Antiproliferative effects of lanreotide autogel in patients with progressive, well-differentiated neuroendocrine tumours

Background: Somatostatin analogues (SSAs) are indicated to relieve carcinoid syndrome but seem to have antiproliferative effects on neuroendocrine tumours (NETs). This is the first prospective study investigating tumour stabilisation with the long-acting SSA lanreotide Autogel in patients with progr...

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Detalles Bibliográficos
Autores: Martín-Richard, Marta|||0000-0003-4933-2463, Massutí, Bartomeu|||0000-0002-7608-3952, Pineda, Eva, Alonso Orduña, Vicente|||0000-0003-2280-1004, Marmol, Maribel, Castellano, Daniel|||0000-0002-9106-0687, Fonseca, Emilio, Galán, Antonio, Llanos, Marta, Sala, María Ángeles, Pericay, Carles|||0000-0002-4975-7851, Rivera, Fernando|||0000-0001-8915-226X, Sastre, Javier, Segura, Ángel, Quindós-Varela, María, Maisonobe, Pascal
Tipo de recurso: artículo
Fecha de publicación:2013
País:España
Institución:Universitat Autònoma de Barcelona
Repositorio:Dipòsit Digital de Documents de la UAB
Idioma:inglés
OAI Identifier:oai:ddd.uab.cat:302940
Acceso en línea:https://ddd.uab.cat/record/302940
https://dx.doi.org/urn:doi:10.1186/1471-2407-13-427
Access Level:acceso abierto
Palabra clave:Antiproliferative effect
Lanreotide autogel
Neuroendocrine tumours
Phase II clinical trial
Somatostatin analogues
Descripción
Sumario:Background: Somatostatin analogues (SSAs) are indicated to relieve carcinoid syndrome but seem to have antiproliferative effects on neuroendocrine tumours (NETs). This is the first prospective study investigating tumour stabilisation with the long-acting SSA lanreotide Autogel in patients with progressive NETs. Methods: This was a multicentre, open-label, phase II trial conducted in 17 Spanish specialist centres. Patients with well-differentiated NETs and radiologically confirmed progression within the previous 6 months received lanreotide Autogel, 120 mg every 28 days over ≤92 weeks. The primary endpoint was progression-free survival (PFS). Secondary endpoints were response rate, tumour biomarkers, symptom control, quality of life (QoL), and safety. Radiographic imaging was assessed by a blinded central radiologist. Results: Of 30 patients included in the efficacy and safety analyses, 40% had midgut tumours and 27% pancreatic tumours; 63% of tumours were functioning. Median PFS time was 12.9 (95% CI: 7.9, 16.5) months, and most patients achieved disease stabilisation (89%) or partial response (4%). No deterioration in QoL was observed. Nineteen patients (63%) experienced treatment-related adverse events, most frequently diarrhoea and asthenia; only one treatment-related adverse event (aerophagia) was severe. Conclusion: Lanreotide Autogel provided effective tumour stabilisation and PFS.