Difference between revisions of "Pancreatic NET - null regimens"

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The purpose of this page is to provide references to "null therapy" such as placebo and observation. While not clinically relevant, these references provide further insight into the historical development of the treatment landscape. See the [[Pancreatic NET|main pancreatic NET page]] for current 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 [[Pancreatic NET|main pancreatic NET page]] for regimens that include active anticancer treatment.
  
 
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=All lines of therapy=
 
=All lines of therapy=
 
==Placebo==
 
==Placebo==
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|[[#top|back to top]]
 
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===Regimen===
 
===Regimen===
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
 
!style="width: 17%"|Study
 
!style="width: 17%"|Study
−
!style="width: 15%"|Years of enrollment
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!style="width: 15%"|Dates of enrollment
 
!style="width: 17%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
!style="width: 17%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
!style="width: 17%"|Comparator
 
!style="width: 17%"|Comparator
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|[https://doi.org/10.1200/jco.2009.22.8510 Rinke et al. 2009 (PROMID)]
 
|[https://doi.org/10.1200/jco.2009.22.8510 Rinke et al. 2009 (PROMID)]
 
|2001-2008
 
|2001-2008
−
| style="background-color:#1a9851" |Phase III (C)
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| style="background-color:#1a9851" |Phase 3 (C)
 
|[[Pancreatic_NET#Octreotide_LAR_monotherapy|Octreotide LAR]]
 
|[[Pancreatic_NET#Octreotide_LAR_monotherapy|Octreotide LAR]]
 
| style="background-color:#d73027" |Inferior TTP
 
| style="background-color:#d73027" |Inferior TTP
 
| style="background-color:#d3d3d3" |
 
| style="background-color:#d3d3d3" |
 
|-
 
|-
−
|[https://www.nejm.org/doi/full/10.1056/NEJMoa1316158 Caplin et al. 2014 (CLARINET)]
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|[https://doi.org/10.1056/NEJMoa1316158 Caplin et al. 2014 (CLARINET)]
 
|2006-2013
 
|2006-2013
−
| style="background-color:#1a9851" |Phase III (C)
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| style="background-color:#1a9851" |Phase 3 (C)
 
|[[Pancreatic_NET#Lanreotide_Depot.2FAutogel_monotherapy|Lanreotide]]
 
|[[Pancreatic_NET#Lanreotide_Depot.2FAutogel_monotherapy|Lanreotide]]
 
| style="background-color:#d73027" |Inferior PFS
 
| style="background-color:#d73027" |Inferior PFS
 
| style="background-color:#d3d3d3" |
 
| style="background-color:#d3d3d3" |
 
|-
 
|-
−
|[https://www.nejm.org/doi/full/10.1056/NEJMoa1003825 Raymond et al. 2011 (A6181111)]
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|[https://doi.org/10.1056/NEJMoa1003825 Raymond et al. 2011 (A6181111)]
 
|2007-2009
 
|2007-2009
−
| style="background-color:#1a9851" |Phase III (C)
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| style="background-color:#1a9851" |Phase 3 (C)
 
|[[Pancreatic_NET#Sunitinib_monotherapy|Sunitinib]]
 
|[[Pancreatic_NET#Sunitinib_monotherapy|Sunitinib]]
 
| style="background-color:#d73027" |Inferior PFS
 
| style="background-color:#d73027" |Inferior PFS
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|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4208619/ Yao et al. 2011 (RADIANT-3)]
 
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4208619/ Yao et al. 2011 (RADIANT-3)]
 
|2007-2009
 
|2007-2009
−
| style="background-color:#1a9851" |Phase III (C)
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| style="background-color:#1a9851" |Phase 3 (C)
 
|[[Pancreatic_NET#Everolimus_monotherapy|Everolimus]]
 
|[[Pancreatic_NET#Everolimus_monotherapy|Everolimus]]
 
| style="background-color:#d73027" |Inferior PFS
 
| style="background-color:#d73027" |Inferior PFS
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|[https://doi.org/10.1016/s1470-2045(20)30493-9 Xu et al. 2020 (SANET-p)]
 
|[https://doi.org/10.1016/s1470-2045(20)30493-9 Xu et al. 2020 (SANET-p)]
 
|2016-2019
 
|2016-2019
−
| style="background-color:#1a9851" |Phase III (C)
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| style="background-color:#1a9851" |Phase 3 (C)
−
|Surufatinib
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|[[#Surufatinib_monotherapy_777|Surufatinib]]
 
| style="background-color:#d73027" |Inferior PFS
 
| style="background-color:#d73027" |Inferior 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. Note: while the initial A6181111 publication seemed to have a significant survival disadvantage for this arm (p=0.02), this finding was no longer significant at the final update (p=0.094). The primary endpoint (PFS) remains significant.''
 
