title: Preoperative chemotherapy in patients with resectable esophageal carcinoma: a single center Phase II study.
abstract: OBJECTIVE
  The role of preoperative chemotherapy in squamous cell esophageal carcinoma remains controversial. A prospective trial was initiated to investigate whether preoperative chemotherapy followed by surgery results in increased progression-free survival in patients with resectable thoracic esophageal carcinoma.
  
  
  METHODS
  Patients with Stage IIb-IIIa/b resectable esophageal carcinoma were eligible for the study. They received two cycles of FLEP regimen chemotherapy (cisplatin, etoposide, leucovorine, 5-fluorouracil) followed by transthoracic extended 2- or 3-field esophagectomy. Two-year progression-free survival was the primary endpoint. To evaluate the potential benefit of the dual-modality approach we compared these results with the outcome of patients who were treated in our center in the same period of time and were non-randomly allocated to surgery alone.
  
  
  RESULTS
  From 2001 to 2008, 63 patients were included in the study (bimodality group) and 58 patients into the surgery-alone group. Median follow-up was 68 (range, 4-123) months. Squamous cell carcinoma had 93% patients. Two-year progression-free survival for all patients was 45.3 and 30.7% (hazard ratio 0.71, 95% confidence interval 0.46-1.08) and median overall survival was 26.5 months and 18.0 months (hazard ratio 0.67, 95% confidence interval 0.41-1.01) in bimodality- and surgery-alone groups, respectively. Patients who underwent R0-resection after bimodality treatment had significantly better overall survival (40.9 months) than after surgery alone (19.0 months, hazard ratio 0.51, 95% confidence interval 0.30-0.81).
  
  
  CONCLUSIONS
  Two cycles of preoperative chemotherapy did not improve progression-free survival of patients with resectable thoracic esophageal carcinoma in intent-to-treat population. However, significantly better results of bimodality approach was seen in R0-resected patients which warrants further trials with more effective chemotherapy combinations.
authors.affiliation: Department of Clinical Pharmacology and Chemotherapy, N.N. Blokhin Russian Cancer Research Center, Moscow atryakin@mail.ru.
authors.forename: Alexey
authors.initials: A
authors.lastname: Tryakin
authors.affiliation: Department of Clinical Pharmacology and Chemotherapy, N.N. Blokhin Russian Cancer Research Center, Moscow.
authors.forename: Ilya
authors.initials: I
authors.lastname: Pokataev
authors.affiliation: Department of Thoracic Surgery, N.N. Blokhin Russian Cancer Research Center, Moscow.
authors.forename: Pavel
authors.initials: P
authors.lastname: Kononets
authors.affiliation: Department of Clinical Pharmacology and Chemotherapy, N.N. Blokhin Russian Cancer Research Center, Moscow.
authors.forename: Mikhail
authors.initials: M
authors.lastname: Fedyanin
authors.affiliation: Department of Abdominal Surgery, N.N. Blokhin Russian Cancer Research Center, Moscow.
authors.forename: Vagan
authors.initials: V
authors.lastname: Bokhyan
authors.affiliation: Department of Endoscopy, N.N. Blokhin Russian Cancer Research Center, Moscow, Russian Federation.
authors.forename: Olga
authors.initials: O
authors.lastname: Malikhova
authors.affiliation: Department of Thoracic Surgery, N.N. Blokhin Russian Cancer Research Center, Moscow.
authors.forename: Kirill
authors.initials: K
authors.lastname: Minin
authors.affiliation: Department of Thoracic Surgery, N.N. Blokhin Russian Cancer Research Center, Moscow.
authors.forename: M
authors.initials: M
authors.lastname: Shogenov
authors.affiliation: Department of Abdominal Surgery, N.N. Blokhin Russian Cancer Research Center, Moscow.
authors.forename: Ivan
authors.initials: I
authors.lastname: Stilidi
authors.affiliation: Department of Clinical Pharmacology and Chemotherapy, N.N. Blokhin Russian Cancer Research Center, Moscow.
authors.forename: Anna
authors.initials: A
authors.lastname: Vybarava
authors.affiliation: Department of Thoracic Surgery, N.N. Blokhin Russian Cancer Research Center, Moscow.
authors.forename: Mikhail
authors.initials: M
authors.lastname: Davydov
authors.affiliation: Department of Clinical Pharmacology and Chemotherapy, N.N. Blokhin Russian Cancer Research Center, Moscow.
authors.forename: Sergei
authors.initials: S
authors.lastname: Tjulandin
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000627:therapeutic use; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000401:mortality / Q000601:surgery; D002945:Cisplatin / Q000008:administration & dosage / Q000627:therapeutic use; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D004938:Esophageal Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000601:surgery; D000077277:Esophageal Squamous Cell Carcinoma; D016629:Esophagectomy; D005047:Etoposide / Q000008:administration & dosage / Q000627:therapeutic use; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000627:therapeutic use; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy / Q000379:methods*; D011446:Prospective Studies
chemical_list: D005047:Etoposide; D002945:Cisplatin; D002955:Leucovorin; D005472:Fluorouracil
keywords: chemotherapy; combined-modality therapy; esophageal cancer; squamous cell carcinoma