Study to Assess the Use of Lanreotide Autogel® 120 mg in Patients With Locally Advanced or Metastatic Gastroenteropancreatic Neuroendocrine Tumours (GEP-NETs) in Routine Clinical Practice

Author(s):  
2018 ◽  
Vol 10 (12) ◽  
pp. 365-376 ◽  
Author(s):  
Thierry Lebret ◽  
Alain Ruffion ◽  
Igor Latorzeff ◽  
Marc Zerbib ◽  
Jean-Luc Moreau ◽  
...  

Background: No published studies have specifically assessed whether treatment modifications to androgen deprivation therapy (ADT) for prostate cancer (PCa) are frequently carried out in routine clinical practice. The current study was conducted to determine what proportion of patients who had initiated hormone therapy with a gonadotropin-releasing hormone (GnRH) analogue then had their treatment regimen modified during the first 24 months. Methods: A prospective, noninterventional study was carried out in routine clinical practice in France. Patients with locally advanced or metastatic PCa were followed up for 2 years after treatment initiation with a GnRH analogue. The primary endpoint was the proportion of patients with a modification to their initial hormone therapy. Results: In total, 1301 patients were enrolled into the study by 204 physicians, and the primary endpoint could be evaluated for 891 patients. The GnRH analogue treatment was initiated for metastatic PCa (24.2%), locally advanced PCa without planned local treatment (20.6%), locally advanced PCa in association with radiotherapy (31.6%), and biochemical recurrence after local treatment (21.4%). Hormonal treatment was modified in 43.8% (390/891) of patients during the 24-month follow-up period after GnRH analogue initiation. In 61.3% of cases (239/390), the type of modification involved a change of GnRH analogue formulation or switch to another GnRH analogue. A total of five significant predictive factors for GnRH analogue treatment modification were identified: metastatic stage; physician sector; physician speciality; presence or absence of urinary symptoms; and intermittent versus continuous ADT. Conclusions: This study shows that in 43.8% of the patients with advanced PCa, ADT is modified in the first 2 years after initiation in routine clinical practice. Predictive factors for alteration of ADT were metastatic stage and the choice of an intermittent schedule.


2020 ◽  
Vol 4 ◽  
Author(s):  
Daleen Geldenhuys ◽  
Bernardo L. Rapoport ◽  
Samuel Fourie ◽  
Waldemar M. Szpak ◽  
Sylvia Rodrigues ◽  
...  

Background: Neuroendocrine tumours are known to impact patients’ quality of life because of the symptoms caused by hypersecretion of serotonin and other peptides, in particular diarrhoea and flushing.Aim: The Q-SYMTU study was a prospective, observational registry that included 24 symptomatic patients with gastroenteropancreatic neuroendocrine tumours.Setting: Multiple oncology practices in South Africa.Method: Patients’ level of satisfaction was evaluated for a 6-month period from initiation of treatment with lanreotide Autogel.Results: The number of patients who had greater than 50% self-reported reduction in daily episodes of diarrhoea and flushing were 67% and 80%, respectively, over a 6-month period.Conclusion: Treatment with lanreotide Autogel was generally well tolerated, as demonstrated by low occurrence of Grade 3 and Grade 4 adverse events (AEs). None of the Grade 4 AEs were related to the study treatment. No Grade 5 AEs were reported.


2019 ◽  
Vol 10 (1) ◽  
pp. 17-22
Author(s):  
MA Hai ◽  
Ehteshamul Haque ◽  
Salim Reza ◽  
Mokhles Uddin ◽  
Kumkum Pervin

Background: Most head and neck cancers are squamous cell carcinomas (SCCHN) that contribute to substantial morbidity and mortality worldwide. The disease is mostly diagnosed at locally advanced stage. Because treatment of head and neck cancers is complex and involves multiple modalities of surgery, radiotherapy and systemic therapy including chemotherapy and molecularly targeted agents; a multidisciplinary approach is needed. The study evaluated the current treatment approaches for patients newly diagnosed with SCCHN in Bangladesh. Methods: This prospective, observational and non-comparative, study enrolled eligible males and females of 18 years newly diagnosed with SCCHN at any stage of disease. No therapeutic intervention was implied rather selection of treatment strategy and dosage of therapy was on discretion of individual oncologist as per routine clinical practice. Results: A total of 64 patients with median age of 55 years were enrolled between August 2008 and July 2011. The majority of patients (42, 65.6%) were males. The major risk factors were betel leaf chewing along with jorda (smokeless tobacco) (62.5%) and cigarette smoking (32.8%), though most of the patients had multiple risk factors. No patient was diagnosed at early stage; all were in locally advanced disease at stage III (52, 81.3%) and IV (12, 18.8%). The oncologists prescribed neoadjuvant chemotherapy in half (32) of the patients, 19 (29.7%) patients received adjuvant chemotherapy and 13 (20.3%) received palliative chemotherapy. Only 3 (4.6%) of the patients received radiotherapy. Chemotherapy combination regimen included docetaxel, cisplatin and 5-fluorouracil (5-FU) and leucovorin was added to 2 patients. The dosage of chemotherapeutic agents was as per routine clinical practice of the oncologists. Neutropenia was the common hematological abnormality reported spontaneously in 16 (25%) patients. No serious adverse event was reported leading the patients to withdraw from therapy. During continuation of therapy 1 patient died due to sudden cardiac arrest who had medical history of previous myocardial infarction. Conclusion: This registry revealed that squamous cell carcinoma of head and neck region are mostly presented in advanced stage in Bangladesh and the majority of the patients are treated with combination chemotherapeutic regimens. Anwer Khan Modern Medical College Journal Vol. 10, No. 1: Jan 2019, P 17-22


2021 ◽  
Vol 129 (07) ◽  
pp. 500-509
Author(s):  
Anja Rinke ◽  
Christoph Maintz ◽  
Lothar Müller ◽  
Matthias M. Weber ◽  
Harald Lahner ◽  
...  

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.


2012 ◽  
Vol 139 (2) ◽  
pp. 269-280 ◽  
Author(s):  
Domenico Angelucci ◽  
Nicola Tinari ◽  
Antonino Grassadonia ◽  
Ettore Cianchetti ◽  
Giampiero Ausili-Cefaro ◽  
...  

Endocrine ◽  
2020 ◽  
Vol 70 (3) ◽  
pp. 575-583 ◽  
Author(s):  
Ignacio Bernabéu ◽  
Carmen Fajardo ◽  
Mónica Marazuela ◽  
Fernando Cordido ◽  
Eva María Venegas ◽  
...  

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.


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