Difference between revisions of "Thyroid cancer, differentiated"

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[[#top|Back to Top]]
 
[[#top|Back to Top]]
 
</div>
 
</div>
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{{#lst:Section editor transclusions|endo}}
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{{#lst:Editorial board transclusions|endo}}
 
''For placebo or observational studies in this condition, please visit [[Thyroid cancer, differentiated - null regimens|this page]].''<br>
 
''For placebo or observational studies in this condition, please visit [[Thyroid cancer, differentiated - null regimens|this page]].''<br>
 
Note: these are regimens tested in histology-specific populations, please see the '''[[Thyroid cancer|main thyroid cancer page]]''' for other regimens.
 
Note: these are regimens tested in histology-specific populations, please see the '''[[Thyroid cancer|main thyroid cancer page]]''' for other regimens.
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{{TOC limit|limit=3}}
 
{{TOC limit|limit=3}}
 
=Guidelines=
 
=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.'''
 
==[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:''' [https://doi.org/10.1089/thy.2016.0628 Guidelines on the management of thyroid nodules and differentiated thyroid cancer] [https://pubmed.ncbi.nlm.nih.gov/28114862/ PubMed]
−
==[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]
+
==[https://www.esmo.org/ ESMO]==
−
===Older===
+
*'''2019:''' Filetti et al. [https://doi.org/10.1093/annonc/mdz400 Thyroid cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up] [https://www.ncbi.nlm.nih.gov/pubmed/31549998 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]
+
**'''2012:''' Pacini et al. [https://doi.org/10.1093/annonc/mds230 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]==
+
**'''2009:''' Pacini et al. [https://doi.org/10.1093/annonc/mdp156 Differentiated thyroid cancer: ESMO clinical recommendations for diagnosis, treatment and follow-up] [https://pubmed.ncbi.nlm.nih.gov/19454437/ PubMed]
−
*[https://www.nccn.org/professionals/physician_gls/pdf/thyroid.pdf NCCN Guidelines - Thyroid Carcinoma]
+
**'''2008:''' Pacini et al. [https://doi.org/10.1093/annonc/mdn115 Differentiated thyroid cancer: ESMO clinical recommendations for diagnosis, treatment and follow-up] [https://pubmed.ncbi.nlm.nih.gov/18456786/ PubMed]
 +
 
 +
==NCCN==
 +
*''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].''
  
 
=Adjuvant therapy=
 
=Adjuvant therapy=
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| style="background-color:#1a9851" |Phase 3 (E-de-esc)
 
| style="background-color:#1a9851" |Phase 3 (E-de-esc)
 
|[[#Radioiodine_ablation|I-131]]; 3.7 GBq
 
|[[#Radioiodine_ablation|I-131]]; 3.7 GBq
−
| style="background-color:#eeee01" |Equivalent rate of ablation
+
| style="background-color:#eeee01" |Equivalent rate of ablation (primary endpoint)
 
|-
 
|-
 
|[https://doi.org/10.1056/NEJMoa1109589 Mallick et al. 2012 (HiLo)]
 
|[https://doi.org/10.1056/NEJMoa1109589 Mallick et al. 2012 (HiLo)]
Line 44: Line 48:
 
| style="background-color:#1a9851" |Phase 3 (E-de-esc)
 
| style="background-color:#1a9851" |Phase 3 (E-de-esc)
 
|[[#Radioiodine_ablation|I-131]]; 3.7 GBq
 
|[[#Radioiodine_ablation|I-131]]; 3.7 GBq
−
| style="background-color:#eeee01" |Non-inferior rate of ablation
+
| style="background-color:#eeee01" |Non-inferior rate of ablation (primary endpoint)
 
|-
 
|-
 
|[https://doi.org/10.1056/nejmoa2111953 Leboulleux et al. 2022 (ESTIMABL2)]
 
|[https://doi.org/10.1056/nejmoa2111953 Leboulleux et al. 2022 (ESTIMABL2)]
Line 83: Line 87:
 
| style="background-color:#eeee01" |Non-inferior rate of ablation
 
| style="background-color:#eeee01" |Non-inferior rate of ablation
 
|-
 
|-
−
|[https://doi.org/10.1200/jco.21.00714 Ho et al. 2022 (ASTRA)]
+
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9851689/ Ho et al. 2022 (ASTRA)]
 
|2013-2016
 
|2013-2016
 
| style="background-color:#1a9851" |Phase 3 (C)
 
| style="background-color:#1a9851" |Phase 3 (C)
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# '''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]
 
