Lanreotide versus placebo for tumour reduction in patients with a ⁶⁸Ga-DOTATATE PET-positive, clinically non-functioning pituitary macroadenoma (GALANT study): a randomised, multicentre, phase 3 trial with blinded outcome assessment.

Boertien TM, Drent ML, Booij J, Majoie CBLM, Stokkel MPM, Hoogmoed J, Pereira AM, Biermasz NR, Simsek S, Veldman RG, Weterings AJ, Vink JM, Tanck MWT, Fliers E, Bisschop PH

The Lancet regional health. Europe13 May 2024Cited by 8 (Europe PMC)

PMID39070749PMCIDPMC11281922DOI10.1016/j.lanepe.2024.100923PepBankPUB-39070749

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Summary

BackgroundNo established medical treatment options currently exist for patients with non-functioning pituitary macroadenoma (NFPMA). Somatostatin analogues may prevent tumour growth, but randomised controlled trials are lacking. In vivo somatostatin receptor assessment with ⁶⁸Ga-DOTATATE PET could help in selecting patients for treatment. We aimed to determine the effect of the somatostatin analogue lanreotide on tumour size in patients with a ⁶⁸Ga-DOTATATE PET-positive NFPMA.MethodsThe GALANT study was an investigator-initiated, multicentre, randomised, double-blind, placebo-controlled, parallel-group, phase 3 trial with recruitment at three academic hospitals in the Netherlands. Adult patients with a suprasellar extending NFPMA, either surgery-naïve or postoperative remnant ≥10 mm, were eligible for inclusion. Important exclusion criteria were previous sellar radiotherapy and use of dopamine receptor agonists. Somatostatin receptor expression in the NFPMA was determined through ⁶⁸Ga-DOTATATE PET/CT, co-registered with MRI. A predefined sample of 44 patients with PET-positive NFPMA were randomly assigned (1:1) to lanreotide acetate 120 mg or placebo, both administered as deep subcutaneous injections every 28 days for 72 weeks. Primary outcome was the change in cranio-caudal tumour diameter measured on pituitary MRI from baseline to end-of-treatment in the intention-to-treat population. Participants, investigators and outcome assessors were masked to treatment allocation. The trial is registered with the Netherlands Trial Registry, NL5136, and EudraCT, 2015-001234-22.FindingsBetween Nov 3, 2015, and Dec 10, 2019, 49 patients were included in the study. Forty-four patients with a ⁶⁸Ga-DOTATATE PET-positive NFPMA were randomly assigned to lanreotide (22 [50%]) or placebo (22 [50%]). Study treatment was completed in 13 (59%) lanreotide and 19 (86%) placebo participants. The mean (SD) change from baseline in cranio-caudal tumour diameter after treatment was +1·2 (2·5) mm with lanreotide and +1·3 (1·5) mm with placebo; adjusted mean difference versus placebo -0·1 mm (95% CI -1·3 to 1·2, p = 0·93). Adverse events occurred in 22 (100%, 147 events) lanreotide and 21 (95%, 94 events) placebo participants. Gastrointestinal complaints were most common, reported by 18 (82%) lanreotide and 8 (36%) placebo participants. There were no treatment-related serious adverse events.InterpretationCompared with placebo, lanreotide treatment did not reduce tumour size or growth in patients with ⁶⁸Ga-DOTATATE PET-positive NFPMA.FundingIpsen Farmaceutica BV.

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study5

5 results from studies that gave the peptide. 5 results from people.

