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| Name | Class |
|---|---|
| Samsung Medical Center | OTHER |
| Seoul St. Mary's Hospital | OTHER |
| Severance Hospital | OTHER |
| Seoul National University Bundang Hospital |
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Lanreotide Autogel® has been established as a standard of care for patients with locally advanced or metastatic GEP-NETs based on the success of CLARINET trial. However, only few patients with Asian ethnicity were included in the trial.
According to the nationwide comprehensive study of patients with GEP-NET in Korea, hindgut primary NETs(Rectal) occured more frequently than western countries. However, small intestine or lung primary NET is relatively rare compared with western countries.1) Considering the clinical characteristics of GEP-NETs are distinct between the patients in Asian and Western countries, further evaluation on the efficacy and safety of Lanreotide Autogel® in Asian patients with GEP-NETs is needed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lanreotide | Patients treated with lanreotide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lanreotide autogel | Drug | Lanreotide autogel 90-120 mcg, every 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival rate at 2 years | Proportion of patients without tumor progression defined by RECIST version 1.1 at 2 years | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | Time between lanreotide treatment initiation and disease progression or death | 2 years |
| Response rates | Proportion of patients with tumor response by RECIST version 1.1 |
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Inclusion Criteria:
Exclusion Criteria:
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G1-2 GEP-NET patients who would be treated with lanreotide will be included in this study.
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| Name | Affiliation | Role |
|---|---|---|
| Changhoon Yoo | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changhoon Yoo | Seoul | Seoul | 138-736 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23091441 | Background | Gastrointestinal Pathology Study Group of Korean Society of Pathologists; Cho MY, Kim JM, Sohn JH, Kim MJ, Kim KM, Kim WH, Kim H, Kook MC, Park DY, Lee JH, Chang H, Jung ES, Kim HK, Jin SY, Choi JH, Gu MJ, Kim S, Kang MS, Cho CH, Park MI, Kang YK, Kim YW, Yoon SO, Bae HI, Joo M, Moon WS, Kang DY, Chang SJ. Current Trends of the Incidence and Pathological Diagnosis of Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs) in Korea 2000-2009: Multicenter Study. Cancer Res Treat. 2012 Sep;44(3):157-65. doi: 10.4143/crt.2012.44.3.157. Epub 2012 Sep 30. | |
| 21659833 |
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| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| ID | Term |
|---|---|
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| OTHER |
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| 2 years |
| Disease control rates | Proportion of patients with tumor response and stable disease by RECIST version 1.1 | 2 years |
| Overall survival | Time between lanreotide treatment initiation and death due to any cause | 2 years |
| Chromogranin A response | Change of serum chromogranin A levels during lanreotide treatment | 2 years |
| Background |
| Kim SJ, Kim JW, Oh DY, Han SW, Lee SH, Kim DW, Im SA, Kim TY, Heo DS, Bang YJ. Clinical course of neuroendocrine tumors with different origins (the pancreas, gastrointestinal tract, and lung). Am J Clin Oncol. 2012 Dec;35(6):549-56. doi: 10.1097/COC.0b013e31821dee0f. |
| 26731013 | Background | Pavel M, O'Toole D, Costa F, Capdevila J, Gross D, Kianmanesh R, Krenning E, Knigge U, Salazar R, Pape UF, Oberg K; Vienna Consensus Conference participants. 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. 2016;103(2):172-85. doi: 10.1159/000443167. Epub 2016 Jan 5. No abstract available. |
| 30536151 | Background | Kang J, Yoo C, Hwang HS, Hong SM, Kim KP, Kim SY, Hong YS, Kim TW, Ryoo BY. Efficacy and safety of lanreotide in Korean patients with metastatic, well-differentiated gastroenteropancreatic-neuroendocrine tumors: a retrospective analysis. Invest New Drugs. 2019 Aug;37(4):763-770. doi: 10.1007/s10637-018-0710-x. Epub 2018 Dec 10. |
| 25014687 | Background | Caplin ME, Pavel M, Cwikla JB, Phan AT, Raderer M, Sedlackova E, Cadiot G, Wolin EM, Capdevila J, Wall L, Rindi G, Langley A, Martinez S, Blumberg J, Ruszniewski P; CLARINET Investigators. Lanreotide in metastatic enteropancreatic neuroendocrine tumors. N Engl J Med. 2014 Jul 17;371(3):224-33. doi: 10.1056/NEJMoa1316158. |
| D009380 | Neoplasms, Nerve Tissue |