Difference between revisions of "Thyroid cancer, differentiated"

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==[https://www.thyroid.org/ ATA]==
 
==[https://www.thyroid.org/ ATA]==
 
*'''2015:''' Guidelines on the management of thyroid nodules and differentiated thyroid cancer [https://pubmed.ncbi.nlm.nih.gov/28114862 PubMed]
 
*'''2015:''' Guidelines on the management of thyroid nodules and differentiated thyroid cancer [https://pubmed.ncbi.nlm.nih.gov/28114862 PubMed]
 
 
==[http://www.esmo.org/ ESMO]==
 
==[http://www.esmo.org/ ESMO]==
 
*'''2019:''' Filetti et al. [https://doi.org/10.1093/annonc/mdz400 Thyroid cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up]
 
*'''2019:''' Filetti et al. [https://doi.org/10.1093/annonc/mdz400 Thyroid cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up]
 
===Older===
 
===Older===
 
*'''2012:''' Pacini et al. [http://annonc.oxfordjournals.org/content/23/suppl_7/vii110.full.pdf+html Thyroid cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up] [https://pubmed.ncbi.nlm.nih.gov/22997443 PubMed]
 
*'''2012:''' Pacini et al. [http://annonc.oxfordjournals.org/content/23/suppl_7/vii110.full.pdf+html Thyroid cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up] [https://pubmed.ncbi.nlm.nih.gov/22997443 PubMed]
 
 
==[https://www.nccn.org/ NCCN]==
 
==[https://www.nccn.org/ NCCN]==
 
*[https://www.nccn.org/professionals/physician_gls/pdf/thyroid.pdf NCCN Guidelines - Thyroid Carcinoma]
 
*[https://www.nccn.org/professionals/physician_gls/pdf/thyroid.pdf NCCN Guidelines - Thyroid Carcinoma]
 
 
=All lines of therapy=
 
=All lines of therapy=
 
==Cabozantinib monotherapy {{#subobject:1dgac6|Regimen=1}}==
 
==Cabozantinib monotherapy {{#subobject:1dgac6|Regimen=1}}==
 
+
<div class="toccolours" style="background-color:#eeeeee">
 
===Regimen variant #1, pediatric dosing {{#subobject:1gacnd|Variant=1}}===
 
===Regimen variant #1, pediatric dosing {{#subobject:1gacnd|Variant=1}}===
 
{| class="wikitable" style="color:white; background-color:#404040"
 
{| class="wikitable" style="color:white; background-color:#404040"
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|}
 
|}
 
''Note: this is the FDA-recommended dose in pediatric patients who are 12 years of age or older with BSA less than 1.2 m<sup>2</sup>.''
 
''Note: this is the FDA-recommended dose in pediatric patients who are 12 years of age or older with BSA less than 1.2 m<sup>2</sup>.''
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Targeted therapy====
 
====Targeted therapy====
 
*[[Cabozantinib (Cometriq)]] 40 mg PO once per day
 
*[[Cabozantinib (Cometriq)]] 40 mg PO once per day
 
'''Continued indefinitely'''
 
'''Continued indefinitely'''
 
+
</div></div><br>
 +
<div class="toccolours" style="background-color:#eeeeee">
 
===Regimen variant #2 {{#subobject:1hzndd|Variant=1}}===
 
===Regimen variant #2 {{#subobject:1hzndd|Variant=1}}===
 
{| class="wikitable" style="color:white; background-color:#404040"
 
{| class="wikitable" style="color:white; background-color:#404040"
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|}
 
|}
 
''Note: this is the FDA-recommended dose for adult patients.''
 
''Note: this is the FDA-recommended dose for adult patients.''
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Targeted therapy====
 
====Targeted therapy====
 
*[[Cabozantinib (Cometriq)]] 60 mg PO once per day
 
*[[Cabozantinib (Cometriq)]] 60 mg PO once per day
 
'''Continued indefinitely'''
 
'''Continued indefinitely'''
 +
</div></div>
 
===References===
 
===References===
 
# '''COSMIC-311:''' Brose MS, Robinson B, Sherman SI, Krajewska J, Lin CC, Vaisman F, Hoff AO, Hitre E, Bowles DW, Hernando J, Faoro L, Banerjee K, Oliver JW, Keam B, Capdevila J. Cabozantinib for radioiodine-refractory differentiated thyroid cancer (COSMIC-311): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2021 Aug;22(8):1126-1138. Epub 2021 Jul 5. [https://doi.org/10.1016/s1470-2045(21)00332-6 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/34237250/ PubMed] NCT03690388
 
# '''COSMIC-311:''' Brose MS, Robinson B, Sherman SI, Krajewska J, Lin CC, Vaisman F, Hoff AO, Hitre E, Bowles DW, Hernando J, Faoro L, Banerjee K, Oliver JW, Keam B, Capdevila J. Cabozantinib for radioiodine-refractory differentiated thyroid cancer (COSMIC-311): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2021 Aug;22(8):1126-1138. Epub 2021 Jul 5. [https://doi.org/10.1016/s1470-2045(21)00332-6 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/34237250/ PubMed] NCT03690388
 
 
==Lenvatinib monotherapy {{#subobject:PYR1|Regimen=1}}==
 
==Lenvatinib monotherapy {{#subobject:PYR1|Regimen=1}}==
 
+
<div class="toccolours" style="background-color:#eeeeee">
 
 
 
===Regimen {{#subobject:PYV1|Variant=1}}===
 
===Regimen {{#subobject:PYV1|Variant=1}}===
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
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|-
 
|-
 
|[https://doi.org/10.1056/NEJMoa1406470 Schlumberger et al. 2015 (SELECT)]
 
|[https://doi.org/10.1056/NEJMoa1406470 Schlumberger et al. 2015 (SELECT)]
 +
{| class="wikitable" style="margin:auto; color:white; background-color:#1B4F26"
 +
|'''[https://www.esmo.org/guidelines/esmo-mcbs/esmo-mcbs-scorecards/scorecard-135-1 <span style="color:white;">ESMO-MCBS (2)</span>]'''
 +
|-
 +
|}
 
|2011-2012
 
|2011-2012
 
| style="background-color:#1a9851" |Phase 3 (E-RT-esc)
 
| style="background-color:#1a9851" |Phase 3 (E-RT-esc)
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|-
 
|-
 
|}
 
|}
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Targeted therapy====
 
====Targeted therapy====
 
*[[Lenvatinib (Lenvima)]] 24 mg PO once per day
 
*[[Lenvatinib (Lenvima)]] 24 mg PO once per day
 
**Per the package insert, patients with eGFR of less than 30 mL/min/1.73m<sup>2</sup> by Cockroft-Gault or Child-Pugh C severe hepatic impairment should receive 14 mg PO once per day
 
**Per the package insert, patients with eGFR of less than 30 mL/min/1.73m<sup>2</sup> by Cockroft-Gault or Child-Pugh C severe hepatic impairment should receive 14 mg PO once per day
 
 
'''28-day cycles'''
 
'''28-day cycles'''
 
