title: A Cancer and Leukemia Group B phase II study of sunitinib malate in patients with previously treated metastatic pancreatic adenocarcinoma (CALGB 80603).
abstract: BACKGROUND
  The Cancer and Leukemia Group B (CALGB) conducted a phase II study evaluating sunitinib in patients with progressive metastatic pancreas adenocarcinoma following prior gemcitabine-based therapy (trial CALGB 80603; ClinicalTrials.gov identifier, NCT00397787). The primary endpoint was to determine the disease control rate (DCR) as measured by the Response Evaluation Criteria in Solid Tumors (complete response, partial response [PR], and stable disease) at 6 weeks.
  
  
  METHODS
  Patients aged ≥18 years with an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2 and with progressive pancreas adenocarcinoma following treatment with gemcitabine were eligible. Sunitinib was dosed at 50 mg orally days 1-28, every 42 days (1 cycle). The statistical plan called for a three-stage design. A DCR ≥15% was considered worthy of further study.
  
  
  RESULTS
  In total, 77 patients were enrolled. Forty-two (54.6%) enrollees were male. The median age was 65 years. The ECOG performance status score distribution was: 0, 39%; 1, 50%; 2, 11%. The DCR was 21.6%; one patient (1.4%) had a PR and 15 patients (20.3%) had stable disease as their best response. The progression-free survival time was 1.31 months (95% confidence interval [CI] 1.25-1.38 months) and overall survival time was 3.68 months (95% CI, 3.06-4.24 months).
  
  
  CONCLUSIONS
  The study met its primary endpoint; however sunitinib had minimal activity and moderate toxicity in a population of gemcitabine-refractory pancreas adenocarcinoma patients. For future studies, limiting enrollment to patients with an ECOG performance status score of 0-1 is recommended.
authors.affiliation: Memorial Sloan-Kettering Cancer Center, New York, New York 10065, USA. oreillye@mskcc.org
authors.forename: Eileen M
authors.initials: EM
authors.lastname: O'Reilly
authors.forename: Donna
authors.initials: D
authors.lastname: Niedzwiecki
authors.forename: Margaret
authors.initials: M
authors.lastname: Hall
authors.forename: Donna
authors.initials: D
authors.lastname: Hollis
authors.forename: Tanios
authors.initials: T
authors.lastname: Bekaii-Saab
authors.forename: Timothy
authors.initials: T
authors.lastname: Pluard
authors.forename: Kathe
authors.initials: K
authors.lastname: Douglas
authors.forename: Ghassan K
authors.initials: GK
authors.lastname: Abou-Alfa
authors.forename: Hedy L
authors.initials: HL
authors.lastname: Kindler
authors.forename: Richard L
authors.initials: RL
authors.lastname: Schilsky
authors.forename: Richard M
authors.initials: RM
authors.lastname: Goldberg
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000556:secondary; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D001859:Bone Neoplasms / Q000188:drug therapy / Q000556:secondary; D005260:Female; D006801:Humans; D007211:Indoles / Q000627:therapeutic use*; D008113:Liver Neoplasms / Q000188:drug therapy / Q000556:secondary; D008175:Lung Neoplasms / Q000188:drug therapy / Q000556:secondary; D008207:Lymphatic Metastasis; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000473:pathology; D011758:Pyrroles / Q000627:therapeutic use*; D016879:Salvage Therapy; D000077210:Sunitinib; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D007211:Indoles; D011758:Pyrroles; D000077210:Sunitinib