Difference between revisions of "Staging page"

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[[#top|Back to Top]]
 
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{{#lst:Section editor transclusions|gi}}
 
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<big>'''Note: these are regimens tested in biomarker-specific populations and includes gastric and gastroesophageal cancers. Please see the [[gastric cancer|main gastric cancer page]] or the [[esophageal cancer|main esophageal cancer page]] for other regimens.'''</big>
 
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{| class="wikitable" style="float:right; margin-right: 5px;"
 
−
|-
 
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|<div style="background-color: #fee0d1; border: 1px solid #808000; padding: 5px; {{border-radius|16px}}" align="right"><font size="4"><b>{{#ask: [[-Has subobject::{{FULLPAGENAME}}]] |?Regimen |limit=10000|format=sum}} [[Tutorial#Regimens|regimens]] on this page</b></font></div>
 
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<div style="background-color: #deebf6; border: 1px solid #808000; padding: 5px; {{border-radius|16px}}"><font size="4"><b>{{#ask: [[-Has subobject::{{FULLPAGENAME}}]] |?Variant |limit=10000|format=sum}} [[Tutorial#Variants|variants]] on this page</b></font></div>
 
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|}
 
−
{{TOC limit|limit=3}}
 
−
=Guidelines=
 
−
==CAP/ASCP/ASCO==
 
−
*'''2017:''' Bartley et al. [https://doi.org/10.1200/JCO.2016.69.4836 HER2 testing and clinical decision making in gastroesophageal adenocarcinoma] [https://pubmed.ncbi.nlm.nih.gov/28129524 PubMed]
 
−
=Metastatic or locally advanced disease, first-line=
 
−
==Capecitabine & Cisplatin (CX) {{#subobject:c58325|Regimen=1}}==
 
−
CX: '''<u>C</u>'''isplatin & '''<u>X</u>'''eloda (Capecitabine)
 
−
<br>XP: '''<u>X</u>'''eloda (Capecitabine) & '''<u>P</u>'''latinol (Cisplatin)
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen {{#subobject:130681|Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
−
!style="width: 20%"|Study
 
−
!style="width: 20%"|Years 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(10)61121-X Bang et al. 2010 (ToGA)]
 
−
|2005-2008
 
−
| style="background-color:#1a9851" |Phase 3 (C)
 
−
|1. [[#Cisplatin_.26_Fluorouracil_.28CF.29_.26_Trastuzumab|CF & Trastuzumab]]<br>2. [[#Capecitabine_.26_Cisplatin_.28CX.29_.26_Trastuzumab|CX & Trastuzumab]]
 
−
| style="background-color:#d73027" |Inferior OS
 
−
|-
 
−
|}
 
−
''Patients:100% adenocarcinoma (19% gastroesophageal junction, 81% gastric). 10% with ECOG of 2.''
 
−
<div class="toccolours" style="background-color:#fdcdac">
 
−
====Biomarker eligibility criteria====
 
−
*Overexpression of HER2 protein by immunohistochemistry or gene amplification by fluorescence in-situ hybridisation
 
−
</div>
 
−
<div class="toccolours" style="background-color:#b3e2cd">
 
−
====Chemotherapy====
 
−
*[[Cisplatin (Platinol)]] 80 mg/m<sup>2</sup> IV over 2 hours once on day 1
 
−
*[[Capecitabine (Xeloda)]] 1000 mg/m<sup>2</sup> PO twice per day on days 1 to 14
 
−
'''21-day cycles'''
 
−
</div></div>
 
−
===References===
 
−
#'''ToGA:''' Bang YJ, Van Cutsem E, Feyereislova A, Chung HC, Shen L, Sawaki A, Lordick F, Ohtsu A, Omuro Y, Satoh T, Aprile G, Kulikov E, Hill J, Lehle M, Rüschoff J, Kang YK; ToGA Trial Investigators. Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial. Lancet. 2010 Aug 28;376(9742):687-97. Epub 2010 Aug 19. [https://doi.org/10.1016/S0140-6736(10)61121-X link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/20728210 PubMed] NCT01041404
 
−
==Capecitabine & Cisplatin (CX) & Trastuzumab {{#subobject:7cbb79|Regimen=1}}==
 
−
CX & Trastuzumab: '''<u>C</u>'''isplatin, '''<u>X</u>'''eloda (Capecitabine), Trastuzumab
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen variant #1, 80/1600 {{#subobject:cdee6d|Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
−
! style="width: 20%" |Study
 
−
! style="width: 20%" |Years 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/10.1200/JCO.2016.71.6852 Shah et al. 2017 (HELOISE)]
 
−
|2011-2015
 
−
| style="background-color:#1a9851" |Phase 3b (C)
 
−
|[[#Capecitabine_.26_Cisplatin_.28CX.29_.26_Trastuzumab|CX & Trastuzumab]]; high-dose
 
−
| style="background-color:#ffffbf" |Did not meet primary endpoint of OS
 
−
|-
 
−
|}
 
−
''Patients: 79% gastric, 21% GE junction, and all patients had an ECOG of 2''
 
−
<div class="toccolours" style="background-color:#fdcdac">
 
−
====Biomarker eligibility criteria====
 
−
Patients had overexpression of HER2 protein by immunohistochemistry AND gene amplification by in-situ hybridization.
 
