Difference between revisions of "Cholangiocarcinoma - null regimens"

From HemOnc.org - A Hematology Oncology Wiki
Jump to navigation Jump to search
m (Text replacement - "0 PubMed]" to "0/ PubMed]")
m (Text replacement - "http://hemonc.org" to "https://hemonc.org")
 
(13 intermediate revisions by 2 users not shown)
Line 3: Line 3:
 
[[#top|Back to Top]]
 
[[#top|Back to Top]]
 
</div>
 
</div>
−
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 [[Cholangiocarcinoma|main cholangiocarcinoma page]] for current regimens.
+
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 [[Cholangiocarcinoma|main cholangiocarcinoma page]] for regimens that include active anticancer treatment.
  
 
{{TOC limit|limit=3}}
 
{{TOC limit|limit=3}}
Line 46: Line 46:
 
===References===
 
===References===
  
−
#'''BCAT:''' Ebata T, Hirano S, Konishi M, Uesaka K, Tsuchiya Y, Ohtsuka M, Kaneoka Y, Yamamoto M, Ambo Y, Shimizu Y, Ozawa F, Fukutomi A, Ando M, Nimura Y, Nagino M; Bile Duct Cancer Adjuvant Trial (BCAT) Study Group. Randomized clinical trial of adjuvant gemcitabine chemotherapy versus observation in resected bile duct cancer. Br J Surg. 2018 Feb;105(3):192-202. [https://doi.org/10.1002/bjs.10776 link to original article] [https://pubmed.ncbi.nlm.nih.gov/29405274 PubMed] UMIN000000820
+
#'''BCAT:''' Ebata T, Hirano S, Konishi M, Uesaka K, Tsuchiya Y, Ohtsuka M, Kaneoka Y, Yamamoto M, Ambo Y, Shimizu Y, Ozawa F, Fukutomi A, Ando M, Nimura Y, Nagino M; Bile Duct Cancer Adjuvant Trial (BCAT) Study Group. Randomized clinical trial of adjuvant gemcitabine chemotherapy versus observation in resected bile duct cancer. Br J Surg. 2018 Feb;105(3):192-202. [https://doi.org/10.1002/bjs.10776 link to original article] [https://pubmed.ncbi.nlm.nih.gov/29405274/ PubMed] UMIN000000820
−
#'''PRODIGE 12-ACCORD 18-UNICANCER GI:''' Edeline J, Benabdelghani M, Bertaut A, Watelet J, Hammel P, Joly JP, Boudjema K, Fartoux L, Bouhier-Leporrier K, Jouve JL, Faroux R, Guerin-Meyer V, Kurtz JE, Assénat E, Seitz JF, Baumgaertner I, Tougeron D, de la Fouchardière C, Lombard-Bohas C, Boucher E, Stanbury T, Louvet C, Malka D, Phelip JM. Gemcitabine and Oxaliplatin Chemotherapy or Surveillance in Resected Biliary Tract Cancer (PRODIGE 12-ACCORD 18-UNICANCER GI): A Randomized Phase III Study. J Clin Oncol. 2019 Mar 10;37(8):658-667. Epub 2019 Feb 1. [https://doi.org/10.1200/JCO.18.00050 link to original article] [https://pubmed.ncbi.nlm.nih.gov/30707660/ PubMed] NCT01313377
+
#'''PRODIGE 12-ACCORD 18-UNICANCER GI:''' Edeline J, Benabdelghani M, Bertaut A, Watelet J, Hammel P, Joly JP, Boudjema K, Fartoux L, Bouhier-Leporrier K, Jouve JL, Faroux R, Guerin-Meyer V, Kurtz JE, Assénat E, Seitz JF, Baumgaertner I, Tougeron D, de la Fouchardière C, Lombard-Bohas C, Boucher E, Stanbury T, Louvet C, Malka D, Phelip JM. Gemcitabine and Oxaliplatin Chemotherapy or Surveillance in Resected Biliary Tract Cancer (PRODIGE 12-ACCORD 18-UNICANCER GI): A Randomized Phase III Study. J Clin Oncol. 2019 Mar 10;37(8):658-667. Epub 2019 Feb 1. [https://doi.org/10.1200/JCO.18.00050 link to original article] [https://pubmed.ncbi.nlm.nih.gov/30707660/ PubMed] [https://clinicaltrials.gov/study/NCT01313377 NCT01313377]
−
