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PMID-33052555 – CLARINET OLE Final Results Lanreotide in NETs

PMID-33052555 – CLARINET OLE Final Results Lanreotide in NETs

Caplin ME, Pavel M, Cwikla JB, et al. Lanreotide autogel/depot in advanced enteropancreatic neuroendocrine tumours: final results of the CLARINET open-label extension study. Endocrine. 2021;71(2):502-513.

Quick Reference

Property Value
PMID 33052555
DOI 10.1007/s12020-020-02475-2
Year 2021
Journal Endocrine
Study Type RCT (open-label extension)
Evidence Level II
Sample 101 patients (from original CLARINET cohort)
Peptide(s) Studied Lanreotide

Key Findings

  • Median progression-free survival from original CLARINET randomization was 32.8 months (95% CI: 30.9-68.0) for lanreotide across the combined core + OLE analysis
  • Among patients who had stable disease at CLARINET core study end, lanreotide maintained disease control in the majority during the extension
  • Long-term safety was consistent with the known profile of lanreotide; no new safety signals emerged over extended treatment
  • Patients who crossed over from placebo to lanreotide in the OLE also demonstrated tumor stabilization
  • Results support prolonged continuous lanreotide therapy in indolent GEP-NETs without evidence of tachyphylaxis

Study Design

Open-label extension of the Phase III CLARINET trial (NCT00842348). Patients who completed the CLARINET core study (both lanreotide and placebo arms) were eligible to receive lanreotide Autogel 120 mg every 28 days until disease progression, unacceptable toxicity, or withdrawal. Efficacy was assessed by RECIST 1.1 and safety by CTCAE monitoring.

Limitations

  • Open-label design introduces bias in efficacy assessment
  • Patient selection bias: only patients completing the core study and willing to continue were enrolled
  • No comparator arm in the extension phase
  • Sample size reduced from core study due to attrition

Clinical Relevance

The CLARINET OLE final results provide the longest follow-up data for lanreotide in GEP-NETs, demonstrating sustained antiproliferative activity over years of continuous treatment. The median PFS of 32.8 months reinforces lanreotide as a durable first-line therapy for well-differentiated, SSTR-positive NETs. These data support clinical guideline recommendations for continued somatostatin analog therapy until progression.

Related

#research #RCT #lanreotide #evidence-level-II