−
</div>
 
−
<div class="toccolours" style="background-color:#b3e2cd">
 
−
====Chemotherapy====
 
−
*[[Cisplatin (Platinol)]] 80 mg/m<sup>2</sup> IV once on day 1
 
−
*[[Capecitabine (Xeloda)]] 800 mg/m<sup>2</sup> PO twice per day on days 1 to 14
 
−
====Targeted therapy====
 
−
*[[Trastuzumab (Herceptin)]] as follows:
 
−
**Cycle 1: 8 mg/kg IV once on day 1
 
−
**Cycle 2 onwards: 6 mg/kg IV once on day 1
 
−
'''21-day cycle for up to 6 cycles'''
 
−
</div>
 
−
<div class="toccolours" style="background-color:#cbd5e7">
 
−
====Subsequent treatment====
 
−
*Trastuzumab maintenance
 
−
</div></div><br>
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen variant #2, 80/2000 {{#subobject:27adc6|Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
−
! style="width: 20%" |Study
 
−
! style="width: 20%" |Years 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(10)61121-X Bang et al. 2010 (ToGA)]
 
−
|2005-2008
 
−
| style="background-color:#1a9851" |Phase 3 (E-RT-esc)
 
−
|1. [[#Cisplatin_.26_Fluorouracil_.28CF.29_4|CF]]<br>2. [[#Capecitabine_.26_Cisplatin_.28CX.29|CX]]
 
−
| style="background-color:#1a9850" |Superior OS<br>Median OS: 13.8 vs 11.1 mo<br>(HR 0.74, 95% CI 0.60-0.91)
 
−
|-
 
−
|[https://doi.org/10.1016/S1470-2045(18)30481-9 Tabernero et al. 2018 (JACOB)]
 
−
|2013-2016
 
−
| style="background-color:#1a9851" |Phase 3 (C)
 
−
|[[#Capecitabine_.26_Cisplatin_.28CX.29.2C_Pertuzumab.2C_Trastuzumab_88|CX, Pertuzumab, Trastuzumab]]
 
−
| style="background-color:#fc8d59" |Seems to have inferior OS<br>Median OS: 14.2 vs 17.5 mo<br>(HR 1.19, 95% CI 1.00-1.41)
 
−
|-
 
−
|}
 
−
''ToGA patients: 81% gastric, 19% GE junction. 10% of patients with ECOG of 2.''
 
−
<div class="toccolours" style="background-color:#fdcdac">
 
−
====Biomarker eligibility criteria====
 
−
*ToGA: overexpression of HER2 protein by immunohistochemistry OR gene amplification by fluorescence in-situ hybridization.
 
−
</div>
 
−
<div class="toccolours" style="background-color:#b3e2cd">
 
−
====Chemotherapy====
 
−
*[[Cisplatin (Platinol)]] 80 mg/m<sup>2</sup> IV once on day 1
 
−
*[[Capecitabine (Xeloda)]] 1000 mg/m<sup>2</sup> PO twice per day on days 1 to 14
 
−
====Targeted therapy====
 
−
*[[Trastuzumab (Herceptin)]] as follows:
 
−
**Cycle 1: 8 mg/kg IV once on day 1
 
−
**Cycle 2 onwards: 6 mg/kg IV once on day 1
 
−
'''21-day cycles'''
 
−
</div></div>
 
−
===References===
 
−
#'''ToGA:''' Bang YJ, Van Cutsem E, Feyereislova A, Chung HC, Shen L, Sawaki A, Lordick F, Ohtsu A, Omuro Y, Satoh T, Aprile G, Kulikov E, Hill J, Lehle M, Rüschoff J, Kang YK; ToGA Trial Investigators. Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial. Lancet. 2010 Aug 28;376(9742):687-97. Epub 2010 Aug 19. [https://doi.org/10.1016/S0140-6736(10)61121-X link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/20728210 PubMed] NCT01041404
 
