title: A Phase II study of a paclitaxel-based chemoradiation regimen with selective surgical salvage for resectable locoregionally advanced esophageal cancer: initial reporting of RTOG 0246.
abstract: OBJECTIVE
  The strategy of definitive chemoradiation with selective surgical salvage in locoregionally advanced esophageal cancer was evaluated in a Phase II trial in Radiation Therapy Oncology Group (RTOG)-affiliated sites.
  
  
  METHODS
  The study was designed to detect an improvement in 1-year survival from 60% to 77.5% (α = 0.05; power = 80%). Definitive chemoradiation involved induction chemotherapy with 5-fluorouracil (5-FU) (650 mg/mg(2)/day), cisplatin (15 mg/mg(2)/day), and paclitaxel (200 mg/mg(2)/day) for two cycles, followed by concurrent chemoradiation with 50.4 Gy (1.8 Gy/fraction) and daily 5-FU (300 mg/mg(2)/day) with cisplatin (15 mg/mg(2)/day) over the first 5 days. Salvage surgical resection was considered for patients with residual or recurrent esophageal cancer who did not have systemic disease.
  
  
  RESULTS
  Forty-three patients with nonmetastatic resectable esophageal cancer were entered from Sept 2003 to March 2006. Forty-one patients were eligible for analysis. Clinical stage was ≥T3 in 31 patients (76%) and N1 in 29 patients (71%), with adenocarcinoma histology in 30 patients (73%). Thirty-seven patients (90%) completed induction chemotherapy followed by concurrent chemoradiation. Twenty-eight patients (68%) experienced Grade 3+ nonhematologic toxicity. Four treatment-related deaths were noted. Twenty-one patients underwent surgery following definitive chemoradiation because of residual (17 patients) or recurrent (3 patients) esophageal cancer,and 1 patient because of choice. Median follow-up of live patients was 22 months, with an estimated 1-year survival of 71%.
  
  
  CONCLUSIONS
  In this Phase II trial (RTOG 0246) evaluating selective surgical salvage after definitive chemoradiation in locoregionally advanced esophageal cancer, the hypothesized 1-year RTOG survival rate (77.5%) was not achieved (1 year, 71%; 95% confidence interval< 54%-82%).
authors.affiliation: Department of Thoracic and Cardiovascular Surgery, The University of Texas M. D. Anderson Cancer Center, Houston, Texas, USA. sswisher@mdanderson.org
authors.forename: Stephen G
authors.initials: SG
authors.lastname: Swisher
authors.forename: Kathryn A
authors.initials: KA
authors.lastname: Winter
authors.forename: Ritsuko U
authors.initials: RU
authors.lastname: Komaki
authors.forename: Jaffer A
authors.initials: JA
authors.lastname: Ajani
authors.forename: Tsung T
authors.initials: TT
authors.lastname: Wu
authors.forename: Wayne L
authors.initials: WL
authors.lastname: Hofstetter
authors.forename: Andre A
authors.initials: AA
authors.lastname: Konski
authors.forename: Christopher G
authors.initials: CG
authors.lastname: Willett
mesh_terms: D000230:Adenocarcinoma / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D059248:Chemoradiotherapy / Q000379:methods* / Q000401:mortality; D002945:Cisplatin / Q000008:administration & dosage; D004938:Esophageal Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D060828:Induction Chemotherapy / Q000379:methods / Q000401:mortality; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000601:surgery; D009367:Neoplasm Staging / Q000379:methods; D018365:Neoplasm, Residual; D017239:Paclitaxel / Q000008:administration & dosage; D011879:Radiotherapy Dosage; D016879:Salvage Therapy / Q000379:methods* / Q000401:mortality; D015996:Survival Rate
chemical_list: D017239:Paclitaxel; D002945:Cisplatin; D005472:Fluorouracil