Difference between revisions of "Thyroid cancer, RET-positive"

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=Advanced or metastatic disease=
 
=Advanced or metastatic disease=
 
==Pralsetinib monotherapy {{#subobject:eahg7q|Regimen=1}}==
 
==Pralsetinib monotherapy {{#subobject:eahg7q|Regimen=1}}==
−
 
+
<div class="toccolours" style="background-color:#eeeeee">
 
===Regimen {{#subobject:91yg11|Variant=1}}===
 
===Regimen {{#subobject:91yg11|Variant=1}}===
 
{| class="wikitable sortable" style="width: 60%; text-align:center;"  
 
{| class="wikitable sortable" style="width: 60%; text-align:center;"  
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|}
 
|}
 
''Note: this trial is denoted as ARROW<sub>RET</sub> to distinguish from other trials of the same name. This is the phase 2 dosing.''
 
''Note: this trial is denoted as ARROW<sub>RET</sub> to distinguish from other trials of the same name. This is the phase 2 dosing.''
 +
<div class="toccolours" style="background-color:#fdcdac">
 
====Biomarker eligibility criteria====
 
====Biomarker eligibility criteria====
 
*RET fusion positive
 
*RET fusion positive
−
 
+
</div>
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Targeted therapy====
 
====Targeted therapy====
 
*[[Pralsetinib (Gavreto)]] 400 mg PO once per day
 
*[[Pralsetinib (Gavreto)]] 400 mg PO once per day
−
 
 
'''Continued indefinitely'''
 
'''Continued indefinitely'''
−
 
+
</div></div>
 
===References===
 
===References===
 
#'''ARROW<sub>RET</sub>:''' Subbiah V, Hu MI, Wirth LJ, Schuler M, Mansfield AS, Curigliano G, Brose MS, Zhu VW, Leboulleux S, Bowles DW, Baik CS, Adkins D, Keam B, Matos I, Garralda E, Gainor JF, Lopes G, Lin CC, Godbert Y, Sarker D, Miller SG, Clifford C, Zhang H, Turner CD, Taylor MH. Pralsetinib for patients with advanced or metastatic RET-altered thyroid cancer (ARROW): a multi-cohort, open-label, registrational, phase 1/2 study. Lancet Diabetes Endocrinol. 2021 Aug;9(8):491-501. Epub 2021 Jun 9. Erratum in: Lancet Diabetes Endocrinol. 2021 Oct;9(10):e4. [https://doi.org/10.1016/s2213-8587(21)00120-0 link to original article] [https://pubmed.ncbi.nlm.nih.gov/34118198/ PubMed] NCT03037385
 
#'''ARROW<sub>RET</sub>:''' Subbiah V, Hu MI, Wirth LJ, Schuler M, Mansfield AS, Curigliano G, Brose MS, Zhu VW, Leboulleux S, Bowles DW, Baik CS, Adkins D, Keam B, Matos I, Garralda E, Gainor JF, Lopes G, Lin CC, Godbert Y, Sarker D, Miller SG, Clifford C, Zhang H, Turner CD, Taylor MH. Pralsetinib for patients with advanced or metastatic RET-altered thyroid cancer (ARROW): a multi-cohort, open-label, registrational, phase 1/2 study. Lancet Diabetes Endocrinol. 2021 Aug;9(8):491-501. Epub 2021 Jun 9. Erratum in: Lancet Diabetes Endocrinol. 2021 Oct;9(10):e4. [https://doi.org/10.1016/s2213-8587(21)00120-0 link to original article] [https://pubmed.ncbi.nlm.nih.gov/34118198/ PubMed] NCT03037385
−
 
 
==Selpercatinib monotherapy {{#subobject:ea894c|Regimen=1}}==
 
==Selpercatinib monotherapy {{#subobject:ea894c|Regimen=1}}==
−
 
+
<div class="toccolours" style="background-color:#eeeeee">
 
===Regimen {{#subobject:9134b2|Variant=1}}===
 
===Regimen {{#subobject:9134b2|Variant=1}}===
 
{| class="wikitable" style="color:white; background-color:#404040"
 
{| class="wikitable" style="color:white; background-color:#404040"
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|-
 
|-
 
|[https://doi.org/10.1056/nejmoa2005651 Wirth et al. 2020 (LIBRETTO-001)]
 
|[https://doi.org/10.1056/nejmoa2005651 Wirth et al. 2020 (LIBRETTO-001)]
 +
{| class="wikitable" style="margin:auto; color:white; background-color:#1B4F26"
 +
|'''[https://www.esmo.org/guidelines/esmo-mcbs/esmo-mcbs-scorecards/scorecard-218-1 <span style="color:white;">ESMO-MCBS (3)</span>]'''
 +
|-
 +
|}
 
|2017-2019
 
|2017-2019
 
| style="background-color:#91cf61" |Phase 1/2 (RT)
 
| style="background-color:#91cf61" |Phase 1/2 (RT)
 
|-
 
|-
 
|}
 
|}
 +
<div class="toccolours" style="background-color:#fdcdac">
 
====Biomarker eligibility criteria====
 
====Biomarker eligibility criteria====
 
*RET fusion-positive thyroid cancer
 
*RET fusion-positive thyroid cancer
 
*RET-mutant medullary thyroid cancer  
 
*RET-mutant medullary thyroid cancer  
−
 
+
</div>
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Targeted therapy====
 
====Targeted therapy====
 
*[[Selpercatinib (Retevmo)]] by the following weight-based criteria:
 
*[[Selpercatinib (Retevmo)]] by the following weight-based criteria:
 