−
#'''HELOISE:''' Shah MA, Xu RH, Bang YJ, Hoff PM, Liu T, Herráez-Baranda LA, Xia F, Garg A, Shing M, Tabernero J. HELOISE: Phase IIIb randomized multicenter study comparing standard-of-care and higher-dose trastuzumab regimens combined with chemotherapy as first-line therapy in patients with human epidermal growth factor receptor 2-positive metastatic gastric or gastroesophageal junction adenocarcinoma. J Clin Oncol. 2017 Aug 1;35(22):2558-2567. Epub 2017 Jun 2.[https://doi.org/10.1200/JCO.2016.71.6852 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/28574779 PubMed] NCT01450696
 
−
#'''JACOB:''' Tabernero J, Hoff PM, Shen L, Ohtsu A, Shah MA, Cheng K, Song C, Wu H, Eng-Wong J, Kim K, Kang YK. Pertuzumab plus trastuzumab and chemotherapy for HER2-positive metastatic gastric or gastro-oesophageal junction cancer (JACOB): final analysis of a double-blind, randomised, placebo-controlled phase 3 study. Lancet Oncol. 2018 Oct;19(10):1372-1384. Epub 2018 Sep 11. [https://doi.org/10.1016/S1470-2045(18)30481-9 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/30217672 PubMed] NCT01774786
 
−
==CapeOx {{#subobject:c699c3|Regimen=1}}==
 
−
CapeOx: '''<u>Cape</u>'''citabine and '''<u>Ox</u>'''aliplatin
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen {{#subobject:d1aac0|Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
−
!style="width: 20%"|Study
 
−
!style="width: 20%"|Years 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/10.1200/JCO.2015.62.6598 Hecht et al. 2015 (LOGiC)]
 
−
|2008-2012
 
−
| style="background-color:#1a9851" |Phase 3 (C)
 
−
|[[#CapeOx_.26_Lapatinib_99|CapeOx & Lapatinib]]
 
−
| style="background-color:#ffffbf" |Did not meet primary endpoint of OS<br>Median OS: 10.5 vs 12.2 mo<br>(HR 1.10, 95% CI 0.89-1.37)
 
−
|-
 
−
|}
 
−
''100% adenocarcinoma histology (4% esophagus, 9% gastroesophageal junction, 87% gastric origin). 9% with ECOG PS of 2.''
 
−
<div class="toccolours" style="background-color:#fdcdac">
 
−
====Biomarker eligibility criteria====
 
−
*HER2 positive
 
−
</div>
 
−
<div class="toccolours" style="background-color:#b3e2cd">
 
−
====Chemotherapy====
 
−
*[[Capecitabine (Xeloda)]] 850 mg/m<sup>2</sup> PO twice per day on days 1 to 14
 
−
*[[Oxaliplatin (Eloxatin)]] 130 mg/m<sup>2</sup> IV once on day 1
 
−
'''21-day cycle for up to 8 cycles'''
 
−
</div></div>
 
−
===References===
 
−
#'''LOGiC:''' Hecht JR, Bang YJ, Qin SK, Chung HC, Xu JM, Park JO, Jeziorski K, Shparyk Y, Hoff PM, Sobrero A, Salman P, Li J, Protsenko SA, Wainberg ZA, Buyse M, Afenjar K, Houé V, Garcia A, Kaneko T, Huang Y, Khan-Wasti S, Santillana S, Press MF, Slamon D. Lapatinib in combination with capecitabine plus oxaliplatin in human epidermal growth factor receptor 2-positive advanced or metastatic gastric, esophageal, or gastroesophageal adenocarcinoma: TRIO-013/LOGiC--a randomized phase III trial. J Clin Oncol. 2016 Feb 10;34(5):443-51. Epub 2015 Nov 30. [https://doi.org/10.1200/JCO.2015.62.6598 link to original article] [https://pubmed.ncbi.nlm.nih.gov/26628478 PubMed] NCT00680901
 
−
#'''HERIZON-GEA-01:''' NCT05152147
 
−
==CapeOx, Pembrolizumab, Trastuzumab {{#subobject:gjg8c3|Regimen=1}}==
 
−
CapeOx, Pembrolizumab, Trastuzumab: '''<u>Cape</u>'''citabine, '''<u>Ox</u>'''aliplatin, Pembrolizumab, Trastuzumab
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen {{#subobject:gzbcc0|Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
−
!style="width: 20%"|Study
 
−
!style="width: 20%"|Years 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://www.ncbi.nlm.nih.gov/pmc/articles/pmc8959470/ Janjigian et al. 2021 (KEYNOTE-811)]
 
−
|2018-2020
 
−
| style="background-color:#1a9851" |Phase 3 (E-RT-esc)
 
−
|1. [[#CapeOx_.26_Trastuzumab|CapeOx & Trastuzumab]]<br>2. [[#Cisplatin_.2C_Fluorouracil_.28CF.29_.26_Trastuzumab|CF & Trastuzumab]]
 
−
| style="background-color:#1a9850" |Superior ORR<sup>1</sup>
 
−
|-
 
−
|}
 
−
''<sup>1</sup>This is an interim secondary endpoint; primary endpoints are PFS and OS.''
 