+
</div></div>
 
===References===
 
===References===
 
<!-- # '''Abstract:''' Martin Schlumberger, Makoto Tahara, Lori J. Wirth, Bruce Robinson, Marcia S. Brose, Rossella Elisei, Corina E. Dutcus, Begoña de las Heras, Junming Zhu, Mouhammed Amir Habra, Kate Newbold, Manisha H. Shah, Ana O. Hoff, Andrew G Gianoukakis, Naomi Kiyota, Matthew Hiram Taylor, Sung-Bae Kim, Monika K Krzyzanowska, Steven I. Sherman. A phase 3, multicenter, double-blind, placebo-controlled trial of lenvatinib (E7080) in patients with 131I-refractory differentiated thyroid cancer (SELECT). 2014 ASCO Annual Meeting abstract LBA6008. [http://meetinglibrary.asco.org/content/132694-144 link to abstract] -->
 
<!-- # '''Abstract:''' Martin Schlumberger, Makoto Tahara, Lori J. Wirth, Bruce Robinson, Marcia S. Brose, Rossella Elisei, Corina E. Dutcus, Begoña de las Heras, Junming Zhu, Mouhammed Amir Habra, Kate Newbold, Manisha H. Shah, Ana O. Hoff, Andrew G Gianoukakis, Naomi Kiyota, Matthew Hiram Taylor, Sung-Bae Kim, Monika K Krzyzanowska, Steven I. Sherman. A phase 3, multicenter, double-blind, placebo-controlled trial of lenvatinib (E7080) in patients with 131I-refractory differentiated thyroid cancer (SELECT). 2014 ASCO Annual Meeting abstract LBA6008. [http://meetinglibrary.asco.org/content/132694-144 link to abstract] -->
 
# '''SELECT:''' Schlumberger M, Tahara M, Wirth LJ, Robinson B, Brose MS, Elisei R, Habra MA, Newbold K, Shah MH, Hoff AO, Gianoukakis AG, Kiyota N, Taylor MH, Kim SB, Krzyzanowska MK, Dutcus CE, de las Heras B, Zhu J, Sherman SI. Lenvatinib versus placebo in radioiodine-refractory thyroid cancer. N Engl J Med. 2015 Feb 12;372(7):621-30. [https://doi.org/10.1056/NEJMoa1406470 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/25671254 PubMed] NCT01321554
 
# '''SELECT:''' Schlumberger M, Tahara M, Wirth LJ, Robinson B, Brose MS, Elisei R, Habra MA, Newbold K, Shah MH, Hoff AO, Gianoukakis AG, Kiyota N, Taylor MH, Kim SB, Krzyzanowska MK, Dutcus CE, de las Heras B, Zhu J, Sherman SI. Lenvatinib versus placebo in radioiodine-refractory thyroid cancer. N Engl J Med. 2015 Feb 12;372(7):621-30. [https://doi.org/10.1056/NEJMoa1406470 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/25671254 PubMed] NCT01321554
 
#'''E7080-C086-308:''' Zheng X, Xu Z, Ji Q, Ge M, Shi F, Qin J, Wang F, Chen G, Zhang Y, Huang R, Tan J, Huang T, Li S, Lv Z, Lin Y, Guo Z, Kubota T, Suzuki T, Ikezawa H, Gao M. A Randomized, Phase III Study of Lenvatinib in Chinese Patients with Radioiodine-Refractory Differentiated Thyroid Cancer. Clin Cancer Res. 2021 Oct 15;27(20):5502-5509. Epub 2021 Jul 29. [https://doi.org/10.1158/1078-0432.ccr-21-0761 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/34326132/ PubMed] NCT02966093
 
#'''E7080-C086-308:''' Zheng X, Xu Z, Ji Q, Ge M, Shi F, Qin J, Wang F, Chen G, Zhang Y, Huang R, Tan J, Huang T, Li S, Lv Z, Lin Y, Guo Z, Kubota T, Suzuki T, Ikezawa H, Gao M. A Randomized, Phase III Study of Lenvatinib in Chinese Patients with Radioiodine-Refractory Differentiated Thyroid Cancer. Clin Cancer Res. 2021 Oct 15;27(20):5502-5509. Epub 2021 Jul 29. [https://doi.org/10.1158/1078-0432.ccr-21-0761 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/34326132/ PubMed] NCT02966093
 
 
==Pazopanib monotherapy {{#subobject:4ee26c|Regimen=1}}==
 
==Pazopanib monotherapy {{#subobject:4ee26c|Regimen=1}}==
 
+
<div class="toccolours" style="background-color:#eeeeee">
 
 
 
===Regimen {{#subobject:8faae3|Variant=1}}===
 
===Regimen {{#subobject:8faae3|Variant=1}}===
 
{| class="wikitable sortable" style="width: 60%; text-align:center;"  
 
{| class="wikitable sortable" style="width: 60%; text-align:center;"  
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|-
 
|-
 
|}
 
|}
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Targeted therapy====
 
====Targeted therapy====
 
*[[Pazopanib (Votrient)]] 800 mg PO once per day  
 
*[[Pazopanib (Votrient)]] 800 mg PO once per day  
 
 
'''28-day cycles'''
 
'''28-day cycles'''
 
+
</div></div>
 
===References===
 
===References===
 
# '''MC057H:''' Bible KC, Suman VJ, Molina JR, Smallridge RC, Maples WJ, Menefee ME, Rubin J, Sideras K, Morris JC 3rd, McIver B, Burton JK, Webster KP, Bieber C, Traynor AM,  Flynn PJ, Goh BC, Tang H, Ivy SP, Erlichman C; Endocrine Malignancies Disease Oriented Group; Mayo Clinic Cancer Center; Mayo Phase 2 Consortium. Efficacy of pazopanib in progressive, radioiodine-refractory, metastatic differentiated thyroid cancers: results of a phase 2 consortium study. Lancet Oncol. 2010 Oct;11(10):962-72. Epub 2010 Sep 17. [https://doi.org/10.1016/s1470-2045(10)70203-5 link to original article] '''contains dosing details in abstract''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3107731/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/20851682 PubMed] NCT00625846
 
# '''MC057H:''' Bible KC, Suman VJ, Molina JR, Smallridge RC, Maples WJ, Menefee ME, Rubin J, Sideras K, Morris JC 3rd, McIver B, Burton JK, Webster KP, Bieber C, Traynor AM,  Flynn PJ, Goh BC, Tang H, Ivy SP, Erlichman C; Endocrine Malignancies Disease Oriented Group; Mayo Clinic Cancer Center; Mayo Phase 2 Consortium. Efficacy of pazopanib in progressive, radioiodine-refractory, metastatic differentiated thyroid cancers: results of a phase 2 consortium study. Lancet Oncol. 2010 Oct;11(10):962-72. Epub 2010 Sep 17. [https://doi.org/10.1016/s1470-2045(10)70203-5 link to original article] '''contains dosing details in abstract''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3107731/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/20851682 PubMed] NCT00625846
 
 
==Placebo==
 
==Placebo==
 
+
<div class="toccolours" style="background-color:#eeeeee">
 
===Regimen===
 
===Regimen===
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
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|-
 
|-
 
|}
 
|}
 
 
''No active antineoplastic treatment.''
 