# 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. [https://doi.org/10.1056/NEJM198310203091601 link to original article] [https://pubmed.ncbi.nlm.nih.gov/6621620/ PubMed]
 
# 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. [https://doi.org/10.1056/NEJM198310203091601 link to original article] [https://pubmed.ncbi.nlm.nih.gov/6621620/ PubMed]
−
#'''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. [https://doi.org/10.1371/journal.pone.0001885 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc2270902/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/18382668/ PubMed] NCT00115895
+
#'''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. [https://doi.org/10.1371/journal.pone.0001885 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc2270902/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/18382668/ PubMed] [https://clinicaltrials.gov/study/NCT00115895 NCT00115895]
 
## '''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. [https://doi.org/10.1080/0284186x.2020.1785003 link to original article] [https://pubmed.ncbi.nlm.nih.gov/32603613/ PubMed]
 
## '''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. [https://doi.org/10.1080/0284186x.2020.1785003 link to original article] [https://pubmed.ncbi.nlm.nih.gov/32603613/ PubMed]
−
# '''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. [https://doi.org/10.1056/NEJMoa1108586 link to original article] [https://pubmed.ncbi.nlm.nih.gov/22551127/ PubMed] NCT00435851
+
# '''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. [https://doi.org/10.1056/NEJMoa1108586 link to original article] [https://pubmed.ncbi.nlm.nih.gov/22551127/ PubMed] [https://clinicaltrials.gov/study/NCT00435851 NCT00435851]
 
## '''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. [https://doi.org/10.1016/S2213-8587(18)30113-X link to original article] [https://pubmed.ncbi.nlm.nih.gov/29807824/ PubMed]
 
## '''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. [https://doi.org/10.1016/S2213-8587(18)30113-X link to original article] [https://pubmed.ncbi.nlm.nih.gov/29807824/ PubMed]
−
# '''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. [https://doi.org/10.1056/NEJMoa1109589 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/22551128/ PubMed] NCT00415233
+
# '''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. [https://doi.org/10.1056/NEJMoa1109589 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/22551128/ PubMed] [https://clinicaltrials.gov/study/NCT00415233 NCT00415233]
−
#'''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://www.ncbi.nlm.nih.gov/pmc/articles/PMC9851689/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/35192411/ PubMed] [https://clinicaltrials.gov/study/NCT01843062 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] [https://clinicaltrials.gov/study/NCT01837745 NCT01837745]
 +
 
 
==Radioiodine & Selumetinib {{#subobject:29y7ur|Regimen=1}}==
 
==Radioiodine & Selumetinib {{#subobject:29y7ur|Regimen=1}}==
 
<div class="toccolours" style="background-color:#eeeeee">
 
<div class="toccolours" style="background-color:#eeeeee">
Line 146: Line 151:
 
<div class="toccolours" style="background-color:#b3e2cd">
 
<div class="toccolours" style="background-color:#b3e2cd">
 
====Radiotherapy====
 
====Radiotherapy====
−
*[[Iodine-131]]
+
*[[Iodine-131]] (dose not specified)
 
====Targeted therapy====
 
====Targeted therapy====
−
*[[Selumetinib (Koselugo)]]
+
*[[Selumetinib (Koselugo)]] 75 mg PO twice per day on days 1 to 28
 +
'''4-week course'''
 
</div></div>
 
</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] [https://clinicaltrials.gov/study/NCT00970359 NCT00970359]
  