#'''BILCAP:''' Primrose JN, Fox RP, Palmer DH, Malik HZ, Prasad R, Mirza D, Anthony A, Corrie P, Falk S, Finch-Jones M, Wasan H, Ross P, Wall L, Wadsley J, Evans JTR, Stocken D, Praseedom R, Ma YT, Davidson B, Neoptolemos JP, Iveson T, Raftery J, Zhu S, Cunningham D, Garden OJ, Stubbs C, Valle JW, Bridgewater J; BILCAP study group. Capecitabine compared with observation in resected biliary tract cancer (BILCAP): a randomised, controlled, multicentre, phase 3 study. Lancet Oncol. 2019 May;20(5):663-673. Epub 2019 Mar 25. Erratum in: Lancet Oncol. 2019 Apr 2. [https://doi.org/10.1016/S1470-2045(18)30915-X link to original article] [https://pubmed.ncbi.nlm.nih.gov/30922733 PubMed] NCT00363584
+
#'''BILCAP:''' Primrose JN, Fox RP, Palmer DH, Malik HZ, Prasad R, Mirza D, Anthoney A, Corrie P, Falk S, Finch-Jones M, Wasan H, Ross P, Wall L, Wadsley J, Evans JTR, Stocken D, Praseedom R, Ma YT, Davidson B, Neoptolemos JP, Iveson T, Raftery J, Zhu S, Cunningham D, Garden OJ, Stubbs C, Valle JW, Bridgewater J; BILCAP study group. Capecitabine compared with observation in resected biliary tract cancer (BILCAP): a randomised, controlled, multicentre, phase 3 study. Lancet Oncol. 2019 May;20(5):663-673. Epub 2019 Mar 25. Erratum in: Lancet Oncol. 2019 Apr 2. [https://doi.org/10.1016/S1470-2045(18)30915-X link to original article] [https://pubmed.ncbi.nlm.nih.gov/30922733/ PubMed] [https://clinicaltrials.gov/study/NCT00363584 NCT00363584]
−
##'''Update:''' Bridgewater J, Fletcher P, Palmer DH, Malik HZ, Prasad R, Mirza D, Anthony A, Corrie P, Falk S, Finch-Jones M, Wasan H, Ross P, Wall L, Wadsley J, Evans TR, Stocken D, Stubbs C, Praseedom R, Ma YT, Davidson B, Neoptolemos J, Iveson T, Cunningham D, Garden OJ, Valle JW, Primrose J; BILCAP study group. Long-Term Outcomes and Exploratory Analyses of the Randomized Phase III BILCAP Study. J Clin Oncol. 2022 Jun 20;40(18):2048-2057. Epub 2022 Mar 22. [https://doi.org/10.1200/jco.21.02568 link to original article] [https://pubmed.ncbi.nlm.nih.gov/35316080/ PubMed]
+
##'''Update:''' Bridgewater J, Fletcher P, Palmer DH, Malik HZ, Prasad R, Mirza D, Anthoney A, Corrie P, Falk S, Finch-Jones M, Wasan H, Ross P, Wall L, Wadsley J, Evans TR, Stocken D, Stubbs C, Praseedom R, Ma YT, Davidson B, Neoptolemos J, Iveson T, Cunningham D, Garden OJ, Valle JW, Primrose J; BILCAP study group. Long-Term Outcomes and Exploratory Analyses of the Randomized Phase III BILCAP Study. J Clin Oncol. 2022 Jun 20;40(18):2048-2057. Epub 2022 Mar 22. [https://doi.org/10.1200/jco.21.02568 link to original article] [https://pubmed.ncbi.nlm.nih.gov/35316080/ PubMed]
  
 
=Metastatic disease, all lines of therapy=
 
=Metastatic disease, all lines of therapy=
Line 62: Line 62:
 
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
|-
 
|-
−
| rowspan="2" |[https://doi.org/10.1093/oxfordjournals.annonc.a010676 Glimelius et al. 1996]
+
|[https://doi.org/10.1093/oxfordjournals.annonc.a010676 Glimelius et al. 1996]
−
|rowspan=2|1991-1995
+
|1991-1995
−
| style="background-color:#1a9851" rowspan="2" |Phase 3 (C)
+
| style="background-color:#1a9851" |Phase 3 (C)
−
|1. [[Cholangiocarcinoma#FELV|FELV]]
+
|1a. [[Cholangiocarcinoma#FELV|FELV]]<br>1b. [[Cholangiocarcinoma#FULV|FULV]]
−
| style="background-color:#d73027" |Inferior OS
 
