Antiproliferative effects of lanreotide autogel in patients with progressive, well-differentiated neuroendocrine tumours : A Spanish, multicentre, open-label, single arm phase II study
Martín-Richard, Marta (Institut d'Investigació Biomèdica Sant Pau)
Massutí, Bartomeu (Hospital General Universitario de Alicante (Alacant, País Valencià))
Pineda, Eva (Ipsen Pharma)
Alonso, Vicente (Hospital Universitario Miguel Servet (Saragossa))
Marmol, Maribel (Hospital Clínic i Provincial de Barcelona)
Castellano, Daniel (Hospital Universitario 12 de Octubre (Madrid))
Fonseca, Emilio (Hospital Clínico Universitario (Salamanca))
Galán, Antonio (Hospital de Sagunto)
Llanos, Marta (Hospital Universitario de Canarias (La Laguna))
Sala, María Ángeles (Hospital Universitario de Basurto (Bilbao, Biscaia))
Pericay, Carles (Parc Taulí Hospital Universitari. Institut d'Investigació i Innovació Parc Taulí (I3PT))
Rivera, Fernando (Hospital Universitario Marqués de Valdecilla (Santander, Cantabria))
Sastre, Javier (Hospital Universitario Clínico San Carlos (Madrid))
Segura, Ángel (Hospital Universitari i Politècnic La Fe (València))
Quindós, Maria (Complejo Hospitalario Universitario de A Coruña)
Maisonobe, Pascal (Ipsen Pharma)
Universitat Autònoma de Barcelona

Date:	2013
Abstract:	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 >12 months in patients with progressive NETs ineligible for surgery or chemotherapy, with a safety profile consistent with the pharmacology of the class. Trial registration: ClinicalTrials. gov Identifier NCT00326469; EU Clinical Trial Register EudraCT no 2004-002871-18. © 2013 Martín-Richard et al. ; licensee BioMed Central Ltd.
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Subject:	Antiproliferative effect ; Lanreotide autogel ; Neuroendocrine tumours ; Phase II clinical trial ; Somatostatin analogues
Published in:	BMC Cancer, Vol. 13 (20 2013) , p. 427, ISSN 1471-2407

DOI: 10.1186/1471-2407-13-427
PMID: 24053191

9 p, 325.6 KB

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Research literature > UAB research groups literature > Research Centres and Groups (research output) > Health sciences and biosciences > Parc Taulí Research and Innovation Institute (I3PT
Research literature > UAB research groups literature > Research Centres and Groups (research output) > Health sciences and biosciences > Institut de Recerca Sant Pau
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