Difference between revisions of "Neuroendocrine tumor - null regimens"

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|[[Neuroendocrine_tumor#Octreotide_LAR_monotherapy|Octreotide LAR]]
 
|[[Neuroendocrine_tumor#Octreotide_LAR_monotherapy|Octreotide LAR]]
 
|style="background-color:#d73027"|Inferior TTP
 
|style="background-color:#d73027"|Inferior TTP
|
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| style="background-color:#d3d3d3" |
 
|-
 
|-
 
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6063317/ Yao et al. 2015 (RADIANT-4)]
 
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6063317/ Yao et al. 2015 (RADIANT-4)]
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|[[#Surufatinib_monotherapy_777|Surufatinib]]
 
|[[#Surufatinib_monotherapy_777|Surufatinib]]
 
| style="background-color:#d73027" |Inferior PFS
 
| style="background-color:#d73027" |Inferior PFS
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| style="background-color:#d3d3d3" |
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|-
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|[https://doi.org/10.1530/erc-23-0337 Baudin et al. 2024 (SPINET)]
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|2016-07 to 2018-07
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| style="background-color:#1a9851" |Phase 3 (C)
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|[[Neuroendocrine_tumor#Lanreotide_LAR_monotherapy|Lanreotide LAR]]
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| style="background-color:#ffffbf" |Did not meet primary endpoint of PFS
 
| style="background-color:#d3d3d3" |
 
| style="background-color:#d3d3d3" |
 
|-
 
|-
 
|}
 
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''No active antineoplastic treatment. Used as a comparator arm and here for reference purposes only.''
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''No active antineoplastic treatment.''
 
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## '''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. [https://doi.org/10.1016/S1470-2045(17)30471-0 link to original article] [https://pubmed.ncbi.nlm.nih.gov/28838862/ PubMed]
 
## '''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. [https://doi.org/10.1016/S1470-2045(17)30471-0 link to original article] [https://pubmed.ncbi.nlm.nih.gov/28838862/ PubMed]
 
# '''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. [https://doi.org/10.1016/s1470-2045(20)30496-4 link to original article] [https://pubmed.ncbi.nlm.nih.gov/32966811/ PubMed] [https://clinicaltrials.gov/study/NCT02588170 NCT02588170]
 
# '''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. [https://doi.org/10.1016/s1470-2045(20)30496-4 link to original article] [https://pubmed.ncbi.nlm.nih.gov/32966811/ PubMed] [https://clinicaltrials.gov/study/NCT02588170 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. [https://doi.org/10.1530/erc-23-0337 link to original article] [https://pubmed.ncbi.nlm.nih.gov/38913539/ PubMed] [https://clinicaltrials.gov/study/NCT02683941 NCT02683941]
  
 
[[Category:Neuroendocrine tumor regimens]]
 
[[Category:Neuroendocrine tumor regimens]]

Latest revision as of 15:47, 25 July 2024

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 Inferior TTP
Yao et al. 2015 (RADIANT-4) 2012-04 to 2013-08 Phase 3 (C) Everolimus Might have inferior OS Equivalent HRQoL
Xu et al. 2020 (SANET-ep) 2015-2019 Phase 3 (C) Surufatinib Inferior PFS
Baudin et al. 2024 (SPINET) 2016-07 to 2018-07 Phase 3 (C) Lanreotide LAR Did not meet primary endpoint of PFS

No active antineoplastic treatment.

References

  1. 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 PubMed NCT00171873
  2. 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 PubMed NCT01524783
    1. 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 PubMed
  3. 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 PubMed NCT02588170
  4. 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 PubMed NCT02683941