−
|-
 
−
|2. [[Cholangiocarcinoma#FULV|FULV]]
 
 
| style="background-color:#d73027" |Inferior OS
 
| style="background-color:#d73027" |Inferior OS
 
|-
 
|-
−
|[http://www.ncbi.nlm.nih.gov/pmc/articles/pmc8082275/ Lamarca et al. 2021 (ABC-06)]
+
|[https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8082275/ Lamarca et al. 2021 (ABC-06)]
 
|2014-2018
 
|2014-2018
 
| style="background-color:#1a9851" |Phase 3 (C)
 
| style="background-color:#1a9851" |Phase 3 (C)
Line 79: Line 76:
 
|}
 
|}
  
−
''No antineoplastic treatment. Included for reference purposes only.''
+
''No antineoplastic treatment.''
 
</div>
 
</div>
 
===References===
 
===References===
  
−
#Glimelius B, Hoffman K, Sjödén PO, Jacobsson G, Sellström H, Enander LK, Linné T, Svensson C. Chemotherapy improves survival and quality of life in advanced pancreatic and biliary cancer. Ann Oncol. 1996 Aug;7(6):593-600. [https://doi.org/10.1093/oxfordjournals.annonc.a010676 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/8879373 PubMed] content property of [http://hemonc.org HemOnc.org]
+
#Glimelius B, Hoffman K, Sjödén PO, Jacobsson G, Sellström H, Enander LK, Linné T, Svensson C. Chemotherapy improves survival and quality of life in advanced pancreatic and biliary cancer. Ann Oncol. 1996 Aug;7(6):593-600. [https://doi.org/10.1093/oxfordjournals.annonc.a010676 link to original article] [https://pubmed.ncbi.nlm.nih.gov/8879373/ PubMed] content property of [https://hemonc.org HemOnc.org]
−
#'''ABC-06:''' Lamarca A, Palmer DH, Wasan HS, Ross PJ, Ma YT, Arora A, Falk S, Gillmore R, Wadsley J, Patel K, Anthoney A, Maraveyas A, Iveson T, Waters JS, Hobbs C, Barber S, Ryder WD, Ramage J, Davies LM, Bridgewater JA, Valle JW; Advanced Biliary Cancer Working Group. Second-line FOLFOX chemotherapy versus active symptom control for advanced biliary tract cancer (ABC-06): a phase 3, open-label, randomised, controlled trial. Lancet Oncol. 2021 May;22(5):690-701. Epub 2021 Mar 30. [https://doi.org/10.1016/s1470-2045(21)00027-9 link to original article] [http://www.ncbi.nlm.nih.gov/pmc/articles/pmc8082275/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/33798493/ PubMed] NCT01926236
+
#'''ABC-06:''' Lamarca A, Palmer DH, Wasan HS, Ross PJ, Ma YT, Arora A, Falk S, Gillmore R, Wadsley J, Patel K, Anthoney A, Maraveyas A, Iveson T, Waters JS, Hobbs C, Barber S, Ryder WD, Ramage J, Davies LM, Bridgewater JA, Valle JW; Advanced Biliary Cancer Working Group. Second-line FOLFOX chemotherapy versus active symptom control for advanced biliary tract cancer (ABC-06): a phase 3, open-label, randomised, controlled trial. Lancet Oncol. 2021 May;22(5):690-701. Epub 2021 Mar 30. [https://doi.org/10.1016/s1470-2045(21)00027-9 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8082275/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/33798493/ PubMed] [https://clinicaltrials.gov/study/NCT01926236 NCT01926236]
  
 
==Placebo==
 
==Placebo==
Line 109: Line 106:
 
