Difference between revisions of "Thyroid cancer"
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m (Text replacement - "<span style="background:#EEEE00; padding:3px 6px 3px 6px; border-color:black; border-width:2px; border-style:solid;">Non-randomized</span>" to "style="background-color:#EEEE00"|Non-randomized") |
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===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] --> | ||
| − | # 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. [http://www.nejm.org/doi/full/10.1056/NEJMoa1406470 link to original article] [ | + | # 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. [http://www.nejm.org/doi/full/10.1056/NEJMoa1406470 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/25671254 PubMed] |
==Pazopanib (Votrient) {{#subobject:4ee26c|Regimen=1}}== | ==Pazopanib (Votrient) {{#subobject:4ee26c|Regimen=1}}== | ||
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|'''Comparator''' | |'''Comparator''' | ||
|- | |- | ||
| − | |[ | + | |[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4366116/ Brose et al. 2014 (DECISION)] |
|style="background-color:#00CD00"|Phase III | |style="background-color:#00CD00"|Phase III | ||
|[[#Sorafenib_.28Nexavar.29|Sorafenib]] | |[[#Sorafenib_.28Nexavar.29|Sorafenib]] | ||
| Line 91: | Line 91: | ||
===References=== | ===References=== | ||
| − | # 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. [ | + | # 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://www.ncbi.nlm.nih.gov/pmc/articles/PMC4366116/ link to PMC article] [https://www.ncbi.nlm.nih.gov/pubmed/24768112 PubMed] |
<!-- # '''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] --> | ||
| − | # 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. [http://www.nejm.org/doi/full/10.1056/NEJMoa1406470 link to original article] [ | + | # 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. [http://www.nejm.org/doi/full/10.1056/NEJMoa1406470 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/25671254 PubMed] |
==Radioiodine ablation== | ==Radioiodine ablation== | ||
| Line 105: | Line 105: | ||
===References=== | ===References=== | ||
| − | # 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. [http://www.nejm.org/doi/full/10.1056/NEJMoa1108586 link to original article] [ | + | # 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. [http://www.nejm.org/doi/full/10.1056/NEJMoa1108586 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/22551127 PubMed] |
==Sorafenib (Nexavar) {{#subobject:36a6b4|Regimen=1}}== | ==Sorafenib (Nexavar) {{#subobject:36a6b4|Regimen=1}}== | ||
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|'''Comparator''' | |'''Comparator''' | ||
|- | |- | ||
| − | |[ | + | |[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4366116/ Brose et al. 2014 (DECISION)] |
|style="background-color:#00CD00"|Phase III | |style="background-color:#00CD00"|Phase III | ||
|[[#Placebo|Placebo]] | |[[#Placebo|Placebo]] | ||
| Line 127: | Line 127: | ||
===References=== | ===References=== | ||
| − | # 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. [ | + | # 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://www.ncbi.nlm.nih.gov/pmc/articles/PMC4366116/ link to PMC article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/24768112 PubMed] |
==Vemurafenib (Zelboraf) {{#subobject:3f8f49|Regimen=1}}== | ==Vemurafenib (Zelboraf) {{#subobject:3f8f49|Regimen=1}}== | ||
| Line 183: | Line 183: | ||
===References=== | ===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. [http://jco.ascopubs.org/content/29/19/2660.long link to original article] '''contains verified protocol''' [ | + | # 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. [http://jco.ascopubs.org/content/29/19/2660.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/21606412 PubMed] |
| − | # 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. [http://jco.ascopubs.org/content/31/29/3639.long link to original article] '''contains verified protocol''' [ | + | # 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. [http://jco.ascopubs.org/content/31/29/3639.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/24002501 PubMed] |
==Placebo== | ==Placebo== | ||
| Line 216: | Line 216: | ||
===References=== | ===References=== | ||
| − | # 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. [http://jco.ascopubs.org/content/30/2/134.long link to original article] '''contains verified protocol''' [ | + | # 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. [http://jco.ascopubs.org/content/30/2/134.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/22025146 PubMed] |
| − | # 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. [http://jco.ascopubs.org/content/31/29/3639.long link to original article] '''contains verified protocol''' [ | + | # 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. [http://jco.ascopubs.org/content/31/29/3639.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/24002501 PubMed] |
==Sorafenib (Nexavar) {{#subobject:7e7480|Regimen=1}}== | ==Sorafenib (Nexavar) {{#subobject:7e7480|Regimen=1}}== | ||
| Line 237: | Line 237: | ||
===References=== | ===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. [http://jco.ascopubs.org/content/28/14/2323.long link to original article] '''contains verified protocol''' [ | + | # 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. [http://jco.ascopubs.org/content/28/14/2323.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/20368568 PubMed] |
==Sunitinib (Sutent) {{#subobject:59fa83|Regimen=1}}== | ==Sunitinib (Sutent) {{#subobject:59fa83|Regimen=1}}== | ||
| Line 257: | Line 257: | ||
===References=== | ===References=== | ||
