Antiproliferative effects of lanreotide autogel in patients with progressive, well-differentiated neuroendocrine tumours: a Spanish, multicentre, open-label, single arm phase II study
1 Medical Oncology Department, Hospital de la Santa Creu y Sant Pau, Av. Sant Antoni Mª Claret, 167, Barcelona 08025, Spain
2 Medical Oncology Department, Hospital General Universitario de Alicante, Alicante, Spain
3 Medical Department, Ipsen Pharma, Barcelona, Spain
4 Medical Oncology Department, University Hospital Miguel Servet, Zaragoza, Spain
5 Medical Oncology Department, Hospital Clinic i Provincial, Barcelona, Spain
6 Medical Oncology Department, University Hospital 12 de Octubre, Madrid, Spain
7 Medical Oncology Department, University Hospital Clínico Salamanca, Salamanca, Spain
8 Medical Oncology Department, Hospital de Sagunto, Sagunto, Spain
9 Medical Oncology Department, University Hospital Canarias, Santa Cruz de Tenerife, Spain
10 Medical Oncology Department, Hospital Universitario de Basurto, Bilbao, Spain
11 Medical Oncology Department, Hospital Universitari de Sabadell, Corporació Sanitaria Universitaria Parc Tauli, Sabadell, Spain
12 Medical Oncology Department, Hospital Marqués de Valdecilla, Santander, Spain
13 Medical Oncology Department, Hospital Clínico San Carlos, Madrid, Spain
14 Medical Oncology Department, Hospital Universitari i Politecnic La Fe, Valencia, Spain
15 Medical Oncology, Hospital A Coruña, A Coruña, Spain
16 Global Medical Affairs, Ipsen Pharma, Boulogne Billancourt, France
BMC Cancer 2013, 13:427 doi:10.1186/1471-2407-13-427Published: 20 September 2013
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.
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.
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.
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.
ClinicalTrials.gov Identifier NCT00326469; EU Clinical Trial Register EudraCT no 2004-002871-18.