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Erschienen in: Investigational New Drugs 4/2019

10.12.2018 | SHORT REPORT

Efficacy and safety of lanreotide in Korean patients with metastatic, well-differentiated gastroenteropancreatic-neuroendocrine tumors: a retrospective analysis

verfasst von: Junho Kang, Changhoon Yoo, Hee-Sang Hwang, Seung-Mo Hong, Kyu-pyo Kim, Sun Young Kim, Yong-Sang Hong, Tae Won Kim, Baek-Yeol Ryoo

Erschienen in: Investigational New Drugs | Ausgabe 4/2019

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Summary

Lanreotide autogel is a long-acting somatostatin analogue with proven efficacy and safety in patients with well-differentiated (WD) gastroenteropancreatic-neuroendocrine tumors (GEP-NETs) in a prior randomized phase III trial (CLARINET). However, the CLARINET study only enrolled patients with Ki-67 index <10%, and few patients of Asian ethnicity were included. We retrospectively analyzed the efficacy and safety of lanreotide in Korean patients with GEP-NETs in the daily practice setting. Between January 2015 and May 2018, 64 patients with metastatic WD GEP-NETs received lanreotide at Asan Medical Center, Seoul, Korea. Of them, 45 (70.3%) patients who received lanreotide as monotherapy were included in the current analysis. The most common primary tumor site was the pancreas (n = 22, 48.9%), followed by the rectum (10, 22.2%) and the small bowel (7, 15.6%). According to RECIST v1.1, a partial response was achieved in one patient (2.2%) and stable disease was achieved in 40 patients (88.9%). The median progression-free survival (PFS) was 16.4 months (95% confidence interval, 9.5–23.3 months). There were no differences in PFS according to the primary tumor site (p = 0.77). Hepatic tumor volume > 25% and prior systemic therapy were significantly associated with poorer PFS in the multivariate analysis. Lanreotide is well-tolerated and effective for Korean patients with GEP-NETs in the daily practice setting.
Literatur
1.
2.
Zurück zum Zitat Rinke A, Muller HH, Schade-Brittinger C et al (2009) Placebo-controlled, double-blind, prospective, randomized study on the effect of octreotide LAR in the control of tumor growth in patients with metastatic neuroendocrine midgut tumors: a report from the PROMID study group. J Clin Oncol 27:4656–4663. https://doi.org/10.1200/JCO.2009.22.8510 CrossRefPubMed Rinke A, Muller HH, Schade-Brittinger C et al (2009) Placebo-controlled, double-blind, prospective, randomized study on the effect of octreotide LAR in the control of tumor growth in patients with metastatic neuroendocrine midgut tumors: a report from the PROMID study group. J Clin Oncol 27:4656–4663. https://​doi.​org/​10.​1200/​JCO.​2009.​22.​8510 CrossRefPubMed
3.
Zurück zum Zitat Yao JC, Shah MH, Ito T, Bohas CL, Wolin EM, van Cutsem E, Hobday TJ, Okusaka T, Capdevila J, de Vries EG, Tomassetti P, Pavel ME, Hoosen S, Haas T, Lincy J, Lebwohl D, Öberg K, RAD001 in Advanced Neuroendocrine Tumors, Third Trial (RADIANT-3) Study Group (2011) Everolimus for advanced pancreatic neuroendocrine tumors. N Engl J Med 364:514–523. https://doi.org/10.1056/NEJMoa1009290 CrossRefPubMedPubMedCentral Yao JC, Shah MH, Ito T, Bohas CL, Wolin EM, van Cutsem E, Hobday TJ, Okusaka T, Capdevila J, de Vries EG, Tomassetti P, Pavel ME, Hoosen S, Haas T, Lincy J, Lebwohl D, Öberg K, RAD001 in Advanced Neuroendocrine Tumors, Third Trial (RADIANT-3) Study Group (2011) Everolimus for advanced pancreatic neuroendocrine tumors. N Engl J Med 364:514–523. https://​doi.​org/​10.​1056/​NEJMoa1009290 CrossRefPubMedPubMedCentral
4.