 
=Advanced or metastatic disease, radioactive iodine-refractory=
 
=Advanced or metastatic disease, radioactive iodine-refractory=
Line 168: Line 174:
 
| style="background-color:#1a9851" |Phase 3 (E-esc)
 
| style="background-color:#1a9851" |Phase 3 (E-esc)
 
|[[Thyroid cancer, differentiated - null regimens#Placebo|Placebo]]
 
|[[Thyroid cancer, differentiated - null regimens#Placebo|Placebo]]
−
| style="background-color:#91cf60" |Seems to have superior OS<br>Median OS: NYR vs 29.9 mo<br>(HR 0.42, 95% CI 0.18-0.97)
+
| style="background-color:#91cf60" |Seems to have superior OS (secondary endpoint)<br>Median OS: NYR vs 29.9 mo<br>(HR 0.42, 95% CI 0.18-0.97)
 
|-
 
|-
 
|}
 
|}
 
<div class="toccolours" style="background-color:#b3e2cd">
 
<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 on days 1 to 28
 
'''28-day cycles'''
 
'''28-day cycles'''
 
</div></div>
 
</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] [https://clinicaltrials.gov/study/NCT03048877 NCT03048877]
 
==Cabozantinib monotherapy {{#subobject:1dgac6|Regimen=1}}==
 
==Cabozantinib monotherapy {{#subobject:1dgac6|Regimen=1}}==
 
<div class="toccolours" style="background-color:#eeeeee">
 
<div class="toccolours" style="background-color:#eeeeee">
Line 205: Line 211:
 
|-
 
|-
 
|[https://doi.org/10.1016/s1470-2045(21)00332-6 Brose et al. 2021 (COSMIC-311)]
 
|[https://doi.org/10.1016/s1470-2045(21)00332-6 Brose et al. 2021 (COSMIC-311)]
−
{| class="wikitable" style="margin:auto; color:white; background-color:#1B4F26"
+
<!-- {| class="wikitable" style="margin:auto; color:white; background-color:#1B4F26"
 
|'''[https://www.esmo.org/guidelines/esmo-mcbs/esmo-mcbs-scorecards/scorecard-302-1 <span style="color:white;">ESMO-MCBS (2)</span>]'''
 
|'''[https://www.esmo.org/guidelines/esmo-mcbs/esmo-mcbs-scorecards/scorecard-302-1 <span style="color:white;">ESMO-MCBS (2)</span>]'''
 
|-
 
|-
−
|}
+
|} -->
 
|2019-02-27 to 2020-08-18
 
|2019-02-27 to 2020-08-18
 
| style="background-color:#1a9851" |Phase 3 (E-RT-esc)
 
| style="background-color:#1a9851" |Phase 3 (E-RT-esc)
Line 218: Line 224:
 
<div class="toccolours" style="background-color:#b3e2cd">
 
<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 on days 1 to 28
−
'''Continued indefinitely'''
+
'''28-day cycles'''
 +
</div></div>
 +
===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] [https://clinicaltrials.gov/study/NCT03690388 NCT03690388]
 +
==Donafenib monotherapy {{#subobject:u7r1ca|Regimen=1}}==
 +
<div class="toccolours" style="background-color:#eeeeee">
 +
===Regimen {{#subobject:44trcd|Variant=1}}===
 +
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 +
!style="width: 20%"|Study
 +
!style="width: 20%"|Dates of enrollment
 +
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 +
!style="width: 20%"|Comparator
 +
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 +
|-
 +
|[https://doi.org/10.1158/1078-0432.ccr-22-3613 Lin et al. 2023 (ZGDD3)]
 +
|2018-08-29 to 2021-02-28
 +
| style="background-color:#1a9851" |Phase 3 (E-esc)
 +
|[[Thyroid cancer, differentiated - null regimens#Placebo|Placebo]]
 +
| style="background-color:#1a9850" |Superior PFS (primary endpoint)<br>Median PFS: 12.9 vs 6.4 mo<br>(HR 0.39, 95% CI 0.25-0.61)
 +
|-
 +
|}
 +
<div class="toccolours" style="background-color:#b3e2cd">
 +
====Targeted therapy====
 +
*[[Donafenib (Zepsun)]] 300 mg PO twice per day on days 1 to 28
 +
'''28-day cycles'''
 