| − | # Carr LL, Mankoff DA, Goulart BH, Eaton KD, Capell PT, Kell EM, Bauman JE, Martins RG. Phase II study of daily sunitinib in FDG-PET-positive, iodine-refractory differentiated thyroid cancer and metastatic medullary carcinoma of the thyroid with functional imaging correlation. Clin Cancer Res. 2010 Nov 1;16(21):5260-8. Epub 2010 Sep 16. [http://clincancerres.aacrjournals.org/content/16/21/5260.long link to original article] '''contains verified protocol''' [ | + | # 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. [http://clincancerres.aacrjournals.org/content/16/21/5260.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/20847059 PubMed] |
==Vandetanib (Caprelsa) {{#subobject:a85524|Regimen=1}}== | ==Vandetanib (Caprelsa) {{#subobject:a85524|Regimen=1}}== | ||
| Line 311: | Line 311: | ||
===References=== | ===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. [http://jco.ascopubs.org/content/28/5/767.long link to original article] '''contains verified protocol''' [ | + | # 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. [http://jco.ascopubs.org/content/28/5/767.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/20065189 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. [http://jcem.endojournals.org/content/95/6/2664.long link to original article] '''contains verified protocol''' [ | + | # 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. [http://jcem.endojournals.org/content/95/6/2664.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/20371662 PubMed] content property of [http://hemonc.org HemOnc.org] |
| − | # 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. [http://jco.ascopubs.org/content/30/2/134.long link to original article] '''contains verified protocol''' [ | + | # 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. [http://jco.ascopubs.org/content/30/2/134.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/22025146 PubMed] |
=Various histologies= | =Various histologies= | ||
| Line 337: | Line 337: | ||
===References=== | ===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. [http://jco.ascopubs.org/content/26/29/4708.long link to original article] '''contains verified protocol''' [ | + | # 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. [http://jco.ascopubs.org/content/26/29/4708.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/18541897 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. [ | + | ## '''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. [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4236619/ link to PMC article] [https://www.ncbi.nlm.nih.gov/pubmed/25315258 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. [http://onlinelibrary.wiley.com/doi/10.1002/cncr.28766/full link to original article] '''contains verified protocol''' [ | + | # 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. [http://onlinelibrary.wiley.com/doi/10.1002/cncr.28766/full link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/24844950 PubMed] |
==Sorafenib (Nexavar) {{#subobject:31cae2|Regimen=1}}== | ==Sorafenib (Nexavar) {{#subobject:31cae2|Regimen=1}}== | ||
| Line 359: | Line 359: | ||
===References=== | ===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. [http://jco.ascopubs.org/content/26/29/4714.long link to original article] '''contains verified protocol''' [ | + | # 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. [http://jco.ascopubs.org/content/26/29/4714.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/18541894 PubMed] |
==Sunitinib (Sutent) {{#subobject:8d6c5|Regimen=1}}== | ==Sunitinib (Sutent) {{#subobject:8d6c5|Regimen=1}}== | ||
| Line 379: | Line 379: | ||
===References=== | ===References=== | ||
| − | # Carr LL, Mankoff DA, Goulart BH, Eaton KD, Capell PT, Kell EM, Bauman JE, Martins RG. Phase II study of daily sunitinib in FDG-PET-positive, iodine-refractory differentiated thyroid cancer and metastatic medullary carcinoma of the thyroid with functional imaging correlation. Clin Cancer Res. 2010 Nov 1;16(21):5260-8. Epub 2010 Sep 16. [http://clincancerres.aacrjournals.org/content/16/21/5260.long link to original article] '''contains verified protocol''' [ | + | # 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. [http://clincancerres.aacrjournals.org/content/16/21/5260.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/20847059 PubMed] |
[[Category:Chemotherapy regimens]] | [[Category:Chemotherapy regimens]] | ||
[[Category:Solid oncology regimens]] | [[Category:Solid oncology regimens]] | ||
Revision as of 02:56, 2 December 2016
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3 regimens on this page
3 variants on this page
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Differentiated thyroid cancer
Lenvatinib (Lenvima)
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Regimen
| Study | Evidence | Comparator |
| Schlumberger et al. 2015 (SELECT) | Phase III | Placebo |
Chemotherapy
- Lenvatinib (Lenvima) 24 mg PO once per day on days 1 to 28
- Per the package insert, patients with creatinine clearance of <30 mL/min by Cockroft-Gault or Child-Pugh C severe hepatic impairment should receive Lenvatinib (Lenvima) 14 mg PO once per day
28-day cycles, given until progression of disease, or unacceptable toxicity
References
- 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 (Votrient)
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Regimen
| Study | Evidence |
| Bible et al. 2010 | Phase II |
Chemotherapy
- Pazopanib (Votrient) 800 mg PO once per day
28-day cycles, given until progression of disease, or unacceptable toxicity
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. link to PMC article contains protocol PubMed
Placebo
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Regimen
| Study | Evidence | Comparator |
| Brose et al. 2014 (DECISION) | Phase III | Sorafenib |
| Schlumberger et al. 2015 (SELECT) | Phase III | Lenvatinib |
No active antineoplastic treatment.
