Difference between revisions of "Adrenocortical carcinoma - null regimens"
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{{TOC limit|limit=3}} | {{TOC limit|limit=3}} | ||
+ | |||
+ | =Adjuvant therapy= | ||
+ | ==Observation== | ||
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
+ | ===Regimen=== | ||
+ | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
+ | !style="width: 20%"|Study | ||
+ | !style="width: 20%"|Dates of enrollment | ||
+ | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
+ | !style="width: 20%"|Comparator | ||
+ | !style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | ||
+ | |- | ||
+ | |[http://www.ncbi.nlm.nih.gov/pmc/articles/pmc10522778/ Terzolo et al. 2023 (ADIUVO)] | ||
+ | |2008-10-23 to 2018-12-27 | ||
+ | |style="background-color:#1a9851"|Phase 3 (C) | ||
+ | |[[Adrenocortical_carcinoma#Mitotane_monotherapy|Mitotane]] | ||
+ | |style="background-color:#ffffbf"|Did not meet primary endpoint of RFS | ||
+ | |- | ||
+ | |} | ||
+ | <div class="toccolours" style="background-color:#cbd5e8"> | ||
+ | ====Preceding treatment==== | ||
+ | *[[Surgery#Adrenalectomy|Adrenalectomy]] | ||
+ | </div> | ||
+ | ''No further treatment.'' | ||
+ | </div></div> | ||
+ | ===References=== | ||
+ | #'''ADIUVO:''' Terzolo M, Fassnacht M, Perotti P, Libé R, Kastelan D, Lacroix A, Arlt W, Haak HR, Loli P, Decoudier B, Lasolle H, Quinkler M, Haissaguerre M, Chabre O, Caron P, Stigliano A, Giordano R, Zatelli MC, Bancos I, Fragoso MCBV, Canu L, Luconi M, Puglisi S, Basile V, Reimondo G, Kroiss M, Megerle F, Hahner S, Kimpel O, Dusek T, Nölting S, Bourdeau I, Chortis V, Ettaieb MH, Cosentini D, Grisanti S, Baudin E, Berchialla P, Bovis F, Sormani MP, Bruzzi P, Beuschlein F, Bertherat J, Berruti A. Adjuvant mitotane versus surveillance in low-grade, localised adrenocortical carcinoma (ADIUVO): an international, multicentre, open-label, randomised, phase 3 trial and observational study. Lancet Diabetes Endocrinol. 2023 Oct;11(10):720-730. Epub 2023 Aug 21. [https://doi.org/10.1016/s2213-8587(23)00193-6 link to original article] [http://www.ncbi.nlm.nih.gov/pmc/articles/pmc10522778/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/37619579/ PubMed] [https://clinicaltrials.gov/study/NCT00777244 NCT00777244] | ||
=Recurrent, locally advanced, or metastatic disease= | =Recurrent, locally advanced, or metastatic disease= | ||
==Placebo== | ==Placebo== | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
===Regimen=== | ===Regimen=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
Line 22: | Line 49: | ||
|} | |} | ||
''No active antineoplastic treatment.'' | ''No active antineoplastic treatment.'' | ||
− | + | </div> | |
===References=== | ===References=== | ||
# '''GALACCTIC:''' Fassnacht M, Berruti A, Baudin E, Demeure MJ, Gilbert J, Haak H, Kroiss M, Quinn DI, Hesseltine E, Ronchi CL, Terzolo M, Choueiri TK, Poondru S, Fleege T, Rorig R, Chen J, Stephens AW, Worden F, Hammer GD. Linsitinib (OSI-906) versus placebo for patients with locally advanced or metastatic adrenocortical carcinoma: a double-blind, randomised, phase 3 study. Lancet Oncol. 2015 Apr;16(4):426-35. Epub 2015 Mar 18. [https://doi.org/10.1016/S1470-2045(15)70081-1 link to original article] [https://pubmed.ncbi.nlm.nih.gov/25795408/ PubMed] [https://clinicaltrials.gov/study/NCT00924989 NCT00924989] | # '''GALACCTIC:''' Fassnacht M, Berruti A, Baudin E, Demeure MJ, Gilbert J, Haak H, Kroiss M, Quinn DI, Hesseltine E, Ronchi CL, Terzolo M, Choueiri TK, Poondru S, Fleege T, Rorig R, Chen J, Stephens AW, Worden F, Hammer GD. Linsitinib (OSI-906) versus placebo for patients with locally advanced or metastatic adrenocortical carcinoma: a double-blind, randomised, phase 3 study. Lancet Oncol. 2015 Apr;16(4):426-35. Epub 2015 Mar 18. [https://doi.org/10.1016/S1470-2045(15)70081-1 link to original article] [https://pubmed.ncbi.nlm.nih.gov/25795408/ PubMed] [https://clinicaltrials.gov/study/NCT00924989 NCT00924989] |
Revision as of 11:04, 3 October 2023
The purpose of this page is to provide references to "null therapy" such as placebo and observation. While not clinically relevant, these references provide further insight into the historical development of the treatment landscape. See the main adrenocortical carcinoma page for current regimens.
Adjuvant therapy
Observation
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Terzolo et al. 2023 (ADIUVO) | 2008-10-23 to 2018-12-27 | Phase 3 (C) | Mitotane | Did not meet primary endpoint of RFS |
Preceding treatment
No further treatment.
References
- ADIUVO: Terzolo M, Fassnacht M, Perotti P, Libé R, Kastelan D, Lacroix A, Arlt W, Haak HR, Loli P, Decoudier B, Lasolle H, Quinkler M, Haissaguerre M, Chabre O, Caron P, Stigliano A, Giordano R, Zatelli MC, Bancos I, Fragoso MCBV, Canu L, Luconi M, Puglisi S, Basile V, Reimondo G, Kroiss M, Megerle F, Hahner S, Kimpel O, Dusek T, Nölting S, Bourdeau I, Chortis V, Ettaieb MH, Cosentini D, Grisanti S, Baudin E, Berchialla P, Bovis F, Sormani MP, Bruzzi P, Beuschlein F, Bertherat J, Berruti A. Adjuvant mitotane versus surveillance in low-grade, localised adrenocortical carcinoma (ADIUVO): an international, multicentre, open-label, randomised, phase 3 trial and observational study. Lancet Diabetes Endocrinol. 2023 Oct;11(10):720-730. Epub 2023 Aug 21. link to original article link to PMC article PubMed NCT00777244
Recurrent, locally advanced, or metastatic disease
Placebo
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Fassnacht et al. 2015 (GALACCTIC) | 2009-2011 | Phase 3 (C) | Linsitinib | Did not meet primary endpoint of OS Median OS: 356 vs 323 days |
No active antineoplastic treatment.
References
- GALACCTIC: Fassnacht M, Berruti A, Baudin E, Demeure MJ, Gilbert J, Haak H, Kroiss M, Quinn DI, Hesseltine E, Ronchi CL, Terzolo M, Choueiri TK, Poondru S, Fleege T, Rorig R, Chen J, Stephens AW, Worden F, Hammer GD. Linsitinib (OSI-906) versus placebo for patients with locally advanced or metastatic adrenocortical carcinoma: a double-blind, randomised, phase 3 study. Lancet Oncol. 2015 Apr;16(4):426-35. Epub 2015 Mar 18. link to original article PubMed NCT00924989