</div></div>
 
</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
+
#'''ZGDD3:''' Lin Y, Qin S, Yang H, Shi F, Yang A, Han X, Liu B, Li Z, Ji Q, Tang L, Deng Z, Ding Y, Fu W, Xie X, Li L, He X, Lv Z, Ma Q, Shen Z, Guo Z, Chen Z, Cui Y, Tan J, Gao Z, Jing S, Lu K, Luo X, Zhang Y, Fang Y, Li Z, Cheng Y, Lei S, Luan S, Chen G, Wang G, Wu L, Liu L. Multicenter Randomized Double-Blind Phase III Trial of Donafenib in Progressive Radioactive Iodine-Refractory Differentiated Thyroid Cancer. Clin Cancer Res. 2023 Aug 1;29(15):2791-2799. [https://doi.org/10.1158/1078-0432.ccr-22-3613 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/37184934/ PubMed] [https://clinicaltrials.gov/study/NCT03602495 NCT03602495]
 +
 
 
==Lenvatinib monotherapy {{#subobject:PYR1|Regimen=1}}==
 
==Lenvatinib monotherapy {{#subobject:PYR1|Regimen=1}}==
 
<div class="toccolours" style="background-color:#eeeeee">
 
<div class="toccolours" style="background-color:#eeeeee">
Line 234: Line 266:
 
|-
 
|-
 
|[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"
+
<!-- {| 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>]'''
 
|'''[https://www.esmo.org/guidelines/esmo-mcbs/esmo-mcbs-scorecards/scorecard-135-1 <span style="color:white;">ESMO-MCBS (2)</span>]'''
 
|-
 
|-
−
|}
+
|} -->
 
|2011-08-05 to 2012-10-04
 
|2011-08-05 to 2012-10-04
 
| style="background-color:#1a9851" |Phase 3 (E-RT-esc)
 
| style="background-color:#1a9851" |Phase 3 (E-RT-esc)
 
|[[Thyroid cancer, differentiated - null regimens#Placebo|Placebo]]
 
|[[Thyroid cancer, differentiated - null regimens#Placebo|Placebo]]
−
| style="background-color:#1a9850" |Superior PFS<br>Median PFS: 18.3 vs 3.6 mo<br>(HR 0.21, 99% CI 0.14-0.31)
+
| style="background-color:#1a9850" |Superior PFS (primary endpoint)<br>Median PFS: 18.3 vs 3.6 mo<br>(HR 0.21, 99% CI 0.14-0.31)
 
|-
 
|-
 
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9401493/ Zheng et al. 2021 (E7080-C086-308)]
 
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9401493/ Zheng et al. 2021 (E7080-C086-308)]
Line 252: Line 284:
 
<div class="toccolours" style="background-color:#b3e2cd">
 
<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 on days 1 to 28
−
**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 class="toccolours" style="background-color:#fff2ae">
 +
====Dose and schedule modifications====
 +
*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.
 
</div></div>
 
</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] [https://clinicaltrials.gov/study/NCT01321554 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://www.ncbi.nlm.nih.gov/pmc/articles/PMC9401493/ link to PMC article] [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://www.ncbi.nlm.nih.gov/pmc/articles/PMC9401493/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/34326132/ PubMed] [https://clinicaltrials.gov/study/NCT02966093 NCT02966093]
 +
 
 
==Pazopanib monotherapy {{#subobject:4ee26c|Regimen=1}}==
 
==Pazopanib monotherapy {{#subobject:4ee26c|Regimen=1}}==
 
<div class="toccolours" style="background-color:#eeeeee">
 
<div class="toccolours" style="background-color:#eeeeee">
Line 275: Line 312:
 