Zurück zum Zitat Yao JC, Fazio N, Singh S, Buzzoni R, Carnaghi C, Wolin E, Tomasek J, Raderer M, Lahner H, Voi M, Pacaud LB, Rouyrre N, Sachs C, Valle JW, Fave GD, van Cutsem E, Tesselaar M, Shimada Y, Oh DY, Strosberg J, Kulke MH, Pavel ME, RAD001 in Advanced Neuroendocrine Tumours, Fourth Trial (RADIANT-4) Study Group (2016) Everolimus for the treatment of advanced, non-functional neuroendocrine tumours of the lung or gastrointestinal tract (RADIANT-4): a randomised, placebo-controlled, phase 3 study. Lancet 387:968–977. https://doi.org/10.1016/S0140-6736(15)00817-X CrossRef Yao JC, Fazio N, Singh S, Buzzoni R, Carnaghi C, Wolin E, Tomasek J, Raderer M, Lahner H, Voi M, Pacaud LB, Rouyrre N, Sachs C, Valle JW, Fave GD, van Cutsem E, Tesselaar M, Shimada Y, Oh DY, Strosberg J, Kulke MH, Pavel ME, RAD001 in Advanced Neuroendocrine Tumours, Fourth Trial (RADIANT-4) Study Group (2016) Everolimus for the treatment of advanced, non-functional neuroendocrine tumours of the lung or gastrointestinal tract (RADIANT-4): a randomised, placebo-controlled, phase 3 study. Lancet 387:968–977. https://​doi.​org/​10.​1016/​S0140-6736(15)00817-X CrossRef
6.
Zurück zum Zitat Raymond E, Dahan L, Raoul J-L, Bang YJ, Borbath I, Lombard-Bohas C, Valle J, Metrakos P, Smith D, Vinik A, Chen JS, Hörsch D, Hammel P, Wiedenmann B, van Cutsem E, Patyna S, Lu DR, Blanckmeister C, Chao R, Ruszniewski P (2011) Sunitinib malate for the treatment of pancreatic neuroendocrine tumors. N Engl J Med 364:501–513. https://doi.org/10.1056/NEJMoa1003825 CrossRef Raymond E, Dahan L, Raoul J-L, Bang YJ, Borbath I, Lombard-Bohas C, Valle J, Metrakos P, Smith D, Vinik A, Chen JS, Hörsch D, Hammel P, Wiedenmann B, van Cutsem E, Patyna S, Lu DR, Blanckmeister C, Chao R, Ruszniewski P (2011) Sunitinib malate for the treatment of pancreatic neuroendocrine tumors. N Engl J Med 364:501–513. https://​doi.​org/​10.​1056/​NEJMoa1003825 CrossRef
7.
Zurück zum Zitat Pavel M, O'Toole D, Costa F et al (2016) ENETS consensus guidelines update for the Management of Distant Metastatic Disease of intestinal, pancreatic, bronchial neuroendocrine neoplasms (NEN) and NEN of unknown primary site. Neuroendocrinology 103:172–185. https://doi.org/10.1159/000443167 CrossRefPubMed Pavel M, O'Toole D, Costa F et al (2016) ENETS consensus guidelines update for the Management of Distant Metastatic Disease of intestinal, pancreatic, bronchial neuroendocrine neoplasms (NEN) and NEN of unknown primary site. Neuroendocrinology 103:172–185. https://​doi.​org/​10.​1159/​000443167 CrossRefPubMed
8.
Zurück zum Zitat Kunz PL, Reidy-Lagunes D, Anthony LB et al (2013) Consensus guidelines for the management and treatment of neuroendocrine tumors. Pancreas 42:557–577 Kunz PL, Reidy-Lagunes D, Anthony LB et al (2013) Consensus guidelines for the management and treatment of neuroendocrine tumors. Pancreas 42:557–577
9.
Zurück zum Zitat Caplin ME, Pavel M, Ćwikła JB, Phan AT, Raderer M, Sedláčková E, Cadiot G, Wolin EM, Capdevila J, Wall L, Rindi G, Langley A, Martinez S, Blumberg J, Ruszniewski P, CLARINET Investigators (2014) Lanreotide in metastatic Enteropancreatic neuroendocrine tumors. N Engl J Med 371:224–233. https://doi.org/10.1056/NEJMoa1316158 CrossRefPubMed Caplin ME, Pavel M, Ćwikła JB, Phan AT, Raderer M, Sedláčková E, Cadiot G, Wolin EM, Capdevila J, Wall L, Rindi G, Langley A, Martinez S, Blumberg J, Ruszniewski P, CLARINET Investigators (2014) Lanreotide in metastatic Enteropancreatic neuroendocrine tumors. N Engl J Med 371:224–233. https://​doi.​org/​10.​1056/​NEJMoa1316158 CrossRefPubMed
10.
