Difference between revisions of "Thyroid cancer, differentiated - null regimens"
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| − | The purpose of this page is to provide references to "null therapy" such as placebo and observation. | + | The purpose of this page is to provide references to "null therapy" such as placebo and observation. These references provide further insight into the historical development of the treatment landscape. See the [[Thyroid cancer, differentiated|main DTC page]] for regimens that include active anticancer treatment. |
{{TOC limit|limit=3}} | {{TOC limit|limit=3}} | ||
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===References=== | ===References=== | ||
| − | #'''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] | + | #'''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] [https://pubmed.ncbi.nlm.nih.gov/35263518/ PubMed] [https://clinicaltrials.gov/study/NCT01837745 NCT01837745] |
=Advanced or metastatic disease, radioactive iodine-refractory= | =Advanced or metastatic disease, radioactive iodine-refractory= | ||
==Placebo== | ==Placebo== | ||
| Line 62: | Line 62: | ||
|[https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8678901/ Lin et al. 2022 (REALITY)] | |[https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8678901/ Lin et al. 2022 (REALITY)] | ||
|2017-2020 | |2017-2020 | ||
| − | | style="background-color:#1a9851" |Phase 3 ( | + | | style="background-color:#1a9851" |Phase 3 (C) |
|[[Thyroid cancer, differentiated#Apatinib_monotherapy|Apatinib]] | |[[Thyroid cancer, differentiated#Apatinib_monotherapy|Apatinib]] | ||
| style="background-color:#fc8d59" |Seems to have inferior OS | | style="background-color:#fc8d59" |Seems to have inferior OS | ||
| + | |- | ||
| + | |[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 (C) | ||
| + | |[[Thyroid cancer, differentiated#Donafenib_monotherapy|Donafenib]] | ||
| + | | style="background-color:#d73027" |Inferior PFS (primary endpoint) | ||
|- | |- | ||
|[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)] | ||
| Line 75: | Line 81: | ||
''No active antineoplastic treatment.'' | ''No active antineoplastic treatment.'' | ||
</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] | + | # '''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] [https://pubmed.ncbi.nlm.nih.gov/22898678/ PubMed] [https://clinicaltrials.gov/study/NCT00537095 NCT00537095] |
| − | # '''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] [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] [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] |
<!-- # '''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] [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] [https://pubmed.ncbi.nlm.nih.gov/25671254/ PubMed] [https://clinicaltrials.gov/study/NCT01321554 NCT01321554] |
| − | # '''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] | + | # '''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] [https://pubmed.ncbi.nlm.nih.gov/34237250/ PubMed] [https://clinicaltrials.gov/study/NCT03690388 NCT03690388] |
| − | #'''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] ''' | + | #'''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] [https://pubmed.ncbi.nlm.nih.gov/34913959/ PubMed] [https://clinicaltrials.gov/study/NCT03048877 NCT03048877] |
| + | #'''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] [https://pubmed.ncbi.nlm.nih.gov/37184934/ PubMed] [https://clinicaltrials.gov/study/NCT03602495 NCT03602495] | ||
[[Category:Thyroid cancer regimens]] | [[Category:Thyroid cancer regimens]] | ||
| − | [[Category: | + | [[Category:Histology-specific pages]] |
[[Category:Endocrine cancers]] | [[Category:Endocrine cancers]] | ||
[[Category:Head and neck cancers]] | [[Category:Head and neck cancers]] | ||
[[Category:Null regimens]] | [[Category:Null regimens]] | ||
Latest revision as of 13:14, 1 February 2024
The purpose of this page is to provide references to "null therapy" such as placebo and observation. These references provide further insight into the historical development of the treatment landscape. See the main DTC page for regimens that include active anticancer treatment.
Adjuvant therapy
Observation
Regimen
| Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Leboulleux et al. 2022 (ESTIMABL2) | 2013-2017 | Phase 3 (E-de-esc) | Radioiodine ablation | Non-inferior composite endpoint |
No treatment after surgery.
Preceding treatment
References
- 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 PubMed NCT01837745
Advanced or metastatic disease, radioactive iodine-refractory
Placebo
Regimen
| Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Leboulleux et al. 2012 (D4200C00079) | 2007-2008 | Randomized Phase 2 (C) | Vandetanib | Inferior PFS |
| Brose et al. 2014 (DECISION) | 2009-2011 | Phase 3 (C) | Sorafenib | Inferior PFS |
| Schlumberger et al. 2015 (SELECT) | 2011-08-05 to 2012-10-04 | Phase 3 (C) | Lenvatinib | Inferior PFS |
| Lin et al. 2022 (REALITY) | 2017-2020 | Phase 3 (C) | Apatinib | Seems to have inferior OS |
| Lin et al. 2023 (ZGDD3) | 2018-08-29 to 2021-02-28 | Phase 3 (C) | Donafenib | Inferior PFS (primary endpoint) |
| Brose et al. 2021 (COSMIC-311) | 2019-02-27 to 2020-08-18 | Phase 3 (C) | Cabozantinib | Inferior PFS |
No active antineoplastic treatment.
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. link to original article PubMed NCT00537095
- 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 link to PMC article PubMed NCT00984282
- 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 NCT01321554
- 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 PubMed NCT03690388
- 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 PubMed NCT03048877
- 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 PubMed NCT03602495