ECE2013 Poster Presentations Thyroid cancer (64 abstracts)
A single-center, open-label, phase II, proof-of-concept study with pasireotide long-acting release in patients with progressive medullary thyroid cancer: 6-month evaluation
Antongiulio Faggiano 1, , Piero Ferolla 3 , Giovanni Vitale 4, , Michela Del Prete 1 , Valeria Ramundo 1 , Raffaella Esposito 1 , Vincenzo Marotta 1 , Francesca Marciello 1 , Anna Chiara Carratù 1 , Luigi Camera 6 , Rosi Fonti 6 & Annamaria Colao 1
1Department of Molecular and Clinical Endocrinology and Oncology, Federico II University of Naples, Napoli, Italy; 2Endocrinology, National Cancer Institute, “Fondazione G. Pascale”, Napoli, Italy; 3Department of Internal Medicine, University of Perugia, Perugia, Italy; 4Ospedale San Luca IRCCS, Istituto Auxologico Italiano, Milan, Italy; 5Department of Medical Sciences, University of Milan, Milano, Italy; 6Department of Biomorphological and Functional Sciences, Federico II University of Naples, Napoli, Italy.
Introduction: Medullary thyroid cancer (MTC) is a well-differentiated neuroendocrine tumor in which somatostatin receptor (sst) expression is higher for sst1 and sst5 than for sst2. This may explain why the available sst2–selective analogues do not work in these patients and why pasireotide (SOM230), a novel, multi-receptor targeted somatostatin analogue with high-binding affinity for sst1,2,3 and sst5 could be effective.
Aim: To evaluate the effectiveness of pasireotide long-acting release (LAR) in MTC patients with progressive disease.
Study design: Trial enrollment started in February 2012 (study registration no. NCT01625520). Twenty patients are expected to be enrolled. At now, 14 consecutive patients with progressive metastatic or persistent postoperative MTC have been enrolled and received pasireotide LAR 60 mg/m.
Results: At 1 month evaluation, calcitonin hypersecretion was significantly decreased in seven patients (by 32–73%), stable in six and progressive in one other. Among the ten patients who were evaluable at 3 month follow-up, calcitonin was significantly decreased in six patients, stable in three and further increased in one. Five patients with bone and bowel symptoms at baseline experienced clinical response. Target tumor lesions were stable in 9/10 patients and progressive in 1/10 who had a 3- and 6-month CT scan. FDG-PET SUVmax was decreased by 36–50% in 2/9 patients with stable disease at CT scan.
Conclusions: This is the first experience on the use of pasireotide (SOM230) in patients with MTC. An antisecretive and antiproliferative response to pasireotide LAR has been observed in patients with progressive MTC.
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Endocrine Abstracts
ISSN 1470-3947 (print) | ISSN 1479-6848 (online)
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