Neuroendocrine tumor - null regimens

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The purpose of this page is to provide references to "null therapy" such as placebo and observation. These references provide further insight into the historical development of the treatment landscape. See the main NET page for regimens that include active anticancer treatment.
=All lines of therapy=
==Placebo==
===Regimen===
Study 	Dates of enrollment	Evidence 	Comparator 	Comparative Efficacy 	Comparative Toxicity
Rinke et al. 2009 (PROMID) 	2001-2008 	Phase 3 (C)	Octreotide LAR	Shorter TTP 	
Vinik et al. 2016 (ELECT) 	2009-05 to 2013-05 	Phase 3 (C)	Lanreotide LAR	Increased need for short-acting octreotide rescue (primary endpoint) 	
Yao et al. 2015 (RADIANT-4) 	2012-04 to 2013-08 	Phase 3 (C)	Everolimus 	Might have shorter OS 	Equivalent HRQoL
Xu et al. 2020 (SANET-ep) 	2015-2019 	Phase 3 (C)	Surufatinib 	Shorter PFS 	
Baudin et al. 2024 (SPINET) 	2016-07 to 2018-07 	Phase 3 (C)	Lanreotide LAR	Did not meet primary endpoint of PFS 	
Chan et al. 2024 (CABINET extrapancreatic)	2018-10 to 2023-08 	Phase 3 (C)	Cabozantinib 	Shorter PFS (primary endpoint)Median PFS: 3.9 vs 8.4 mo(HR 2.63, 95% CI 1.69-4.00)	
No active antineoplastic treatment.
===References===
# PROMID: Rinke A, Müller HH, Schade-Brittinger C, Klose KJ, Barth P, Wied M, Mayer C, Aminossadati B, Pape UF, Bläker M, Harder J, Arnold C, Gress T, Arnold R; PROMID Study Group. 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. 2009 Oct 1;27(28):4656-63. Epub 2009 Aug 24. link to original article EuroPMC NCT00171873
##Update: Rinke A, Wittenberg M, Schade-Brittinger C, Aminossadati B, Ronicke E, Gress TM, Müller HH, Arnold R; PROMID Study Group. 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 (PROMID): Results of Long-Term Survival. Neuroendocrinology. 2017;104(1):26-32. Epub 2016 Jan 6. link to original article EuroPMC
##HRQoL analysis: Rinke A, Neary MP, Eriksson J, Hunger M, Doan T, Karli D, Arnold R. Health-Related Quality of Life for Long-Acting Octreotide versus Placebo in Patients with Metastatic Midgut Neuroendocrine Tumors in the Phase 3 PROMID Trial. Neuroendocrinology. 2019;109(2):141-151. Epub 2019 Mar 11. link to original article EuroPMC
# RADIANT-4: 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. 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. 2016 Mar 5;387(10022):968-977. Epub 2015 Dec 17. link to original article link to PMC article EuroPMC NCT01524783
## HRQoL analysis: Pavel ME, Singh S, Strosberg JR, Bubuteishvili-Pacaud L, Degtyarev E, Neary MP, Carnaghi C, Tomasek J, Wolin E, Raderer M, Lahner H, Valle JW, Pommier R, Van Cutsem E, Tesselaar MET, Fave GD, Buzzoni R, Hunger M, Eriksson J, Cella D, Ricci JF, Fazio N, Kulke MH, Yao JC. Health-related quality of life for everolimus versus placebo in patients with advanced, non-functional, well-differentiated gastrointestinal or lung neuroendocrine tumours (RADIANT-4): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2017 Oct;18(10):1411-1422. Epub 2017 Aug 30. link to original article EuroPMC
# ELECT: Vinik AI, Wolin EM, Liyanage N, Gomez-Panzani E, Fisher GA; ELECT Study Group. Evaluation of Lanreotide Depot/Autogel Efficacy and Safety as a Carcinoid Syndrome Treatment (ELECT): A Randomized, Double-Blind, Placebo-Controlled Trial. Endocr Pract. 2016 Sep;22(9):1068-80. Epub 2016 May 23. link to original article EuroPMC NCT00774930
# SANET-ep: Xu J, Shen L, Zhou Z, Li J, Bai C, Chi Y, Li Z, Xu N, Li E, Liu T, Bai Y, Yuan Y, Li X, Wang X, Chen J, Ying J, Yu X, Qin S, Yuan X, Zhang T, Deng Y, Xiu D, Cheng Y, Tao M, Jia R, Wang W, Li J, Fan S, Peng M, Su W. Surufatinib in advanced extrapancreatic neuroendocrine tumours (SANET-ep): a randomised, double-blind, placebo-controlled, phase 3 study. Lancet Oncol. 2020 Nov;21(11):1500-1512. Epub 2020 Sep 20. link to original article EuroPMC NCT02588170
#SPINET: Baudin E, Capdevila J, Hörsch D, Singh S, Caplin ME, Wolin EM, Buikhuisen W, Raderer M, Dansin E, Grohe C, Ferone D, Houchard A, Truong-Thanh XM, Reidy-Lagunes D. Treatment of advanced BP-NETS with lanreotide autogel/depot vs placebo: the phase III SPINET study. Endocr Relat Cancer. 2024 Jul 22;31(9):e230337. link to original article EuroPMC NCT02683941
#CABINET extrapancreatic: Chan JA, Geyer S, Zemla T, Knopp MV, Behr S, Pulsipher S, Ou FS, Dueck AC, Acoba J, Shergill A, Wolin EM, Halfdanarson TR, Konda B, Trikalinos NA, Tawfik B, Raj N, Shaheen S, Vijayvergia N, Dasari A, Strosberg JR, Kohn EC, Kulke MH, O'Reilly EM, Meyerhardt JA. Phase 3 Trial of Cabozantinib to Treat Advanced Neuroendocrine Tumors. N Engl J Med. 2025 Feb;392(7):653-665. Epub 2024 Sep 18. link to original article link to EuroPMC NCT03375320
Category:Neuroendocrine tumor regimens
Category:Disease-specific pages
Category:Endocrine cancers
Category:Null regimens