−
<div class="toccolours" style="background-color:#fdcdac">
 
−
====Biomarker eligibility criteria====
 
−
*HER2 positive
 
−
</div>
 
−
<div class="toccolours" style="background-color:#b3e2cd">
 
−
====Chemotherapy====
 
−
*[[Capecitabine (Xeloda)]] 1000 mg/m<sup>2</sup> PO twice per day on days 1 to 14
 
−
*[[Oxaliplatin (Eloxatin)]] 130 mg/m<sup>2</sup> IV over 2 hours once on day 1
 
−
====Immunotherapy====
 
−
*[[Pembrolizumab (Keytruda)]] 200 mg IV once on day 1
 
−
====Targeted therapy====
 
−
*[[Trastuzumab (Herceptin)]] as follows:
 
−
**Cycle 1: 8 mg/kg IV once on day 1
 
−
**Cycle 2 onwards: 6 mg/kg IV once on day 1
 
−
'''21-day cycles'''
 
−
</div></div>
 
−
===References===
 
−
#'''KEYNOTE-811:''' Janjigian YY, Kawazoe A, Yañez P, Li N, Lonardi S, Kolesnik O, Barajas O, Bai Y, Shen L, Tang Y, Wyrwicz LS, Xu J, Shitara K, Qin S, Van Cutsem E, Tabernero J, Li L, Shah S, Bhagia P, Chung HC. The KEYNOTE-811 trial of dual PD-1 and HER2 blockade in HER2-positive gastric cancer. Nature. 2021 Dec;600(7890):727-730. Epub 2021 Dec 15. [https://doi.org/10.1038/s41586-021-04161-3 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8959470/ link to PMC article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/34912120/ PubMed] NCT03615326
 
−
==CapeOx & Trastuzumab {{#subobject:gh6cc3|Regimen=1}}==
 
−
CapeOx & Trastuzumab: '''<u>Cape</u>'''citabine, '''<u>Ox</u>'''aliplatin, Trastuzumab
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen {{#subobject:d1aac0|Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
−
!style="width: 20%"|Study
 
−
!style="width: 20%"|Years 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://www.ncbi.nlm.nih.gov/pmc/articles/pmc8959470/ Janjigian et al. 2021 (KEYNOTE-811)]
 
−
|2018-2020
 
−
| style="background-color:#1a9851" |Phase 3 (C)
 
−
|1. [[#CapeOx.2C_Pembrolizumab.2C_Trastuzumab|CapeOx, Pembrolizumab, Trastuzumab]]<br>2. [[#Cisplatin_.2C_Fluorouracil_.28CF.29.2C_Pembrolizumab.2C_Trastuzumab_88|CF, Pembrolizumab, Trastuzumab]]
 
−
| style="background-color:#d73027" |Inferior ORR<sup>1</sup>
 
−
|-
 
−
|}
 
−
''<sup>1</sup>This is an interim secondary endpoint; primary endpoints are PFS and OS.''<br>
 
−
''Note: to our knowledge, this regimen was not tested as an experimental arm in an RCT in this context, prior to becoming a standard comparator arm.''
 
−
<div class="toccolours" style="background-color:#fdcdac">
 
−
====Biomarker eligibility criteria====
 
−
*HER2 positive
 
−
</div>
 
−
<div class="toccolours" style="background-color:#b3e2cd">
 
−
====Chemotherapy====
 
−
*[[Capecitabine (Xeloda)]] 1000 mg/m<sup>2</sup> PO twice per day on days 1 to 14
 
−
*[[Oxaliplatin (Eloxatin)]] 130 mg/m<sup>2</sup> IV over 2 hours once on day 1
 
−
====Targeted therapy====
 
−
*[[Trastuzumab (Herceptin)]] as follows:
 
−
**Cycle 1: 8 mg/kg IV once on day 1
 
−
**Cycle 2 onwards: 6 mg/kg IV once on day 1
 
−
'''21-day cycles'''
 
−
</div></div>
 
−
===References===
 
−
#'''KEYNOTE-811:''' Janjigian YY, Kawazoe A, Yañez P, Li N, Lonardi S, Kolesnik O, Barajas O, Bai Y, Shen L, Tang Y, Wyrwicz LS, Xu J, Shitara K, Qin S, Van Cutsem E, Tabernero J, Li L, Shah S, Bhagia P, Chung HC. The KEYNOTE-811 trial of dual PD-1 and HER2 blockade in HER2-positive gastric cancer. Nature. 2021 Dec;600(7890):727-730. Epub 2021 Dec 15. [https://doi.org/10.1038/s41586-021-04161-3 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8959470/ link to PMC article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/34912120/ PubMed] NCT03615326
 