''No active antineoplastic treatment.''
 
+
</div></div>
 
===References===
 
===References===
 
# '''D4200C00079:''' Leboulleux S, Bastholt L, Krause T, de la Fouchardiere C, Tennvall J, Awada A, Gómez JM, Bonichon F, Leenhardt L, Soufflet C, Licour M, Schlumberger MJ. Vandetanib in locally advanced or metastatic differentiated thyroid cancer: a randomised, double-blind, phase 2 trial. Lancet Oncol. 2012 Sep;13(9):897-905. Epub 2012 Aug 14. [https://doi.org/10.1016/S1470-2045(12)70335-2 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/22898678 PubMed] NCT00537095
 
# '''D4200C00079:''' Leboulleux S, Bastholt L, Krause T, de la Fouchardiere C, Tennvall J, Awada A, Gómez JM, Bonichon F, Leenhardt L, Soufflet C, Licour M, Schlumberger MJ. Vandetanib in locally advanced or metastatic differentiated thyroid cancer: a randomised, double-blind, phase 2 trial. Lancet Oncol. 2012 Sep;13(9):897-905. Epub 2012 Aug 14. [https://doi.org/10.1016/S1470-2045(12)70335-2 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/22898678 PubMed] NCT00537095
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# '''SELECT:''' Schlumberger M, Tahara M, Wirth LJ, Robinson B, Brose MS, Elisei R, Habra MA, Newbold K, Shah MH, Hoff AO, Gianoukakis AG, Kiyota N, Taylor MH, Kim SB, Krzyzanowska MK, Dutcus CE, de las Heras B, Zhu J, Sherman SI. Lenvatinib versus placebo in radioiodine-refractory thyroid cancer. N Engl J Med. 2015 Feb 12;372(7):621-30. [https://doi.org/10.1056/NEJMoa1406470 link to original article] [https://pubmed.ncbi.nlm.nih.gov/25671254 PubMed] NCT01321554
 
# '''SELECT:''' Schlumberger M, Tahara M, Wirth LJ, Robinson B, Brose MS, Elisei R, Habra MA, Newbold K, Shah MH, Hoff AO, Gianoukakis AG, Kiyota N, Taylor MH, Kim SB, Krzyzanowska MK, Dutcus CE, de las Heras B, Zhu J, Sherman SI. Lenvatinib versus placebo in radioiodine-refractory thyroid cancer. N Engl J Med. 2015 Feb 12;372(7):621-30. [https://doi.org/10.1056/NEJMoa1406470 link to original article] [https://pubmed.ncbi.nlm.nih.gov/25671254 PubMed] NCT01321554
 
# '''COSMIC-311:''' Brose MS, Robinson B, Sherman SI, Krajewska J, Lin CC, Vaisman F, Hoff AO, Hitre E, Bowles DW, Hernando J, Faoro L, Banerjee K, Oliver JW, Keam B, Capdevila J. Cabozantinib for radioiodine-refractory differentiated thyroid cancer (COSMIC-311): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2021 Aug;22(8):1126-1138. Epub 2021 Jul 5. [https://doi.org/10.1016/s1470-2045(21)00332-6 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/34237250/ PubMed] NCT03690388
 
# '''COSMIC-311:''' Brose MS, Robinson B, Sherman SI, Krajewska J, Lin CC, Vaisman F, Hoff AO, Hitre E, Bowles DW, Hernando J, Faoro L, Banerjee K, Oliver JW, Keam B, Capdevila J. Cabozantinib for radioiodine-refractory differentiated thyroid cancer (COSMIC-311): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2021 Aug;22(8):1126-1138. Epub 2021 Jul 5. [https://doi.org/10.1016/s1470-2045(21)00332-6 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/34237250/ PubMed] NCT03690388
 
 
==Radioiodine ablation {{#subobject:29fcfa|Regimen=1}}==
 
==Radioiodine ablation {{#subobject:29fcfa|Regimen=1}}==
 
+
<div class="toccolours" style="background-color:#eeeeee">
 
===Regimen variant #1, 1.1 GBq {{#subobject:e834eb|Variant=1}}===
 
===Regimen variant #1, 1.1 GBq {{#subobject:e834eb|Variant=1}}===
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
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|-
 
|-
 
|}
 
|}
 +
<div class="toccolours" style="background-color:#cbd5e8">
 
====Preceding treatment====
 
====Preceding treatment====
 
*[[Surgery#Thyroidectomy|Thyroidectomy]]
 
*[[Surgery#Thyroidectomy|Thyroidectomy]]
 +
</div>
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Radiotherapy====
 
====Radiotherapy====
 
*[[Iodine-131]] 1.1 GBq
 
*[[Iodine-131]] 1.1 GBq
 
 
'''One course'''
 
'''One course'''
 +
</div></div><br>
 +
<div class="toccolours" style="background-color:#eeeeee">
 
===Regimen variant #2, 3.7 GBq {{#subobject:ca6380|Variant=1}}===
 
===Regimen variant #2, 3.7 GBq {{#subobject:ca6380|Variant=1}}===
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
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|-
 
|-
 
|}
 
|}
 +
<div class="toccolours" style="background-color:#cbd5e8">
 
====Preceding treatment====
 
====Preceding treatment====
 
*[[Surgery#Thyroidectomy|Thyroidectomy]]
 
*[[Surgery#Thyroidectomy|Thyroidectomy]]
 +
</div>
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Radiotherapy====
 
====Radiotherapy====
 
*[[Iodine-131]] 3.7 GBq
 
*[[Iodine-131]] 3.7 GBq
 
 
'''One course'''
 
'''One course'''
 
+
</div></div><br>
 +
<div class="toccolours" style="background-color:#eeeeee">
 
===Regimen variant #3, variable {{#subobject:75cca1|Variant=1}}===
 
===Regimen variant #3, variable {{#subobject:75cca1|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: "The amount of 131I administered was arbitrarily determined by whoever was treating the patient"; included here for historic reference only.''
 
