title: Chemoradiation with and without surgery in patients with locally advanced squamous cell carcinoma of the esophagus.
abstract: OBJECTIVE
  Combined chemoradiotherapy with and without surgery are widely accepted alternatives for the curative treatment of patients with locally advanced esophageal cancer. The value of adding surgery to chemotherapy and radiotherapy is unknown.
  
  
  METHODS
  Patients with locally advanced squamous cell carcinoma (SCC) of the esophagus were randomly allocated to either induction chemotherapy followed by chemoradiotherapy (40 Gy) followed by surgery (arm A), or the same induction chemotherapy followed by chemoradiotherapy (at least 65 Gy) without surgery (arm B). Primary outcome was overall survival time.
  
  
  RESULTS
  The median observation time was 6 years. The analysis of 172 eligible, randomized patients (86 patients per arm) showed overall survival to be equivalent between the two treatment groups (log-rank test for equivalence, P < .05). Local progression-free survival was better in the surgery group (2-year progression-free survival, 64.3%; 95% CI, 52.1% to 76.5%) than in the chemoradiotherapy group (2-year progression-free survival, 40.7%; 95% CI, 28.9% to 52.5%; hazard ratio [HR] for arm B v arm A, 2.1; 95% CI, 1.3 to 3.5; P = .003). Treatment-related mortality was significantly increased in the surgery group than in the chemoradiotherapy group (12.8% v 3.5%, respectively; P = .03). Cox regression analysis revealed clinical tumor response to induction chemotherapy to be the single independent prognostic factor for overall survival (HR, 0.30; 95% CI, 0.19 to 0.47; P < .0001).
  
  
  CONCLUSIONS
  Adding surgery to chemoradiotherapy improves local tumor control but does not increase survival of patients with locally advanced esophageal SCC. Tumor response to induction chemotherapy identifies a favorable prognostic group within these high-risk patients, regardless of the treatment group.
authors.affiliation: Department of Medical Oncology and Hematology, Kliniken Essen-Mitte, Henricistr 92, D-45136 Essen, Germany. m.stahl@kliniken-essen-mitte.de
authors.forename: Michael
authors.initials: M
authors.lastname: Stahl
authors.forename: Martin
authors.initials: M
authors.lastname: Stuschke
authors.forename: Nils
authors.initials: N
authors.lastname: Lehmann
authors.forename: Hans-Joachim
authors.initials: HJ
authors.lastname: Meyer
authors.forename: Martin K
authors.initials: MK
authors.lastname: Walz
authors.forename: Siegfried
authors.initials: S
authors.lastname: Seeber
authors.forename: Bodo
authors.initials: B
authors.lastname: Klump
authors.forename: Wilfried
authors.initials: W
authors.lastname: Budach
authors.forename: Reinhard
authors.initials: R
authors.lastname: Teichmann
authors.forename: Marcus
authors.initials: M
authors.lastname: Schmitt
authors.forename: Gerd
authors.initials: G
authors.lastname: Schmitt
authors.forename: Claus
authors.initials: C
authors.lastname: Franke
authors.forename: Hansjochen
authors.initials: H
authors.lastname: Wilke
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000532:radiotherapy* / Q000601:surgery; D002945:Cisplatin / Q000008:administration & dosage; D003131:Combined Modality Therapy; D004938:Esophageal Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy* / Q000601:surgery; D005047:Etoposide / Q000008:administration & dosage; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D016019:Survival Analysis
chemical_list: D005047:Etoposide; D002945:Cisplatin; D002955:Leucovorin; D005472:Fluorouracil