−
==Cisplatin & Fluorouracil (CF) {{#subobject:4d9936|Regimen=1}}==
 
−
CF: '''<u>C</u>'''isplatin & '''<u>F</u>'''luorouracil
 
−
<br>FP: '''<u>F</u>'''luorouracil & '''<u>P</u>'''latinol (Cisplatin)
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen {{#subobject:782e95|Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
−
! style="width: 20%" |Study
 
−
! style="width: 20%" |Years 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(10)61121-X Bang et al. 2010 (ToGA)]
 
−
|2005-2008
 
−
| style="background-color:#1a9851" |Phase 3 (C)
 
−
|1. [[#Cisplatin_.26_Fluorouracil_.28CF.29_.26_Trastuzumab|CF & Trastuzumab]]<br>2. [[#Capecitabine_.26_Cisplatin_.28CX.29_.26_Trastuzumab|CX & Trastuzumab]]
 
−
| style="background-color:#d73027" |Inferior OS
 
−
|-
 
−
|}
 
−
''ToGA Patients: 100% adenocarcinoma (19% gastroesophageal junction, 81% gastric). 10% with ECOG of 2.''
 
−
<div class="toccolours" style="background-color:#fdcdac">
 
−
====Biomarker eligibility criteria====
 
−
*Overexpression of HER2 protein by immunohistochemistry or gene amplification by fluorescence in-situ hybridisation.
 
−
</div>
 
−
<div class="toccolours" style="background-color:#b3e2cd">
 
−
====Chemotherapy====
 
−
*[[Cisplatin (Platinol)]] 80 mg/m<sup>2</sup> IV over 1 to 3 hours once on day 1, '''given first'''
 
−
*[[Fluorouracil (5-FU)]] 800 mg/m<sup>2</sup>/day IV continuous infusion over 120 hours, started on day 1, '''given second''' (total dose per cycle: 4000 mg/m<sup>2</sup>)
 
−
'''21-day cycle for up to 6 cycles'''
 
−
</div></div>
 
−
===References===
 
−
#'''ToGA:''' Bang YJ, Van Cutsem E, Feyereislova A, Chung HC, Shen L, Sawaki A, Lordick F, Ohtsu A, Omuro Y, Satoh T, Aprile G, Kulikov E, Hill J, Lehle M, Rüschoff J, Kang YK; ToGA Trial Investigators. Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial. Lancet. 2010 Aug 28;376(9742):687-97. Epub 2010 Aug 19. [https://doi.org/10.1016/S0140-6736(10)61121-X link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/20728210 PubMed] NCT01041404
 
−
==Cisplatin & Fluorouracil (CF) & Trastuzumab {{#subobject:ca9cd1|Regimen=1}}==
 
−
CF & Trastuzumab: '''<u>C</u>'''isplatin, '''<u>F</u>'''luorouracil, Trastuzumab
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen {{#subobject:b2731|Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
−
!style="width: 20%"|Study
 
−
!style="width: 20%"|Years 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(10)61121-X Bang et al. 2010 (ToGA)]
 
−
|2005-2008
 
−
| style="background-color:#1a9851" |Phase 3 (E-esc)
 
−
|1. [[#Cisplatin_.26_Fluorouracil_.28CF.29_4|CF]]<br>2. [[#Capecitabine_.26_Cisplatin_.28CX.29|CX]]
 
−
| style="background-color:#1a9850" |Superior OS<br>Median OS: 13.8 vs 11.1 mo<br>(HR 0.74, 95% CI 0.60-0.91)
 
−
|-
 
−
|}
 
−
''Patients: 100% adenocarcinoma (19% gastroesophageal junction, 81% gastric). 10% with ECOG of 2.''
 
−
<div class="toccolours" style="background-color:#fdcdac">
 
−
====Biomarker eligibility criteria====
 
−
*Patients had overexpression of HER2 protein by immunohistochemistry or gene amplification by fluorescence in-situ hybridisation.
 
−
</div>
 
−
<div class="toccolours" style="background-color:#b3e2cd">
 
−
====Chemotherapy====
 
−
*[[Cisplatin (Platinol)]] 80 mg/m<sup>2</sup> IV once on day 1
 
−
*[[Fluorouracil (5-FU)]] 800 mg/m<sup>2</sup>/day IV continuous infusion over 120 hours, started on day 1 (total dose per cycle: 4000 mg/m<sup>2</sup>)
 
−
====Targeted therapy====
 
−
*[[Trastuzumab (Herceptin)]] as follows:
 
−
**Cycle 1: 8 mg/kg IV once on day 1
 
−
**Cycle 2 onwards: 6 mg/kg IV once on day 1
 
−
'''21-day cycles'''
 
