Tumor shrinkage with lanreotide Autogel 120 mg as primary therapy in acromegaly: results of a prospective multicenter clinical trial

J Clin Endocrinol Metab. 2014 Apr;99(4):1282-90. doi: 10.1210/jc.2013-3318. Epub 2013 Jan 1.


Context: Methodological shortcomings often compromise investigations into the effects of primary somatostatin-analog treatment on tumor size in acromegaly. There are also limited data for the long-acting lanreotide formulation.

Objective: The aim of the study was to better characterize the effects of primary lanreotide Autogel treatment on tumor size in patients with GH-secreting macroadenomas.

Design: PRIMARYS was a 48-week, multicenter, open-label, single-arm study.

Setting: The study was conducted at specialist endocrine centers.

Patients: Treatment-naïve acromegalic patients with GH-secreting macroadenomas participated in the study.

Intervention: Lanreotide Autogel 120 mg was administered sc every 28 days (without dose titration).

Outcome measures: The primary endpoint was the proportion of patients with clinically significant (≥20%) tumor volume reduction (TVR) at week 48/last post-baseline value available using central assessments from three readers. The null hypothesis (H0) for the primary endpoint was that the proportion with TVR was ≤55%. Secondary endpoints included: TVR at other time points, GH and IGF-1, acromegalic symptoms, quality of life (QoL), and safety.

Results: Sixty-four of 90 (71.1%) patients completed the study. Clinically significant TVR at 48 weeks/last post-baseline value available was achieved by 62.9% (95% confidence interval, 52.0, 72.9) of 89 patients in the primary analysis (intention-to-treat population; H0 not rejected) and 71.9-75.3% in sensitivity (n = 89) and secondary analyses (n = 63) (H0 rejected). At 12 weeks, 54.1% had clinically significant TVR. Early and sustained improvements also occurred in GH and IGF-1, acromegalic symptoms, and QoL. No patients withdrew due to gastrointestinal intolerance.

Conclusions: Primary treatment with lanreotide Autogel, administered at 120 mg (highest available dose) without dose titration, in patients with GH-secreting macroadenomas provides early and sustained reductions in tumor volume, GH and IGF-1, and acromegalic symptoms, and improves QoL.

Trial registration: ClinicalTrials.gov NCT00690898.

Publication types

  • Clinical Trial, Phase III
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acromegaly / drug therapy*
  • Acromegaly / pathology
  • Adenoma / drug therapy*
  • Adenoma / pathology
  • Adolescent
  • Adult
  • Aged
  • Female
  • Gels
  • Growth Hormone-Secreting Pituitary Adenoma / drug therapy*
  • Growth Hormone-Secreting Pituitary Adenoma / pathology
  • Humans
  • Male
  • Middle Aged
  • Neoadjuvant Therapy
  • Peptides, Cyclic / administration & dosage*
  • Somatostatin / administration & dosage
  • Somatostatin / analogs & derivatives*
  • Treatment Outcome
  • Tumor Burden / drug effects*
  • Young Adult


  • Gels
  • Peptides, Cyclic
  • lanreotide
  • Somatostatin

Associated data

  • ClinicalTrials.gov/NCT00690898