''Note: "The amount of 131I administered was arbitrarily determined by whoever was treating the patient"; included here for historic reference only.''
 +
<div class="toccolours" style="background-color:#cbd5e8">
 
====Preceding treatment====
 
====Preceding treatment====
 
*[[Surgery#Thyroidectomy|Thyroidectomy]]
 
*[[Surgery#Thyroidectomy|Thyroidectomy]]
 +
</div>
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Radiotherapy====
 
====Radiotherapy====
 
*[[Iodine-131]]
 
*[[Iodine-131]]
 +
</div></div>
 
===References===
 
===References===
 
# '''Case report:''' Seidlin SM, Marinelli LD, Oshry E. Radioactive iodine therapy; effect on functioning metastases of adenocarcinoma of the thyroid. J Am Med Assoc. 1946 Dec 7;132(14):838-47. [https://jamanetwork.com/journals/jama/article-abstract/290151 link to original article] [https://pubmed.ncbi.nlm.nih.gov/20274882 PubMed]
 
# '''Case report:''' Seidlin SM, Marinelli LD, Oshry E. Radioactive iodine therapy; effect on functioning metastases of adenocarcinoma of the thyroid. J Am Med Assoc. 1946 Dec 7;132(14):838-47. [https://jamanetwork.com/journals/jama/article-abstract/290151 link to original article] [https://pubmed.ncbi.nlm.nih.gov/20274882 PubMed]
Line 259: Line 268:
 
#'''ASTRA:''' Ho AL, Dedecjus M, Wirth LJ, Tuttle RM, Inabnet WB 3rd, Tennvall J, Vaisman F, Bastholt L, Gianoukakis AG, Rodien P, Paschke R, Elisei R, Viola D, So K, Carroll D, Hovey T, Thakre B, Fagin JA; ASTRA investigator group. Selumetinib Plus Adjuvant Radioactive Iodine in Patients With High-Risk Differentiated Thyroid Cancer: A Phase III, Randomized, Placebo-Controlled Trial (ASTRA). J Clin Oncol. 2022 Jun 10;40(17):1870-1878. Epub 2022 Feb 22. [https://doi.org/10.1200/jco.21.00714 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/35192411/ PubMed] NCT01843062
 
#'''ASTRA:''' Ho AL, Dedecjus M, Wirth LJ, Tuttle RM, Inabnet WB 3rd, Tennvall J, Vaisman F, Bastholt L, Gianoukakis AG, Rodien P, Paschke R, Elisei R, Viola D, So K, Carroll D, Hovey T, Thakre B, Fagin JA; ASTRA investigator group. Selumetinib Plus Adjuvant Radioactive Iodine in Patients With High-Risk Differentiated Thyroid Cancer: A Phase III, Randomized, Placebo-Controlled Trial (ASTRA). J Clin Oncol. 2022 Jun 10;40(17):1870-1878. Epub 2022 Feb 22. [https://doi.org/10.1200/jco.21.00714 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/35192411/ PubMed] NCT01843062
 
#'''ESTIMABL2:''' Leboulleux S, Bournaud C, Chougnet CN, Zerdoud S, Al Ghuzlan A, Catargi B, Do Cao C, Kelly A, Barge ML, Lacroix L, Dygai I, Vera P, Rusu D, Schneegans O, Benisvy D, Klein M, Roux J, Eberle MC, Bastie D, Nascimento C, Giraudet AL, Le Moullec N, Bardet S, Drui D, Roudaut N, Godbert Y, Morel O, Drutel A, Lamartina L, Schvartz C, Velayoudom FL, Schlumberger MJ, Leenhardt L, Borget I. Thyroidectomy without Radioiodine in Patients with Low-Risk Thyroid Cancer. N Engl J Med. 2022 Mar 10;386(10):923-932. [https://doi.org/10.1056/nejmoa2111953 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/35263518/ PubMed] NCT01837745
 
#'''ESTIMABL2:''' Leboulleux S, Bournaud C, Chougnet CN, Zerdoud S, Al Ghuzlan A, Catargi B, Do Cao C, Kelly A, Barge ML, Lacroix L, Dygai I, Vera P, Rusu D, Schneegans O, Benisvy D, Klein M, Roux J, Eberle MC, Bastie D, Nascimento C, Giraudet AL, Le Moullec N, Bardet S, Drui D, Roudaut N, Godbert Y, Morel O, Drutel A, Lamartina L, Schvartz C, Velayoudom FL, Schlumberger MJ, Leenhardt L, Borget I. Thyroidectomy without Radioiodine in Patients with Low-Risk Thyroid Cancer. N Engl J Med. 2022 Mar 10;386(10):923-932. [https://doi.org/10.1056/nejmoa2111953 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/35263518/ PubMed] NCT01837745
 
 
==Radioiodine & Selumetinib {{#subobject:29y7ur|Regimen=1}}==
 
==Radioiodine & Selumetinib {{#subobject:29y7ur|Regimen=1}}==
 
+
<div class="toccolours" style="background-color:#eeeeee">
 
===Regimen {{#subobject:u8rq80|Variant=1}}===
 
===Regimen {{#subobject:u8rq80|Variant=1}}===
 
{| class="wikitable sortable" style="width: 60%; text-align:center;"  
 
{| class="wikitable sortable" style="width: 60%; text-align:center;"  
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|-
 
|-
 
|}
 
|}
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Radiotherapy====
 
====Radiotherapy====
 
*[[Iodine-131]]
 
*[[Iodine-131]]
 
====Targeted therapy====
 
====Targeted therapy====
 
*[[Selumetinib (Koselugo)]]
 
*[[Selumetinib (Koselugo)]]
 +
</div></div>
 
===References===
 
===References===
 
# '''MSK 09-048:''' Ho AL, Grewal RK, Leboeuf R, Sherman EJ, Pfister DG, Deandreis D, Pentlow KS, Zanzonico PB, Haque S, Gavane S, Ghossein RA, Ricarte-Filho JC, Domínguez JM, Shen R, Tuttle RM, Larson SM, Fagin JA. Selumetinib-enhanced radioiodine uptake in advanced thyroid cancer. N Engl J Med. 2013 Feb 14;368(7):623-32. [https://doi.org/10.1056/NEJMoa1209288 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc3615415/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/23406027 PubMed] NCT00970359
 
# '''MSK 09-048:''' Ho AL, Grewal RK, Leboeuf R, Sherman EJ, Pfister DG, Deandreis D, Pentlow KS, Zanzonico PB, Haque S, Gavane S, Ghossein RA, Ricarte-Filho JC, Domínguez JM, Shen R, Tuttle RM, Larson SM, Fagin JA. Selumetinib-enhanced radioiodine uptake in advanced thyroid cancer. N Engl J Med. 2013 Feb 14;368(7):623-32. [https://doi.org/10.1056/NEJMoa1209288 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc3615415/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/23406027 PubMed] NCT00970359
 
 
==Sorafenib monotherapy {{#subobject:36a6b4|Regimen=1}}==
 
==Sorafenib monotherapy {{#subobject:36a6b4|Regimen=1}}==
 
+
<div class="toccolours" style="background-color:#eeeeee">
 
===Regimen {{#subobject:237686|Variant=1}}===
 
===Regimen {{#subobject:237686|Variant=1}}===
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
Line 297: Line 306:
 
|-
 
|-
 
|}
 
|}
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Targeted therapy====
 
====Targeted therapy====
 
*[[Sorafenib (Nexavar)]] 400 mg PO twice per day
 
*[[Sorafenib (Nexavar)]] 400 mg PO twice per day
 
 
'''Continued indefinitely'''
 
'''Continued indefinitely'''
 +
</div></div>
 
===References===
 
===References===
 
# '''DECISION:''' Brose MS, Nutting CM, Jarzab B, Elisei R, Siena S, Bastholt L, de la Fouchardiere C, Pacini F, Paschke R, Shong YK, Sherman SI, Smit JW, Chung J, Kappeler C, Peña C, Molnár I, Schlumberger MJ; DECISION investigators. Sorafenib in radioactive iodine-refractory, locally advanced or metastatic differentiated thyroid cancer: a randomised, double-blind, phase 3 trial. Lancet. 2014 Jul 26;384(9940):319-28. Epub 2014 Apr 24. [https://doi.org/10.1016/s0140-6736(14)60421-9 link to original article] '''contains dosing details in manuscript''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4366116/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/24768112 PubMed] NCT00984282
 