−
</div></div>
 
−
===References===
 
−
#'''ToGA:''' Bang YJ, Van Cutsem E, Feyereislova A, Chung HC, Shen L, Sawaki A, Lordick F, Ohtsu A, Omuro Y, Satoh T, Aprile G, Kulikov E, Hill J, Lehle M, Rüschoff J, Kang YK; ToGA Trial Investigators. Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial. Lancet. 2010 Aug 28;376(9742):687-97. Epub 2010 Aug 19. [https://doi.org/10.1016/S0140-6736(10)61121-X link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/20728210 PubMed] NCT01041404
 
−
#'''HERIZON-GEA-01:''' NCT05152147
 
−
#'''KEYNOTE-811:''' NCT03615326
 
−
=Metastatic or locally advanced disease, subsequent lines of therapy=
 
−
==Docetaxel monotherapy {{#subobject:4f3230|Regimen=1}}==
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen {{#subobject:3b47ab|Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
−
! style="width: 20%" |Study
 
−
! style="width: 20%" |Years 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/S1470-2045(17)30111-0 Thuss-Patience et al. 2017 (GATSBY)]
 
−
|2012-2013
 
−
| style="background-color:#1a9851" |Phase 2/3 (C)
 
−
|[[#Trastuzumab_emtansine_monotherapy_99|T-DM1]]
 
−
| style="background-color:#ffffbf" |Did not meet primary endpoint of OS<br>Median OS: 8.6 vs 7.9 mo<br>(HR 0.87, 95% CI 0.66-1.15)
 
−
|-
 
−
|}
 
−
''Note: study patients could only have been treated by one other regimen and could not have been exposed to anthracyclines''
 
−
''Patients: 68% gastric, 32% GEJ''
 
−
<div class="toccolours" style="background-color:#fdcdac">
 
−
====Biomarker eligibility criteria====
 
−
*HER2-positive disease
 
−
</div>
 
−
<div class="toccolours" style="background-color:#b3e2cd">
 
−
====Chemotherapy====
 
−
*[[Docetaxel (Taxotere)]] 75 mg/m<sup>2</sup> IV once on day 1
 
−
'''21-day cycles'''
 
−
</div></div>
 
−
===References===
 
−
#'''GATSBY:''' Thuss-Patience PC, Shah MA, Ohtsu A, Van Cutsem E, Ajani JA, Castro H, Mansoor W, Chung HC, Bodoky G, Shitara K, Phillips GDL, van der Horst T, Harle-Yge ML, Althaus BL, Kang YK. Trastuzumab emtansine versus taxane use for previously treated HER2-positive locally advanced or metastatic gastric or gastro-oesophageal junction adenocarcinoma (GATSBY): an international randomised, open-label, adaptive, phase 2/3 study. Lancet Oncol. 2017 May;18(5):640-653. Epub 2017 Mar 23. [https://doi.org/10.1016/S1470-2045(17)30111-0 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/28343975 PubMed] NCT01641939
 
−
==Trastuzumab deruxtecan monotherapy {{#subobject:d2616v|Regimen=1}}==
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen {{#subobject:577cd6|Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
−
! style="width: 20%" |Study
 
−
! style="width: 20%" |Years 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/10.1056/nejmoa2004413 Shitara et al. 2020 (DESTINY-Gastric01)]
 
−
|2017-2019
 
−
| style="background-color:#1a9851" |Randomized Phase 2 (E-RT-switch-ooc)
 
−
|Investigator's choice of:<br> 1. [[#Irinotecan_monotherapy_2|Irinotecan]]<br>2. [[#Paclitaxel_monotherapy|Paclitaxel]]
 
−
| style="background-color:#1a9850" |Superior OS<br>Median OS: 12.5 vs 8.4 mo<br>(HR 0.59, 95% CI 0.39-0.88)
 
−
|-
 
−
|}
 
−
''Note: the dose is different from the FDA-approved dose for breast cancer.''
 
−
''Patients had received a median of two prior therapies for advanced or metastatic disease (17% had received at least four prior therapies, 72% had previously received ramucirumab and 86% had received taxanes).''
 
−
''The median time since the last administration of trastuzumab was 5.9 months in the trastuzumab deruxtecan group and 6.5 months among those in the investigator's choice group.'' 
 
