CHICAGO–PET-CT guided active surveillance showed comparable survival outcomes to neck dissection, but results in substantially fewer neck dissections and complications in patients with locally advanced head and neck squamous cell cancer (HNSCC) treated with primary radical chemoradiotherapy, data presented at the 2015 American Society of Clinical Oncology (ASCO) annual meeting have shown.
“Traditionally, planned neck dissection has been the standard of care for advanced N2/N3 nodal disease,” said Hisham Mehanna, MD, PhD, Chair of Head and Neck Surgery at the University of Birmingham in the United Kingdom. “However, with improved imaging, there has been an improved ability to identify complete responders with surveillance.”
For the PET-NECK study, researchers enrolled 564 patients with locally advanced nodal metastases of HNSCC receiving chemoradiotherapy and eligible for neck dissection.
Participants were randomly assigned 1:1 to undergo planned neck dissection before or after chemoradiotherapy (control) or chemoradiotherapy followed 10 to 12 weeks by FDG-PET-CT with neck dissection only if PET-CT demonstrated incomplete or equivocal response of nodal disease.
Of those with oral cancer, 75% were p16-positive, meaning their tumors tested positive for the tumor suppressor protein cyclin-dependent kinase inhibitor 2A.
Speaking on patient demographics, Dr. Mehanna said, “There were no major imbalances between the two groups.”
Results showed that at a median follow-up of 36 months, the hazard ratio for overall survival was 0.92 (95% CI: 0.65, 1.32; P=0.004), suggesting noninferiority of PET-CT guided active surveillance to neck dissection.
“The surveillance arm is strongly noninferior to planned neck dissection,” Dr. Mehanna said.
Researchers found that there were no differences between p16-positive and -negative patients. There was also no difference in quality of life between the treatment arms; however, there was a higher proportion of serious adverse events in the planned neck dissection arm than the surveillance arm (P=0.001).
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In total, 54 neck dissections were performed in the surveillance arm compared with 221 neck dissections in the control arm. There were 22 and 85 surgical complications in the surveillance and control arms, respectively.
Dr. Mehanna concluded, “The PET-CT guided surveillance arm resulted in equivalent noninferior overall survival, but only 20% of patients received neck dissections. There were fewer neck dissections and fewer serious adverse events with a similar quality of life.”
The findings ultimately support the use of PET-CT guided active surveillance in routine practice for patients with locally advanced HNSCC.
- Mehanna HM, Wong WL, McConkey CC, et al. PET-NECK: A multi-centre, randomized, phase III, controlled trial (RCT) comparing PETCT guided active surveillance with planned neck dissection (ND) for locally advanced (N2/N3) nodal metastases (LANM) in patients with head and neck squamous cell cancer (HNSCC) treated with primary radical chemoradiotherapy (CRT). J Clin Oncol. 2015;33:(suppl; abstr 6009).