References
- 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
- 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
- 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
Sorafenib (Nexavar)
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Regimen
| Study | Evidence | Comparator |
| Brose et al. 2014 (DECISION) | Phase III | Placebo |
Chemotherapy
- Sorafenib (Nexavar) 400 mg PO BID
References
- 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 contains verified protocol PubMed
Vemurafenib (Zelboraf)
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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
- Vemurafenib (Zelboraf) 960 mg PO BID
28-day cycles until progression or intolerable toxicity
References
- 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 SD article contains verified protocol PubMed
Medullary thyroid cancer
Cabozantinib (Cometriq)
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Regimen
| Study | Evidence | Comparator |
| Kurzrock et al. 2011 | Non-randomized | |
| Elisei et al. 2013 | Phase III | Placebo |
Chemotherapy
- Cabozantinib (Cometriq) 140 mg PO once per day, at least 2 hours before or 1 hour after meals
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 PubMed
- 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 PubMed
Placebo
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Regimen
| Study | Evidence | Comparator |
| Wells et al. 2011 | Phase III | Vandetanib |
| Elisei et al. 2013 | Phase III | Cabozantinib |
No active antineoplastic treatment. Included for reference purposes only.
References
- 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 PubMed
- 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 PubMed
Sorafenib (Nexavar)
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Regimen
| Study | Evidence |
| Lam et al. 2010 | Phase II |
Chemotherapy
- Sorafenib (Nexavar) 400 mg PO BID
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 PubMed
Sunitinib (Sutent)
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Regimen
| Study | Evidence |
| Carr et al. 2010 | Phase II |
Chemotherapy
- Sunitinib (Sutent) 37.5 mg PO once per day
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 PubMed
Vandetanib (Caprelsa)
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Regimen #1
| Study | Evidence | Comparator |
| Wells et al. 2010 | Phase II | |
| Wells et al. 2011 | Phase III | Placebo |
Chemotherapy
- Vandetanib (Caprelsa) 300 mg PO once per day
Continued until progression or intolerance
Regimen #2
| Study | Evidence |
| Robinson et al. 2010 | Phase II, <20 patients |
Chemotherapy
- Vandetanib (Caprelsa) 100 mg PO once per day
Continued until progression or intolerance
At progression, eligible patients could increase the dose to 300 mg PO once per day; see paper for details.
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 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 PubMed content property of HemOnc.org
- 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 PubMed
Various histologies
Axitinib (Inlyta)
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Regimen
| Study | Evidence |
| Cohen et al. 2008 | Phase II |
| Locati et al. 2014 | Phase II |
Chemotherapy
- Axitinib (Inlyta) 5 mg PO BID
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 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
Sorafenib (Nexavar)
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Regimen
| Study | Evidence |
| Gupta-Abramson et al. 2008 | Phase II |
Chemotherapy
- Sorafenib (Nexavar) 400 mg PO BID
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 PubMed
Sunitinib (Sutent)
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Regimen
| Study | Evidence |
| Carr et al. 2010 | Phase II |
Chemotherapy
- Sunitinib (Sutent) 37.5 mg PO once per day
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 PubMed