<div class="toccolours" style="background-color:#b3e2cd">
 
<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 on days 1 to 28
 
'''28-day cycles'''
 
'''28-day cycles'''
 
</div></div>
 
</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] [https://clinicaltrials.gov/study/NCT00625846 NCT00625846]
 
==Sorafenib monotherapy {{#subobject:36a6b4|Regimen=1}}==
 
==Sorafenib monotherapy {{#subobject:36a6b4|Regimen=1}}==
 
<div class="toccolours" style="background-color:#eeeeee">
 
<div class="toccolours" style="background-color:#eeeeee">
Line 291: Line 328:
 
|-
 
|-
 
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4366116/ Brose et al. 2014 (DECISION)]
 
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4366116/ Brose et al. 2014 (DECISION)]
−
{| class="wikitable" style="margin:auto; color:white; background-color:#1B4F26"
+
<!-- {| class="wikitable" style="margin:auto; color:white; background-color:#1B4F26"
 
|'''[https://www.esmo.org/guidelines/esmo-mcbs/esmo-mcbs-scorecards/scorecard-136-1 <span style="color:white;">ESMO-MCBS (2)</span>]'''
 
|'''[https://www.esmo.org/guidelines/esmo-mcbs/esmo-mcbs-scorecards/scorecard-136-1 <span style="color:white;">ESMO-MCBS (2)</span>]'''
 
|-
 
|-
−
|}
+
|} -->
 
|2009-2011
 
|2009-2011
 
| style="background-color:#1a9851" |Phase 3 (E-RT-esc)
 
| style="background-color:#1a9851" |Phase 3 (E-RT-esc)
Line 303: Line 340:
 
<div class="toccolours" style="background-color:#b3e2cd">
 
<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 on days 1 to 28
−
'''Continued indefinitely'''
+
'''28-day cycles'''
 
</div></div>
 
</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] [https://clinicaltrials.gov/study/NCT00984282 NCT00984282]
 
==Sunitinib monotherapy {{#subobject:8d6c5|Regimen=1}}==
 
==Sunitinib monotherapy {{#subobject:8d6c5|Regimen=1}}==
 
<div class="toccolours" style="background-color:#eeeeee">
 
<div class="toccolours" style="background-color:#eeeeee">
Line 325: Line 363:
 
<div class="toccolours" style="background-color:#b3e2cd">
 
<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 on days 1 to 42
−
'''Continued indefinitely'''
+
'''42-day cycles'''
 
</div></div>
 
</div></div>
 
===References===
 
===References===
Line 345: Line 383:
 
| style="background-color:#1a9851" |Randomized Phase 2 (E-esc)
 
| style="background-color:#1a9851" |Randomized Phase 2 (E-esc)
 
|[[Thyroid cancer, differentiated - null regimens#Placebo|Placebo]]
 
|[[Thyroid cancer, differentiated - null regimens#Placebo|Placebo]]
−
| style="background-color:#1a9850" |Superior PFS
+
| style="background-color:#1a9850" |Superior PFS (primary endpoint)<br>Median PFS: 11.1 vs 5.9 mo<br>(HR 0.63, 60% CI 0.54-0.74)
 
|-
 
|-
 
|}
 
|}
Line 354: Line 392:
 
</div></div>
 
</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] [https://clinicaltrials.gov/study/NCT00537095 NCT00537095]
  
 
=Advanced or metastatic disease, all lines of therapy=
 
=Advanced or metastatic disease, all lines of therapy=
Line 377: Line 415:
 
</div></div>
 
</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] [https://clinicaltrials.gov/study/NCT00389441 NCT00389441]
  
 
[[Category:Thyroid cancer regimens]]
 
[[Category:Thyroid cancer regimens]]
−
[[Category:Disease-specific pages]]
+
[[Category:Histology-specific pages]]
 
[[Category:Endocrine cancers]]
 
[[Category:Endocrine cancers]]
 
[[Category:Head and neck cancers]]
 
[[Category:Head and neck cancers]]

Latest revision as of 17:51, 23 June 2024

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

For placebo or observational studies in this condition, please visit this page.
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

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.

