title: A phase II randomized trial of induction chemotherapy versus no induction chemotherapy followed by preoperative chemoradiation in patients with esophageal cancer.
abstract: BACKGROUND
  The contribution of induction chemotherapy (IC) before preoperative chemoradiation for esophageal cancer (EC) is not known. We hypothesized that IC would increase the rate of pathologic complete response (pathCR).
  
  
  METHODS
  Trimodality-eligibile patients were randomized to receive no IC (Arm A) or IC (oxaliplatin/FU; Arm B) before oxaliplatin/FU/radiation. Surgery was attempted ∼5-6 weeks after chemoradiation. The pathCR rate, post-surgery 30-day mortality, overall survival (OS), and toxic effects were assessed. Bayesian methods and Fisher's exact test were used.
  
  
  RESULTS
  One hundred twenty-six patients were randomized dynamically to balance the two arms for histology, baseline stage, gender, race, and age. Fifty-five patients in Arm A and 54 in Arm B underwent surgery. The median actuarial OS for all patients (54 deaths) was 45.62 months [95% confidence interval (CI), 27.63-NA], with median OS 45.62 months (95% CI 25.56-NA) in Arm A and 43.68 months (95% CI 27.63-NA) in Arm B (P = 0.69). The pathCR rate in Arm A was 13% (7 of 55) and 26% (14 of 54) in Arm B (two-sided Fisher's exact test, P = 0.094). Safety was similar in both arms.
  
  
  CONCLUSIONS
  These data suggest that IC produces non-significant increase in the pathCR rate and does not prolong OS. Further development of IC before chemoradiation may not be beneficial. Clinical trial no.: NCT 00525915 (www.clinicaltrials.gov).
authors: Departments of Gastrointestinal Medical Oncology.
authors: J A
authors: JA
authors: Ajani
authors: L
authors: L
authors: Xiao
authors: J A
authors: JA
authors: Roth
authors: W L
authors: WL
authors: Hofstetter
authors: G
authors: G
authors: Walsh
authors: R
authors: R
authors: Komaki
authors: Z
authors: Z
authors: Liao
authors: D C
authors: DC
authors: Rice
authors: A A
authors: AA
authors: Vaporciyan
authors: D M
authors: DM
authors: Maru
authors: J H
authors: JH
authors: Lee
authors: M S
authors: MS
authors: Bhutani
authors: A
authors: A
authors: Eid
authors: J C
authors: JC
authors: Yao
authors: A P
authors: AP
authors: Phan
authors: A
authors: A
authors: Halpin
authors: A
authors: A
authors: Suzuki
authors: T
authors: T
authors: Taketa
authors: P F
authors: PF
authors: Thall
authors: S G
authors: SG
authors: Swisher
mesh_terms: D000328:Adult; D000368:Aged; D001499:Bayes Theorem; D059248:Chemoradiotherapy; D002945:Cisplatin / Q000008:administration & dosage; D003131:Combined Modality Therapy; D004938:Esophageal Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy* / Q000601:surgery; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D005500:Follow-Up Studies; D006801:Humans; D060828:Induction Chemotherapy; D008297:Male; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D000077150:Oxaliplatin; D057234:Preoperative Period; D012074:Remission Induction
chemical_list: D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D002945:Cisplatin; D005472:Fluorouracil
keywords: chemoradiation; esophageal carcinoma; esophageal preservation; induction chemotherapy; pathologic complete response; randomized trial
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