Thyroid cancer, differentiated

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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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