title: A single-arm, nonrandomized phase II trial of neoadjuvant gemcitabine and oxaliplatin in patients with resectable pancreas adenocarcinoma.
abstract: BACKGROUND
  The role for neoadjuvant systemic therapy in resectable pancreas adenocarcinoma remains undefined.
  
  
  OBJECTIVE
  We evaluated the efficacy of gemcitabine and oxaliplatin administered as preoperative therapy in patients with resectable pancreas adenocarcinoma.
  
  
  METHODS
  Eligible patients were screened using computed tomography-pancreas angiography, laparoscopy, endoscopic ultrasonography, and fine-needle aspiration cytology to identify 38 patients who received 4 cycles of neoadjuvant gemcitabine 1000 mg/m intravenously over 100 minutes and oxaliplatin 80 mg/m intravenously over 2 hours, every 2 weeks. Patients whose tumors remained resectable at restaging proceeded to operation and subsequently received 5 cycles of adjuvant gemcitabine (1000 mg/m intravenously over 30 minutes days 1, 8, and 15 every 4 weeks). The primary endpoint was 18-month overall survival and secondary endpoints included radiological, tumor marker and pathological response to neoadjuvant therapy, time to recurrence, patterns of failure, and feasibility of obtaining preoperative core biopsies.
  
  
  RESULTS
  Thirty-five of 38 patients (92%) completed neoadjuvant therapy. Twenty-seven patients underwent tumor resection (resectability rate 71%), of which 26 initiated adjuvant therapy for a total of 23 patients (60.5%) who completed all planned therapy. The 18-month survival was 63% (24 patients alive). The median overall survival for all 38 patients was 27.2 months (95% confidence interval: 17-NA) and the median disease-specific survival was 30.6 months (95% confidence interval: 19-NA).
  
  
  CONCLUSIONS
  This study met its endpoint and provided a signal suggesting that exploration of neoadjuvant systemic therapy is worthy of further investigation in resectable pancreas adenocarcinoma. Improved patient selection and more active systemic regimens are key. Clinical trials identification: NCT00536874.
authors.affiliation: *Gastrointestinal Oncology Service †Department of Medicine ‡Hepatopancreaticobiliary Surgery Service §Gastroenterology and Nutrition Service Departments of ¶Epidemiology and Biostatistics ‖Pathology **Radiology ††Surgery; and ‡‡Gastric and Mixed Tumor Service, Memorial Sloan-Kettering Cancer Center, New York, NY.
authors.forename: Eileen M
authors.initials: EM
authors.lastname: OʼReilly
authors.forename: Anna
authors.initials: A
authors.lastname: Perelshteyn
authors.forename: William R
authors.initials: WR
authors.lastname: Jarnagin
authors.forename: Mark
authors.initials: M
authors.lastname: Schattner
authors.forename: Hans
authors.initials: H
authors.lastname: Gerdes
authors.forename: Marinela
authors.initials: M
authors.lastname: Capanu
authors.forename: Laura H
authors.initials: LH
authors.lastname: Tang
authors.forename: Joseph
authors.initials: J
authors.lastname: LaValle
authors.forename: Corinne
authors.initials: C
authors.lastname: Winston
authors.forename: Ronald P
authors.initials: RP
authors.lastname: DeMatteo
authors.forename: Michael
authors.initials: M
authors.lastname: DʼAngelica
authors.forename: Robert C
authors.initials: RC
authors.lastname: Kurtz
authors.forename: Ghassan K
authors.initials: GK
authors.lastname: Abou-Alfa
authors.forename: David S
authors.initials: DS
authors.lastname: Klimstra
authors.forename: Maeve A
authors.initials: MA
authors.lastname: Lowery
authors.forename: Murray F
authors.initials: MF
authors.lastname: Brennan
authors.forename: Daniel G
authors.initials: DG
authors.lastname: Coit
authors.forename: Diane L
authors.initials: DL
authors.lastname: Reidy
authors.forename: T Peter
authors.initials: TP
authors.lastname: Kingham
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Allen
mesh_terms: D000230:Adenocarcinoma / Q000175:diagnosis / Q000628:therapy*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000627:therapeutic use; D001706:Biopsy; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000627:therapeutic use*; D000077150:Oxaliplatin; D010180:Pancreatectomy / Q000379:methods*; D010190:Pancreatic Neoplasms / Q000175:diagnosis / Q000628:therapy*; D012189:Retrospective Studies; D012264:Ribonucleotide Reductases / Q000037:antagonists & inhibitors; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D000970:Antineoplastic Agents; D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D003841:Deoxycytidine; D012264:Ribonucleotide Reductases; D000093542:Gemcitabine