The phase II E3311 trial offers new information about using reduced-intensity treatment in patients with human papillomavirus (HPV)-associated oropharyngeal cancer who are at intermediate risk of recurrence. These findings were presented by Robert L. Ferris, MD, PhD, and colleagues during the 2021 ASCO Annual Meeting (Abstract 6010).
Robert L. Ferris, MD, PhD
Although many surgeons and patients may favor the organ-preservation approach of transoral robotic surgery, there remain serious concerns about both short- and long-term toxicities associated with chemotherapy. First, this trial found a better way to assess each patient's individual risk (presented during the 2020 ASCO Annual Meeting). The novel method uses tumor testing along with patient characteristics to measure the level of risk: low, intermediate, or high.
Physicians may safely consider offering patients less therapy if their risk of disease recurrence is low; high-risk patients may receive standard chemotherapy and radiation after surgery; but what about patients with an intermediate risk? The E3311 phase II study proved that intermediate-risk patients could safely forgo chemotherapy altogether and receive transoral surgery followed by a lower dose of radiation than is standard and still have good outcomes.
Data on 3-Year Progression-Free Survival
The analysis presented at the 2021 ASCO Annual Meeting reported on 3-year progression-free survival data. The 3-year progression-free survival estimates for the two medium-risk groups were 94.9% for a 50-Gy dose of radiation and 93.5% for a 60-Gy dose. Researchers also reported on an exploratory comparison of quality of life between the two intermediate-risk groups. Patient reports (FACT–HN) completed at baseline (before surgery) and 6 months after radiation therapy revealed that 63% vs 49% of patients in the 50-Gy or 60-Gy arms, respectively, had stable or improved quality of life.
Primary transoral surgery followed by reduced-dose radiation therapy is safe in patients with intermediate-risk HPV-positive oropharyngeal cancer, with favorable quality of life and functional outcomes.— Robert L. Ferris, MD, PhD
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Dr. Ferris, of UPMC Hillman Cancer Center, said: “Primary transoral surgery followed by reduced-dose radiation therapy is safe in patients with intermediate-risk HPV-positive oropharyngeal cancer, with favorable quality of life and functional outcomes.”
He continued: “With 3 years of follow-up, this group continued to have better outcomes than the group on usual high-dose radiation plus chemotherapy. Our patient stratification identified low- and intermediate-risk patients well, preserving patients' throat function and sparing them unnecessary short- and long-term toxicities. These data support…plans for a phase III confirmatory trial.”
Disclosure: For full disclosures of the study authors, visit coi.asco.org.
