title: Phase II trial of preoperative chemoradiotherapy with oxaliplatin, cisplatin, and 5-FU in locally advanced esophageal and gastric cancer.
abstract: BACKGROUND
  Based on a phase I study showing the feasibility of combining of oxaliplatin, cisplatin, and 5-fluorouracil (5-FU) (OCF) with radiation therapy (RT) in esophageal cancer, the efficacy of this regimen in esophageal, gastroesophageal (GE), and gastric (G) cancer was assessed in this phase II multicenter study.
  
  
  METHODS
  Patients with resectable tumors were eligible. Treatment included two cycles of oxaliplatin 85 mg/m(2), cisplatin 55 mg/m(2), and continuously infused 5-FU 3 g/m(2) in 96 h and concurrent RT (45 Gy), followed by surgery after 6-8 weeks. Primary end point was complete pathologic response (pCR).
  
  
  RESULTS
  Forty-one patients were enrolled. Tumor location was esophagus 39% (squamous 10/adenocarcinoma 6), GE junction 32%, and stomach 29%. G3-G4 adverse events included asthenia (27%) and neutropenia (14%). One toxic death occurred. Thirty-one patients (75.6%) underwent surgery (R0 in 94%). Pathologic response was achieved in 58% of patients, with pCR in 50% and 16% of esophageal and GE/G cancer, respectively. pCR was achieved in 67% of squamous cell carcinoma. Survival: median follow-up, 50.4 months; median progression-free survival and overall survival were 23.2 and 28.4 months, respectively.
  
  
  CONCLUSIONS
  Preoperative OCF plus RT showed an acceptable toxicity and promising activity especially in squamous cell esophageal cancer.
authors.affiliation: Section of Gastrointestinal Surgery, Hospital Universitario del Mar and Institut de Recerca Hospital del Mar (IMIM), Universitat Autónoma de Barcelona, Barcelona. Electronic address: pera@parcdesalutmar.cat.
authors.forename: M
authors.initials: M
authors.lastname: Pera
authors.affiliation: Department of Medical Oncology and Radiation Therapy, Hospital Clínic Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), University of Barcelona Medical School, Barcelona.
authors.forename: R
authors.initials: R
authors.lastname: Gallego
authors.affiliation: Service of Medical Oncology, Hospital Universitario del Mar and Institut de Recerca Hospital del Mar (IMIM), Barcelona.
authors.forename: C
authors.initials: C
authors.lastname: Montagut
authors.affiliation: Service of Medical Oncology, Hospital de Sant Pau, Barcelona.
authors.forename: M
authors.initials: M
authors.lastname: Martín-Richard
authors.affiliation: Services of Pathology.
authors.forename: M
authors.initials: M
authors.lastname: Iglesias
authors.affiliation: Department of Medical Oncology and Radiation Therapy, Hospital Clínic Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), University of Barcelona Medical School, Barcelona.
authors.forename: C
authors.initials: C
authors.lastname: Conill
authors.affiliation: Services of Radiotherapy, Hospital Universitario del Mar and Institut de Recerca Hospital del Mar (IMIM), Barcelona.
authors.forename: A
authors.initials: A
authors.lastname: Reig
authors.affiliation: Services of Digestive Surgery.
authors.forename: C
authors.initials: C
authors.lastname: Balagué
authors.affiliation: Services of Radiation Therapy, Hospital de Sant Pau, Barcelona.
authors.forename: L
authors.initials: L
authors.lastname: Pétriz
authors.affiliation: Service of Gastrointestinal Surgery, Hospital Clinic, Barcelona, Spain.
authors.forename: D
authors.initials: D
authors.lastname: Momblan
authors.affiliation: Service of Medical Oncology, Hospital Universitario del Mar and Institut de Recerca Hospital del Mar (IMIM), Barcelona.
authors.forename: J
authors.initials: J
authors.lastname: Bellmunt
authors.affiliation: Department of Medical Oncology and Radiation Therapy, Hospital Clínic Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), University of Barcelona Medical School, Barcelona.
authors.forename: J
authors.initials: J
authors.lastname: Maurel
mesh_terms: D000230:Adenocarcinoma / Q000473:pathology / Q000628:therapy*; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000473:pathology / Q000628:therapy*; D059248:Chemoradiotherapy / Q000379:methods; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D018572:Disease-Free Survival; D004938:Esophageal Neoplasms / Q000473:pathology / Q000628:therapy*; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy / Q000379:methods*; D009367:Neoplasm Staging; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000009:adverse effects; D000077150:Oxaliplatin; D013274:Stomach Neoplasms / Q000473:pathology / Q000628:therapy*
chemical_list: D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D002945:Cisplatin; D005472:Fluorouracil