The Journal of Clinical Oncology has published the results of the largest prospective multicenter trial conducted of FDG-PET/CT in head and neck cancer, providing rigorous data about its performance. The nonrandomized phase two trial, ACRIN 6685, followed 287 patients with newly diagnosed stage T2 to T4 disease, all being considered for surgery when at least one side of the neck had no evidence of lymph node involvement based on a physical exam, preoperative MRI and/or a CT evaluation (clinically node-negative or cN0). It found that FDG-PET/CT imaging achieved a true negative in 94 percent of patients (by standardized uptake value (SUV) analysis), or 87 percent of patients (by visual assessment). The trial was designed and conducted by researchers in the ECOG-ACRIN Cancer Researcher Group with support from the National Cancer Institute, part of the National Institutes of Health.
"The information provided by FDG-PET/CT of the cN0 neck changed the surgical plan 22 percent of the time," said the study's principal investigator and lead author Val J. Lowe, MD, a nuclear medicine specialist at Mayo Clinic in Rochester, MN. "These findings suggest that FDG-PET/CT may assist the clinician in deciding on the best therapy for the clinically N0 neck in head and neck squamous cell carcinoma, possibly preventing patient morbidity and/or saving significant costs."
The reliability of FDG-PET/CT in detecting lymph node metastases in head and neck cancer is well proven and is reported to be cost-effective in staging patients with cN0 necks. Most of the data is single-institutional and retrospective. Surgeons often perform elective neck dissections in patients with cN0 necks at high risk for recurrence because clinical exam and structural imaging do not reliably identify all metastatic disease. This approach has been found to improve survival but may be associated with substantial complications for patients.
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"A negative scan in the cN0 neck has been demonstrated by our study to have a very high negative predictive value," said co-principal investigator and co-author Brendan C. Stack, Jr., MD, a surgeon at the University of Arkansas for Medical Sciences. "Additionally, the positive PET leads the surgeon to consider resection of nodal levels that might harbor occult metastatic disease."
Participants older than 18 years of age with newly diagnosed, first-time head and neck squamous cell carcinoma were recruited from 22 qualified sites in the United States and one in Beijing, China. FDG-PET/CT was compared with pathology findings at neck dissection. Participants all received a pre-surgical FDG-PET/CT scan to which the surgeon was initially blinded and a contrast-enhanced MRI or CT scan of the neck (all within four weeks of surgery).