In advanced, progressive pNET
RADIANT-3 has a robust clinical trial design
RADIANT-3: The largest (N=410) phase 3 trial in the treatment of advanced, progressive pNET1
*0 vs 1 and 2.
†Yes or no.
‡BSC could include SSA therapy.
§Crossover to AFINITOR was allowed upon disease progression.
†Yes or no.
‡BSC could include SSA therapy.
§Crossover to AFINITOR was allowed upon disease progression.
Trial overview1
- This was a prospective, double-blind, randomized, parallel-group, placebo-controlled, international, multicenter Phase III study of treatment with AFINITOR versus placebo in advanced, progressive pNET
- The primary end point was PFS‖
- After the primary end point was achieved, the study was unblinded and patients were enrolled in the open-label period to assess the secondary end point of OS1
- Other secondary end points: safety, objective response rate (complete response or partial response), and response duration
Key eligibility criteria1
- Advanced (unresectable or metastatic) pNET
- Radiologic disease progression ≤12 months prior to randomization
- Measurable disease per RECIST
- Prior antitumor therapy allowed
- WHO performance status ≤2
‖PFS was defined as the time from randomization to the first documentation of disease progression or death from any cause.
Abbreviations:
BSC, best supportive care; OS, overall survival; PFS, progression-free survival; pNET, pancreatic neuroendocrine tumor(s); RADIANT, RAD001 in Advanced Neuroendocrine Tumors; RECIST, Response Evaluation Criteria In Solid Tumors; SSA, somatostatin analogue; WHO, World Health Organization.
BSC, best supportive care; OS, overall survival; PFS, progression-free survival; pNET, pancreatic neuroendocrine tumor(s); RADIANT, RAD001 in Advanced Neuroendocrine Tumors; RECIST, Response Evaluation Criteria In Solid Tumors; SSA, somatostatin analogue; WHO, World Health Organization.
Reference:
- Yao JC, Shah MH, Ito T, et al; for the RAD001 in Advanced Neuroendocrine Tumors, Third Trial (RADIANT-3) Study Group. Everolimus for advanced pancreatic neuroendocrine tumors. N Engl J Med. 2011;364(6):514-523.
