Difference between revisions of "Adrenocortical carcinoma - null regimens"
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− | 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 [[Adrenocortical carcinoma|main adrenocortical carcinoma page]] for | + | 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 [[Adrenocortical carcinoma|main adrenocortical carcinoma page]] for regimens that include active anticancer treatment. |
{{TOC limit|limit=3}} | {{TOC limit|limit=3}} |
Revision as of 12:54, 14 October 2023
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 adrenocortical carcinoma page for regimens that include active anticancer treatment.
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