title: An open-label, multicentre biomarker-oriented AIO phase II trial of sunitinib for patients with chemo-refractory advanced gastric cancer.
abstract: BACKGROUND
  Sunitinib monotherapy in pretreated patients with advanced gastric cancer (AGC) was investigated. Preplanned analyses of tumour biomarkers on treatment outcome were performed.
  
  
  METHODS
  Patients received sunitinib 50mg/day for 4 weeks with 2 weeks rest until disease progression or unacceptable toxicity. The primary end-point was objective response rate (ORR). Secondary end-points included progression-free survival (PFS), overall survival (OS) and safety.
  
  
  RESULTS
  Fifty-two patients were enrolled and treated (safety population, SP). In the intention to treat population (n=51); the ORR was 3.9%, median PFS was 1.28 months [95% CI, 1.18-1.90], median OS was 5.81 months [95% CI, 3.48-12.32], the estimated one-year survival rate was 23.7% [95%CI: 12.8-36.5]. In subgroup analyses, tumour VEGF-C expression compared with no expression was associated with significantly shorter median PFS (1.23 versus 2.86 months, logrank p=0.0119) but there was no difference in tumour control rate (p=0.142). In the SP, serious adverse events occurred in 26 patients, leading to 13 deaths, all sunitinib unrelated. Thirty-eight patients died from progressive disease, nine died <60 days after treatment start.
  
  
  CONCLUSIONS
  Sunitinib monotherapy was associated with limited tumour response and good/moderate tolerability in this setting.
authors.affiliation: 1st Department of Internal Medicine, University Hospital of Mainz, Langenbeckstraße 1, 55101 Mainz, Germany. moehler@mail.uni-mainz.de
authors.forename: M
authors.initials: M
authors.lastname: Moehler
authors.forename: A
authors.initials: A
authors.lastname: Mueller
authors.forename: J T
authors.initials: JT
authors.lastname: Hartmann
authors.forename: M P
authors.initials: MP
authors.lastname: Ebert
authors.forename: S E
authors.initials: SE
authors.lastname: Al-Batran
authors.forename: P
authors.initials: P
authors.lastname: Reimer
authors.forename: M
authors.initials: M
authors.lastname: Weihrauch
authors.forename: F
authors.initials: F
authors.lastname: Lordick
authors.forename: T
authors.initials: T
authors.lastname: Trarbach
authors.forename: S
authors.initials: S
authors.lastname: Biesterfeld
authors.forename: M
authors.initials: M
authors.lastname: Kabisch
authors.forename: D
authors.initials: D
authors.lastname: Wachtlin
authors.forename: P R
authors.initials: PR
authors.lastname: Galle
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D014408:Biomarkers, Tumor / Q000378:metabolism*; D018450:Disease Progression; D005260:Female; D015972:Gene Expression Regulation, Neoplastic; D006801:Humans; D007150:Immunohistochemistry / Q000379:methods; D007211:Indoles / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009154:Mutation; D011446:Prospective Studies; D011505:Protein-Tyrosine Kinases / Q000037:antagonists & inhibitors; D011758:Pyrroles / Q000627:therapeutic use*; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000378:metabolism*; D000077210:Sunitinib; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D014408:Biomarkers, Tumor; D007211:Indoles; D011758:Pyrroles; D011505:Protein-Tyrosine Kinases; D000077210:Sunitinib