Difference between revisions of "Thyroid cancer"
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|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4164813/ Elisei et al. 2013 (EXAM)] | |[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4164813/ Elisei et al. 2013 (EXAM)] | ||
| − | | style="background-color:#1a9851" |Phase III (E) | + | | style="background-color:#1a9851" |Phase III (E-RT) |
|[[#Placebo_2|Placebo]] | |[[#Placebo_2|Placebo]] | ||
| style="background-color:#1a9850" |Superior PFS | | style="background-color:#1a9850" |Superior PFS | ||
Revision as of 03:28, 8 September 2019
| Section editor | |
|---|---|
 |
Jeena M. Varghese, MBBS MD Anderson Cancer Center Houston, TX |
Note: some thyroid cancer regimens can be found on dedicated pages:
3 regimens on this page
3 variants on this page
|
Guidelines
ATA
- 2015: Guidelines on the management of thyroid nodules and differentiated thyroid cancer PubMed
- 2015: Guidelines for the management of medullary thyroid carcinoma PubMed
- 2012: Guidelines for management of patients with anaplastic thyroid cancer PubMed
ESMO
- 2012: Thyroid cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up PubMed
NCCN
Differentiated thyroid cancer, all lines of therapy
Lenvatinib monotherapy
| back to top |
Regimen
| Study | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|
| Schlumberger et al. 2015 (SELECT) | Phase III (E) | 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
- 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
Pazopanib monotherapy
| back to top |
Regimen
| Study | Evidence |
|---|---|
| Bible et al. 2010 | Phase II |
Chemotherapy
- Pazopanib (Votrient) 800 mg PO once per day
28-day cycles
References
- 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
| back to top |
Regimen
| Study | Evidence | Comparator | Comparative 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
- 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
- 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 PMC article PubMed
- 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
Radioiodine ablation
| back to top |
Variant #1, 1.1 GBq
| Study | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|
| Schlumberger et al. 2012 (ESTIMABL1) | Phase III (E) | I-131 3.7 GBq | Equivalent outcome |
| Mallick et al. 2012 (HiLo) | Phase III (E) | I-131 3.7 GBq | Non-inferior rate of ablation |
Preceding treatment
Radiotherapy
- Iodine-131 1.1 GBq
One course
Variant #2, 3.7 GBq
| Study | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|
| Schlumberger et al. 2012 (ESTIMABL1) | Phase III (C) | I-131 1.1 GBq | Equivalent outcome |
| Mallick et al. 2012 (HiLo) | Phase III (C) | I-131 1.1 GBq | Non-inferior rate of ablation |
Preceding treatment
Radiotherapy
- Iodine-131 3.7 GBq
One course
Variant #3, variable
| Study | Evidence |
|---|---|
| Maxon et al. 1983 | 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
- 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
- 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
- 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
- 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
- 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 protocol PubMed
Sorafenib monotherapy
| back to top |
Regimen
| Study | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|
| Brose et al. 2014 (DECISION) | Phase III (E) | Placebo | Superior PFS |
Chemotherapy
- Sorafenib (Nexavar) 400 mg PO twice per day
Continued indefinitely
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. contains verified protocol link to PMC article PubMed
Vandetanib monotherapy
| back to top |
Regimen
| Study | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|
| Leboulleux et al. 2012 | Randomized Phase II (E) | Placebo | Superior PFS |
Chemotherapy
- Vandetanib (Caprelsa) 300 mg PO once per day
Continued indefinitely
References
- 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
Medullary thyroid cancer, all lines of therapy
Cabozantinib monotherapy
| back to top |
Regimen
| Study | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|
| Kurzrock et al. 2011 | Non-randomized | ||
| Elisei et al. 2013 (EXAM) | Phase III (E-RT) | Placebo | Superior PFS |
Chemotherapy
- Cabozantinib (Cometriq) 140 mg PO once per day, at least 2 hours before or 1 hour after meals
Continued indefinitely
References
- 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
- 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
- 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
| back to top |
Regimen
| Study | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|
| Wells et al. 2011 (LPS14811) | Phase III (C) | Vandetanib | Inferior PFS |
| Elisei et al. 2013 (EXAM) | Phase III (C) | Cabozantinib | Inferior PFS |
No active antineoplastic treatment. Included for reference purposes only.
References
- LPS14811: 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
- 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
Sorafenib monotherapy
| back to top |
Regimen
| Study | Evidence |
|---|---|
| Lam et al. 2010 | Phase II |
Chemotherapy
- Sorafenib (Nexavar) 400 mg PO twice per day
Continued indefinitely
References
- 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
| back to top |
Regimen
| Study | Evidence |
|---|---|
| Carr et al. 2010 | Phase II |
Chemotherapy
- Sunitinib (Sutent) 37.5 mg PO once per day
Continued indefinitely
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. link to original article contains verified protocol link to PMC article PubMed
Vandetanib monotherapy
| back to top |
Variant #1, 100 mg/day
| Study | Evidence |
|---|---|
| Robinson et al. 2010 | Phase II, <20 patients |
Chemotherapy
- Vandetanib (Caprelsa) 100 mg PO once per day
Continued indefinitely
Subsequent treatment
- At progression, eligible patients could increase the dose to 300 mg PO once per day; see paper for details
Variant #2, 300 mg/day
| Study | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|
| Wells et al. 2010 | Phase II | ||
| Wells et al. 2011 (LPS14811) | Phase III (E) | Placebo | Superior PFS |
Chemotherapy
- Vandetanib (Caprelsa) 300 mg PO once per day
Continued indefinitely
References
- 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
- 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
- LPS14811: 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
| back to top |
Regimen
| Study | Evidence |
|---|---|
| Cohen et al. 2008 | Phase II |
| Locati et al. 2014 | Phase II |
Chemotherapy
- Axitinib (Inlyta) 5 mg PO twice per day
Continued indefinitely
References
- 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
- 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
- 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
Doxorubicin monotherapy
| back to top |
Regimen
| Study | Evidence |
|---|---|
| Gottlieb et al. 1974 | Non-randomized |
Of historic interest.
Chemotherapy
References
- Gottlieb JA, Hill CS Jr. Chemotherapy of thyroid cancer with adriamycin: experience with 30 patients. N Engl J Med. 1974 Jan 24;290(4):193-7. link to original article PubMed
Sorafenib monotherapy
| back to top |
Regimen
| Study | Evidence | Efficacy |
|---|---|---|
| Gupta-Abramson et al. 2008 | Phase II | ORR: 23% (95% CI, 10-42) |
Chemotherapy
- Sorafenib (Nexavar) 400 mg PO twice per day
Continued indefinitely
References
- 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
| back to top |
Regimen
| Study | Evidence | Efficacy |
|---|---|---|
| Carr et al. 2010 | Phase II | ORR: 31% (95% CI: 16-47) |
Chemotherapy
- Sunitinib (Sutent) 37.5 mg PO once per day
Continued indefinitely
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. link to original article contains verified protocol link to PMC article PubMed