01HumanRandomized controlled trialEfficacy outcome
In NFPMA patients, mean (SD) diameter change was +1.2 (2.5) mm with lanreotide versus +1.3 (1.5) mm with placebo, adjusted difference -0.1 mm (95% CI -1.3 to 1.2, p = 0.93).
In plain wordsIn NFPMA patients, lanreotide did not significantly change tumor diameter compared with placebo.
Peptide
Lanreotide
Outcome
No significant changeCranio-caudal tumor diameter change
Study
n = 44
Comparator
placebo
Analysis
Primary
Outcome group
Tumor growth · Endocrine and hormones
Studied dose
120 mg every 28 days · deep subcutaneous injection · 72 weeksAs given in this study (human).
Measurements
Mean change in cranio-caudal tumour diameter
1.2 mm
lanreotide, change from baseline (SD 2.5)
SD of change in tumour diameter
2.5 mm
lanreotide
Mean change in cranio-caudal tumour diameter
1.3 mm
placebo, change from baseline (SD 1.5)
SD of change in tumour diameter
1.5 mm
placebo
Adjusted mean difference versus placebo
−0.1 mm
lanreotide versus placebo
95% CI of adjusted mean difference
−1.3 to 1.2 mm
lanreotide versus placebo
P value
0.93 p
lanreotide versus placebo
Source sentences
Summary
The mean (SD) change from baseline in cranio-caudal tumour diameter after treatment was +1·2 (2·5) mm with lanreotide and +1·3 (1·5) mm with placebo; adjusted mean difference versus placebo -0·1 mm (95% CI -1·3 to 1·2, p = 0·93).
3 context sentences(design, population, supporting numbers)
Summary · context
The GALANT study was an investigator-initiated, multicentre, randomised, double-blind, placebo-controlled, parallel-group, phase 3 trial with recruitment at three academic hospitals in the Netherlands.
Summary · context
Adult patients with a suprasellar extending NFPMA, either surgery-naïve or postoperative remnant ≥10 mm, were eligible for inclusion.
Summary · context
A predefined sample of 44 patients with PET-positive NFPMA were randomly assigned (1:1) to lanreotide acetate 120 mg or placebo, both administered as deep subcutaneous injections every 28 days for 72 weeks.
Show in the study text Report a problemFND-3907074902
02HumanRandomized controlled trialOther
In NFPMA patients, treatment completion was 13 (59%) with lanreotide versus 19 (86%) with placebo.
In plain wordsIn NFPMA patients, 13 (59%) completed lanreotide treatment versus 19 (86%) with placebo.
Peptide
Lanreotide
Outcome
DecreaseTreatment completion
Study
n = 44
Comparator
placebo
Outcome group
Treatment adherence and retention · Whole body
Studied dose
120 mg every 28 days · deep subcutaneous injection · 72 weeksAs given in this study (human).
Measurements
Treatment completion
13 participants
lanreotide
Treatment completion
59%
lanreotide
Treatment completion
19 participants
placebo
Treatment completion
86%
placebo
Source sentences
Summary
Study treatment was completed in 13 (59%) lanreotide and 19 (86%) placebo participants.
3 context sentences(design, population, supporting numbers)
Summary · context
The GALANT study was an investigator-initiated, multicentre, randomised, double-blind, placebo-controlled, parallel-group, phase 3 trial with recruitment at three academic hospitals in the Netherlands.
Summary · context
Adult patients with a suprasellar extending NFPMA, either surgery-naïve or postoperative remnant ≥10 mm, were eligible for inclusion.
Summary · context
A predefined sample of 44 patients with PET-positive NFPMA were randomly assigned (1:1) to lanreotide acetate 120 mg or placebo, both administered as deep subcutaneous injections every 28 days for 72 weeks.
Show in the study text Report a problemFND-3907074901
03HumanRandomized controlled trialSafety outcome
In NFPMA patients, adverse events affected 22 (100%, 147 events) with lanreotide versus 21 (95%, 94 events) with placebo.
In plain wordsIn NFPMA patients, adverse events affected 100% with lanreotide versus 95% with placebo.
Peptide
Lanreotide
Outcome
IncreaseAdverse events
Study
n = 44
Comparator
placebo
Outcome group
Adverse events · Whole body
Studied dose
120 mg every 28 days · deep subcutaneous injection · 72 weeksAs given in this study (human).
Measurements
Participants with adverse events
22 participants
lanreotide
Participants with adverse events
100%
lanreotide
