title: Preoperative taxane-based chemotherapy and celecoxib for carcinoma of the esophagus and gastroesophageal junction: results of a phase 2 trial.
abstract: OBJECTIVE
  The primary objective of this study was to determine the rate of pathological response after preoperative celecoxib and concurrent taxane-based chemotherapy in patients with cancer of the esophagus and gastroesophageal junction.
  
  
  METHODS
  Thirty-nine patients were enrolled in this single-arm, phase II clinical trial. Patients were administered daily celecoxib in combination with two to three cycles of carboplatin and paclitaxel with preoperative intent. Levels of cyclooxygenase (COX)-2 expression in resected tumors were analyzed by immunohistochemistry and correlated with clinical outcome measures. Postoperatively, patients were administered daily celecoxib for 1 year or until documented tumor recurrence.
  
  
  RESULTS
  All patients received two to three cycles of chemotherapy plus celecoxib 800 mg/d. Toxicities were as expected. A major clinical response (complete response + partial response) was noted in 22 patients (56%); six patients (15%) had a complete clinical response. Thirty-seven patients underwent esophagectomy. Five patients had a major pathological response (12.8%). Four-year overall and disease-free survivals were 40.9% and 30.3%, respectively. Patients with tumors expressing COX-2 demonstrated a higher likelihood of a major clinical response response (62% versus 50%) and an improved overall survival, compared with patients with COX-2-negative tumors.
  
  
  CONCLUSIONS
  Preoperative celecoxib with concurrent chemotherapy demonstrated sufficient effect on pathologic response to warrant further study. Patients with tumors expressing COX-2 demonstrated trends toward improved response to preoperative therapy and improved overall survival compared with nonexpressors.
authors.affiliation: Thoracic Surgery Division, Department of Cardiothoracic Surgery, New York Presbyterian Hospital, Weill Cornell Medical College, New York City, New York 10021, USA. nkaltork@med.cornell.edu
authors.forename: Nasser K
authors.initials: NK
authors.lastname: Altorki
authors.forename: Paul
authors.initials: P
authors.lastname: Christos
authors.forename: Jeff L
authors.initials: JL
authors.lastname: Port
authors.forename: Paul C
authors.initials: PC
authors.lastname: Lee
authors.forename: Farooq
authors.initials: F
authors.lastname: Mirza
authors.forename: Cathy
authors.initials: C
authors.lastname: Spinelli
authors.forename: Roger
authors.initials: R
authors.lastname: Keresztes
authors.forename: Debra
authors.initials: D
authors.lastname: Beneck
authors.forename: Subroto
authors.initials: S
authors.lastname: Paul
authors.forename: Brendon M
authors.initials: BM
authors.lastname: Stiles
authors.forename: Yuwei
authors.initials: Y
authors.lastname: Zhang
authors.forename: David S
authors.initials: DS
authors.lastname: Schrump
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001952:Bridged-Ring Compounds / Q000008:administration & dosage; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D000068579:Celecoxib; D051546:Cyclooxygenase 2 / Q000378:metabolism; D004938:Esophageal Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D004943:Esophagogastric Junction; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011300:Preoperative Care; D011720:Pyrazoles / Q000008:administration & dosage; D013449:Sulfonamides / Q000008:administration & dosage; D016019:Survival Analysis; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D001952:Bridged-Ring Compounds; D011720:Pyrazoles; D013449:Sulfonamides; D043823:Taxoids; C080625:taxane; D051546:Cyclooxygenase 2; D000068579:Celecoxib