# '''DECISION:''' Brose MS, Nutting CM, Jarzab B, Elisei R, Siena S, Bastholt L, de la Fouchardiere C, Pacini F, Paschke R, Shong YK, Sherman SI, Smit JW, Chung J, Kappeler C, Peña C, Molnár I, Schlumberger MJ; DECISION investigators. Sorafenib in radioactive iodine-refractory, locally advanced or metastatic differentiated thyroid cancer: a randomised, double-blind, phase 3 trial. Lancet. 2014 Jul 26;384(9940):319-28. Epub 2014 Apr 24. [https://doi.org/10.1016/s0140-6736(14)60421-9 link to original article] '''contains dosing details in manuscript''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4366116/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/24768112 PubMed] NCT00984282
 
 
==Vandetanib monotherapy {{#subobject:83e502|Regimen=1}}==
 
==Vandetanib monotherapy {{#subobject:83e502|Regimen=1}}==
 
+
<div class="toccolours" style="background-color:#eeeeee">
 
===Regimen {{#subobject:d2f77d|Variant=1}}===
 
===Regimen {{#subobject:d2f77d|Variant=1}}===
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
Line 321: Line 330:
 
|-
 
|-
 
|}
 
|}
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Targeted therapy====
 
====Targeted therapy====
 
*[[Vandetanib (Caprelsa)]] 300 mg PO once per day
 
*[[Vandetanib (Caprelsa)]] 300 mg PO once per day
 
 
'''Continued indefinitely'''
 
'''Continued indefinitely'''
 
+
</div></div>
 
===References===
 
===References===
 
# '''D4200C00079:''' Leboulleux S, Bastholt L, Krause T, de la Fouchardiere C, Tennvall J, Awada A, Gómez JM, Bonichon F, Leenhardt L, Soufflet C, Licour M, Schlumberger MJ. Vandetanib in locally advanced or metastatic differentiated thyroid cancer: a randomised, double-blind, phase 2 trial. Lancet Oncol. 2012 Sep;13(9):897-905. Epub 2012 Aug 14. [https://doi.org/10.1016/S1470-2045(12)70335-2 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/22898678 PubMed] NCT00537095
 
# '''D4200C00079:''' Leboulleux S, Bastholt L, Krause T, de la Fouchardiere C, Tennvall J, Awada A, Gómez JM, Bonichon F, Leenhardt L, Soufflet C, Licour M, Schlumberger MJ. Vandetanib in locally advanced or metastatic differentiated thyroid cancer: a randomised, double-blind, phase 2 trial. Lancet Oncol. 2012 Sep;13(9):897-905. Epub 2012 Aug 14. [https://doi.org/10.1016/S1470-2045(12)70335-2 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/22898678 PubMed] NCT00537095
 
 
=Advanced or metastatic disease=
 
=Advanced or metastatic disease=
 
 
==Apatinib monotherapy {{#subobject:7hgub6|Regimen=1}}==
 
==Apatinib monotherapy {{#subobject:7hgub6|Regimen=1}}==
 
+
<div class="toccolours" style="background-color:#eeeeee">
 
===Regimen {{#subobject:afjug7|Variant=1}}===
 
===Regimen {{#subobject:afjug7|Variant=1}}===
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
Line 348: Line 355:
 
|-
 
|-
 
|}
 
|}
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Targeted therapy====
 
====Targeted therapy====
 
*[[Apatinib (Aitan)]] 500 mg PO once per day
 
*[[Apatinib (Aitan)]] 500 mg PO once per day
 
 
'''28-day cycles'''
 
'''28-day cycles'''
 
+
</div></div>
 
===References===
 
===References===
 
#'''REALITY:''' Lin Y, Qin S, Li Z, Yang H, Fu W, Li S, Chen W, Gao Z, Miao W, Xu H, Zhang Q, Zhao X, Bao J, Li L, Ren Y, Lin C, Jing S, Ma Q, Liang J, Chen G, Zhang H, Zhang Y, Zhou X, Sang Y, Hou Z. Apatinib vs Placebo in Patients With Locally Advanced or Metastatic, Radioactive Iodine-Refractory Differentiated Thyroid Cancer: The REALITY Randomized Clinical Trial. JAMA Oncol. 2022 Feb 1;8(2):242-250. [https://doi.org/10.1001/jamaoncol.2021.6268 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8678901/ link to PMC article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/34913959/ PubMed] NCT03048877
 
#'''REALITY:''' Lin Y, Qin S, Li Z, Yang H, Fu W, Li S, Chen W, Gao Z, Miao W, Xu H, Zhang Q, Zhao X, Bao J, Li L, Ren Y, Lin C, Jing S, Ma Q, Liang J, Chen G, Zhang H, Zhang Y, Zhou X, Sang Y, Hou Z. Apatinib vs Placebo in Patients With Locally Advanced or Metastatic, Radioactive Iodine-Refractory Differentiated Thyroid Cancer: The REALITY Randomized Clinical Trial. JAMA Oncol. 2022 Feb 1;8(2):242-250. [https://doi.org/10.1001/jamaoncol.2021.6268 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8678901/ link to PMC article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/34913959/ PubMed] NCT03048877
 
 
==Axitinib monotherapy {{#subobject:73fcb6|Regimen=1}}==
 
==Axitinib monotherapy {{#subobject:73fcb6|Regimen=1}}==
 
+
<div class="toccolours" style="background-color:#eeeeee">
 
===Regimen {{#subobject:aff447|Variant=1}}===
 
===Regimen {{#subobject:aff447|Variant=1}}===
 
{| class="wikitable sortable" style="width: 60%; text-align:center;"  
 
{| class="wikitable sortable" style="width: 60%; text-align:center;"  
Line 369: Line 375:
 
|-
 
|-
 
|}
 
|}
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Targeted therapy====
 
====Targeted therapy====
 
*[[Axitinib (Inlyta)]] 5 mg PO twice per day
 
*[[Axitinib (Inlyta)]] 5 mg PO twice per day
 
'''Continued indefinitely'''
 
'''Continued indefinitely'''
 +
</div></div>
 
===References===
 
===References===
 
# '''A4061027:''' Locati LD, Licitra L, Agate L, Ou SH, Boucher A, Jarzab B, Qin S, Kane MA, Wirth LJ, Chen C, Kim S, Ingrosso A, Pithavala YK, Bycott P, Cohen EE. Treatment of advanced thyroid cancer with axitinib: Phase 2 study with pharmacokinetic/pharmacodynamic and quality-of-life assessments. Cancer. 2014 Sep 1;120(17):2694-703. Epub 2014 May 20. [https://doi.org/10.1002/cncr.28766 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/24844950 PubMed] NCT00389441
 
