Lanreotide Autogel 120 mg at extended dosing intervals in patients with acromegaly biochemically controlled with octreotide LAR: the LEAD study

Eur J Endocrinol. 2015 Sep;173(3):313-23. doi: 10.1530/EJE-15-0215. Epub 2015 Jun 5.

Abstract

Objective: To evaluate extended dosing intervals (EDIs) with lanreotide Autogel 120 mg in patients with acromegaly previously biochemically controlled with octreotide LAR 10 or 20 mg.

Design and methods: Patients with acromegaly had received octreotide LAR 10 or 20 mg/4 weeks for ≥ 6 months and had normal IGF1 levels. Lanreotide Autogel 120 mg was administered every 6 weeks for 24 weeks (phase 1); depending on week-24 IGF1 levels, treatment was then administered every 4, 6 or 8 weeks for a further 24 weeks (phase 2). Hormone levels, patient-reported outcomes and adverse events were assessed.

Primary endpoint: proportion of patients on 6- or 8-week EDIs with normal IGF1 levels at week 48 (study end).

Results: 107/124 patients completed the study (15 withdrew from phase 1 and two from phase 2). Of 124 patients enrolled, 77.4% were allocated to 6- or 8-week EDIs in phase 2 and 75.8% (95% CI: 68.3-83.3) had normal IGF1 levels at week 48 with the EDI (primary analysis). A total of 88.7% (83.1-94.3) had normal IGF1 levels after 24 weeks with 6-weekly dosing. GH levels were ≤ 2.5 μg/l in > 90% of patients after 24 and 48 weeks. Patient preferences for lanreotide Autogel 120 mg every 4, 6 or 8 weeks over octreotide LAR every 4 weeks were high.

Conclusions: Patients with acromegaly achieving biochemical control with octreotide LAR 10 or 20 mg/4 weeks are possible candidates for lanreotide Autogel 120 mg EDIs. EDIs are effective and well received among such patients.

MeSH terms

  • Acromegaly / drug therapy*
  • Acromegaly / metabolism
  • Adenoma / drug therapy*
  • Adenoma / metabolism
  • Adult
  • Aged
  • Antineoplastic Agents / administration & dosage*
  • Antineoplastic Agents / therapeutic use
  • Delayed-Action Preparations
  • Female
  • Growth Hormone-Secreting Pituitary Adenoma / drug therapy*
  • Growth Hormone-Secreting Pituitary Adenoma / metabolism
  • Human Growth Hormone / metabolism*
  • Humans
  • Insulin-Like Growth Factor I / metabolism*
  • Male
  • Middle Aged
  • Octreotide / therapeutic use
  • Peptides, Cyclic / administration & dosage*
  • Somatostatin / administration & dosage
  • Somatostatin / analogs & derivatives*
  • Treatment Outcome

Substances

  • Antineoplastic Agents
  • Delayed-Action Preparations
  • IGF1 protein, human
  • Peptides, Cyclic
  • lanreotide
  • Human Growth Hormone
  • Somatostatin
  • Insulin-Like Growth Factor I
  • Octreotide