Endocrinology · Phase 3
PRIMARYS: acromegaly and tumor volume
What was tested?
Open-label lanreotide treatment without a comparison group in acromegaly with pituitary macroadenoma. ↗
Registered primary question: The proportion with a relevant reduction in pituitary tumor volume on MRI at week 48. ↗
What the reviewed report found
Journal year 2014 · Article summary reviewed 2026-09-15
The primary analysis found at least 20% tumor-volume reduction in 62.9% of 89 participants, but the prespecified null hypothesis was not rejected. Hormonal and symptom measures also improved.↗
Keep in context: The report describes 90 entrants and 89 in the primary analysis; the registry lists 108 enrolled. These are source-specific counts, not an interchangeable analyzed population. ↗↗
What a closer reading adds
Selected full-text sections checked 2026-09-20. These notes add context to the earlier article summary; they are not a complete risk-of-bias assessment.
Why the favorable percentage was not a positive primary test
The primary analysis tested whether the response proportion exceeded a prespecified threshold. Although 62.9% met the tumor-shrinkage definition, the primary confidence interval did not clear that threshold. Sensitivity analyses used other readers and do not replace the primary analysis. Full text ↗ · Indexed abstract ↗
Sections: Statistical analyses; Primary endpoint: proportions of patients with ≥ 20% reduction in tumor volume at week 48/LVA.
Completion and adverse-event withdrawals
The full text reports 90 treated participants and 64 completers. Five participants withdrew with treatment-emergent adverse events; three events were considered treatment related. Absence of withdrawal for gastrointestinal intolerance is narrower than absence of adverse events. Full text ↗ · Indexed abstract ↗
Sections: Patient disposition and baseline characteristics.
Participants, design, limitations and sources
Registry snapshot
- Registry enrollment
- 108 · reported actual
- Registry status
- Completed
- Allocation and masking
- Na · Open label
- Design
- Single group
- Eligible ages
- 18 Years to 75 Years
- Registry results
- Posted in this snapshot
Registry source ↗ · Updated 2022-10-14; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
PRIMARYS: acromegaly
- Design in the report
- 48-week open-label, single-arm study with centrally assessed tumor volume.↗
- Participants in the report
- 90 treatment-naïve people with acromegaly and growth-hormone-secreting macroadenomas entered; 64 completed.↗
- Limitations
- No control group, attrition and differences between primary and sensitivity analyses limit causal interpretation. No gastrointestinal-intolerance withdrawals does not mean no adverse events.↗
This reading covers the article abstract and record metadata. Read its preserved Human Evidence Review →
How the study identity and sources were checked
Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.
Registry
Lanreotide as Primary Treatment for Acromegalic Patients With Pituitary Gland Macroadenoma ↗
Protocol identifier: 2-79-52030-207. Sponsor: Ipsen.
Retrieved 2026-09-20; SHA-256 a04b02f7056d0c92cae0bb50c02e3bb5debeda139b94e9e4c39fc68cc1f22297.
PMID 24423301
Exact trial identity is declared in PubMed’s ClinicalTrials.gov databank field. The registry independently labels this reference RESULT. These source labels do not establish that every result in a paper applies to this trial.
Identity metadata retrieved 2026-09-20. EFetch batch XML; locate MedlineCitation/PMID 24423301. SHA-256 0e6795be99af1c93f3a3e2726fc8a17152661ca29e8dead110bff36feb856127.
Scientific summary uses the original 2026-09-15 source snapshot: SHA-256 b36766502f349560e081866b918e66b57fcd9b2022520b5b4dffeecec32622a4.
Selected full text: PMC4009579
Retrieved 2026-09-20; SHA-256 8aedba94eb8490af07f6c229618fa55608624f08d137e1600fb71c413f5ce257. Section identifiers and hashes are included in the cited study data.