# '''A4061027:''' Locati LD, Licitra L, Agate L, Ou SH, Boucher A, Jarzab B, Qin S, Kane MA, Wirth LJ, Chen C, Kim S, Ingrosso A, Pithavala YK, Bycott P, Cohen EE. Treatment of advanced thyroid cancer with axitinib: Phase 2 study with pharmacokinetic/pharmacodynamic and quality-of-life assessments. Cancer. 2014 Sep 1;120(17):2694-703. Epub 2014 May 20. [https://doi.org/10.1002/cncr.28766 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/24844950 PubMed] NCT00389441
 
 
==Sunitinib monotherapy {{#subobject:8d6c5|Regimen=1}}==
 
==Sunitinib monotherapy {{#subobject:8d6c5|Regimen=1}}==
 
+
<div class="toccolours" style="background-color:#eeeeee">
 
===Regimen {{#subobject:d1cea4|Variant=1}}===
 
===Regimen {{#subobject:d1cea4|Variant=1}}===
 
{| class="wikitable sortable" style="width: 80%; text-align:center;"  
 
{| class="wikitable sortable" style="width: 80%; text-align:center;"  
Line 390: Line 397:
 
|-
 
|-
 
|}
 
|}
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Targeted therapy====
 
====Targeted therapy====
 
*[[Sunitinib (Sutent)]] 37.5 mg PO once per day
 
*[[Sunitinib (Sutent)]] 37.5 mg PO once per day
 
'''Continued indefinitely'''
 
'''Continued indefinitely'''
 +
</div></div>
 
===References===
 
===References===
 
# Carr LL, Mankoff DA, Goulart BH, Eaton KD, Capell PT, Kell EM, Bauman JE, Martins RG. Phase II study of daily sunitinib in FDG-PET-positive, iodine-refractory differentiated thyroid cancer and metastatic medullary carcinoma of the thyroid with functional imaging correlation. Clin Cancer Res. 2010 Nov 1;16(21):5260-8. Epub 2010 Sep 16. [https://doi.org/10.1158/1078-0432.CCR-10-0994 link to original article] '''contains dosing details in manuscript''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3063514/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/20847059 PubMed]
 
# Carr LL, Mankoff DA, Goulart BH, Eaton KD, Capell PT, Kell EM, Bauman JE, Martins RG. Phase II study of daily sunitinib in FDG-PET-positive, iodine-refractory differentiated thyroid cancer and metastatic medullary carcinoma of the thyroid with functional imaging correlation. Clin Cancer Res. 2010 Nov 1;16(21):5260-8. Epub 2010 Sep 16. [https://doi.org/10.1158/1078-0432.CCR-10-0994 link to original article] '''contains dosing details in manuscript''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3063514/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/20847059 PubMed]
 
 
[[Category:Thyroid cancer regimens]]
 
[[Category:Thyroid cancer regimens]]
 
[[Category:Disease-specific pages]]
 
[[Category:Disease-specific pages]]
 
[[Category:Endocrine cancers]]
 
[[Category:Endocrine cancers]]
 
[[Category:Head and neck cancers]]
 
[[Category:Head and neck cancers]]

Revision as of 17:33, 13 February 2023

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

11 regimens on this page
14 variants on this page


Guidelines

ATA

  • 2015: Guidelines on the management of thyroid nodules and differentiated thyroid cancer PubMed

ESMO

Older

NCCN

All lines of therapy

Cabozantinib monotherapy

Regimen variant #1, pediatric dosing

FDA-recommended dose

Note: this is the FDA-recommended dose in pediatric patients who are 12 years of age or older with BSA less than 1.2 m2.

Targeted therapy

Continued indefinitely


Regimen variant #2

FDA-recommended dose
Study Years of enrollment Evidence Comparator Comparative Efficacy
Brose et al. 2021 (COSMIC-311) 2019-2020 Phase 3 (E-RT-esc) Placebo Superior PFS
Median PFS: NYR vs 1.9 mo
(HR 0.22, 96% CI 0.13-0.36)

Note: this is the FDA-recommended dose for adult patients.

Targeted therapy

Continued indefinitely

References

  1. COSMIC-311: Brose MS, Robinson B, Sherman SI, Krajewska J, Lin CC, Vaisman F, Hoff AO, Hitre E, Bowles DW, Hernando J, Faoro L, Banerjee K, Oliver JW, Keam B, Capdevila J. Cabozantinib for radioiodine-refractory differentiated thyroid cancer (COSMIC-311): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2021 Aug;22(8):1126-1138. Epub 2021 Jul 5. link to original article contains dosing details in manuscript PubMed NCT03690388

Lenvatinib monotherapy

Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
Schlumberger et al. 2015 (SELECT)
ESMO-MCBS (2)
2011-2012 Phase 3 (E-RT-esc) Placebo Superior PFS
Median PFS: 18.3 vs 3.6 mo
(HR 0.21, 99% CI 0.14-0.31)
Zheng et al. 2021 (E7080-C086-308) 2017-NR Phase 3 (E-esc) Placebo Superior PFS
Median PFS: 23.9 vs 3.7 mo
(HR 0.16, 95% CI 0.10-0.26)

Targeted therapy

  • Lenvatinib (Lenvima) 24 mg PO once per day
    • Per the package insert, patients with eGFR of less than 30 mL/min/1.73m2 by Cockroft-Gault or Child-Pugh C severe hepatic impairment should receive 14 mg PO once per day

28-day cycles

References

  1. SELECT: Schlumberger M, Tahara M, Wirth LJ, Robinson B, Brose MS, Elisei R, Habra MA, Newbold K, Shah MH, Hoff AO, Gianoukakis AG, Kiyota N, Taylor MH, Kim SB, Krzyzanowska MK, Dutcus CE, de las Heras B, Zhu J, Sherman SI. Lenvatinib versus placebo in radioiodine-refractory thyroid cancer. N Engl J Med. 2015 Feb 12;372(7):621-30. link to original article contains dosing details in abstract PubMed NCT01321554
  2. E7080-C086-308: Zheng X, Xu Z, Ji Q, Ge M, Shi F, Qin J, Wang F, Chen G, Zhang Y, Huang R, Tan J, Huang T, Li S, Lv Z, Lin Y, Guo Z, Kubota T, Suzuki T, Ikezawa H, Gao M. A Randomized, Phase III Study of Lenvatinib in Chinese Patients with Radioiodine-Refractory Differentiated Thyroid Cancer. Clin Cancer Res. 2021 Oct 15;27(20):5502-5509. Epub 2021 Jul 29. link to original article contains dosing details in abstract PubMed NCT02966093

Pazopanib monotherapy

Regimen

Study Years of enrollment Evidence
Bible et al. 2010 (MC057H) 2008-2009 Phase 2

Targeted therapy

28-day cycles

References

  1. MC057H: Bible KC, Suman VJ, Molina JR, Smallridge RC, Maples WJ, Menefee ME, Rubin J, Sideras K, Morris JC 3rd, McIver B, Burton JK, Webster KP, Bieber C, Traynor AM, Flynn PJ, Goh BC, Tang H, Ivy SP, Erlichman C; Endocrine Malignancies Disease Oriented Group; Mayo Clinic Cancer Center; Mayo Phase 2 Consortium. Efficacy of pazopanib in progressive, radioiodine-refractory, metastatic differentiated thyroid cancers: results of a phase 2 consortium study. Lancet Oncol. 2010 Oct;11(10):962-72. Epub 2010 Sep 17. link to original article contains dosing details in abstract link to PMC article PubMed NCT00625846

Placebo

Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
Leboulleux et al. 2012 (D4200C00079) 2007-2008 Randomized Phase 2 (C) Vandetanib Inferior PFS
Brose et al. 2014 (DECISION) 2009-2011 Phase 3 (C) Sorafenib Inferior PFS
Schlumberger et al. 2015 (SELECT) 2011-2012 Phase 3 (C) Lenvatinib Inferior PFS
Brose et al. 2021 (COSMIC-311) 2019-2020 Phase 3 (C) Cabozantinib Inferior PFS

No active antineoplastic treatment.