''No active antineoplastic treatment. Used as a comparator arm and here for reference purposes only. Note: while the initial A6181111 publication seemed to have a significant survival disadvantage for this arm (p=0.02), this finding was no longer significant at the final update (p=0.094). The primary endpoint (PFS) remains significant.''
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</div>
 
===References===
 
===References===
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# '''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. [https://doi.org/10.1200/jco.2009.22.8510 link to original article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/19704057 PubMed] NCT00171873
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# '''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. [https://doi.org/10.1200/jco.2009.22.8510 link to original article] [https://pubmed.ncbi.nlm.nih.gov/19704057/ PubMed] [https://clinicaltrials.gov/study/NCT00171873 NCT00171873]
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# '''A6181111:''' Raymond E, Dahan L, Raoul JL, 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. Sunitinib malate for the treatment of pancreatic neuroendocrine tumors. N Engl J Med. 2011 Feb 10;364(6):501-13. Erratum in: N Engl J Med. 2011 Mar 17;364(11):1082. [https://www.nejm.org/doi/full/10.1056/NEJMoa1003825 link to original article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/21306237 PubMed] NCT00428597
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# '''A6181111:''' Raymond E, Dahan L, Raoul JL, 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. Sunitinib malate for the treatment of pancreatic neuroendocrine tumors. N Engl J Med. 2011 Feb 10;364(6):501-13. Erratum in: N Engl J Med. 2011 Mar 17;364(11):1082. [https://doi.org/10.1056/NEJMoa1003825 link to original article] [https://pubmed.ncbi.nlm.nih.gov/21306237/ PubMed] [https://clinicaltrials.gov/study/NCT00428597 NCT00428597]
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## '''HRQoL analysis:''' Vinik A, Bottomley A, Korytowsky B, Bang YJ, Raoul JL, Valle JW, Metrakos P, Hörsch D, Mundayat R, Reisman A, Wang Z, Chao RC, Raymond E. Patient-reported outcomes and quality of life with sunitinib versus placebo for pancreatic neuroendocrine tumors: results from an international phase III trial. Target Oncol. 2016 Dec;11(6):815-824. [https://link.springer.com/article/10.1007%2Fs11523-016-0462-5 link to original article] [https://pubmed.ncbi.nlm.nih.gov/27924459 PubMed]
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## '''HRQoL analysis:''' Vinik A, Bottomley A, Korytowsky B, Bang YJ, Raoul JL, Valle JW, Metrakos P, Hörsch D, Mundayat R, Reisman A, Wang Z, Chao RC, Raymond E. Patient-reported outcomes and quality of life with sunitinib versus placebo for pancreatic neuroendocrine tumors: results from an international phase III trial. Target Oncol. 2016 Dec;11(6):815-824. [https://doi.org/10.1007/s11523-016-0462-5 link to original article] [https://pubmed.ncbi.nlm.nih.gov/27924459/ PubMed]
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## '''Update:''' Faivre S, Niccoli P, Castellano D, Valle JW, Hammel P, Raoul JL, Vinik A, Van Cutsem E, Bang YJ, Lee SH, Borbath I, Lombard-Bohas C, Metrakos P, Smith D, Chen JS, Ruszniewski P, Seitz JF, Patyna S, Lu DR, Ishak KJ, Raymond E. Sunitinib in pancreatic neuroendocrine tumors: updated progression-free survival and final overall survival from a phase III randomized study. Ann Oncol. 2017 Feb 1;28(2):339-343. [https://doi.org/10.1093/annonc/mdw561 link to original article] [https://pubmed.ncbi.nlm.nih.gov/27836885 PubMed]
+
## '''Update:''' Faivre S, Niccoli P, Castellano D, Valle JW, Hammel P, Raoul JL, Vinik A, Van Cutsem E, Bang YJ, Lee SH, Borbath I, Lombard-Bohas C, Metrakos P, Smith D, Chen JS, Ruszniewski P, Seitz JF, Patyna S, Lu DR, Ishak KJ, Raymond E. Sunitinib in pancreatic neuroendocrine tumors: updated progression-free survival and final overall survival from a phase III randomized study. Ann Oncol. 2017 Feb 1;28(2):339-343. [https://doi.org/10.1093/annonc/mdw561 link to original article] [https://pubmed.ncbi.nlm.nih.gov/27836885/ PubMed]
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# '''RADIANT-3:''' 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. Everolimus for advanced pancreatic neuroendocrine tumors. N Engl J Med. 2011 Feb 10;364(6):514-23. [https://www.nejm.org/doi/full/10.1056/NEJMoa1009290 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4208619/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/21306238 PubMed] NCT00510068