−
<div class="toccolours" style="background-color:#fdcdac">
 
−
====Biomarker eligibility criteria====
 
−
*HER2 over-expression
 
−
</div>
 
−
<div class="toccolours" style="background-color:#b3e2cd">
 
−
====Antibody-drug conjugate therapy====
 
−
*[[Trastuzumab deruxtecan (Enhertu)]] 6.4 mg/kg IV once on day 1
 
−
'''21-day cycles'''
 
−
</div></div>
 
−
===References===
 
−
#'''DESTINY-Gastric01:''' Shitara K, Bang YJ, Iwasa S, Sugimoto N, Ryu MH, Sakai D, Chung HC, Kawakami H, Yabusaki H, Lee J, Saito K, Kawaguchi Y, Kamio T, Kojima A, Sugihara M, Yamaguchi K; DESTINY-Gastric01 Investigators. Trastuzumab Deruxtecan in Previously Treated HER2-Positive Gastric Cancer. N Engl J Med. 2020 Jun 18;382(25):2419-2430. Epub 2020 May 29. [https://doi.org/10.1056/nejmoa2004413 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/32469182 PubMed] NCT03329690
 
−
==Irinotecan monotherapy {{#subobject:6df2c0|Regimen=1}}==
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen {{#subobject:fa1ef9|Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
−
! style="width: 20%" |Study
 
−
! style="width: 20%" |Years 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/10.1056/nejmoa2004413 Shitara et al. 2020 (DESTINY-Gastric01)]
 
−
|2017-2019
 
−
| style="background-color:#1a9851" |Randomized Phase 2 (C)
 
−
|[[#Trastuzumab_deruxtecan_monotherapy|Trastuzumab deruxtecan]]
 
−
| style="background-color:#d73027" |Inferior OS
 
−
|-
 
−
|}
 
−
<div class="toccolours" style="background-color:#fdcdac">
 
−
====Biomarker eligibility criteria====
 
−
*DESTINY-Gastric01: HER2 over-expression
 
−
</div>
 
−
<div class="toccolours" style="background-color:#b3e2cd">
 
−
====Chemotherapy====
 
−
*[[Irinotecan (Camptosar)]] 150 mg/m<sup>2</sup> IV once on day 1
 
−
'''14-day cycles'''
 
−
</div></div>
 
−
===References===
 
−
#'''DESTINY-Gastric01:''' Shitara K, Bang YJ, Iwasa S, Sugimoto N, Ryu MH, Sakai D, Chung HC, Kawakami H, Yabusaki H, Lee J, Saito K, Kawaguchi Y, Kamio T, Kojima A, Sugihara M, Yamaguchi K; DESTINY-Gastric01 Investigators. Trastuzumab Deruxtecan in Previously Treated HER2-Positive Gastric Cancer. N Engl J Med. 2020 Jun 18;382(25):2419-2430. Epub 2020 May 29. [https://doi.org/10.1056/nejmoa2004413 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/32469182 PubMed] NCT03329690
 
−
==Paclitaxel monotherapy {{#subobject:2dcad9|Regimen=1}}==
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen variant #1, 80 mg/m<sup>2</sup> weekly {{#subobject:0e8f41|Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
−
! style="width: 20%" |Study
 
−
! style="width: 20%" |Years 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/S1470-2045(17)30111-0 Thuss-Patience et al. 2017 (GATSBY)]
 
−
|2012-2013
 
−
| style="background-color:#1a9851" |Phase 2/3 (C)
 
−
|[[#Trastuzumab_emtansine_monotherapy_99|T-DM1]]
 
−
| style="background-color:#ffffbf" |Did not meet primary endpoint of OS<br>Median OS: 8.6 vs 7.9 mo<br>(HR 0.87, 95% CI 0.66-1.15)
 
−
|-
 
−
|}
 
−
''GATSBY included patients with GE junction malignancy (68% gastric, 32% GE junction)''
 
−
<div class="toccolours" style="background-color:#fdcdac">
 
−
====Biomarker eligibility criteria====
 
−
*Overexpression of HER2 protein by immunohistochemistry or gene amplification by fluorescence in-situ hybridisation
 
−
</div>
 
−
<div class="toccolours" style="background-color:#b3e2cd">
 
−
====Chemotherapy====
 
−
*[[Paclitaxel (Taxol)]] 80 mg/m<sup>2</sup> IV once per day on days 1, 8, 15
 
−
'''21-day cycles'''
 
−
</div></div><br>
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen variant #2, 80 mg/m<sup>2</sup>, 3 out of 4 weeks {{#subobject:dd21e8|Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
−
! style="width: 20%" |Study
 
−
! style="width: 20%" |Years 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/10.1200/JCO.2013.53.6136 Satoh et al. 2014 (TyTAN)]
 
−
|2007-2009
 
−
| style="background-color:#1a9851" |Phase 3 (C)
 
−
|[[#Lapatinib_.26_Paclitaxel_99|Lapatinib & Paclitaxel]]
 
−
| style="background-color:#ffffbf" |Did not meet primary endpoint of OS<br>Median OS: 8.9 vs 11 mo<br>(HR 1.19, 95% CI 0.90-1.56)
 
