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An open-label, single-group, multicenter phase II study of lanreotide autogel (LAN) in Japanese patients (pts) with neuroendocrine tumors (NET).

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471Background: LAN is a long-acting somatostatin analog indicated in EU for the treatment of carcinoid syndrome and in the US and EU as antiproliferative treatment in pts with gastroenteropancreatic (GEP)… Click to show full abstract

471Background: LAN is a long-acting somatostatin analog indicated in EU for the treatment of carcinoid syndrome and in the US and EU as antiproliferative treatment in pts with gastroenteropancreatic (GEP) -NET. The antitumor efficacy of LAN in pts with GEP-NET was evaluated in the phase III CLARINET study. No study to date has reported the antitumor effects of somatostatin analog in Japanese pts with NET. Methods: In this open-label, single-arm study, Japanese pts with Grade 1 or 2 unresectable metastatic or locally advanced NET received 120 mg once every 4 weeks for 48 weeks. Pts who completed the study were subsequently enrolled in the long-term extension study. The primary endpoint was the clinical benefit rate (CBR: the ratio of pts with a complete response, a partial response (PR), or stable disease over 24 weeks). Secondary endpoints included progression-free survival (PFS), objective response rate (ORR) (RECIST 1.1, central review), serum chromogranin A (CgA) level and quality of life using the EOR...

Keywords: phase; study; label single; open label; single group

Journal Title: Journal of Clinical Oncology
Year Published: 2017

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