References

  1. D4200C00079: Leboulleux S, Bastholt L, Krause T, de la Fouchardiere C, Tennvall J, Awada A, Gómez JM, Bonichon F, Leenhardt L, Soufflet C, Licour M, Schlumberger MJ. Vandetanib in locally advanced or metastatic differentiated thyroid cancer: a randomised, double-blind, phase 2 trial. Lancet Oncol. 2012 Sep;13(9):897-905. Epub 2012 Aug 14. link to original article contains dosing details in abstract PubMed NCT00537095
  2. DECISION: Brose MS, Nutting CM, Jarzab B, Elisei R, Siena S, Bastholt L, de la Fouchardiere C, Pacini F, Paschke R, Shong YK, Sherman SI, Smit JW, Chung J, Kappeler C, Peña C, Molnár I, Schlumberger MJ; DECISION investigators. Sorafenib in radioactive iodine-refractory, locally advanced or metastatic differentiated thyroid cancer: a randomised, double-blind, phase 3 trial. Lancet. 2014 Jul 26;384(9940):319-28. Epub 2014 Apr 24. link to original article link to PMC article PubMed NCT00984282
  3. SELECT: Schlumberger M, Tahara M, Wirth LJ, Robinson B, Brose MS, Elisei R, Habra MA, Newbold K, Shah MH, Hoff AO, Gianoukakis AG, Kiyota N, Taylor MH, Kim SB, Krzyzanowska MK, Dutcus CE, de las Heras B, Zhu J, Sherman SI. Lenvatinib versus placebo in radioiodine-refractory thyroid cancer. N Engl J Med. 2015 Feb 12;372(7):621-30. link to original article PubMed NCT01321554
  4. COSMIC-311: Brose MS, Robinson B, Sherman SI, Krajewska J, Lin CC, Vaisman F, Hoff AO, Hitre E, Bowles DW, Hernando J, Faoro L, Banerjee K, Oliver JW, Keam B, Capdevila J. Cabozantinib for radioiodine-refractory differentiated thyroid cancer (COSMIC-311): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2021 Aug;22(8):1126-1138. Epub 2021 Jul 5. link to original article contains dosing details in manuscript PubMed NCT03690388

Radioiodine ablation

Regimen variant #1, 1.1 GBq

Study Years of enrollment Evidence Comparator Comparative Efficacy
Schlumberger et al. 2012 (ESTIMABL1) 2007-2010 Phase 3 (E-de-esc) I-131; 3.7 GBq Equivalent rate of ablation
Mallick et al. 2012 (HiLo) 2007-2010 Phase 3 (E-de-esc) I-131; 3.7 GBq Non-inferior rate of ablation
Leboulleux et al. 2022 (ESTIMABL2) 2013-2017 Phase 3 (C) Observation Non-inferior composite endpoint

Preceding treatment

Radiotherapy

One course


Regimen variant #2, 3.7 GBq

Study Years of enrollment Evidence Comparator Comparative Efficacy
Schlumberger et al. 2012 (ESTIMABL1) 2007-2010 Phase 3 (C) I-131; 1.1 GBq Equivalent outcome
Mallick et al. 2012 (HiLo) 2007-2010 Phase 3 (C) I-131; 1.1 GBq Non-inferior rate of ablation
Ho et al. 2022 (ASTRA) 2013-2016 Phase 3 (C) RAI & Selumetinib Did not meet primary endpoint of CR rate at 18 months

Preceding treatment

Radiotherapy

One course


Regimen variant #3, variable

Study Years of enrollment Evidence
Maxon et al. 1983 NR in abstract Non-randomized

Note: "The amount of 131I administered was arbitrarily determined by whoever was treating the patient"; included here for historic reference only.

Preceding treatment

Radiotherapy

References

  1. Case report: Seidlin SM, Marinelli LD, Oshry E. Radioactive iodine therapy; effect on functioning metastases of adenocarcinoma of the thyroid. J Am Med Assoc. 1946 Dec 7;132(14):838-47. link to original article PubMed
  2. Maxon HR, Thomas SR, Hertzberg VS, Kereiakes JG, Chen IW, Sperling MI, Saenger EL. Relation between effective radiation dose and outcome of radioiodine therapy for thyroid cancer. N Engl J Med. 1983 Oct 20;309(16):937-41. link to original article PubMed
  3. SYTJ001T/2000: Mäenpää HO, Heikkonen J, Vaalavirta L, Tenhunen M, Joensuu H. Low vs. high radioiodine activity to ablate the thyroid after thyroidectomy for cancer: a randomized study. PLoS One. 2008 Apr 2;3(4):e1885. link to original article link to PMC article PubMed NCT00115895
    1. Update: Ahtiainen V, Vaalavirta L, Tenhunen M, Joensuu H, Mäenpää H. Randomised comparison of 1.1 GBq and 3.7 GBq radioiodine to ablate the thyroid in the treatment of low-risk thyroid cancer: a 13-year follow-up. Acta Oncol. 2020 Sep;59(9):1064-1071. Epub 2020 Jun 30. link to original article PubMed
  4. ESTIMABL1: Schlumberger M, Catargi B, Borget I, Deandreis D, Zerdoud S, Bridji B, Bardet S, Leenhardt L, Bastie D, Schvartz C, Vera P, Morel O, Benisvy D, Bournaud C, Bonichon F, Dejax C, Toubert ME, Leboulleux S, Ricard M, Benhamou E; Tumeurs de la Thyroïde Refractaires Network for the Essai Stimulation Ablation Equivalence Trial. Strategies of radioiodine ablation in patients with low-risk thyroid cancer. N Engl J Med. 2012 May 3;366(18):1663-73. link to original article PubMed NCT00435851
    1. Update: Schlumberger M, Leboulleux S, Catargi B, Deandreis D, Zerdoud S, Bardet S, Rusu D, Godbert Y, Buffet C, Schvartz C, Vera P, Morel O, Benisvy D, Bournaud C, Toubert ME, Kelly A, Benhamou E, Borget I. Outcome after ablation in patients with low-risk thyroid cancer (ESTIMABL1): 5-year follow-up results of a randomised, phase 3, equivalence trial. Lancet Diabetes Endocrinol. 2018 Aug;6(8):618-626. Epub 2018 May 26. link to original article PubMed
  5. HiLo: Mallick U, Harmer C, Yap B, Wadsley J, Clarke S, Moss L, Nicol A, Clark PM, Farnell K, McCready R, Smellie J, Franklyn JA, John R, Nutting CM, Newbold K, Lemon C, Gerrard G, Abdel-Hamid A, Hardman J, Macias E, Roques T, Whitaker S, Vijayan R, Alvarez P, Beare S, Forsyth S, Kadalayil L, Hackshaw A. Ablation with low-dose radioiodine and thyrotropin alfa in thyroid cancer. N Engl J Med. 2012 May 3;366(18):1674-85. link to original article contains dosing details in abstract PubMed NCT00415233
  6. ASTRA: Ho AL, Dedecjus M, Wirth LJ, Tuttle RM, Inabnet WB 3rd, Tennvall J, Vaisman F, Bastholt L, Gianoukakis AG, Rodien P, Paschke R, Elisei R, Viola D, So K, Carroll D, Hovey T, Thakre B, Fagin JA; ASTRA investigator group. Selumetinib Plus Adjuvant Radioactive Iodine in Patients With High-Risk Differentiated Thyroid Cancer: A Phase III, Randomized, Placebo-Controlled Trial (ASTRA). J Clin Oncol. 2022 Jun 10;40(17):1870-1878. Epub 2022 Feb 22. link to original article contains dosing details in abstract PubMed NCT01843062
  7. ESTIMABL2: Leboulleux S, Bournaud C, Chougnet CN, Zerdoud S, Al Ghuzlan A, Catargi B, Do Cao C, Kelly A, Barge ML, Lacroix L, Dygai I, Vera P, Rusu D, Schneegans O, Benisvy D, Klein M, Roux J, Eberle MC, Bastie D, Nascimento C, Giraudet AL, Le Moullec N, Bardet S, Drui D, Roudaut N, Godbert Y, Morel O, Drutel A, Lamartina L, Schvartz C, Velayoudom FL, Schlumberger MJ, Leenhardt L, Borget I. Thyroidectomy without Radioiodine in Patients with Low-Risk Thyroid Cancer. N Engl J Med. 2022 Mar 10;386(10):923-932. link to original article contains dosing details in abstract PubMed NCT01837745

