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Tumor Shrinkage With Lanreotide Autogel 120 mg as Primary Therapy in Acromegaly: Results of a Prospective Multicenter Clinical Trial
CONTEXT: Methodological 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. OBJECTIVE: The aim of the study was to better characterize the effects o...
Autores principales: | , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Endocrine Society
2014
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4009579/ https://www.ncbi.nlm.nih.gov/pubmed/24423301 http://dx.doi.org/10.1210/jc.2013-3318 |
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author | Caron, Philippe J. Bevan, John S. Petersenn, Stephan Flanagan, Daniel Tabarin, Antoine Prévost, Gaëtan Maisonobe, Pascal Clermont, Antoine |
author_facet | Caron, Philippe J. Bevan, John S. Petersenn, Stephan Flanagan, Daniel Tabarin, Antoine Prévost, Gaëtan Maisonobe, Pascal Clermont, Antoine |
author_sort | Caron, Philippe J. |
collection | PubMed |
description | CONTEXT: Methodological 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. OBJECTIVE: The aim of the study was to better characterize the effects of primary lanreotide Autogel treatment on tumor size in patients with GH-secreting macroadenomas. DESIGN: PRIMARYS was a 48-week, multicenter, open-label, single-arm study. SETTING: The study was conducted at specialist endocrine centers. PATIENTS: Treatment-naïve acromegalic patients with GH-secreting macroadenomas participated in the study. INTERVENTION: Lanreotide 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 (H(0)) 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. RESULTS: Sixty-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; H(0) not rejected) and 71.9–75.3% in sensitivity (n = 89) and secondary analyses (n = 63) (H(0) 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. CONCLUSIONS: Primary 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. |
format | Online Article Text |
id | pubmed-4009579 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2014 |
publisher | Endocrine Society |
record_format | MEDLINE/PubMed |
spelling | pubmed-40095792014-05-14 Tumor Shrinkage With Lanreotide Autogel 120 mg as Primary Therapy in Acromegaly: Results of a Prospective Multicenter Clinical Trial Caron, Philippe J. Bevan, John S. Petersenn, Stephan Flanagan, Daniel Tabarin, Antoine Prévost, Gaëtan Maisonobe, Pascal Clermont, Antoine J Clin Endocrinol Metab Endocrine Care CONTEXT: Methodological 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. OBJECTIVE: The aim of the study was to better characterize the effects of primary lanreotide Autogel treatment on tumor size in patients with GH-secreting macroadenomas. DESIGN: PRIMARYS was a 48-week, multicenter, open-label, single-arm study. SETTING: The study was conducted at specialist endocrine centers. PATIENTS: Treatment-naïve acromegalic patients with GH-secreting macroadenomas participated in the study. INTERVENTION: Lanreotide 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 (H(0)) 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. RESULTS: Sixty-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; H(0) not rejected) and 71.9–75.3% in sensitivity (n = 89) and secondary analyses (n = 63) (H(0) 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. CONCLUSIONS: Primary 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. Endocrine Society 2014-04 2013-12-19 /pmc/articles/PMC4009579/ /pubmed/24423301 http://dx.doi.org/10.1210/jc.2013-3318 Text en Copyright © 2014 by The Endocrine Society This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/us/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Endocrine Care Caron, Philippe J. Bevan, John S. Petersenn, Stephan Flanagan, Daniel Tabarin, Antoine Prévost, Gaëtan Maisonobe, Pascal Clermont, Antoine Tumor Shrinkage With Lanreotide Autogel 120 mg as Primary Therapy in Acromegaly: Results of a Prospective Multicenter Clinical Trial |
title | Tumor Shrinkage With Lanreotide Autogel 120 mg as Primary Therapy in Acromegaly: Results of a Prospective Multicenter Clinical Trial |
title_full | Tumor Shrinkage With Lanreotide Autogel 120 mg as Primary Therapy in Acromegaly: Results of a Prospective Multicenter Clinical Trial |
title_fullStr | Tumor Shrinkage With Lanreotide Autogel 120 mg as Primary Therapy in Acromegaly: Results of a Prospective Multicenter Clinical Trial |
title_full_unstemmed | Tumor Shrinkage With Lanreotide Autogel 120 mg as Primary Therapy in Acromegaly: Results of a Prospective Multicenter Clinical Trial |
title_short | Tumor Shrinkage With Lanreotide Autogel 120 mg as Primary Therapy in Acromegaly: Results of a Prospective Multicenter Clinical Trial |
title_sort | tumor shrinkage with lanreotide autogel 120 mg as primary therapy in acromegaly: results of a prospective multicenter clinical trial |
topic | Endocrine Care |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4009579/ https://www.ncbi.nlm.nih.gov/pubmed/24423301 http://dx.doi.org/10.1210/jc.2013-3318 |
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