scholarly journals Observational, multicentre study to evaluate the effectiveness in routine clinical practice of Lanreotide Autogel 120 mg at extended dosing intervals (>4 weeks) for the treatment of acromegaly: SOMACROL study

2018 ◽  
Author(s):  
Cristina Alvarez Escola ◽  
Carmen Fajardo ◽  
Monica Marazuela ◽  
Fernando Cordido Carballido ◽  
Eva Maria Venegas ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Multicentre Study ◽  
Routine Clinical Practice ◽  
Dosing Intervals ◽  
Lanreotide Autogel

scholarly journals Effectiveness of lanreotide autogel 120 mg at extended dosing intervals for acromegaly

Endocrine ◽  
2020 ◽  
Vol 70 (3) ◽  
pp. 575-583 ◽  
Author(s):  
Ignacio Bernabéu ◽  
Carmen Fajardo ◽  
Mónica Marazuela ◽  
Fernando Cordido ◽  
Eva María Venegas ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Treatment Adherence ◽  
Treatment Satisfaction ◽  
Serum Insulin ◽  
Routine Clinical Practice ◽  
Biochemical Control ◽  
The Mean ◽  
Long Acting ◽  
Dosing Intervals ◽  
Lanreotide Autogel

Abstract Purpose Recent data indicate that extended dosing intervals (EDIs) with lanreotide autogel 120 mg are effective and well-received among patients with acromegaly who have achieved biochemical control with monthly injections of long-acting somatostatin analogues (SSAs). We further evaluated the effectiveness of lanreotide autogel 120 mg delivered at EDIs (>4 weeks) in routine clinical practice. Methods Cross-sectional, multicentre, observational study conducted to determine the effectiveness—measured by control of serum insulin-like growth factor 1 (IGF-1)—of lanreotide autogel 120 mg at dosing intervals >4 weeks for ≥6 months in selected patients with acromegaly treated in routine clinical practice (NCT02807233). Secondary assessments included control of growth hormone (GH) levels, treatment adherence, patient satisfaction, and quality of life (QoL) using validated questionnaires (EQ-5D, AcroQoL, and TSQM-9). Patients who received radiotherapy within the last 6 months were excluded. Results Among 109 patients evaluated, mean (SD) age was 59.1 (13.2) years. IGF-1 values were normal (mean [SD]: 175.0 [74.5], 95% CI: 160.8 –189.1) in 91.7% of cases and normal in 91.4% of patients without previous radiotherapy treatment (n = 81). GH levels were ≤2.5 and ≤1 ng/mL, respectively, in 80.6% and 58.3%. Most patients were treated either every 5–6 (57.8%) or 7–8 weeks (38.5%), with 2.8% treated greater than every 8 weeks. The mean AcroQoL score was 63.0 (20.1). The mean global treatment satisfaction score (TSQM-9) was 75.1 (16.6). Treatment adherence (defined as no missed injections) was 94.5%. Conclusion Lanreotide autogel 120 mg at intervals of >4 weeks provided IGF-1 control in more than 90% of patients with acromegaly. Treatment satisfaction and adherence were good. These findings support use of extended dosing intervals in patients who have achieved good biochemical control with long-acting SSAs.

scholarly journals Multicenter, Observational Study of Lanreotide Autogel for the Treatment of Patients with Neuroendocrine Tumors in Routine Clinical Practice in Germany and Austria

2021 ◽  
Vol 129 (07) ◽  
pp. 500-509
Author(s):  
Anja Rinke ◽  
Christoph Maintz ◽  
Lothar Müller ◽  
Matthias M. Weber ◽  
Harald Lahner ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Neuroendocrine Tumors ◽  
Chromogranin A ◽  
Carcinoid Syndrome ◽  
Evaluation Criteria ◽  
Routine Clinical Practice ◽  
Good Tolerability ◽  
Multicenter Observational Study ◽  
Long Term Treatment ◽  
Lanreotide Autogel

Abstract Background The long-acting somatostatin analog lanreotide autogel is effective in the treatment of patients with neuroendocrine tumors. Objective To evaluate the long-term treatment response in patients with neuroendocrine tumors receiving lanreotide autogel in routine clinical practice. Methods Non-interventional, 24-month study in patients with neuroendocrine tumors treated with lanreotide autogel (NCT01840449). Results Patients (n=80) from 26 centers in Germany and Austria were enrolled. Neuroendocrine tumors were mainly grade 1/2, metastasized, intestinal, and associated with carcinoid syndrome; 88.9% had received previous neuroendocrine tumor treatment. Of those, 84.4% had previous surgery, 18.7% had received octreotide. The primary endpoint, defined by a <50% chromogranin A increase at month 12 compared with the lowest value between baseline and month 3 was achieved by 89.5% patients. Stable disease according to Response Evaluation Criteria in Solid Tumors 1.1 was observed in 76.9 and 75.0% patients at months 12 and 24 of lanreotide treatment, respectively. Mean change of chromogranin A levels from baseline to month 24 was −0.12 × upper limit of normal (95% CI, −0.22; −0.45). In a post hoc analysis, 38.5% of the subgroup of patients with carcinoid syndrome had daily diarrhea at baseline vs. 21.4% at month 24. At baseline, 27.8% of patients received lanreotide 120 mg every 4 weeks vs. 56.7% at month 24. Quality of life data were heterogeneous. No new safety issues arose and/or required further investigation. Conclusions Our study reflects routine lanreotide autogel use in patients with advanced/metastatic neuroendocrine tumors. This analysis shows effectiveness with stabilization of disease-related symptoms and good tolerability of lanreotide autogel in clinical practice.

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