Background: This study evaluated the negative predictive value for node negativity in HNSCC. Methods: Patients were enrolled from 8/10 until 12/16 from 38 centers in the US and 1 center in China. This was a prospective, non-randomized trial. The study was designed to recruit 292 patients; however, 287 were enrolled by study closure. Inclusion criteria were newly diagnosed cT2-T4 SCC patients from the head and neck with one side cN0 who were willing to undergo an elective neck dissection. CN0 was determined by a negative neck CT or MR scan. Exclusions included non-SCC, non-surgical candidates, skin, nasopharynx or sinus primaries. PET/CT imaging reading performed centrally and pathology were analyzed at the neck level (left or right). To estimate confidence intervals, we used a nonparametric bootstrap to account for the correlation of data between sides of neck of the same patient. Correlative data and other image analyses will be reported separately. Results: PET/CT scans and pathology were available for 211 (table) N0 sides of neck for review at last interim analysis. NPV estimate with 95% CI for bilateral necks: 0.896 (0.831, 0.950) and specific to the N0 sides: 0.922 (0.862, 0.973). Conclusions: FDG PET/CT has high NPV for node negativity in HNSCC. This may obviate the need for elective neck dissection in N0 HNSCC patients. This trial was open about three times longer than planned, and a major obstacle to accrual was the generalized assumption among the oncology community that PET/CT had a high NPV. Therefore, patients sent to study centers for further diagnosis and treatment often had their PET/CT scans performed on non-ACRIN certified equipment. This required investigators to forgo offering the trial or the PET/CT was repeated. Our results may suggest application for pre-operative PET/CT nodal imaging of other primaries/lymphatic basins staged cN0. Funding from the National Cancer Institute through the grants U01 CA079778, U01 CA080098, CA180820, CA180794. Clinical trial information:
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Introduction: End of treatment FDG-PET/CT activity is a powerful predictor of survival outcome in patients with Hodgkin, Diffuse large B cell and Follicular lymphomas. The predictive value of interim PET/CT scan on survival in Hodgkin lymphoma is also well established. To date, there are limited data regarding the prognostic significance of interim and end of treatment FDG-PET/scan results in adult patients with Burkitt lymphoma (BL), mainly due to the rarity of this entity. In this single-center retrospective study we analyzed the survival outcomes of patients with BL according to the findings on interim and end of treatment FDG-PET/CT scans using the Deauville criteria.
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