Antiproliferative effects of lanreotide autogel in patients with progressive, well-differentiated neuroendocrine tumours: a Spanish, multicentre, open-label, single arm phase II study
Por:
Martin-Richard, M, Massuti, B, Pineda, E, Alonso, V, Marmol, M, Castellano, D, Fonseca, E, Galan, A, Llanos, M, Sala, MA, Pericay, C, Rivera, F, Sastre, J, Segura, A, Quindos, M, Maisonobe, P
Publicada:
20 sep 2013
Resumen:
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.
Filiaciones:
Martin-Richard, M:
Hosp Santa Creu & Sant Pau, Med Oncol Dept, Barcelona 08025, Spain
Massuti, B:
Hosp Gen Univ Alicante, Dept Med Oncol, Alicante, Spain
Pineda, E:
Ipsen Pharma, Dept Med, Barcelona, Spain
Alonso, V:
Univ Hosp Miguel Servet, Dept Med Oncol, Zaragoza, Spain
Marmol, M:
Hosp Clin Barcelona, Med Oncol Dept, Barcelona, Spain
Castellano, D:
Univ Hosp 12 Octubre, Dept Med Oncol, Madrid, Spain
Fonseca, E:
Univ Hosp Clin Salamanca, Dept Med Oncol, Salamanca, Spain
Galan, A:
Hosp Sagunto, Dept Med Oncol, Sagunto, Spain
Llanos, M:
Univ Hosp Canarias, Dept Med Oncol, Santa Cruz De Tenerife, Spain
Sala, MA:
Hosp Univ Basurto, Dept Med Oncol, Bilbao, Spain
Pericay, C:
Corp Sanitaria Univ, Hosp Univ Sabadell, Dept Med Oncol, Sabadell, Spain
Rivera, F:
Hosp Marques de Valdecilla, Med Oncol Dept, Santander, Spain
Sastre, J:
Hosp Clin San Carlos, Dept Med Oncol, Madrid, Spain
Segura, A:
Hosp Univ & Politecn La Fe, Dept Med Oncol, Valencia, Spain
Quindos, M:
Hosp A Coruna, La Coruna, Spain
Maisonobe, P:
Ipsen Pharma, Global Med Affairs, Boulogne, Billancourt, France
Gold, Green Published
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