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Management of Locally Advanced Adenocarcinoma of the Esophagus and Gastroesophageal Junction: Finally a Consensus.

ABSTRACT: Opinion statement: Adenocarcinoma of the esophagus is increasing in incidence in Western nations leading to increased interest in and opportunity to study optimal management. Randomized trials have now robustly demonstrated the preoperative therapy with chemoradiotherapy and chemotherapy alone improves survival outcome for the bulk of curable patients, those with locally advanced T1N1M0 and T2-3 N0-1 M0 disease. Evidence suggests but does not confirm that radiation-containing regimens are more beneficial. Clinical staging is designed to exclude patients with T1N0M0 disease who may be treated with surgery alone and those with metastatic disease who may not benefit from intensive local therapy. The approach to clinical staging includes endoscopy with ultrasound and fine needle aspirate to assess local and regional disease, supplemented by CT and PET scanning primarily to exclude metastatic disease. Minimally invasive approaches to esophagectomy may be used with the goal of reducing complications, but there is no evidence that mortality or ultimate outcome is improved.

SUBMITTER: Kleinberg L

PROVIDER: S-EPMC4625398 | biostudies-literature | 2015 Jul

REPOSITORIES: biostudies-literature

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Management of Locally Advanced Adenocarcinoma of the Esophagus and Gastroesophageal Junction: Finally a Consensus.

Kleinberg Lawrence L Brock Malcolm M Gibson Michael M

Current treatment options in oncology 20150701 7

Opinion statement: Adenocarcinoma of the esophagus is increasing in incidence in Western nations leading to increased interest in and opportunity to study optimal management. Randomized trials have now robustly demonstrated the preoperative therapy with chemoradiotherapy and chemotherapy alone improves survival outcome for the bulk of curable patients, those with locally advanced T1N1M0 and T2-3 N0-1 M0 disease. Evidence suggests but does not confirm that radiation-containing regimens are more b ...[more]

PMID: 26112428

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Project description:On September 22, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval for pembrolizumab (Keytruda, Merck & Co., Inc., Whitehouse Station, NJ) for the treatment of patients with recurrent, locally advanced or metastatic, gastric or gastroesophageal junction (GEJ) adenocarcinoma with disease progression on or after two or more systemic therapies, including fluoropyrimidine- and platinum-containing chemotherapy and, if appropriate, HER2/neu-targeted therapy, and whose tumors express programmed death-ligand 1 (PD-L1), as determined by an FDA-approved test. Approval was based on demonstration of durable overall response rate (ORR) in a multicenter, open-label, multicohort trial (KEYNOTE-059/Cohort 1) that enrolled 259 patients with locally advanced or metastatic gastric or GEJ adenocarcinoma. Among the 55% (n = 143) of patients whose tumors expressed PD-L1 based on a combined positive score ?1 and either were microsatellite stable or had undetermined microsatellite instability or mismatch repair status, the confirmed ORR as determined by blinded independent central review was 13.3% (95% CI, 8.2-20.0); 1.4% had complete responses. Response durations ranged from 2.8+ to 19.4+ months; 11 patients (58%) had response durations of 6 months or longer, and 5 patients (26%) had response durations of 12 months or longer. The most common (?20%) adverse reactions of pembrolizumab observed in KEYNOTE-059/Cohort 1 were fatigue, decreased appetite, nausea, and constipation. The most frequent (?2%) serious adverse drug reactions were pleural effusion, pneumonia, dyspnea, pulmonary embolism, and pneumonitis. Pembrolizumab was approved concurrently with the PD-L1 immunohistochemistry 22C3 pharmDx test (Dako, Agilent, Santa Clara, CA) for selection of patients with gastric cancer for treatment with pembrolizumab based on PD-L1 tumor expression. IMPLICATIONS FOR PRACTICE: This report presents key information on the basis for Food and Drug Administration approval of pembrolizumab for the treatment of patients with locally advanced or metastatic gastric or GEJ adenocarcinoma whose tumors express PD-L1. The report discusses the basis for limiting the indication to patients with PD-L1-expressing tumors and the basis for recommending that PD-L1 status be assessed using a fresh tumor specimen if PD-L1 expression is not detected in an archival gastric or GEJ cancer specimen.

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Dataset Information

Management of Locally Advanced Adenocarcinoma of the Esophagus and Gastroesophageal Junction: Finally a Consensus.

Publications

Management of Locally Advanced Adenocarcinoma of the Esophagus and Gastroesophageal Junction: Finally a Consensus.

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