title: Maintenance sunitinib or observation in metastatic pancreatic adenocarcinoma: a phase II randomised trial.
abstract: BACKGROUND
  New strategies to prolong disease control warrant investigation in patients with metastatic pancreatic adenocarcinoma. This open-label, randomised, multi-centre phase II trial explored the role of maintenance sunitinib after first-line chemotherapy in this setting.
  
  
  METHODS
  Patients with pathologic diagnosis of metastatic pancreatic adenocarcinoma, performance status >50%, no progression after 6 months of chemotherapy were centrally randomised by an independent contract research organisation, which was also responsible for data collection and monitoring, to observation (arm A) or sunitinib at 37.5mg daily until progression or a maximum of 6 months (arm B). The primary outcome measure was the probability of being progression-free at 6 months (PFS-6) from randomisation. Assuming P0 = 10%; P1 = 30%, α .10; β .10, the target accrual was 26 patients per arm.
  
  
  RESULTS
  28 per arm were randomised. One arm B patient had kidney cancer and was excluded. Sunitinib was given for a median of 91 days (7-186). Main grade 3-4 toxicity was thrombocytopenia, neutropenia and hand-foot syndrome (12%), diarrhoea 8%. In arm A versus B, PFS-6 was 3.6% (95% confidence interval (CI): 0-10.6%) and 22.2% (95% CI: 6.2-38.2%; P<0.01); 2 y overall survival was 7.1% (95% CI: 0-16.8%) and 22.9% (95% CI: 5.8-40.0%; P = 0.11), stable disease 21.4% and 51.9% (P = 0.02).
  
  
  CONCLUSIONS
  This is the first randomised trial on maintenance therapy in metastatic pancreatic adenocarcinoma. The primary end-point was fulfilled and 2 y overall survival was remarkably high, suggesting that maintenance sunitinib is promising and should be further explored in this patient population.
authors.affiliation: S. Raffaele Scientific Institute, Milan, Italy. Electronic address: reni.michele@hsr.it.
authors.forename: Michele
authors.initials: M
authors.lastname: Reni
authors.forename: Stefano
authors.initials: S
authors.lastname: Cereda
authors.forename: Michele
authors.initials: M
authors.lastname: Milella
authors.forename: Anna
authors.initials: A
authors.lastname: Novarino
authors.forename: Alessandro
authors.initials: A
authors.lastname: Passardi
authors.forename: Andrea
authors.initials: A
authors.lastname: Mambrini
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Di Lucca
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Aprile
authors.forename: Carmen
authors.initials: C
authors.lastname: Belli
authors.forename: Marco
authors.initials: M
authors.lastname: Danova
authors.forename: Francesca
authors.initials: F
authors.lastname: Bergamo
authors.forename: Enrico
authors.initials: E
authors.lastname: Franceschi
authors.forename: Clara
authors.initials: C
authors.lastname: Fugazza
authors.forename: Domenica
authors.initials: D
authors.lastname: Ceraulo
authors.forename: Eugenio
authors.initials: E
authors.lastname: Villa
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007211:Indoles / Q000627:therapeutic use*; D060046:Maintenance Chemotherapy; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D011758:Pyrroles / Q000627:therapeutic use*; D000077210:Sunitinib; D016019:Survival Analysis
chemical_list: D000970:Antineoplastic Agents; D007211:Indoles; D011758:Pyrroles; D000077210:Sunitinib
keywords: Anti-angiogenic therapy; Maintenance therapy; Metastatic disease; Pancreas; Pancreatic adenocarcinoma; Pancreatic cancer; Phase II trial; Randomised trial; Sunitinib