherapy in patients with human papillomavirus-positive (HPV+) throat cancer. The results of the randomized phase 2 trial E3311 were published in the Journal of Clinical Oncology. The ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) designed and conducted the trial.
"For intermediate-risk patients, reduced-dose postoperative radiation therapy without chemotherapy appears sufficient," said senior study author Barbara Burtness, MD, Professor of Medicine, Co-leader of the Developmental Therapeutics Research Program at Yale Cancer Center and chairperson of the ECOG-ACRIN's Head and Neck Cancer Committee. "With three years of follow-up, this group continued to have better outcomes than the group on usual high-dose radiation plus chemotherapy."
The incidence of HPV+ throat cancer has been increasing in recent years, especially in individuals under the age of 45. This change is attributed to the increasing prevalence of HPV infection in developed countries, the practice of oral sex, and the rising number of sexual partners. Patients with HPV-related throat cancer experience a profound, acute decrease in physical functioning and quality of life as a result of surgery, chemotherapy, and radiation treatments.
“Surgeons and patients widely favor the organ-preservation approach of robot-assisted surgery, which has been in use since 2009 when it was cleared for use by the FDA. However, serious concerns remain about both short- and long-term toxicities associated with chemotherapy and radiation therapy,” added Burtness. “Considering that this type of cancer is occurring in increasing numbers in younger people, who will be at risk for life-long consequences of chemotherapy and radiation treatment, there is need for new approaches.”
The E3311 trial results show survival and quality of life data on 359 trial participants with HPV+ throat cancer who completed the treatment protocol. All patients underwent robot-assisted surgery and were then assigned to treatment based on their individual risk factors for local recurrence. Patients at intermediate risk were randomized to two arms of radiation alone, both at doses lower than usual. Patients at high risk were assigned to usual radiation therapy plus chemotherapy. Patients at low risk were observed. With a medium of 35.2 months of follow-up for 359 evaluable patients, progression-free survival was 96% for the group of patients randomized to radiation doses at 60 Gy and 94.9% for the group of patients at intermediate risk randomized to radiation doses at 50 Gy. By comparison, progression-free survival in the group that received usual high-dose radiation (66 Gy) plus chemotherapy was 90.7%.
“The E3311 findings build a strong case that usual high-dose radiation and chemotherapy may not be necessary,” said first author Robert L. Ferris, MD, PhD, Director of the UPMC Hillman Cancer Center in Pittsburgh and a surgical oncologist specializing in head and neck cancer. “The study will continue to follow patients to measure the long-term effects and toxicities from chemotherapy radiation therapy."
The study was funded by the National Cancer Institute, part of the National Institutes of Health.
For more information on the ECOG-ACRIN research: https://ecog-acrin.org/news-and-info-press-releases-a-new-post-surgery-approach-for-hpv-related-throat-cancer-e3311-results-published-in-the-journal-of-clinical-oncology