**Less than 50 kg: 120 mg PO twice per day
 
**Less than 50 kg: 120 mg PO twice per day
 
**50 kg or more: 160 mg PO twice per day
 
**50 kg or more: 160 mg PO twice per day
−
 
 
'''Continued indefinitely'''
 
'''Continued indefinitely'''
−
 
+
</div></div>
 
===References===
 
===References===
 
# '''LIBRETTO-001:''' Wirth LJ, Sherman E, Robinson B, Solomon B, Kang H, Lorch J, Worden F, Brose M, Patel J, Leboulleux S, Godbert Y, Barlesi F, Morris JC, Owonikoko TK, Tan DSW, Gautschi O, Weiss J, de la Fouchardière C, Burkard ME, Laskin J, Taylor MH, Kroiss M, Medioni J, Goldman JW, Bauer TM, Levy B, Zhu VW, Lakhani N, Moreno V, Ebata K, Nguyen M, Heirich D, Zhu EY, Huang X, Yang L, Kherani J, Rothenberg SM, Drilon A, Subbiah V, Shah MH, Cabanillas ME. Efficacy of Selpercatinib in RET-Altered Thyroid Cancers. N Engl J Med. 2020 Aug 27;383(9):825-835. [https://doi.org/10.1056/nejmoa2005651 link to original article] [https://pubmed.ncbi.nlm.nih.gov/32846061 PubMed] NCT03157128
 
# '''LIBRETTO-001:''' Wirth LJ, Sherman E, Robinson B, Solomon B, Kang H, Lorch J, Worden F, Brose M, Patel J, Leboulleux S, Godbert Y, Barlesi F, Morris JC, Owonikoko TK, Tan DSW, Gautschi O, Weiss J, de la Fouchardière C, Burkard ME, Laskin J, Taylor MH, Kroiss M, Medioni J, Goldman JW, Bauer TM, Levy B, Zhu VW, Lakhani N, Moreno V, Ebata K, Nguyen M, Heirich D, Zhu EY, Huang X, Yang L, Kherani J, Rothenberg SM, Drilon A, Subbiah V, Shah MH, Cabanillas ME. Efficacy of Selpercatinib in RET-Altered Thyroid Cancers. N Engl J Med. 2020 Aug 27;383(9):825-835. [https://doi.org/10.1056/nejmoa2005651 link to original article] [https://pubmed.ncbi.nlm.nih.gov/32846061 PubMed] NCT03157128
−
 
 
[[Category:Thyroid cancer regimens]]
 
[[Category:Thyroid cancer regimens]]
 
[[Category:Biomarker-specific pages]]
 
[[Category:Biomarker-specific pages]]
 
[[Category:Endocrine cancers]]
 
[[Category:Endocrine cancers]]
 
[[Category:Head and neck cancers]]
 
[[Category:Head and neck cancers]]

Revision as of 14:32, 20 February 2023

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Section editor transclusions Note: these are regimens tested in biomarker-specific populations, please see the main thyroid cancer page for other regimens.

2 regimens on this page
2 variants on this page


Advanced or metastatic disease

Pralsetinib monotherapy

Regimen

Study Years of enrollment Evidence
Subbiah et al. 2021 (ARROWRET) 2017-2020 Phase 1/2 (RT)

Note: this trial is denoted as ARROWRET to distinguish from other trials of the same name. This is the phase 2 dosing.

Biomarker eligibility criteria

  • RET fusion positive

Targeted therapy

Continued indefinitely

References

  1. ARROWRET: Subbiah V, Hu MI, Wirth LJ, Schuler M, Mansfield AS, Curigliano G, Brose MS, Zhu VW, Leboulleux S, Bowles DW, Baik CS, Adkins D, Keam B, Matos I, Garralda E, Gainor JF, Lopes G, Lin CC, Godbert Y, Sarker D, Miller SG, Clifford C, Zhang H, Turner CD, Taylor MH. Pralsetinib for patients with advanced or metastatic RET-altered thyroid cancer (ARROW): a multi-cohort, open-label, registrational, phase 1/2 study. Lancet Diabetes Endocrinol. 2021 Aug;9(8):491-501. Epub 2021 Jun 9. Erratum in: Lancet Diabetes Endocrinol. 2021 Oct;9(10):e4. link to original article PubMed NCT03037385

Selpercatinib monotherapy

Regimen

FDA-recommended dose
Study Years of enrollment Evidence
Wirth et al. 2020 (LIBRETTO-001)
ESMO-MCBS (3)
2017-2019 Phase 1/2 (RT)

Biomarker eligibility criteria

  • RET fusion-positive thyroid cancer
  • RET-mutant medullary thyroid cancer

Targeted therapy

  • Selpercatinib (Retevmo) by the following weight-based criteria:
    • Less than 50 kg: 120 mg PO twice per day
    • 50 kg or more: 160 mg PO twice per day

Continued indefinitely

References

  1. LIBRETTO-001: Wirth LJ, Sherman E, Robinson B, Solomon B, Kang H, Lorch J, Worden F, Brose M, Patel J, Leboulleux S, Godbert Y, Barlesi F, Morris JC, Owonikoko TK, Tan DSW, Gautschi O, Weiss J, de la Fouchardière C, Burkard ME, Laskin J, Taylor MH, Kroiss M, Medioni J, Goldman JW, Bauer TM, Levy B, Zhu VW, Lakhani N, Moreno V, Ebata K, Nguyen M, Heirich D, Zhu EY, Huang X, Yang L, Kherani J, Rothenberg SM, Drilon A, Subbiah V, Shah MH, Cabanillas ME. Efficacy of Selpercatinib in RET-Altered Thyroid Cancers. N Engl J Med. 2020 Aug 27;383(9):825-835. link to original article PubMed NCT03157128
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