2017 Section 7 Green Book

C. Schilling et al. / European Journal of Cancer 51 (2015) 2777 e 2784

q Department of Histopathology, San Carlo Hospital Rome, Italy r Department of Nuclear Medicine, Cristo Re Hospital, Rome, Italy s Department of Head and Neck Surgery, CHU Dinant Godinne, Universite´ Catholique de Louvain, Belgium t Department of Otolaryngology, Ospedale S. Chiara, Trento, Italy u Department of Nuclear Medicine, Ospedale S. Chiara, Trento, Italy v Department of Surgical Pathology, Ospedale S. Chiara, Trento, Italy w Department of Maxillofacial Surgery CHU de Charleroi Belgium, Belgium x Department of Maxillofacial Surgery, Azienda Ospedaliera, Universitaria of Parma, Italy y Department of Pathology Azienda Ospedaliera Universitaria of Parma, Italy z Department of Head and Neck Surgery Centre Alexis Vautrin, Vandoeuvre Les Nancy, France aa Department of Pathology Centre Alexis Vautrin, Vandoeuvre Les Nancy, France ab Department of Informatics, Kings’ College London, UK ac Department of Cellular Pathology, Newcastle University Hospital, UK

Received 13 July 2015; received in revised form 22 August 2015; accepted 23 August 2015 Available online 18 November 2015

Abstract Purpose: Optimum management of the N0 neck is unresolved in oral cancer. Sentinel node biopsy (SNB) can reliably detect microscopic lymph node metastasis. The object of this study was to establish whether the technique was both reliable in staging the N0 neck and a safe oncological procedure in patients with early-stage oral squamous cell carcinoma. Methods: An European Organisation for Research and Treatment of Cancer-approved pro- spective, observational study commenced in 2005. Fourteen European centres recruited 415 patients with radiologically staged T1 e T2N0 squamous cell carcinoma. SNB was undertaken with an average of 3.2 nodes removed per patient. Patients were excluded if the sentinel node (SN) could not be identified. A positive SN led to a neck dissection within 3 weeks. Analysis was performed at 3-year follow-up. Results: An SN was found in 99.5% of cases. Positive SNs were found in 23% (94 in 415). A false-negative result occurred in 14% (15 in 109) of patients, of whom eight were subsequently rescued by salvage therapy. Recurrence after a positive SNB and subsequent neck dissection occurred in 22 patients, of which 16 (73%) were in the neck and just six patients were rescued. Only minor complications (3%) were reported following SNB. Disease-specific survival was 94%. The sensitivity of SNB was 86% and the negative predictive value 95%. Conclusion: These data show that SNB is a reliable and safe oncological technique for staging the clinically N0 neck in patients with T1 and T2 oral cancer. EORTC Protocol 24021: Sentinel Node Biopsy in the Management of Oral and Oropharyn-

KEYWORDS Oral Cancer; Sentinel lymph node biopsy; Metastasis; Recurrence; Micrometastasis; Lymphoscintigraphy

geal Squamous Cell Carcinoma. ª 2015 Published by Elsevier Ltd.

1. Introduction

‘wait and see’ policy [7] . The corollary of this strategy is that up to 80% of stage I/II patients undergo an un- necessary neck dissection. Sentinel node biopsy (SNB) is capable of detecting occult metastases in head and neck cancer [8 e 11] and is becoming established in a range of other cancers [12,13] . SNB offers a potential solution for management of the N0 neck but at the present time it is not widely offered. There is a paucity of data on the expected success of the tech- nique, particularly with respect to the accuracy of sentinel node (SN) detection, disease recurrence and survival. The Sentinel European Node Trial (SENT) study population is the largest cohort of oral cancer patients in which SNB was performed as a sole staging procedure without

Head and neck squamous cell carcinoma is the eighth most common cancer worldwide in males and is increasing significantly amongst females [1] Approximately half the patients with oral cancer present with stage I/II disease and up to 33% [2,3] have occult cervical disease undetectable by current imaging techniques (computed tomography [CT]/magnetic reso- nance imaging [MRI]/ultrasound/positron-emission to- mography) [4,5] . Cervical metastasis is associated with a 50% reduction in cure. Consequently, if the estimated chance of metastasis exceeds 20% [6] , current practice is to offer an elective neck dissection (END) rather than

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