Evidence map›Paper›PMID 32366244›Full record

Trial reportBMC endocrine disorders2020

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).

Zhenmei An, Ting Lei, Lian Duan, Pei Hu, Zhongping Gou, Lihui Zhang, Lucie Durand-Gasselin, Nan Wang, Yan Wang, Feng Gu and 1 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIIComparative StudyEquivalence Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC endocrine disorders, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02493517 (A Phase III, Prospective, Randomised, Open Label Study to Compare the Efficacy and Safety of Lanreotide Autogel® 60, 90 or 120 mg With Lanreotide 40 mg PR in Subjects With Active Acromegaly), which is not on this map. Cited by 1 paper, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed, 1 pooled it
0.3field-weighted citation impact, top 41% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

NCT02493517 phase3completednot on this map

A Phase III, Prospective, Randomised, Open Label Study to Compare the Efficacy and Safety of Lanreotide Autogel® 60, 90 or 120 mg With Lanreotide 40 mg PR in Subjects With Active Acromegaly

TypeinterventionalSponsorIpsenRan2014 to 2017Enrolled128ConditionsAcromegalyArmsLanreotide Autogel®, Lanreotide Acetate
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 synthesis or guideline pooled it, 3 citations in OpenAlex.

  1. Pooled it
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 4 institutions in 2 countries.

Zhenmei AnWest China Hospital, Sichuan University, Chengdu, Sichuan, China.
Ting LeiTongji Hospital, Tongji Medical college of HUST, Wuhan, China.
Lian DuanPeking Union Medical College Hospital, PUMCH, No.1 Shuaifuyuan, Wangfujing, Dongcheng District, Beijing, 100730, China.
Pei HuPeking Union Medical College Hospital, PUMCH, No.1 Shuaifuyuan, Wangfujing, Dongcheng District, Beijing, 100730, China.
Zhongping GouWest China Hospital, Sichuan University, Chengdu, Sichuan, China.
Lihui ZhangThe second hospital of Hebei Medical University, Shijiazhuang, China.
Lucie Durand-GasselinIpsen Innovation, Les Ulis, France.
Nan WangIpsen Pharma, Beijing, China.
Yan WangIpsen Pharma, Beijing, China.
Feng GuPeking Union Medical College Hospital, PUMCH, No.1 Shuaifuyuan, Wangfujing, Dongcheng District, Beijing, 100730, China. gufeng@gusmedsci.cn.
LANTERN study investigators
Chinese Academy of Medical Sciences & Peking Union Medical College · CNHebei Medical University · CNSichuan University · CNIpsen (France) · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLanreotide autogel is a somatostatin analog (SSA) approved for the treatment of acromegaly in 73 countries worldwide; however, it is not yet approved in China. The aim of this study was to evaluate the efficacy and safety of lanreotide autogel compared with lanreotide 40 mg prolonged release (PR) in Chinese patients with active acromegaly.

methodsLANTERN was a phase 3, randomized, open-label, non-inferiority study. Patients with active acromegaly who had undergone surgery ≥3 months prior, or were unlikely or unable to undergo surgery, were treated with lanreotide autogel 60/90/120 mg (monthly deep subcutaneous injection) or lanreotide 40 mg PR (intramuscular injection every 7, 10, or 14 days) for 32 weeks. Primary endpoint was mean change-from-baseline in age-adjusted insulin-like growth factor-1 (IGF-1) standard deviation scores (SDS) at the end-of-study. Secondary endpoints included: growth hormone (GH) levels ≤2.5 μg/L or ≤ 1.0 μg/L, ≥20% reduction in tumor volume (TV) and safety.

resultsIn total, 128 patients were randomized and received study treatment. Lanreotide autogel was non-inferior to lanreotide 40 mg PR: treatment difference (95% CI) for IGF-1 SDS between groups was - 0.32 (- 0.74, 0.11; per protocol population) and - 0.27 (- 0.63, 0.09; intention-to-treat [ITT] population), respectively. Reductions in IGF-1 (- 6.453 vs - 7.003) and GH levels (- 9.548 μg/L vs - 13.182 μg/L), and the proportion of patients with ≥1 acromegaly symptom (- 20.3% vs - 32.5%) were observed from baseline to end-of-study in lanreotide autogel and lanreotide 40 mg PR groups, respectively. In the lanreotide autogel group, 45.5% (25/55) patients achieved ≥20% reduction in TV compared with 50.9% (25/53) in lanreotide 40 mg PR group (ITT). Safety profiles were similar in both treatment groups.

conclusionsLanreotide autogel was non-inferior to lanreotide 40 mg PR in Chinese patients with active acromegaly after 32 weeks of treatment.

trial registrationRetrospectively registered on ClinicalTrials.gov: NCT02493517 (9 July 2015); prospectively registered on chinadrugtrials.org.cn: CTR20140698 (24 October 2014).

Indexed as

AdenomaAdultAntineoplastic AgentsBlood GlucoseChinaDelayed-Action PreparationsFemaleGlycated HemoglobinGrowth Hormone-Secreting Pituitary AdenomaHuman Growth HormoneHumansInjections, IntramuscularInjections, SubcutaneousInsulin-Like Growth Factor IMagnetic Resonance ImagingMaleAntineoplastic AgentsBlood GlucoseDelayed-Action PreparationsGlycated Hemoglobinhemoglobin A1c protein, humanHuman Growth HormoneInsulin-Like Growth Factor IlanreotidePeptides, CyclicSomatostatinAcromegalyChinese patientsClinical trialLanreotideLanreotide autogelSomatostatin analogs

Identifiers

PMID32366244
PMCPMC7199333
OpenAlexW3023158028

What OpenQuestion holds

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LicenceCC BY
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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.