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      Tumor Shrinkage With Lanreotide Autogel 120 mg as Primary Therapy in Acromegaly: Results of a Prospective Multicenter Clinical Trial

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          Abstract

          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.

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          Most cited references22

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          Guidelines for acromegaly management: an update.

          The Acromegaly Consensus Group reconvened in November 2007 to update guidelines for acromegaly management. The meeting participants comprised 68 pituitary specialists, including neurosurgeons and endocrinologists with extensive experience treating patients with acromegaly. EVIDENCE/CONSENSUS PROCESS: Goals of treatment and the appropriate imaging and biochemical and clinical monitoring of patients with acromegaly were enunciated, based on the available published evidence. The group developed a consensus on the approach to managing acromegaly including appropriate roles for neurosurgery, medical therapy, and radiation therapy in the management of these patients.
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            The outcome of surgery in 668 patients with acromegaly using current criteria of biochemical 'cure'.

            The aim of this study was to illustrate the present role of transsphenoidal surgery as primary therapy in GH-secreting adenomas, and to compare the results concerning control of disease with previous series using older criteria of cure. We report on a consecutive series of 688 acromegalic patients treated over a time period of 19 years. Biochemical cure was defined as normalisation of basal GH level, suppression of GH levels to below 1 ng/ml during an oral glucose load and normalisation of IGF-I levels. Of the 506 patients undergoing primary transsphenoidal surgery, a total of 57.3% postoperatively fulfilled the criteria used. The rate of biochemical 'cure' correlated with the magnitude of the initial GH levels, the tumour size and invasion. The overall complication rate was below 2%. Mortality in this series was 0.1% (1 of 688). During a follow-up period of 10.7 years only two recurrences (0.4%) occurred. However, in the patients treated by transcranial surgery and by repeat surgery the cure rate was found to be relatively low (5.2 and 21.3% respectively). These data suggest that surgery remains with very few exceptions the primary treatment of acromegaly for (i) a high cure rate, (ii) low morbidity, (iii) low recurrence rate and (iv) immediate decline of GH. Based on current criteria of cure, recurrences are uncommon. However, cure by surgery alone is improbable in patients harbouring extended, invasive tumours with high secretory activity, in whom further adjuvant treatment is mandatory.
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              Meta-Analysis on the Effects of Octreotide on Tumor Mass in Acromegaly

              Background The long-acting somatostatin analogue octreotide is used either as an adjuvant or primary therapy to lower growth hormone (GH) levels in patients with acromegaly and may also induce pituitary tumor shrinkage. Objective We performed a meta-analysis to accurately assess the effect of octreotide on pituitary tumor shrinkage. Data Sources A computerized Medline and Embase search was undertaken to identify potentially eligible studies. Study Eligibility Criteria Eligibility criteria included treatment with octreotide, availability of numerical metrics on tumor shrinkage and clear definition of a clinically relevant reduction in tumor size. Primary endpoints included the proportion of patients with tumor shrinkage and mean percentage reduction in tumor volume. Data Extraction and Analysis The electronic search identified 2202 articles. Of these, 41 studies fulfilling the eligibility criteria were selected for data extraction and analysis. In total, 1685 patients were included, ranging from 6 to 189 patients per trial. For the analysis of the effect of octreotide on pituitary tumor shrinkage a random effect model was used to account for differences in both effect size and sampling error. Results Octreotide was shown to induce tumor shrinkage in 53.0% [95% CI: 45.0%–61.0%] of treated patients. In patients treated with the LAR formulation of octreotide, this increased to 66.0%, [95% CI: 57.0%–74.0%). In the nine studies in which tumor shrinkage was quantified, the overall weighted mean percentage reduction in tumor size was 37.4% [95% CI: 22.4%–52.4%], rising to 50.6% [95% CI: 42.7%–58.4%] with octreotide LAR. Limitations Most trials examined were open-label and had no control group. Conclusions Octreotide LAR induces clinically relevant tumor shrinkage in more than half of patients with acromegaly.
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                Author and article information

                Journal
                J Clin Endocrinol Metab
                J. Clin. Endocrinol. Metab
                jcem
                jceme
                jcem
                The Journal of Clinical Endocrinology and Metabolism
                Endocrine Society (Chevy Chase, MD )
                0021-972X
                1945-7197
                April 2014
                19 December 2013
                19 December 2013
                : 99
                : 4
                : 1282-1290
                Affiliations
                Department of Endocrinology and Metabolic Diseases (P.J.C.), Centre Hospitalier Universitaire Larrey, F-31059 Toulouse, France; Department of Endocrinology (J.S.B.), Aberdeen Royal Infirmary, Aberdeen AB25 2ZP, United Kingdom; ENDOC Center for Endocrine Tumors (S.P.), 20357 Hamburg, Germany; Department of Endocrinology (D.F.), Derriford Hospital, Plymouth PL6 8DH, United Kingdom; Department of Endocrinology, Diabetes, Metabolic Diseases, and Nutrition (A.T.), University of Bordeaux 2, CHU Bordeaux, 33076 Bordeaux, France; Department of Endocrinology, Diabetes, and Metabolic Diseases (G.P.), CHU Rouen, 76031 Rouen, France; Ipsen Pharma (P.M., A.C.), 92100 Boulogne-Billancourt, France
                Author notes
                Address all correspondence and requests for reprints to: Professor Philippe J. Caron, Department of Endocrinology and Metabolic Diseases, Centre Hospitalier Universitaire Larrey, 24 Chemin de Pouvourville, TSA 30030, Toulouse F-31059, France. E-mail: caron.p@ 123456chu-toulouse.fr .
                Article
                13-3318
                10.1210/jc.2013-3318
                4009579
                24423301
                18cffce6-0de3-44af-b4f2-0b1fa47434f7
                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.

                History
                : 30 August 2013
                : 4 December 2013
                Categories
                5
                10
                Endocrine Care

                Endocrinology & Diabetes
                Endocrinology & Diabetes

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