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Distribution of lymph node metastases in esophageal carcinoma [TIGER study]: study protocol of a multinational observational study.

ABSTRACT: BACKGROUND:An important parameter for survival in patients with esophageal carcinoma is lymph node status. The distribution of lymph node metastases depends on tumor characteristics such as tumor location, histology, invasion depth, and on neoadjuvant treatment. The exact distribution is unknown. Neoadjuvant treatment and surgical strategy depends on the distribution pattern of nodal metastases but consensus on the extent of lymphadenectomy has not been reached. The aim of this study is to determine the distribution of lymph node metastases in patients with resectable esophageal or gastro-esophageal junction carcinoma in whom a transthoracic esophagectomy with a 2- or 3-field lymphadenectomy is performed. This can be the foundation for a uniform worldwide staging system and establishment of the optimal surgical strategy for esophageal cancer patients. METHODS:The TIGER study is an international observational cohort study with 50 participating centers. Patients with a resectable esophageal or gastro-esophageal junction carcinoma in whom a transthoracic esophagectomy with a 2- or 3-field lymphadenectomy is performed in participating centers will be included. All lymph node stations will be excised and separately individually analyzed by pathological examination. The aim is to include 5000 patients. The primary endpoint is the distribution of lymph node metastases in esophageal and esophago-gastric junction carcinoma specimens following transthoracic esophagectomy with at least 2-field lymphadenectomy in relation to tumor histology, tumor location, invasion depth, number of lymph nodes and lymph node metastases, pre-operative diagnostics, neo-adjuvant therapy and (disease free) survival. DISCUSSION:The TIGER study will provide a roadmap of the location of lymph node metastases in relation to tumor histology, tumor location, invasion depth, number of lymph nodes and lymph node metastases, pre-operative diagnostics, neo-adjuvant therapy and survival. Patient-tailored treatment can be developed based on these results, such as the optimal radiation field and extent of lymphadenectomy based on the primary tumor characteristics. TRIAL REGISTRATION:NCT03222895 , date of registration: July 19th, 2017.

SUBMITTER: Hagens ERC

PROVIDER: S-EPMC6610993 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

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Distribution of lymph node metastases in esophageal carcinoma [TIGER study]: study protocol of a multinational observational study.

Hagens Eliza R C ERC van Berge Henegouwen Mark I MI van Sandick Johanna W JW Cuesta Miguel A MA van der Peet Donald L DL Heisterkamp Joos J Nieuwenhuijzen Grard A P GAP Rosman Camiel C Scheepers Joris J G JJG Sosef Meindert N MN van Hillegersberg Richard R Lagarde Sjoerd M SM Nilsson Magnus M Räsänen Jari J Nafteux Philippe P Pattyn Piet P Hölscher Arnulf H AH Schröder Wolfgang W Schneider Paul M PM Mariette Christophe C Castoro Carlo C Bonavina Luigi L Rosati Riccardo R de Manzoni Giovanni G Mattioli Sandro S Garcia Josep Roig JR Pera Manuel M Griffin Michael M Wilkerson Paul P Chaudry M Asif MA Sgromo Bruno B Tucker Olga O Cheong Edward E Moorthy Krishna K Walsh Thomas N TN Reynolds John J Tachimori Yuji Y Inoue Haruhiro H Matsubara Hisahiro H Kosugi Shin-Ichi SI Chen Haiquan H Law Simon Y K SYK Pramesh C S CS Puntambekar Shailesh P SP Murthy Sudish S Linden Philip P Hofstetter Wayne L WL Kuppusamy Madhan K MK Shen K Robert KR Darling Gail E GE Sabino Flávio D FD Grimminger Peter P PP Meijer Sybren L SL Bergman Jacques J G H M JJGHM Hulshof Maarten C C M MCCM van Laarhoven Hanneke W M HWM Mearadji Banafsche B Bennink Roel J RJ Annema Jouke T JT Dijkgraaf Marcel G W MGW Gisbertz Suzanne S SS

BMC cancer 20190704 1

<h4>Background</h4>An important parameter for survival in patients with esophageal carcinoma is lymph node status. The distribution of lymph node metastases depends on tumor characteristics such as tumor location, histology, invasion depth, and on neoadjuvant treatment. The exact distribution is unknown. Neoadjuvant treatment and surgical strategy depends on the distribution pattern of nodal metastases but consensus on the extent of lymphadenectomy has not been reached. The aim of this study is ...[more]

PMID: 31272485

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Project description:ObjectivesTo improve clinical lymph node staging (cN-stage) in oesophageal adenocarcinoma by developing and externally validating three prediction models; one with clinical variables only, one with positron emission tomography (PET) radiomics only, and a combined clinical and radiomics model.MethodsConsecutive patients with fluorodeoxyglucose (FDG) avid tumours treated with neoadjuvant therapy between 2010 and 2016 in two international centres (n = 130 and n = 60, respectively) were included. Four clinical variables (age, gender, clinical T-stage and tumour regression grade) and PET radiomics from the primary tumour were used for model development. Diagnostic accuracy, area under curve (AUC), discrimination and calibration were calculated for each model. The prognostic significance was also assessed.ResultsThe incidence of lymph node metastases was 58% in both cohorts. The areas under the curve of the clinical, radiomics and combined models were 0.79, 0.69 and 0.82 in the developmental cohort, and 0.65, 0.63 and 0.69 in the external validation cohort, with good calibration demonstrated. The area under the curve of current cN-stage in development and validation cohorts was 0.60 and 0.66, respectively. For overall survival, the combined clinical and radiomics model achieved the best discrimination performance in the external validation cohort (X2 = 6.08, df = 1, p = 0.01).ConclusionAccurate diagnosis of lymph node metastases is crucial for prognosis and guiding treatment decisions. Despite finding improved predictive performance in the development cohort, the models using PET radiomics derived from the primary tumour were not fully replicated in an external validation cohort.Advances in knowledgeThis international study attempted to externally validate a new prediction model for lymph node metastases using PET radiomics. A model combining clinical variables and PET radiomics improved discrimination of lymph node metastases, but these results were not externally replicated.

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Distribution of lymph node metastases in esophageal carcinoma [TIGER study]: study protocol of a multinational observational study.

Publications

Distribution of lymph node metastases in esophageal carcinoma [TIGER study]: study protocol of a multinational observational study.

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