ATA

ESMO

NCCN

Adjuvant therapy

Radioiodine ablation

Regimen variant #1, 1.1 GBq

Study Dates 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 (primary endpoint)
Mallick et al. 2012 (HiLo) 2007-2010 Phase 3 (E-de-esc) I-131; 3.7 GBq Non-inferior rate of ablation (primary endpoint)
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 Dates 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 Dates of enrollment Evidence
Maxon et al. 1983 1974-12 to 1982-07 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 link to PMC article 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 Dates of enrollment Evidence
Ho et al. 2013 (MSK 09-048) 2010-2011 Non-randomized

Radiotherapy

Targeted therapy

4-week course

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

Advanced or metastatic disease, radioactive iodine-refractory

Apatinib monotherapy

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Lin et al. 2022 (REALITY) 2017-2020 Phase 3 (E-esc) Placebo Seems to have superior OS (secondary endpoint)
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

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 Dates of enrollment Evidence Comparator Comparative Efficacy
Brose et al. 2021 (COSMIC-311) 2019-02-27 to 2020-08-18 Phase 3 (E-RT-esc) Placebo Superior PFS (co-primary endpoint)
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

28-day cycles

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

Donafenib monotherapy

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Lin et al. 2023 (ZGDD3) 2018-08-29 to 2021-02-28 Phase 3 (E-esc) Placebo Superior PFS (primary endpoint)
Median PFS: 12.9 vs 6.4 mo
(HR 0.39, 95% CI 0.25-0.61)

Targeted therapy

28-day cycles

References

  1. ZGDD3: Lin Y, Qin S, Yang H, Shi F, Yang A, Han X, Liu B, Li Z, Ji Q, Tang L, Deng Z, Ding Y, Fu W, Xie X, Li L, He X, Lv Z, Ma Q, Shen Z, Guo Z, Chen Z, Cui Y, Tan J, Gao Z, Jing S, Lu K, Luo X, Zhang Y, Fang Y, Li Z, Cheng Y, Lei S, Luan S, Chen G, Wang G, Wu L, Liu L. Multicenter Randomized Double-Blind Phase III Trial of Donafenib in Progressive Radioactive Iodine-Refractory Differentiated Thyroid Cancer. Clin Cancer Res. 2023 Aug 1;29(15):2791-2799. link to original article contains dosing details in manuscript PubMed NCT03602495

Lenvatinib monotherapy

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Schlumberger et al. 2015 (SELECT) 2011-08-05 to 2012-10-04 Phase 3 (E-RT-esc) Placebo Superior PFS (primary endpoint)
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 (primary endpoint)
Median PFS: 23.9 vs 3.7 mo
(HR 0.16, 95% CI 0.10-0.26)

Targeted therapy

28-day cycles

Dose and schedule modifications

  • 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.

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 link to PMC article PubMed NCT02966093

Pazopanib monotherapy

Regimen

Study Dates 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

Sorafenib monotherapy

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Brose et al. 2014 (DECISION) 2009-2011 Phase 3 (E-RT-esc) Placebo Superior PFS (primary endpoint)
Median PFS: 10.8 vs 5.8 mo
(HR 0.59, 95% CI 0.45-0.76)

Targeted therapy

28-day cycles

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

Sunitinib monotherapy

Regimen

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

Targeted therapy

42-day cycles

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

Vandetanib monotherapy

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Leboulleux et al. 2012 (D4200C00079) 2007-2008 Randomized Phase 2 (E-esc) Placebo Superior PFS (primary endpoint)
Median PFS: 11.1 vs 5.9 mo
(HR 0.63, 60% CI 0.54-0.74)

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, all lines of therapy

Axitinib monotherapy

Regimen

Study Dates 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
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