Author: Mehanna H, et al.
Patients with head and neck cancer who underwent PET/CT–guided surveillance achieved similar survival outcomes as those who underwent planned neck dissections, according to the results of a prospective, randomized controlled trial. However, surveillance led to fewer surgical operations and complications and appeared more cost-effective than neck dissection, results showed.
Patients with head and neck cancer frequently undergo invasive surgery following treatment to remove remaining cancer cells, according to study background.
“After treatment, remaining cancer cells play something akin to hide and seek,” Hisham Mehanna, MBChB, PhD, FRCS, chair of head and neck surgery at University of Birmingham and director of the Institute of Head and Neck Studies and Education, said in a press release. “Our study shows that we can hunt them down, find them and remove them effectively.”
Mehanna and colleagues sought to define the role of image-guided surveillance compared with planned neck dissection for the management of patients with advanced, nodal head and neck squamous cell carcinoma previously treated with primary chemoradiotherapy. The analysis included data from 564 patients (mean age, 58 years; 82% men) who researchers randomly assigned to PET/CT–guided surveillance (n = 282) performed 12 weeks after the end of treatment or planned neck dissection (n = 282).
Oropharyngeal cancer served as the most common cancer subtype (84%). Seventy-five percent of patients had HPV-16–positive disease. Patients assigned surveillance only underwent neck dissection if their PET/CT scans showed incomplete or equivocal response to chemoradiotherapy.
The trial was designed to assess noninferiority of PET/CT–guided surveillance. OS served as a coprimary endpoint. Median follow-up was 36 months, with 92% of patients (n = 520) followed for at least 2 years. Ninety-six percent of patients assigned surveillance underwent PET/CT per protocol at 12 weeks. Fifty-four patients in the surveillance arm underwent neck dissections compared with 221 patients in the planned surgery arm. The surgical complication rate was similar in both cohorts (42% vs. 38%). Overall, 122 patients had died at the time of reporting (surveillance, n = 60; neck dissection, n = 62).
The rate of 2-year OS was 84.9% (95% CI, 80.7-89.1) in the surveillance arm compared with 81.5% (95% CI, 76.9-86.3) in the planned neck dissection arm. These data met the study’s noninferiority threshold (HR = 0.92; 95% CI, 0.65-1.32).
HPV–16 status did not have a significant effect on OS. Survival appeared comparable between the planned surgery and surveillance groups among patients with p16–positive (HR = 0.74; 95% CI, 0.4-1.37) and p16–negative tumors (HR = 0.98; 95% CI, 0.58-1.66). Both arms had similar rates of 2-year locoregional control (91.9% vs. 91.4%).
More patients assigned neck dissection experienced an adverse event (169 vs. 113). Patients in the surveillance arm had better quality of life scores at 6 months (P = .03); however, this difference became nonsignificant by 12 months. Surveillance appeared more cost-effective than neck dissection, with a per-person cost savings of $2,190.
“Patient outcomes, and avoiding unnecessary surgery, are the main goals of this study,” Mehanna said. “But there is a cost saving to be made, too. … Carry that [savings] across the tens of thousands of cases each year across the world and you see a significant saving that can be redistributed into other therapies.” – by Cameron Kelsall
N Engl J Med. 2016;doi:10.1056/NEJMoa1514493.
The National Institute for Health Research Health Technology Assessment Program funded this study. Please see the full study for a list of the researchers’ relevant financial disclosures.