Randomized Study of Temozolomide or Temozolomide and Capecitabine in Patients With Advanced Pancreatic Neuroendocrine Tumors (ECOG-ACRIN E2211)

PURPOSE Patients with advanced pancreatic neuroendocrine tumors (NETs) have few treatment options that yield objective responses. Retrospective and small prospective studies suggest that capecitabine and temozolomide are associated with high response rates (RRs) and long progression-free survival (PFS). PATIENTS AND METHODS E2211 was a multicenter, randomized, phase II trial comparing temozolomide versus capecitabine/temozolomide in patients with advanced low-grade or intermediate-grade pancreatic NETs. Key eligibility criteria included progression within the preceding 12 months and no prior temozolomide, dimethyl-triazeno-imidazole-carboxamide or dacarbazine, capecitabine or fluorouracil. The primary end…

• A
  Amgen
• BS
  Bristol-Myers Squibb
• EL
  Eli Lilly and Company
• P
  Pfizer
• AC
  American College of Radiology Imaging Network

  Awards: U10CA180820, UG1CA233253, U10CA180888
• AB
  Array BioPharma
• TP
  Taiho Pharmaceutical
• FP
  Five Prime Therapeutics
• EC
  ECOG-ACRIN Cancer Research Group

  Awards: U10CA180888, UG1CA189863, UG1CA233180, UG1CA233337, U10CA180821, U10CA180820, U10CA180794
• SP
  Syndax Pharmaceuticals
• NI
  National Institutes of Health

  Awards: UG1CA233160, UG1CA233253, UG1CA189863, UG1CA233180, UG1CA233290, UG1CA233320, UG1CA233329, UG1CA233337, U10CA180821, U10CA180888, U10CA180820, UG1CA233331, UG1CA189821, U10CA180794
• S
  Samsung
• P
  Pharmacyclics
• NC
  National Cancer Institute

  Awards: UG1CA233329, UG1CA189863, UG1CA189821, UG1CA233253, UG1CA233320, UG1CA233290, U10CA180820, U10CA180821, UG1CA233180, UG1CA233337, U10CA180794, UG1CA233160, U10CA180888, UG1CA233331
• DS
  Daiichi Sankyo Europe