−
|-
 
−
|[https://doi.org/10.1056/nejmoa2004413 Shitara et al. 2020 (DESTINY-Gastric01)]
 
−
|2017-2019
 
−
| style="background-color:#1a9851" |Randomized Phase 2 (C)
 
−
|[[#Trastuzumab_deruxtecan_monotherapy|Trastuzumab deruxtecan]]
 
−
| style="background-color:#d73027" |Inferior OS
 
−
|-
 
−
|}
 
−
<div class="toccolours" style="background-color:#fdcdac">
 
−
====Biomarker eligibility criteria====
 
−
*HER2-positive disease
 
−
</div>
 
−
<div class="toccolours" style="background-color:#b3e2cd">
 
−
====Chemotherapy====
 
−
*[[Paclitaxel (Taxol)]] 80 mg/m<sup>2</sup> IV over 60 minutes once per day on days 1, 8, 15
 
−
'''28-day cycles'''
 
−
</div></div>
 
−
===References===
 
−
#'''TyTAN:''' Satoh T, Xu RH, Chung HC, Sun GP, Doi T, Xu JM, Tsuji A, Omuro Y, Li J, Wang JW, Miwa H, Qin SK, Chung IJ, Yeh KH, Feng JF, Mukaiyama A, Kobayashi M, Ohtsu A, Bang YJ. Lapatinib plus paclitaxel versus paclitaxel alone in the second-line treatment of HER2-amplified advanced gastric cancer in Asian populations: TyTAN--a randomized, phase III study. J Clin Oncol. 2014 Jul 1;32(19):2039-49. Epub 2014 May 27. [https://doi.org/10.1200/JCO.2013.53.6136 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/24868024 PubMed] NCT00486954
 
−
#'''GATSBY:''' Thuss-Patience PC, Shah MA, Ohtsu A, Van Cutsem E, Ajani JA, Castro H, Mansoor W, Chung HC, Bodoky G, Shitara K, Phillips GDL, van der Horst T, Harle-Yge ML, Althaus BL, Kang YK. Trastuzumab emtansine versus taxane use for previously treated HER2-positive locally advanced or metastatic gastric or gastro-oesophageal junction adenocarcinoma (GATSBY): an international randomised, open-label, adaptive, phase 2/3 study. Lancet Oncol. 2017 May;18(5):640-653. Epub 2017 Mar 23. [https://doi.org/10.1016/S1470-2045(17)30111-0 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/28343975 PubMed] NCT01641939
 
−
#'''DESTINY-Gastric01:''' Shitara K, Bang YJ, Iwasa S, Sugimoto N, Ryu MH, Sakai D, Chung HC, Kawakami H, Yabusaki H, Lee J, Saito K, Kawaguchi Y, Kamio T, Kojima A, Sugihara M, Yamaguchi K; DESTINY-Gastric01 Investigators. Trastuzumab Deruxtecan in Previously Treated HER2-Positive Gastric Cancer. N Engl J Med. 2020 Jun 18;382(25):2419-2430. Epub 2020 May 29. [https://doi.org/10.1056/nejmoa2004413 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/32469182 PubMed] NCT03329690
 
−
==Paclitaxel & Ramucirumab {{#subobject:fdd93f|Regimen=1}}==
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen {{#subobject:f66446|Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
−
! style="width: 20%" |Study
 
−
! style="width: 20%" |Years of enrollment
 
−
! style="width: 20%" |[[Levels_of_Evidence#Evidence|Evidence]]
 
−
! style="width: 20%" |Comparator
 
−
! style="width: 20%" |[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
−
|-
 
−
|Awaiting publication (DESTINY-Gastric04)
 
−
|2021-ongoing
 
−
| style="background-color:#1a9851" |Phase 3 (C)
 
−
|[[#Trastuzumab_deruxtecan_monotherapy|Trastuzumab deruxtecan]]
 
−
| style="background-color:#d3d3d3" |In progress
 
−
|-
 
−
|}
 
−
''Note: Dosing information is from CT.gov.''
 
−
<div class="toccolours" style="background-color:#b3e2cd">
 
−
====Targeted therapy====
 
−
*[[Ramucirumab (Cyramza)]] 8 mg/kg IV once per day on days 1 & 15
 
−
====Chemotherapy====
 
−
*[[Paclitaxel (Taxol)]] 80 mg/m<sup>2</sup> IV once per day on days 1, 8, 15
 
−
'''28-day cycles'''
 
−
</div></div>
 
−
===References===
 
−
#'''DESTINY-Gastric04:''' NCT04704934
 
−
[[Category:Gastric cancer regimens]]
 
−
[[Category:Biomarker-specific pages]]
 
−
[[Category:Gastroesophageal cancers]]
 

Latest revision as of 00:13, 18 June 2023

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