title: Balloon catheter hypoxic abdominal perfusion with Mitomycin C and Melphalan for locally advanced pancreatic cancer: a phase I-II trial.
abstract: BACKGROUND
  Developments in balloon catheter methodology have made hypoxic abdominal perfusion (HAP) with anti-tumour agents possible with only minimal invasive surgery. The initial reports on this modality and celiac axis stop-flow infusion for treatment of pancreatic cancer were very promising in terms of tumour response, median survival and pain reduction. Recent reports, however, have not been able to confirm these results and some have disputed the efficacy of these currently still applied treatment modalities.
  
  
  METHODS
  Twenty-one patients with advanced pancreatic carcinoma were included in a phase I-II trial of HAP with MMC and Melphalan followed by celiac axis infusion (CAI) with the same agents six weeks later. Tumour response was assessed by abdominal-CT and by determining tumour markers. Effect on pain reduction was assessed by evaluation of pain registration forms.
  
  
  RESULTS
  HAP resulted in augmented regional drug concentrations. One patient died after CAI due to acute mesenterial ischaemia. One agent-toxicity related death was observed in the phase-I study. Significant hematological toxicity was observed after HAP and CAI at MTD. No patients were considered resectable after treatment. Median survival after HAP was 6 months (range 1-29). Pain reduction was experienced by only 5/18 patients and was short-lived.
  
  
  CONCLUSIONS
  In contrast to earlier reports HAP and CAI with MMC and Melphalan did not demonstrate any benefit in terms of tumour response, median survival and pain reduction, compared to less invasive treatment options. As this treatment was associated with significant toxic side-effects and even one procedure related death, we do not consider this a therapeutic option in patients with advanced pancreatic cancer.
authors.affiliation: Department of Experimental Surgical Oncology, Erasmus Medical Center Rotterdam, Daniel den Hoed Cancer Centre, Groene Hilledijk 301, Rotterdam 3075 EA, The Netherlands.
authors.forename: M G A
authors.initials: MG
authors.lastname: van IJken
authors.forename: B
authors.initials: B
authors.lastname: van Etten
authors.forename: G
authors.initials: G
authors.lastname: Guetens
authors.forename: T L M
authors.initials: TL
authors.lastname: ten Hagen
authors.forename: J
authors.initials: J
authors.lastname: Jeekel
authors.forename: E A
authors.initials: EA
authors.lastname: de Bruijn
authors.forename: A M M
authors.initials: AM
authors.lastname: Eggermont
authors.forename: C H J
authors.initials: CH
authors.lastname: van Eijck
mesh_terms: D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D021721:Balloon Occlusion / Q000379:methods; D010478:Chemotherapy, Cancer, Regional Perfusion / Q000379:methods; D005260:Female; D006801:Humans; D000860:Hypoxia; D007261:Infusions, Intra-Arterial / Q000379:methods; D008297:Male; D008558:Melphalan / Q000008:administration & dosage*; D008875:Middle Aged; D016685:Mitomycin / Q000008:administration & dosage*; D010146:Pain / Q000188:drug therapy / Q000209:etiology; D010147:Pain Measurement; D010190:Pancreatic Neoplasms / Q000150:complications / Q000188:drug therapy*; D012074:Remission Induction; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D016685:Mitomycin; D008558:Melphalan