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

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<big>'''Note: these are regimens tested in biomarker-specific populations, please see the [[Thyroid cancer|main thyroid cancer page]] for other regimens.'''</big>
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'''Note: these are regimens tested in biomarker-specific populations, please see the [[Thyroid cancer|main thyroid cancer page]] for other regimens.'''
 
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=Guidelines=
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'''Given the rapid change in evidence in many areas of hematology/oncology, readers are encouraged to consider any guideline published 5+ years ago to be for historical purposes, only.'''
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==NCCN==
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*''NCCN does not currently have guidelines at this granular level; please see [https://www.nccn.org/guidelines/guidelines-detail?category=1&id=1470 NCCN Guidelines - Thyroid Carcinoma].''
 
=Advanced or metastatic disease=
 
=Advanced or metastatic disease=
 
==Pralsetinib monotherapy {{#subobject:eahg7q|Regimen=1}}==
 
==Pralsetinib monotherapy {{#subobject:eahg7q|Regimen=1}}==
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{| class="wikitable sortable" style="width: 60%; text-align:center;"  
 
{| class="wikitable sortable" style="width: 60%; text-align:center;"  
 
!style="width: 33%"|Study
 
!style="width: 33%"|Study
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!style="width: 33%"|Years of enrollment
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!style="width: 33%"|Dates of enrollment
 
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
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|[https://doi.org/10.1016/s2213-8587(21)00120-0 Subbiah et al. 2021 (ARROW<sub>RET</sub>)]
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|[https://doi.org/10.1016/s2213-8587(21)00120-0 Subbiah et al. 2021 (ARROW<sub>RET-thyroid</sub>)]
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<!-- {| class="wikitable" style="margin:auto; color:white; background-color:#1B4F26"
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|'''[https://www.esmo.org/guidelines/esmo-mcbs/esmo-mcbs-scorecards/scorecard-303-1 <span style="color:white;">ESMO-MCBS (3)</span>]'''
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|2017-2020
 
|2017-2020
 
| style="background-color:#91cf61" |Phase 1/2 (RT)
 
| style="background-color:#91cf61" |Phase 1/2 (RT)
 
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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.''
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''Note: this trial is denoted as ARROW<sub>RET-thyroid</sub> to distinguish from other arms of this basket trial. This was the recommended phase 2 dosing.''
 
<div class="toccolours" style="background-color:#fdcdac">
 
<div class="toccolours" style="background-color:#fdcdac">
 
====Biomarker eligibility criteria====
 
====Biomarker eligibility criteria====
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===References===
 
===References===
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#'''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
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#'''ARROW<sub>RET-thyroid</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] '''dosing details in abstract have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/34118198/ PubMed] [https://clinicaltrials.gov/study/NCT03037385 NCT03037385]
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==Selpercatinib monotherapy {{#subobject:ea894c|Regimen=1}}==
 
==Selpercatinib monotherapy {{#subobject:ea894c|Regimen=1}}==
 
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{| class="wikitable sortable" style="width: 60%; text-align:center;"  
 
!style="width: 33%"|Study
 
!style="width: 33%"|Study
−
!style="width: 33%"|Years of enrollment
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!style="width: 33%"|Dates of enrollment
 
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
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|-
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|[https://doi.org/10.1056/nejmoa2005651 Wirth et al. 2020 (LIBRETTO-001)]
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|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10777663/ Wirth et al. 2020 (LIBRETTO-001<sub>thyroid</sub>)]
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<!-- {| 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>]'''
 
|'''[https://www.esmo.org/guidelines/esmo-mcbs/esmo-mcbs-scorecards/scorecard-218-1 <span style="color:white;">ESMO-MCBS (3)</span>]'''
 
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|2017-2019
 
|2017-2019
 
| style="background-color:#91cf61" |Phase 1/2 (RT)
 
| style="background-color:#91cf61" |Phase 1/2 (RT)
 
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''Note: Wirth et al. 2020 only mentioned the 160 mg dosing; the FDA label includes weight-based recommendations.''
 
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====Biomarker eligibility criteria====
 
====Biomarker eligibility criteria====
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===References===
 
===References===
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# '''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
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# '''LIBRETTO-001<sub>thyroid</sub>:''' 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] '''dosing details in manuscript have been reviewed by our editors''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10777663/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/32846061/ PubMed] [https://clinicaltrials.gov/study/NCT03157128 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]]

Latest revision as of 23:41, 15 July 2024

Back to Top

Section editor
Unfilled
If you are interested in this role, please contact us at [email protected].

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


Guidelines

Given the rapid change in evidence in many areas of hematology/oncology, readers are encouraged to consider any guideline published 5+ years ago to be for historical purposes, only.

NCCN

Advanced or metastatic disease

Pralsetinib monotherapy

Regimen

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

Note: this trial is denoted as ARROWRET-thyroid to distinguish from other arms of this basket trial. This was the recommended phase 2 dosing.

Biomarker eligibility criteria

  • RET fusion positive

Targeted therapy

Continued indefinitely

References

  1. ARROWRET-thyroid: 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 dosing details in abstract have been reviewed by our editors PubMed NCT03037385

Selpercatinib monotherapy

Regimen

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

Note: Wirth et al. 2020 only mentioned the 160 mg dosing; the FDA label includes weight-based recommendations.

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-001thyroid: 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 dosing details in manuscript have been reviewed by our editors link to PMC article PubMed NCT03157128
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