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## '''Update:''' Fazio N, Kulke M, Rosbrook B, Fernandez K, Raymond E. Updated Efficacy and Safety Outcomes for Patients with Well-Differentiated Pancreatic Neuroendocrine Tumors Treated with Sunitinib. Target Oncol. 2021 Jan;16(1):27-35. Epub 2021 Jan 7. [https://doi.org/10.1007/s11523-020-00784-0 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc7810649/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/33411058/ PubMed]
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## '''Update:''' Yao JC, Pavel M, Lombard-Bohas C, Van Cutsem E, Voi M, Brandt U, He W, Chen D, Capdevila J, de Vries EGE, Tomassetti P, Hobday T, Pommier R, Öberg K. Everolimus for the treatment of advanced pancreatic neuroendocrine tumors: overall survival and circulating biomarkers from the randomized, phase III RADIANT-3 study. J Clin Oncol. 2016 Nov 10;34(32):3906-3913. Epub 2016 Sep 30. [https://doi.org/10.1200/JCO.2016.68.0702 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5791842/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/27621394 PubMed]
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# '''RADIANT-3:''' 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. Everolimus for advanced pancreatic neuroendocrine tumors. N Engl J Med. 2011 Feb 10;364(6):514-23. [https://doi.org/10.1056/NEJMoa1009290 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4208619/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/21306238/ PubMed] [https://clinicaltrials.gov/study/NCT00510068 NCT00510068]
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# '''CLARINET:''' 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. Lanreotide in metastatic enteropancreatic neuroendocrine tumors. N Engl J Med. 2014 Jul 17;371(3):224-33. [https://www.nejm.org/doi/full/10.1056/NEJMoa1316158 link to original article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/25014687 PubMed] NCT00353496
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## '''Update:''' Yao JC, Pavel M, Lombard-Bohas C, Van Cutsem E, Voi M, Brandt U, He W, Chen D, Capdevila J, de Vries EGE, Tomassetti P, Hobday T, Pommier R, Öberg K. Everolimus for the treatment of advanced pancreatic neuroendocrine tumors: overall survival and circulating biomarkers from the randomized, phase III RADIANT-3 study. J Clin Oncol. 2016 Nov 10;34(32):3906-3913. Epub 2016 Sep 30. [https://doi.org/10.1200/JCO.2016.68.0702 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5791842/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/27621394/ PubMed]
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# '''SANET-p:''' Xu J, Shen L, Bai C, Wang W, Li J, Yu X, Li Z, Li E, Yuan X, Chi Y, Yin Y, Lou W, Xu N, Bai Y, Zhang T, Xiu D, Wang X, Yuan Y, Chen J, Qin S, Jia R, Lu M, Cheng Y, Zhou Z, Li J, He J, Su W. Surufatinib in advanced pancreatic neuroendocrine tumours (SANET-p): a randomised, double-blind, placebo-controlled, phase 3 study. Lancet Oncol. 2020 Nov;21(11):1489-1499. Epub 2020 Sep 20. [https://doi.org/10.1016/s1470-2045(20)30493-9 link to original article] [https://pubmed.ncbi.nlm.nih.gov/32966810 PubMed] NCT02589821
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# '''CLARINET:''' 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. Lanreotide in metastatic enteropancreatic neuroendocrine tumors. N Engl J Med. 2014 Jul 17;371(3):224-33. [https://doi.org/10.1056/NEJMoa1316158 link to original article] [https://pubmed.ncbi.nlm.nih.gov/25014687/ PubMed] [https://clinicaltrials.gov/study/NCT00353496 NCT00353496]
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# '''SANET-p:''' Xu J, Shen L, Bai C, Wang W, Li J, Yu X, Li Z, Li E, Yuan X, Chi Y, Yin Y, Lou W, Xu N, Bai Y, Zhang T, Xiu D, Wang X, Yuan Y, Chen J, Qin S, Jia R, Lu M, Cheng Y, Zhou Z, Li J, He J, Su W. Surufatinib in advanced pancreatic neuroendocrine tumours (SANET-p): a randomised, double-blind, placebo-controlled, phase 3 study. Lancet Oncol. 2020 Nov;21(11):1489-1499. Epub 2020 Sep 20. [https://doi.org/10.1016/s1470-2045(20)30493-9 link to original article] [https://pubmed.ncbi.nlm.nih.gov/32966810/ PubMed] [https://clinicaltrials.gov/study/NCT02589821 NCT02589821]
  