Zurück zum Zitat Ito T, Honma Y, Hijioka S, Kudo A, Fukutomi A, Nozaki A, Kimura Y, Motoi F, Isayama H, Komoto I, Hisamatsu S, Nakajima A, Shimatsu A (2017) Phase II study of lanreotide autogel in Japanese patients with unresectable or metastatic well-differentiated neuroendocrine tumors. Investig New Drugs 35:499–508. https://doi.org/10.1007/s10637-017-0466-8 CrossRef Ito T, Honma Y, Hijioka S, Kudo A, Fukutomi A, Nozaki A, Kimura Y, Motoi F, Isayama H, Komoto I, Hisamatsu S, Nakajima A, Shimatsu A (2017) Phase II study of lanreotide autogel in Japanese patients with unresectable or metastatic well-differentiated neuroendocrine tumors. Investig New Drugs 35:499–508. https://​doi.​org/​10.​1007/​s10637-017-0466-8 CrossRef
12.
13.
Zurück zum Zitat Caplin ME, Pavel M, Ćwikła JB, Phan AT, Raderer M, Sedláčková E, Cadiot G, Wolin EM, Capdevila J, Wall L, Rindi G, Langley A, Martinez S, Gomez-Panzani E, Ruszniewski P, CLARINET Investigators (2016) Anti-tumour effects of lanreotide for pancreatic and intestinal neuroendocrine tumours: the CLARINET open-label extension study. Endocr Relat Cancer 23:191–199. https://doi.org/10.1530/ERC-15-0490 CrossRefPubMedPubMedCentral Caplin ME, Pavel M, Ćwikła JB, Phan AT, Raderer M, Sedláčková E, Cadiot G, Wolin EM, Capdevila J, Wall L, Rindi G, Langley A, Martinez S, Gomez-Panzani E, Ruszniewski P, CLARINET Investigators (2016) Anti-tumour effects of lanreotide for pancreatic and intestinal neuroendocrine tumours: the CLARINET open-label extension study. Endocr Relat Cancer 23:191–199. https://​doi.​org/​10.​1530/​ERC-15-0490 CrossRefPubMedPubMedCentral
14.
Zurück zum Zitat Palazzo M, Lombard-Bohas C, Cadiot G, Matysiak-Budnik T, Rebours V, Vullierme MP, Couvelard A, Hentic O, Ruszniewski P (2013) Ki67 proliferation index, hepatic tumor load, and pretreatment tumor growth predict the antitumoral efficacy of lanreotide in patients with malignant digestive neuroendocrine tumors. Eur J Gastroenterol Hepatol 25:232–238. https://doi.org/10.1097/MEG.0b013e328359d1a6 CrossRefPubMed Palazzo M, Lombard-Bohas C, Cadiot G, Matysiak-Budnik T, Rebours V, Vullierme MP, Couvelard A, Hentic O, Ruszniewski P (2013) Ki67 proliferation index, hepatic tumor load, and pretreatment tumor growth predict the antitumoral efficacy of lanreotide in patients with malignant digestive neuroendocrine tumors. Eur J Gastroenterol Hepatol 25:232–238. https://​doi.​org/​10.​1097/​MEG.​0b013e328359d1a6​ CrossRefPubMed
17.
Zurück zum Zitat Frilling A, Modlin IM, Kidd M, Russell C, Breitenstein S, Salem R, Kwekkeboom D, Lau WY, Klersy C, Vilgrain V, Davidson B, Siegler M, Caplin M, Solcia E, Schilsky R, Working Group on Neuroendocrine Liver Metastases (2013) Recommendations for management of patients with neuroendocrine liver metastases. Lancet Oncol 15:e8–e21. https://doi.org/10.1016/S1470-2045(13)70362-0 CrossRef Frilling A, Modlin IM, Kidd M, Russell C, Breitenstein S, Salem R, Kwekkeboom D, Lau WY, Klersy C, Vilgrain V, Davidson B, Siegler M, Caplin M, Solcia E, Schilsky R, Working Group on Neuroendocrine Liver Metastases (2013) Recommendations for management of patients with neuroendocrine liver metastases. Lancet Oncol 15:e8–e21. https://​doi.​org/​10.​1016/​S1470-2045(13)70362-0 CrossRef
Metadaten
Titel
Efficacy and safety of lanreotide in Korean patients with metastatic, well-differentiated gastroenteropancreatic-neuroendocrine tumors: a retrospective analysis
verfasst von
Junho Kang
Changhoon Yoo
Hee-Sang Hwang
Seung-Mo Hong
Kyu-pyo Kim
Sun Young Kim
Yong-Sang Hong
Tae Won Kim
Baek-Yeol Ryoo
Publikationsdatum
10.12.2018
Verlag
Springer US
Erschienen in
Investigational New Drugs / Ausgabe 4/2019
Print ISSN: 0167-6997
Elektronische ISSN: 1573-0646
DOI
https://doi.org/10.1007/s10637-018-0710-x

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