PET-CT Surveillance versus Neck Dissection in Advanced Head and Neck Cancer
- Study type
- Clinical trial
- Study name
- PET-NECK
- Design
- Prospective randomised controlled noninferiority trial
- Sample size
- 564 patients (282 in the planned surgery group and 282 in the surveillance group) from 37 centres in the United Kingdom
- Source
- N Engl J Med · 2016
In plain words
In this study, patients with advanced head and neck cancer treated with chemoradiotherapy were divided into two groups: one group had planned neck surgery, while the other was checked with a PET-CT scan 12 weeks later and had an operation only if disease remained or looked suspicious. Survival was similar in the two groups, but the PET-CT group had far fewer operations. Quality of life was also similar in both groups, and the monitoring approach cost less.
Key results
Treatment arms and regimens
Definitive concurrent chemoradiotherapy, then PET-CT about 12 weeks after completion of chemoradiotherapy; neck dissection only for an incomplete or equivocal response on PET-CT.
Chemoradiotherapy (both groups, per the registered protocol): each centre's usual regimen from the trial's list of approved regimens; recommended standard regimen: radiotherapy 65 to 70 Gy in 30 to 35 daily fractions of 2 Gy or more per fraction, with at least 2 doses of IV cisplatin 75 to 100 mg/m² every 3 or 4 weeks or carboplatin (AUC 4.5 to 5). Induction chemotherapy (platinum or TPF) before concurrent chemoradiotherapy and concurrent cetuximab were also among the trial regimens, and randomisation was stratified by regimen type.
Planned neck dissection with the same chemoradiotherapy. In the registered protocol (ISRCTN), neck dissection was performed before chemoradiotherapy and within 2 to 4 weeks of randomisation, and the recommended procedure was modified radical neck dissection (removal of levels I to V preserving one or more of the spinal accessory nerve, internal jugular vein and sternocleidomastoid muscle). For the exact timing used in the trial, see the full text of the paper.
Source of the regimen details: Abstract of the paper; ISRCTN13735240 registry (chemoradiotherapy and surgical regimens, eligibility criteria) and ClinicalTrials.gov NCT00720070
Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.
Study population
Eligibility criteria (ISRCTN registry): squamous cell carcinoma of the oropharynx, larynx, oral cavity, hypopharynx or unknown primary; N2 (a, b or c) or N3 nodal metastasis on examination and CT/MRI; indication for radical concurrent chemoradiotherapy for the primary tumour; fit for neck dissection. Exclusion criteria: surgery to the primary tumour, N1, radiotherapy alone, distant metastasis, previous treatment for head and neck cancer and age under 18. In practice 17% had N2a and 61% N2b disease; 84% had oropharyngeal cancer and 75% of tumour samples were p16-positive (a marker of human papillomavirus involvement).
Endpoints
Primary endpoint: overall survival. Other assessments included the number of neck dissections, surgical complications, p16 expression, quality of life and cost-effectiveness.
Safety and side effects
Surgical complication rates were similar in the two groups (42% vs 38%). Grade 3 or higher adverse event data are not reported in the abstract.
Clinical significance and place in guidelines
The results of this trial show that PET-CT-guided surveillance can replace planned neck dissection after chemoradiotherapy in N2 or N3 patients and avoid many operations without reducing survival. The status of this approach in current clinical guidelines should be checked separately, as the abstract does not mention it.
Limitations
Based on the abstract, median follow-up was 36 months and the primary endpoint was reported as 2-year survival. Most patients had oropharyngeal cancer (84%) and 75% of these were p16-positive; extending the results to other subgroups should be done with caution. Further details of limitations are in the full text of the paper.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.