Radioiodine & Selumetinib

Regimen

Study Years of enrollment Evidence
Ho et al. 2013 (MSK 09-048) 2010-2011 Non-randomized

Radiotherapy

Targeted therapy

References

  1. MSK 09-048: Ho AL, Grewal RK, Leboeuf R, Sherman EJ, Pfister DG, Deandreis D, Pentlow KS, Zanzonico PB, Haque S, Gavane S, Ghossein RA, Ricarte-Filho JC, Domínguez JM, Shen R, Tuttle RM, Larson SM, Fagin JA. Selumetinib-enhanced radioiodine uptake in advanced thyroid cancer. N Engl J Med. 2013 Feb 14;368(7):623-32. link to original article link to PMC article PubMed NCT00970359

Sorafenib monotherapy

Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
Brose et al. 2014 (DECISION) 2009-2011 Phase 3 (E-RT-esc) Placebo Superior PFS

Targeted therapy

Continued indefinitely

References

  1. DECISION: Brose MS, Nutting CM, Jarzab B, Elisei R, Siena S, Bastholt L, de la Fouchardiere C, Pacini F, Paschke R, Shong YK, Sherman SI, Smit JW, Chung J, Kappeler C, Peña C, Molnár I, Schlumberger MJ; DECISION investigators. Sorafenib in radioactive iodine-refractory, locally advanced or metastatic differentiated thyroid cancer: a randomised, double-blind, phase 3 trial. Lancet. 2014 Jul 26;384(9940):319-28. Epub 2014 Apr 24. link to original article contains dosing details in manuscript link to PMC article PubMed NCT00984282

Vandetanib monotherapy

Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
Leboulleux et al. 2012 (D4200C00079) 2007-2008 Randomized Phase 2 (E-esc) Placebo Superior PFS

Targeted therapy

Continued indefinitely

References

  1. D4200C00079: Leboulleux S, Bastholt L, Krause T, de la Fouchardiere C, Tennvall J, Awada A, Gómez JM, Bonichon F, Leenhardt L, Soufflet C, Licour M, Schlumberger MJ. Vandetanib in locally advanced or metastatic differentiated thyroid cancer: a randomised, double-blind, phase 2 trial. Lancet Oncol. 2012 Sep;13(9):897-905. Epub 2012 Aug 14. link to original article contains dosing details in abstract PubMed NCT00537095

Advanced or metastatic disease

Apatinib monotherapy

Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
Lin et al. 2022 (REALITY) 2017-2020 Phase 3 (E-esc) Placebo Seems to have superior OS
Median OS: NYR vs 29.9 mo
(HR 0.42, 95% CI 0.18-0.97)

Targeted therapy

28-day cycles

References

  1. REALITY: Lin Y, Qin S, Li Z, Yang H, Fu W, Li S, Chen W, Gao Z, Miao W, Xu H, Zhang Q, Zhao X, Bao J, Li L, Ren Y, Lin C, Jing S, Ma Q, Liang J, Chen G, Zhang H, Zhang Y, Zhou X, Sang Y, Hou Z. Apatinib vs Placebo in Patients With Locally Advanced or Metastatic, Radioactive Iodine-Refractory Differentiated Thyroid Cancer: The REALITY Randomized Clinical Trial. JAMA Oncol. 2022 Feb 1;8(2):242-250. link to original article link to PMC article contains dosing details in manuscript PubMed NCT03048877

Axitinib monotherapy

Regimen

Study Years of enrollment Evidence
Locati et al. 2014 (A4061027) 2006-2008 Phase 2

Targeted therapy

Continued indefinitely

References

  1. A4061027: Locati LD, Licitra L, Agate L, Ou SH, Boucher A, Jarzab B, Qin S, Kane MA, Wirth LJ, Chen C, Kim S, Ingrosso A, Pithavala YK, Bycott P, Cohen EE. Treatment of advanced thyroid cancer with axitinib: Phase 2 study with pharmacokinetic/pharmacodynamic and quality-of-life assessments. Cancer. 2014 Sep 1;120(17):2694-703. Epub 2014 May 20. link to original article contains dosing details in manuscript PubMed NCT00389441

Sunitinib monotherapy

Regimen

Study Years of enrollment Evidence Efficacy
Carr et al. 2010 2007-2009 Phase 2 ORR: 31% (95% CI: 16-47)

Targeted therapy

Continued indefinitely

References

  1. Carr LL, Mankoff DA, Goulart BH, Eaton KD, Capell PT, Kell EM, Bauman JE, Martins RG. Phase II study of daily sunitinib in FDG-PET-positive, iodine-refractory differentiated thyroid cancer and metastatic medullary carcinoma of the thyroid with functional imaging correlation. Clin Cancer Res. 2010 Nov 1;16(21):5260-8. Epub 2010 Sep 16. link to original article contains dosing details in manuscript link to PMC article PubMed