</div></div>
 
</div></div>
 
===References===
 
===References===
−
#'''ClarIDHy:''' Abou-Alfa GK, Macarulla T, Javle MM, Kelley RK, Lubner SJ, Adeva J, Cleary JM, Catenacci DV, Borad MJ, Bridgewater J, Harris WP, Murphy AG, Oh DY, Whisenant J, Lowery MA, Goyal L, Shroff RT, El-Khoueiry AB, Fan B, Wu B, Chamberlain CX, Jiang L, Gliser C, Pandya SS, Valle JW, Zhu AX. Ivosidenib in IDH1-mutant, chemotherapy-refractory cholangiocarcinoma (ClarIDHy): a multicentre, randomised, double-blind, placebo-controlled, phase 3 study. Lancet Oncol. 2020 Jun;21(6):796-807. Epub 2020 May 13. Erratum in: Lancet Oncol. 2020 Oct;21(10):e462. [https://doi.org/10.1016/s1470-2045(20)30157-1 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc7523268/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/32416072 PubMed] NCT02989857
+
#'''ClarIDHy:''' Abou-Alfa GK, Macarulla T, Javle MM, Kelley RK, Lubner SJ, Adeva J, Cleary JM, Catenacci DV, Borad MJ, Bridgewater J, Harris WP, Murphy AG, Oh DY, Whisenant J, Lowery MA, Goyal L, Shroff RT, El-Khoueiry AB, Fan B, Wu B, Chamberlain CX, Jiang L, Gliser C, Pandya SS, Valle JW, Zhu AX. Ivosidenib in IDH1-mutant, chemotherapy-refractory cholangiocarcinoma (ClarIDHy): a multicentre, randomised, double-blind, placebo-controlled, phase 3 study. Lancet Oncol. 2020 Jun;21(6):796-807. Epub 2020 May 13. Erratum in: Lancet Oncol. 2020 Oct;21(10):e462. [https://doi.org/10.1016/s1470-2045(20)30157-1 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc7523268/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/32416072/ PubMed] [https://clinicaltrials.gov/study/NCT02989857 NCT02989857]
  
 
[[Category:Cholangiocarcinoma regimens]]
 
[[Category:Cholangiocarcinoma regimens]]
 
[[Category:Disease-specific pages]]
 
[[Category:Disease-specific pages]]
−
[[Category:Hepatobiliary cancers]]
+
[[Category:Biliary tract cancers]]
 
[[Category:Null regimens]]
 
[[Category:Null regimens]]

Latest revision as of 19:27, 23 June 2024

Back to Top

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 cholangiocarcinoma page for regimens that include active anticancer treatment.


Adjuvant therapy

Observation

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Primrose et al. 2019 (BILCAP) 2006-2014 Phase 3 (C) Capecitabine Did not meet primary endpoint of OS1
Ebata et al. 2018 (BCAT) 2007-2011 Phase 3 (C) Gemcitabine Did not meet primary endpoint of OS
Edeline et al. 2019 (PRODIGE 12-ACCORD 18-UNICANCER GI) 2009-2014 Phase 3 (C) GemOx Did not meet primary endpoint of RFS

1Reported efficacy is based on the 2022 update.
No antineoplastic treatment after surgery.

