Axitinib and Long-Acting Octreotide in Advanced Extrapancreatic Neuroendocrine Tumors: A Randomized, Double-Blind, Placebo-Controlled, Phase III Clinical Trial (AXINET, GETNE 1107) - PubMed
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- #axitinib
- #neuroendocrine tumors
- #clinical trial
- Axitinib combined with long-acting octreotide was evaluated in a phase III trial (AXINET, GETNE 1107) for advanced extrapancreatic neuroendocrine tumors (epNETs).
- The study was randomized, double-blind, and placebo-controlled, involving 256 patients with unresectable/metastatic G1-2 epNETs.
- Primary endpoint was investigator-assessed progression-free survival (PFS), with a median PFS of 17.2 months for axitinib vs. 13.1 months for placebo.
- Blinded independent central review (BICR) showed a median PFS of 16.6 months for axitinib vs. 9.9 months for placebo (HR 0.71, P=0.017).
- Objective response rate (ORR) was significantly higher with axitinib (17.5% vs. 4.6% per investigator; 12.8% vs. 3.2% per BICR).
- Common grade ≥3 toxicities included hypertension (24.0% vs. 9.2%) and diarrhea (13.6% vs. 1.5%).
- Axitinib improved PFS per BICR and ORR but did not meet the primary endpoint of investigator-assessed PFS.