title: Long-term survival after resection for non-pancreatic periampullary cancer followed by adjuvant intra-arterial chemotherapy and concomitant radiotherapy.
abstract: BACKGROUND
  There is no consensus regarding the optimal adjuvant treatment after resection of non-pancreatic periampullary adenocarcinoma (NPPC; distal common bile duct, ampulla, duodenum).
  
  
  OBJECTIVE
  The present study was conducted to evaluate the impacts on longterm survival and recurrence of adjuvant intra-arterial chemotherapy (IAC) and concomitant radiotherapy (RT) in patients submitted to resection for NPPC or pancreatic ductal adenocarcinoma (PDAC) in a randomized controlled trial.
  
  
  METHODS
  A total of 120 patients with PDAC (n = 62) or NPPC (n = 58) were prestratified at a ratio of 1:1 for tumour origin and randomized. Half of these patients were treated with adjuvant IAC/RT and the other half were treated with surgery alone. Follow-up was completed for all patients up to 5 years after resection or until death.
  
  
  RESULTS
  There was no survival benefit in either the whole group (primary endpoint) or the PDAC group after IAC/RT. In the NPPC group, longterm survival was observed in 10 patients in the IAC/RT group and five patients in the control group: median survival was 37 months and 28 months, respectively. The occurrence of liver metastases was reduced by IAC/RT from 57% to 29% (P = 0.038). Cox regression analysis revealed a substantial effect of IAC/RT on survival (hazard ratio: 0.44, 95% confidence interval 0.23-0.83; P = 0.011).
  
  
  CONCLUSIONS
  This longterm analysis shows that median and longterm survival were improved after IAC/RT in patients with NPPC, probably because of the effective and sustained reduction of liver metastases. The present results illustrate that NPPC requires an adjuvant approach distinct from that in pancreatic cancer and indicate that further investigation of this issue is warranted.
authors: Department of Surgery, Erasmus Medical Centre, Rotterdam, the Netherlands.
authors: Joris I
authors: JI
authors: Erdmann
authors: Department of Surgery, Erasmus Medical Centre, Rotterdam, the Netherlands.
authors: Marjolein J M
authors: MJ
authors: Morak
authors: Department of Surgery, Methodologist-statistician, Erasmus Medical Centre, Rotterdam, the Netherlands.
authors: Hugo J
authors: HJ
authors: Duivenvoorden
authors: Department of Pathology, Erasmus Medical Centre, Rotterdam, the Netherlands.
authors: Herman
authors: H
authors: van Dekken
authors: Department of Surgery, Erasmus Medical Centre, Rotterdam, the Netherlands.
authors: Geert
authors: G
authors: Kazemier
authors: Department of Surgery, Erasmus Medical Centre, Rotterdam, the Netherlands.
authors: Niels F M
authors: NF
authors: Kok
authors: Department of Surgery, Erasmus Medical Centre, Rotterdam, the Netherlands.
authors: Casper H J
authors: CH
authors: van Eijck
mesh_terms: D000230:Adenocarcinoma / Q000401:mortality / Q000556:secondary / Q000628:therapy*; D000368:Aged; D014670:Ampulla of Vater / Q000473:pathology / Q000601:surgery*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D001662:Biliary Tract Surgical Procedures / Q000009:adverse effects / Q000401:mortality; D059186:Chemoradiotherapy, Adjuvant / Q000009:adverse effects / Q000401:mortality; D003138:Common Bile Duct Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D018450:Disease Progression; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D007261:Infusions, Intra-Arterial; D053208:Kaplan-Meier Estimate; D008113:Liver Neoplasms / Q000517:prevention & control / Q000556:secondary; D008297:Male; D015999:Multivariate Analysis; D009426:Netherlands; D016016:Proportional Hazards Models; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome