Difference between revisions of "Gallbladder cancer - null regimens"
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Warner-admin (talk | contribs) m (Text replacement - "'''contains protocol'''" to "'''contains dosing details in abstract'''") |
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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 [[Gallbladder cancer|main gallbladder cancer page]] for regimens that include active anticancer treatment. |
{{TOC limit|limit=3}} | {{TOC limit|limit=3}} | ||
=Neoadjuvant therapy= | =Neoadjuvant therapy= | ||
==No neoadjuvant therapy== | ==No neoadjuvant therapy== | ||
− | + | <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;" | ||
!style="width: 20%"|Study | !style="width: 20%"|Study | ||
− | !style="width: 20%"| | + | !style="width: 20%"|Dates of enrollment |
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
!style="width: 20%"|Comparator | !style="width: 20%"|Comparator | ||
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | !style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | ||
|- | |- | ||
− | |Awaiting publication (ECOG-ACRIN EA2197) | + | |[https://www.clinicaltrials.gov/study/NCT04559139 Awaiting publication (ECOG-ACRIN EA2197)] |
|2020-ongoing | |2020-ongoing | ||
| style="background-color:#1a9851" |Phase 3 (C) | | style="background-color:#1a9851" |Phase 3 (C) | ||
− | |[[#Cisplatin_.26_Gemcitabine_.28GC. | + | |[[#Cisplatin_.26_Gemcitabine_.28GC.29_666|GC]] |
− | | style="background-color:#d3d3d3" | | + | | style="background-color:#d3d3d3" |TBD if different primary endpoint of OS |
|- | |- | ||
|} | |} | ||
''No systemic therapy prior to surgery.'' | ''No systemic therapy prior to surgery.'' | ||
+ | <div class="toccolours" style="background-color:#cbd5e8"> | ||
====Subsequent treatment==== | ====Subsequent treatment==== | ||
*[[Surgery#Surgical_resection|Surgical resection]] | *[[Surgery#Surgical_resection|Surgical resection]] | ||
+ | </div></div> | ||
+ | ===References=== | ||
+ | #'''ECOG-ACRIN EA2197:''' [https://clinicaltrials.gov/study/NCT04559139 NCT04559139] | ||
+ | |||
+ | =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]] | ||
+ | |- | ||
+ | |[https://doi.org/10.1016/s0140-6736(22)02038-4 Nakachi et al 2023 (ASCOT)] | ||
+ | |2013-09-09 to 2018-06-22 | ||
+ | | style="background-color:#1a9851" |Phase 3 (C) | ||
+ | |[[Gallbladder_cancer#S-1_monotherapy|S-1]] | ||
+ | | style="background-color:#d73027" |Inferior OS | ||
+ | |- | ||
+ | |} | ||
+ | ''No systemic therapy after surgery.'' | ||
+ | <div class="toccolours" style="background-color:#cbd5e8"> | ||
+ | ====Preceding treatment==== | ||
+ | *[[Surgery#Surgical_resection|Surgical resection]] | ||
+ | </div></div> | ||
===References=== | ===References=== | ||
− | #''' | + | #'''ASCOT:''' Nakachi K, Ikeda M, Konishi M, Nomura S, Katayama H, Kataoka T, Todaka A, Yanagimoto H, Morinaga S, Kobayashi S, Shimada K, Takahashi Y, Nakagohri T, Gotoh K, Kamata K, Shimizu Y, Ueno M, Ishii H, Okusaka T, Furuse J; Hepatobiliary and Pancreatic Oncology Group of the Japan Clinical Oncology Group (JCOG-HBPOG). Adjuvant S-1 compared with observation in resected biliary tract cancer (JCOG1202, ASCOT): a multicentre, open-label, randomised, controlled, phase 3 trial. Lancet. 2023 Jan 21;401(10372):195-203. PMID: 36681415. [https://doi.org/10.1016/s0140-6736(22)02038-4 link to original article] [https://pubmed.ncbi.nlm.nih.gov/36681415/ PubMed] UMIN000011688 |
=Metastatic or unresectable disease, all lines of therapy= | =Metastatic or unresectable disease, all lines of therapy= | ||
==Best supportive care== | ==Best supportive care== | ||
− | + | <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;" | ||
!style="width: 20%"|Study | !style="width: 20%"|Study | ||
− | !style="width: 20%"| | + | !style="width: 20%"|Dates of enrollment |
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
!style="width: 20%"|Comparator | !style="width: 20%"|Comparator | ||
Line 40: | Line 68: | ||
|rowspan=2|2006-2008 | |rowspan=2|2006-2008 | ||
| style="background-color:#1a9851" rowspan="2" |Randomized (C) | | style="background-color:#1a9851" rowspan="2" |Randomized (C) | ||
− | |1. [[# | + | |1. [[#FUFA_999|FUFA]] |
| style="background-color:#ffffbf" |Did not meet primary endpoint of OS | | style="background-color:#ffffbf" |Did not meet primary endpoint of OS | ||
|- | |- | ||
Line 48: | Line 76: | ||
|} | |} | ||
''No active antineoplastic treatment.'' | ''No active antineoplastic treatment.'' | ||
− | + | </div> | |
===References=== | ===References=== | ||
− | #Sharma A, Dwary AD, Mohanti BK, Deo SV, Pal S, Sreenivas V, Raina V, Shukla NK, Thulkar S, Garg P, Chaudhary SP. Best supportive care compared with chemotherapy for unresectable gall bladder cancer: a randomized controlled study. J Clin Oncol. 2010 Oct 20;28(30):4581-6. Epub 2010 Sep 20. [https://doi.org/10.1200/JCO.2010.29.3605 link to original article] | + | #Sharma A, Dwary AD, Mohanti BK, Deo SV, Pal S, Sreenivas V, Raina V, Shukla NK, Thulkar S, Garg P, Chaudhary SP. Best supportive care compared with chemotherapy for unresectable gall bladder cancer: a randomized controlled study. J Clin Oncol. 2010 Oct 20;28(30):4581-6. Epub 2010 Sep 20. [https://doi.org/10.1200/JCO.2010.29.3605 link to original article] [https://pubmed.ncbi.nlm.nih.gov/20855823/ PubMed] |
[[Category:Gallbladder cancer regimens]] | [[Category:Gallbladder cancer regimens]] | ||
[[Category:Disease-specific pages]] | [[Category:Disease-specific pages]] | ||
− | [[Category: | + | [[Category:Biliary tract cancers]] |
[[Category:Null regimens]] | [[Category:Null regimens]] |
Latest revision as of 00:56, 27 January 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 gallbladder cancer page for regimens that include active anticancer treatment.
Neoadjuvant therapy
No neoadjuvant therapy
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Awaiting publication (ECOG-ACRIN EA2197) | 2020-ongoing | Phase 3 (C) | GC | TBD if different primary endpoint of OS |
No systemic therapy prior to surgery.
Subsequent treatment
References
- ECOG-ACRIN EA2197: NCT04559139
Adjuvant therapy
Observation
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Nakachi et al 2023 (ASCOT) | 2013-09-09 to 2018-06-22 | Phase 3 (C) | S-1 | Inferior OS |
No systemic therapy after surgery.
Preceding treatment
References
- ASCOT: Nakachi K, Ikeda M, Konishi M, Nomura S, Katayama H, Kataoka T, Todaka A, Yanagimoto H, Morinaga S, Kobayashi S, Shimada K, Takahashi Y, Nakagohri T, Gotoh K, Kamata K, Shimizu Y, Ueno M, Ishii H, Okusaka T, Furuse J; Hepatobiliary and Pancreatic Oncology Group of the Japan Clinical Oncology Group (JCOG-HBPOG). Adjuvant S-1 compared with observation in resected biliary tract cancer (JCOG1202, ASCOT): a multicentre, open-label, randomised, controlled, phase 3 trial. Lancet. 2023 Jan 21;401(10372):195-203. PMID: 36681415. link to original article PubMed UMIN000011688
Metastatic or unresectable disease, all lines of therapy
Best supportive care
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Sharma et al. 2010 | 2006-2008 | Randomized (C) | 1. FUFA | Did not meet primary endpoint of OS |
2. mGEMOX | Seems to have inferior OS |
No active antineoplastic treatment.
References
- Sharma A, Dwary AD, Mohanti BK, Deo SV, Pal S, Sreenivas V, Raina V, Shukla NK, Thulkar S, Garg P, Chaudhary SP. Best supportive care compared with chemotherapy for unresectable gall bladder cancer: a randomized controlled study. J Clin Oncol. 2010 Oct 20;28(30):4581-6. Epub 2010 Sep 20. link to original article PubMed