Difference between revisions of "Desmoid tumor - null regimens"

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| style="background-color:#d73027" |Inferior PFS
 
| style="background-color:#d73027" |Inferior PFS
 
|-
 
|-
|[https://www.clinicaltrials.gov/ct2/show/NCT03785964 Awaiting publication (DeFi)]
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|[https://doi.org/10.1056/NEJMoa2210140 Gounder et al. 2023 (DeFi)]
|2019-2022
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|2019-05 to 2020-08
 
| style="background-color:#1a9851" |Phase 3 (C)
 
| style="background-color:#1a9851" |Phase 3 (C)
 
|[[Desmoid_tumor#Nirogacestat_monotherapy_77|Nirogacestat]]
 
|[[Desmoid_tumor#Nirogacestat_monotherapy_77|Nirogacestat]]
| style="background-color:#d3d3d3" |TBD
+
| style="background-color:#d73027" |Inferior PFS
 
|-
 
|-
 
|}
 
|}
''No active antineoplastic treatment. Used as a comparator arm and here for reference purposes only.''
+
''No active antineoplastic treatment.''
 
===References===
 
===References===
 
# '''Alliance A091105:''' Gounder MM, Mahoney MR, Van Tine BA, Ravi V, Attia S, Deshpande HA, Gupta AA, Milhem MM, Conry RM, Movva S, Pishvaian MJ, Riedel RF, Sabagh T, Tap WD, Horvat N, Basch E, Schwartz LH, Maki RG, Agaram NP, Lefkowitz RA, Mazaheri Y, Yamashita R, Wright JJ, Dueck AC, Schwartz GK. Sorafenib for Advanced and Refractory Desmoid Tumors. N Engl J Med. 2018 Dec 20;379(25):2417-2428. [https://doi.org/10.1056/NEJMoa1805052 link to original article] '''contains dosing details in abstract''' [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc6447029/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/30575484/ PubMed] NCT02066181
 
# '''Alliance A091105:''' Gounder MM, Mahoney MR, Van Tine BA, Ravi V, Attia S, Deshpande HA, Gupta AA, Milhem MM, Conry RM, Movva S, Pishvaian MJ, Riedel RF, Sabagh T, Tap WD, Horvat N, Basch E, Schwartz LH, Maki RG, Agaram NP, Lefkowitz RA, Mazaheri Y, Yamashita R, Wright JJ, Dueck AC, Schwartz GK. Sorafenib for Advanced and Refractory Desmoid Tumors. N Engl J Med. 2018 Dec 20;379(25):2417-2428. [https://doi.org/10.1056/NEJMoa1805052 link to original article] '''contains dosing details in abstract''' [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc6447029/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/30575484/ PubMed] NCT02066181
# '''DeFi:''' NCT03785964
+
#'''DeFi:''' Gounder M, Ratan R, Alcindor T, Schoeffski P, van der Graaf WT, Wilky BA, Riedel RF, Lim A, Smith LM, Moody S, Attia S, Chawla S, D'Amato G, Federman N, Merriam P, Van Tine BA, Vincenzi B, Benson C, Bui NQ, Chugh R, Tinoco G, Charlson J, Dileo P, Hartner L, Lapeire L, Mazzeo F, Palmerini E, Reichardt P, Stacchiotti S, Bailey HH, Burgess MA, Cote GM, Davis LE, Deshpande H, Gelderblom H, Grignani G, Loggers E, Philip T, Pressey JG, Kummar S, Kasper B. Nirogacestat, a γ-Secretase Inhibitor for Desmoid Tumors. N Engl J Med. 2023 Mar 9;388(10):898-912. [https://doi.org/10.1056/NEJMoa2210140 link to original article] [https://pubmed.ncbi.nlm.nih.gov/36884323/ PubMed] NCT03785964
 
[[Category:Desmoid tumor regimens]]
 
[[Category:Desmoid tumor regimens]]
 
[[Category:Disease-specific pages]]
 
[[Category:Disease-specific pages]]
 
[[Category:Soft tissue sarcomas]]
 
[[Category:Soft tissue sarcomas]]
 
[[Category:Null regimens]]
 
[[Category:Null regimens]]

Revision as of 00:25, 22 May 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 desmoid tumor page for current regimens.


All lines of therapy

Placebo

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Gounder et al. 2018 (Alliance A091105) 2014-2016 Phase 3 (C) Sorafenib Inferior PFS
Gounder et al. 2023 (DeFi) 2019-05 to 2020-08 Phase 3 (C) Nirogacestat Inferior PFS

No active antineoplastic treatment.

References

  1. Alliance A091105: Gounder MM, Mahoney MR, Van Tine BA, Ravi V, Attia S, Deshpande HA, Gupta AA, Milhem MM, Conry RM, Movva S, Pishvaian MJ, Riedel RF, Sabagh T, Tap WD, Horvat N, Basch E, Schwartz LH, Maki RG, Agaram NP, Lefkowitz RA, Mazaheri Y, Yamashita R, Wright JJ, Dueck AC, Schwartz GK. Sorafenib for Advanced and Refractory Desmoid Tumors. N Engl J Med. 2018 Dec 20;379(25):2417-2428. link to original article contains dosing details in abstract link to PMC article PubMed NCT02066181
  2. DeFi: Gounder M, Ratan R, Alcindor T, Schoeffski P, van der Graaf WT, Wilky BA, Riedel RF, Lim A, Smith LM, Moody S, Attia S, Chawla S, D'Amato G, Federman N, Merriam P, Van Tine BA, Vincenzi B, Benson C, Bui NQ, Chugh R, Tinoco G, Charlson J, Dileo P, Hartner L, Lapeire L, Mazzeo F, Palmerini E, Reichardt P, Stacchiotti S, Bailey HH, Burgess MA, Cote GM, Davis LE, Deshpande H, Gelderblom H, Grignani G, Loggers E, Philip T, Pressey JG, Kummar S, Kasper B. Nirogacestat, a γ-Secretase Inhibitor for Desmoid Tumors. N Engl J Med. 2023 Mar 9;388(10):898-912. link to original article PubMed NCT03785964