Trial reportThe Journal of clinical endocrinology and metabolism2014
Tumor shrinkage with lanreotide Autogel 120 mg as primary therapy in acromegaly: results of a prospective multicenter clinical trial.
Trial report in The Journal of clinical endocrinology and metabolism, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00690898 (Phase IIIb, Multicentre, Open-label, Single-arm, Study to Assess the Efficacy and Safety of Lanreotide Autogel 120 mg Administered Every 28 Days as Primary Medical Treatment in Acromegalic Patients With Macroadenoma), which is not on this map. Cited by 81 papers, 3 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Phase IIIb, Multicentre, Open-label, Single-arm, Study to Assess the Efficacy and Safety of Lanreotide Autogel 120 mg Administered Every 28 Days as Primary Medical Treatment in Acromegalic Patients With Macroadenoma
Who cites it
81 citing papers in PubMed, 3 syntheses or guidelines pooled it, 180 citations in OpenAlex.
- Surgical and non-surgical interventions for primary and salvage treatment of growth hormone-secreting pituitary adenomas in adults.The Cochrane database of systematic reviews · 2024Pooled it
- Pasireotide-Induced Shrinkage in GH and ACTH Secreting Pituitary Adenoma: A Systematic Review and Meta-Analysis.Frontiers in endocrinology · 2022Pooled it
- Surgical interventions and medical treatments in treatment-naïve patients with acromegaly: systematic review and meta-analysis.The Journal of clinical endocrinology and metabolism · 2014Pooled it
- Efficacy and safety of lanreotide autogel compared with lanreotide 40 mg prolonged release in Chinese patients with active acromegaly: results from a phase 3, prospective, randomized, and open-label study (LANTERN).BMC endocrine disorders · 2020Trial
- Trial
- Trial
- Osilodrostat, a potent oral 11β-hydroxylase inhibitor: 22-week, prospective, Phase II study in Cushing's disease.Pituitary · 2016Trial
- Effects of lanreotide Autogel primary therapy on symptoms and quality-of-life in acromegaly: data from the PRIMARYS study.Pituitary · 2016Trial
- Reassuring long-term data on efficacy and safety of pegvisomant monotherapy in a large series of patients with acromegaly.Pituitary · 2026Article
- Pituitary adenoma imaging as a determinant of acromegaly diagnosis and outcomes.The Journal of clinical endocrinology and metabolism · 2026Review
- Current treatment landscape of acromegaly.The Journal of clinical endocrinology and metabolism · 2026Review
- Review
- Long-term safety and efficacy of pegvisomant monotherapy for acromegaly: final data from the full ACROSTUDY cohort.Pituitary · 2026Article
- AIP expression and imaging findings in somatotroph adenomas after pre-operative lanreotide therapy for acromegaly.Pituitary · 2026Article
- Case report of two growth hormone-secreting invasive pituitary adenomas and literature review.Archives of medical science : AMS · 2026Article
- Consensus on acromegaly therapeutic outcomes: an update.Nature reviews. Endocrinology · 2025Review
- Gross total resection in low-grade and pretreated high-grade invasive growth hormone pituitary adenomas promises favorable outcomes.Discover oncology · 2025Article
- Review
- Preoperative medical therapy for acromegaly: current knowledge and clinical significance.Frontiers in endocrinology · 2025Review
- Acromegaly: diagnostic challenges and individualized treatment.Expert review of endocrinology & metabolism · 2025Review
21 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 6 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
contextMethodological 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.
objectiveThe aim of the study was to better characterize the effects of primary lanreotide Autogel treatment on tumor size in patients with GH-secreting macroadenomas.
designPRIMARYS was a 48-week, multicenter, open-label, single-arm study.
settingThe study was conducted at specialist endocrine centers. PATIENTS: Treatment-naïve acromegalic patients with GH-secreting macroadenomas participated in the study.
interventionLanreotide 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.
resultsSixty-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.
conclusionsPrimary 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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.