 
[[Category:Pancreatic NET regimens]]
 
[[Category:Pancreatic NET regimens]]

Latest revision as of 12:07, 23 June 2024

Back to Top

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 pancreatic 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
Caplin et al. 2014 (CLARINET) 2006-2013 Phase 3 (C) Lanreotide Inferior PFS
Raymond et al. 2011 (A6181111) 2007-2009 Phase 3 (C) Sunitinib Inferior PFS Less diarrhea; Seems to have better insomnia
Yao et al. 2011 (RADIANT-3) 2007-2009 Phase 3 (C) Everolimus Inferior PFS
Xu et al. 2020 (SANET-p) 2016-2019 Phase 3 (C) Surufatinib Inferior PFS

No active antineoplastic treatment. Used as a comparator arm and here for reference purposes only. Note: while the initial A6181111 publication seemed to have a significant survival disadvantage for this arm (p=0.02), this finding was no longer significant at the final update (p=0.094). The primary endpoint (PFS) remains significant.

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. A6181111: Raymond E, Dahan L, Raoul JL, 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. Sunitinib malate for the treatment of pancreatic neuroendocrine tumors. N Engl J Med. 2011 Feb 10;364(6):501-13. Erratum in: N Engl J Med. 2011 Mar 17;364(11):1082. link to original article PubMed NCT00428597
    1. HRQoL analysis: Vinik A, Bottomley A, Korytowsky B, Bang YJ, Raoul JL, Valle JW, Metrakos P, Hörsch D, Mundayat R, Reisman A, Wang Z, Chao RC, Raymond E. Patient-reported outcomes and quality of life with sunitinib versus placebo for pancreatic neuroendocrine tumors: results from an international phase III trial. Target Oncol. 2016 Dec;11(6):815-824. link to original article PubMed
    2. Update: Faivre S, Niccoli P, Castellano D, Valle JW, Hammel P, Raoul JL, Vinik A, Van Cutsem E, Bang YJ, Lee SH, Borbath I, Lombard-Bohas C, Metrakos P, Smith D, Chen JS, Ruszniewski P, Seitz JF, Patyna S, Lu DR, Ishak KJ, Raymond E. Sunitinib in pancreatic neuroendocrine tumors: updated progression-free survival and final overall survival from a phase III randomized study. Ann Oncol. 2017 Feb 1;28(2):339-343. link to original article PubMed
    3. Update: Fazio N, Kulke M, Rosbrook B, Fernandez K, Raymond E. Updated Efficacy and Safety Outcomes for Patients with Well-Differentiated Pancreatic Neuroendocrine Tumors Treated with Sunitinib. Target Oncol. 2021 Jan;16(1):27-35. Epub 2021 Jan 7. link to original article link to PMC article PubMed
  3. RADIANT-3: 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. Everolimus for advanced pancreatic neuroendocrine tumors. N Engl J Med. 2011 Feb 10;364(6):514-23. link to original article link to PMC article PubMed NCT00510068
    1. Update: Yao JC, Pavel M, Lombard-Bohas C, Van Cutsem E, Voi M, Brandt U, He W, Chen D, Capdevila J, de Vries EGE, Tomassetti P, Hobday T, Pommier R, Öberg K. Everolimus for the treatment of advanced pancreatic neuroendocrine tumors: overall survival and circulating biomarkers from the randomized, phase III RADIANT-3 study. J Clin Oncol. 2016 Nov 10;34(32):3906-3913. Epub 2016 Sep 30. link to original article link to PMC article PubMed
  4. CLARINET: 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. Lanreotide in metastatic enteropancreatic neuroendocrine tumors. N Engl J Med. 2014 Jul 17;371(3):224-33. link to original article PubMed NCT00353496
  5. SANET-p: Xu J, Shen L, Bai C, Wang W, Li J, Yu X, Li Z, Li E, Yuan X, Chi Y, Yin Y, Lou W, Xu N, Bai Y, Zhang T, Xiu D, Wang X, Yuan Y, Chen J, Qin S, Jia R, Lu M, Cheng Y, Zhou Z, Li J, He J, Su W. Surufatinib in advanced pancreatic neuroendocrine tumours (SANET-p): a randomised, double-blind, placebo-controlled, phase 3 study. Lancet Oncol. 2020 Nov;21(11):1489-1499. Epub 2020 Sep 20. link to original article PubMed NCT02589821
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