Adverse events
147 events
lanreotide
Participants with adverse events
21 participants
placebo
Participants with adverse events
95%
placebo
Adverse events
94 events
placebo
Source sentences
Summary
Adverse events occurred in 22 (100%, 147 events) lanreotide and 21 (95%, 94 events) placebo participants.
3 context sentences(design, population, supporting numbers)
Summary · context
The GALANT study was an investigator-initiated, multicentre, randomised, double-blind, placebo-controlled, parallel-group, phase 3 trial with recruitment at three academic hospitals in the Netherlands.
Summary · context
Adult patients with a suprasellar extending NFPMA, either surgery-naïve or postoperative remnant ≥10 mm, were eligible for inclusion.
Summary · context
A predefined sample of 44 patients with PET-positive NFPMA were randomly assigned (1:1) to lanreotide acetate 120 mg or placebo, both administered as deep subcutaneous injections every 28 days for 72 weeks.
Show in the study text Report a problemFND-3907074903
04HumanRandomized controlled trialSafety outcome
In NFPMA patients, gastrointestinal complaints affected 18 (82%) with lanreotide versus 8 (36%) with placebo.
In plain wordsIn NFPMA patients, digestive complaints affected 82% with lanreotide versus 36% with placebo.
Peptide
Lanreotide
Outcome
IncreaseGastrointestinal complaints
Study
n = 44
Comparator
placebo
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
120 mg every 28 days · deep subcutaneous injection · 72 weeksAs given in this study (human).
Measurements
Participants with gastrointestinal complaints
18 participants
lanreotide
Participants with gastrointestinal complaints
82%
lanreotide
Participants with gastrointestinal complaints
8 participants
placebo
Participants with gastrointestinal complaints
36%
placebo
Source sentences
Summary
Gastrointestinal complaints were most common, reported by 18 (82%) lanreotide and 8 (36%) placebo participants.
3 context sentences(design, population, supporting numbers)
Summary · context
The GALANT study was an investigator-initiated, multicentre, randomised, double-blind, placebo-controlled, parallel-group, phase 3 trial with recruitment at three academic hospitals in the Netherlands.
Summary · context
Adult patients with a suprasellar extending NFPMA, either surgery-naïve or postoperative remnant ≥10 mm, were eligible for inclusion.
Summary · context
A predefined sample of 44 patients with PET-positive NFPMA were randomly assigned (1:1) to lanreotide acetate 120 mg or placebo, both administered as deep subcutaneous injections every 28 days for 72 weeks.
Show in the study text Report a problemFND-3907074904
05HumanRandomized controlled trialSafety outcome
In NFPMA patients, no treatment-related serious adverse events occurred in the lanreotide-placebo trial.
In plain wordsIn NFPMA patients, no treatment-related serious adverse events occurred in the lanreotide-placebo trial.
Peptide
Lanreotide
Outcome
Not applicableTreatment-related serious adverse events
Study
n = 44
Comparator
placebo
Outcome group
Adverse events · Whole body
Studied dose
120 mg every 28 days · deep subcutaneous injection · 72 weeksAs given in this study (human).
Source sentences
Summary
There were no treatment-related serious adverse events.
3 context sentences(design, population, supporting numbers)
Summary · context
The GALANT study was an investigator-initiated, multicentre, randomised, double-blind, placebo-controlled, parallel-group, phase 3 trial with recruitment at three academic hospitals in the Netherlands.
Summary · context
Adult patients with a suprasellar extending NFPMA, either surgery-naïve or postoperative remnant ≥10 mm, were eligible for inclusion.
Summary · context
A predefined sample of 44 patients with PET-positive NFPMA were randomly assigned (1:1) to lanreotide acetate 120 mg or placebo, both administered as deep subcutaneous injections every 28 days for 72 weeks.
Show in the study text Report a problemFND-3907074905

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Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 1
27 Oct 2026, 16:36 UTC
First added · source update from Europe PMC

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