ECE2024 Rapid Communications Rapid Communications 5: Pituitary and Neuroendocrinology | Part I (8 abstracts)
Lanreotide in patients with a 68Ga-DOTATATE PET-positive, clinically non-functioning pituitary macroadenoma (GALANT study): A randomised, double-blind, placebo-controlled trial
Tessel M. Boertien 1 , M.L. Drent 2 , Jan Booij 3 , Charles B.L.M. Majoie 3 , Marcel P.M. Stokkel 4 , Jantien Hoogmoed 5 , Alberto M. Pereira 1,6 , Nienke Biermasz 6 , Suat Simsek 7 , Ronald Groote Veldman 8 , Annick J. Weterings 1 , Juan M. Vink 1 , Michael W.T. . Tanck 9 , Eric Fliers 1 & Peter H. Bisschop 1
1Amsterdam UMC location AMC, Endocrinology and Metabolism, Amsterdam, Netherlands; 2Amsterdam UMC location VUMC, Endocrinology and Metabolism, Amsterdam, Netherlands; 3Amsterdam UMC location AMC, Radiology and Nuclear Medicine, Amsterdam, Netherlands; 4Netherlands Cancer Institute, Nuclear Medicine, Amsterdam, Netherlands; 5Amsterdam UMC location AMC, Neurosurgery, Amsterdam, Netherlands; 6Leiden University Medical Centre (LUMC), Endocrinology, Leiden, Netherlands; 7Northwest Clinics location Alkmaar, Internal Medicine, Alkmaar, Netherlands; 8Medical Spectrum Twente, Internal Medicine, Enschede, Netherlands; 9Amsterdam UMC location AMC, Epidemiology and Data Science, Amsterdam, Netherlands
Background: Patients with non-functioning pituitary macroadenoma (NFMA) currently have no established medical treatment options. Somatostatin analogues may decrease tumour size, 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 NFMA.
Methods: The GALANT study was an investigator-initiated, multicentre, randomised, double-blind, placebo-controlled, phase 3 trial performed in the Netherlands and funded by Ipsen Farmaceutica BV (EudraCT 2015-001234-22; NTR NL5136). We included adult patients with a suprasellar extending NFMA (≥10 mm), either surgery-naïve or postoperative remnant. Important exclusion criteria were previous sellar radiotherapy and use of dopamine receptor agonists. Somatostatin receptor expression in the NFMA was determined by 68Ga-DOTATATE PET/CT, co-registered with pituitary MRI. A predefined sample of 44 patients with PET-positive NFMA were randomly assigned (1:1) to lanreotide 120 mg or placebo subcutaneous injections every 28 days for 72 weeks. The primary outcome was change from baseline in cranio-caudal tumour diameter in the intention-to-treat population. Participants, investigators and outcome assessors were masked to treatment allocation.
Results: 49 patients were included in order to randomise 44 PET-positive patients between lanreotide (n=22) and placebo (n=22). Study treatment was completed in 13 (59%) lanreotide and 19 (86%) placebo participants; outcome data were available for all participants. The mean (SD) change in cranio-caudal tumour diameter was +1.2 (2.5) mm with lanreotide and +1.3 (1.5) mm with placebo; ANCOVA adjusted mean difference vs placebo –0.1 mm (95% CI –1.3 to 1.2, P=0.93). Sensitivity analyses corroborated the main results. Treatment discontinuation due to tumour progression occurred in three lanreotide and three placebo participants. Four participants in the lanreotide group withdrew due to adverse events and two due to other reasons. Adverse events occurred in 22 (100%) lanreotide and 21 (95%) 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.
Conclusion: Compared with placebo, lanreotide treatment did not reduce tumour size or growth of 68Ga-DOTATATE PET-positive NFMA. The results of this first successfully completed double-blind and placebo-controlled intervention trial in NFMA patients do not support the use of somatostatin analogues in these patients.
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Endocrine Abstracts
ISSN 1470-3947 (print) | ISSN 1479-6848 (online)
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