Thyroid cancer

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 Jeena M. Varghese, MBBS
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3 regimens on this page
3 variants on this page


Guidelines

ESMO

NCCN

Differentiated thyroid cancer, all lines of therapy

Lenvatinib monotherapy

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Regimen

Study Evidence Comparator Efficacy
Schlumberger et al. 2015 (SELECT) Phase III Placebo Superior PFS

Chemotherapy

  • 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. 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

Pazopanib monotherapy

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Regimen

Study Evidence
Bible et al. 2010 Phase II

Chemotherapy

28-day cycles

References

  1. 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. contains protocol link to PMC article PubMed

Placebo

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Regimen

Study Evidence Comparator Efficacy
Leboulleux et al. 2012 Randomized Phase II (C) Vandetanib Inferior PFS
Brose et al. 2014 (DECISION) Phase III (C) Sorafenib Inferior PFS
Schlumberger et al. 2015 (SELECT) Phase III (C) Lenvatinib Inferior PFS

No active antineoplastic treatment.

References

  1. 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 protocol PubMed
  2. 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 PMC article PubMed
  3. 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

Radioiodine ablation

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Regimen

To be completed

References

  1. 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
  2. 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 PubMed

Sorafenib monotherapy

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Regimen

Study Evidence Comparator Efficacy
Brose et al. 2014 (DECISION) Phase III (E) Placebo Superior PFS

Chemotherapy

References

  1. 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. contains verified protocol link to PMC article PubMed

Vandetanib monotherapy

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Regimen

Study Evidence Comparator Efficacy
Leboulleux et al. 2012 Randomized Phase II (E) Placebo Superior PFS

Chemotherapy

Continued until progression or intolerance

References

  1. 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 protocol PubMed

Vemurafenib monotherapy

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Regimen

Study Evidence
Brose et al. 2016 Phase II

Note: this study was in patients with papillary thyroid cancer, only.

Chemotherapy

28-day cycles until progression or intolerable toxicity

References

  1. Brose MS, Cabanillas ME, Cohen EE, Wirth LJ, Riehl T, Yue H, Sherman SI, Sherman EJ. Vemurafenib in patients with BRAF(V600E)-positive metastatic or unresectable papillary thyroid cancer refractory to radioactive iodine: a non-randomised, multicentre, open-label, phase 2 trial. Lancet Oncol. 2016 Sep;17(9):1272-82. Epub 2016 Jul 23. link to original article contains verified protocol link to PMC article PubMed

Medullary thyroid cancer, all lines of therapy

Cabozantinib monotherapy

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Regimen

Study Evidence Comparator Efficacy
Kurzrock et al. 2011 Non-randomized
Elisei et al. 2013 (EXAM) Phase III (E) Placebo Superior PFS

Chemotherapy

References

  1. Kurzrock R, Sherman SI, Ball DW, Forastiere AA, Cohen RB, Mehra R, Pfister DG, Cohen EE, Janisch L, Nauling F, Hong DS, Ng CS, Ye L, Gagel RF, Frye J, Müller T, Ratain MJ, Salgia R. Activity of XL184 (Cabozantinib), an oral tyrosine kinase inhibitor, in patients with medullary thyroid cancer. J Clin Oncol. 2011 Jul 1;29(19):2660-6. Epub 2011 May 23. link to original article contains verified protocol link to PMC article PubMed
  2. EXAM: Elisei R, Schlumberger MJ, Müller SP, Schöffski P, Brose MS, Shah MH, Licitra L, Jarzab B, Medvedev V, Kreissl MC, Niederle B, Cohen EE, Wirth LJ, Ali H, Hessel C, Yaron Y, Ball D, Nelkin B, Sherman SI. Cabozantinib in progressive medullary thyroid cancer. J Clin Oncol. 2013 Oct 10;31(29):3639-46. Epub 2013 Sep 3. Erratum in: J Clin Oncol. 2014 Jun 10;32(17):1864. link to original article contains verified protocol link to PMC article PubMed
    1. Update: Schlumberger M, Elisei R, Müller S, Schöffski P, Brose M, Shah M, Licitra L, Krajewska J, Kreissl MC, Niederle B, Cohen EEW, Wirth L, Ali H, Clary DO, Yaron Y, Mangeshkar M, Ball D, Nelkin B, Sherman S. Overall survival analysis of EXAM, a phase III trial of cabozantinib in patients with radiographically progressive medullary thyroid carcinoma. Ann Oncol. 2017 Nov 1;28(11):2813-2819. link to original article PubMed

Placebo

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Regimen

Study Evidence Comparator Efficacy
Wells et al. 2011 Phase III (C) Vandetanib Inferior PFS
Elisei et al. 2013 Phase III (C) Cabozantinib Inferior PFS

No active antineoplastic treatment. Included for reference purposes only.

References

  1. Wells SA Jr, Robinson BG, Gagel RF, Dralle H, Fagin JA, Santoro M, Baudin E, Elisei R, Jarzab B, Vasselli JR, Read J, Langmuir P, Ryan AJ, Schlumberger MJ. Vandetanib in patients with locally advanced or metastatic medullary thyroid cancer: a randomized, double-blind phase III trial. J Clin Oncol. 2012 Jan 10;30(2):134-41. Epub 2011 Oct 24. link to original article contains verified protocol link to PMC article PubMed
  2. Elisei R, Schlumberger MJ, Müller SP, Schöffski P, Brose MS, Shah MH, Licitra L, Jarzab B, Medvedev V, Kreissl MC, Niederle B, Cohen EE, Wirth LJ, Ali H, Hessel C, Yaron Y, Ball D, Nelkin B, Sherman SI. Cabozantinib in progressive medullary thyroid cancer. J Clin Oncol. 2013 Oct 10;31(29):3639-46. Epub 2013 Sep 3. Erratum in: J Clin Oncol. 2014 Jun 10;32(17):1864. link to original article contains verified protocol link to PMC article PubMed