Preceding treatment

References

  1. BCAT: Ebata T, Hirano S, Konishi M, Uesaka K, Tsuchiya Y, Ohtsuka M, Kaneoka Y, Yamamoto M, Ambo Y, Shimizu Y, Ozawa F, Fukutomi A, Ando M, Nimura Y, Nagino M; Bile Duct Cancer Adjuvant Trial (BCAT) Study Group. Randomized clinical trial of adjuvant gemcitabine chemotherapy versus observation in resected bile duct cancer. Br J Surg. 2018 Feb;105(3):192-202. link to original article PubMed UMIN000000820
  2. PRODIGE 12-ACCORD 18-UNICANCER GI: Edeline J, Benabdelghani M, Bertaut A, Watelet J, Hammel P, Joly JP, Boudjema K, Fartoux L, Bouhier-Leporrier K, Jouve JL, Faroux R, Guerin-Meyer V, Kurtz JE, Assénat E, Seitz JF, Baumgaertner I, Tougeron D, de la Fouchardière C, Lombard-Bohas C, Boucher E, Stanbury T, Louvet C, Malka D, Phelip JM. Gemcitabine and Oxaliplatin Chemotherapy or Surveillance in Resected Biliary Tract Cancer (PRODIGE 12-ACCORD 18-UNICANCER GI): A Randomized Phase III Study. J Clin Oncol. 2019 Mar 10;37(8):658-667. Epub 2019 Feb 1. link to original article PubMed NCT01313377
  3. BILCAP: Primrose JN, Fox RP, Palmer DH, Malik HZ, Prasad R, Mirza D, Anthoney A, Corrie P, Falk S, Finch-Jones M, Wasan H, Ross P, Wall L, Wadsley J, Evans JTR, Stocken D, Praseedom R, Ma YT, Davidson B, Neoptolemos JP, Iveson T, Raftery J, Zhu S, Cunningham D, Garden OJ, Stubbs C, Valle JW, Bridgewater J; BILCAP study group. Capecitabine compared with observation in resected biliary tract cancer (BILCAP): a randomised, controlled, multicentre, phase 3 study. Lancet Oncol. 2019 May;20(5):663-673. Epub 2019 Mar 25. Erratum in: Lancet Oncol. 2019 Apr 2. link to original article PubMed NCT00363584
    1. Update: Bridgewater J, Fletcher P, Palmer DH, Malik HZ, Prasad R, Mirza D, Anthoney A, Corrie P, Falk S, Finch-Jones M, Wasan H, Ross P, Wall L, Wadsley J, Evans TR, Stocken D, Stubbs C, Praseedom R, Ma YT, Davidson B, Neoptolemos J, Iveson T, Cunningham D, Garden OJ, Valle JW, Primrose J; BILCAP study group. Long-Term Outcomes and Exploratory Analyses of the Randomized Phase III BILCAP Study. J Clin Oncol. 2022 Jun 20;40(18):2048-2057. Epub 2022 Mar 22. link to original article PubMed

Metastatic disease, all lines of therapy

Best supportive care

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Glimelius et al. 1996 1991-1995 Phase 3 (C) 1a. FELV
1b. FULV 		Inferior OS
Lamarca et al. 2021 (ABC-06) 2014-2018 Phase 3 (C) 1a. mFOLFOX6
1b. mFOLFOX6 (L-Leucovorin) 		Seems to have inferior OS

No antineoplastic treatment.

References

  1. Glimelius B, Hoffman K, Sjödén PO, Jacobsson G, Sellström H, Enander LK, Linné T, Svensson C. Chemotherapy improves survival and quality of life in advanced pancreatic and biliary cancer. Ann Oncol. 1996 Aug;7(6):593-600. link to original article PubMed content property of HemOnc.org
  2. ABC-06: Lamarca A, Palmer DH, Wasan HS, Ross PJ, Ma YT, Arora A, Falk S, Gillmore R, Wadsley J, Patel K, Anthoney A, Maraveyas A, Iveson T, Waters JS, Hobbs C, Barber S, Ryder WD, Ramage J, Davies LM, Bridgewater JA, Valle JW; Advanced Biliary Cancer Working Group. Second-line FOLFOX chemotherapy versus active symptom control for advanced biliary tract cancer (ABC-06): a phase 3, open-label, randomised, controlled trial. Lancet Oncol. 2021 May;22(5):690-701. Epub 2021 Mar 30. link to original article link to PMC article PubMed NCT01926236

Placebo

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Abou-Alfa et al. 2020 (ClarIDHy) 2017-2019 Phase 3 (C) Ivosidenib Inferior PFS

No active antineoplastic treatment.

Biomarker eligibility criteria

  • IDH1 mutation

References

  1. ClarIDHy: Abou-Alfa GK, Macarulla T, Javle MM, Kelley RK, Lubner SJ, Adeva J, Cleary JM, Catenacci DV, Borad MJ, Bridgewater J, Harris WP, Murphy AG, Oh DY, Whisenant J, Lowery MA, Goyal L, Shroff RT, El-Khoueiry AB, Fan B, Wu B, Chamberlain CX, Jiang L, Gliser C, Pandya SS, Valle JW, Zhu AX. Ivosidenib in IDH1-mutant, chemotherapy-refractory cholangiocarcinoma (ClarIDHy): a multicentre, randomised, double-blind, placebo-controlled, phase 3 study. Lancet Oncol. 2020 Jun;21(6):796-807. Epub 2020 May 13. Erratum in: Lancet Oncol. 2020 Oct;21(10):e462. link to original article link to PMC article PubMed NCT02989857
Retrieved from "https://hemonc.org/w/index.php?title=Cholangiocarcinoma_-_null_regimens&oldid=86547"