Sorafenib monotherapy

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Regimen

Study Evidence
Lam et al. 2010 Phase II

Chemotherapy

References

  1. Lam ET, Ringel MD, Kloos RT, Prior TW, Knopp MV, Liang J, Sammet S, Hall NC, Wakely PE Jr, Vasko VV, Saji M, Snyder PJ, Wei L, Arbogast D, Collamore M, Wright JJ, Moley JF, Villalona-Calero MA, Shah MH. Phase II clinical trial of sorafenib in metastatic medullary thyroid cancer. J Clin Oncol. 2010 May 10;28(14):2323-30. Epub 2010 Apr 5. link to original article contains verified protocol link to PMC article PubMed

Sunitinib monotherapy

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Regimen

Study Evidence
Carr et al. 2010 Phase II

Chemotherapy

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 verified protocol link to PMC article PubMed

Vandetanib monotherapy

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Variant #1, 100 mg/d

Study Evidence
Robinson et al. 2010 Phase II, <20 patients

Chemotherapy

Continued until progression or intolerance

At progression, eligible patients could increase the dose to 300 mg PO once per day; see paper for details.

Variant #2, 300 mg/d

Study Evidence Comparator Efficacy
Wells et al. 2010 Phase II
Wells et al. 2011 Phase III (E) Placebo Superior PFS

Chemotherapy

Continued until progression or intolerance

References

  1. Wells SA Jr, Gosnell JE, Gagel RF, Moley J, Pfister D, Sosa JA, Skinner M, Krebs A, Vasselli J, Schlumberger M. Vandetanib for the treatment of patients with locally advanced or metastatic hereditary medullary thyroid cancer. J Clin Oncol. 2010 Feb 10;28(5):767-72. Epub 2010 Jan 11. link to original article contains verified protocol link to PMC article PubMed
  2. Robinson BG, Paz-Ares L, Krebs A, Vasselli J, Haddad R. Vandetanib (100 mg) in patients with locally advanced or metastatic hereditary medullary thyroid cancer. J Clin Endocrinol Metab. 2010 Jun;95(6):2664-71. Epub 2010 Apr 6. link to original article contains verified protocol link to PMC article PubMed content property of HemOnc.org
  3. Wells SA Jr, Robinson BG, Gagel RF, Dralle H, Fagin JA, Santoro M, Baudin E, Elisei R, Jarzab B, Vasselli JR, Read J, Langmuir P, Ryan AJ, Schlumberger MJ. Vandetanib in patients with locally advanced or metastatic medullary thyroid cancer: a randomized, double-blind phase III trial. J Clin Oncol. 2012 Jan 10;30(2):134-41. Epub 2011 Oct 24. link to original article contains verified protocol link to PMC article PubMed

Various histologies, advanced or metastatic disease

Axitinib monotherapy

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Regimen

Study Evidence
Cohen et al. 2008 Phase II
Locati et al. 2014 Phase II

Chemotherapy

References

  1. Cohen EE, Rosen LS, Vokes EE, Kies MS, Forastiere AA, Worden FP, Kane MA, Sherman E, Kim S, Bycott P, Tortorici M, Shalinsky DR, Liau KF, Cohen RB. Axitinib is an active treatment for all histologic subtypes of advanced thyroid cancer: results from a phase II study. J Clin Oncol. 2008 Oct 10;26(29):4708-13. Epub 2008 Jun 9. link to original article contains verified protocol link to PMC article PubMed
    1. Update: Cohen EE, Tortorici M, Kim S, Ingrosso A, Pithavala YK, Bycott P. A Phase II trial of axitinib in patients with various histologic subtypes of advanced thyroid cancer: long-term outcomes and pharmacokinetic/pharmacodynamic analyses. Cancer Chemother Pharmacol. 2014 Dec;74(6):1261-70. Epub 2014 Oct 15. link to PMC article PubMed
  2. 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 verified protocol PubMed

Dabrafenib & Trametinib

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Regimen

Study Evidence Efficacy
Subbiah et al. 2017 Phase II, <20 pts ORR: 63% (95% CI, 35-85)

Patients in this trial had previously treated anaplastic thyroid cancer with BRAF p.V600E mutation.

Chemotherapy

Continuously

References

  1. Subbiah V, Kreitman RJ, Wainberg ZA, Cho JY, Schellens JHM, Soria JC, Wen PY, Zielinski C, Cabanillas ME, Urbanowitz G, Mookerjee B, Wang D, Rangwala F, Keam B. Dabrafenib and trametinib treatment in patients with locally advanced or metastatic BRAF V600-mutant anaplastic thyroid cancer. J Clin Oncol. 2018 Jan 1;36(1):7-13. Epub 2017 Oct 26. link to original article contains verified protocol PubMed

Sorafenib monotherapy

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Regimen

Study Evidence Efficacy
Gupta-Abramson et al. 2008 Phase II ORR: 23% (95% CI, 10-42)

Chemotherapy

Continuously

References

  1. Gupta-Abramson V, Troxel AB, Nellore A, Puttaswamy K, Redlinger M, Ransone K, Mandel SJ, Flaherty KT, Loevner LA, O'Dwyer PJ, Brose MS. Phase II trial of sorafenib in advanced thyroid cancer. J Clin Oncol. 2008 Oct 10;26(29):4714-9. Epub 2008 Jun 9. link to original article contains verified protocol link to PMC article PubMed

Sunitinib monotherapy

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Regimen

Study Evidence ORR
Carr et al. 2010 Phase II 31% (95% CI: 16-47)

Chemotherapy

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 verified protocol link to PMC article PubMed
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