Difference between revisions of "Gastric cancer - historical"
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− | The purpose of this page is to provide references to regimens that are obsolete, outdated, or of historical interest only | + | <span id="BackToTop"></span> |
− | + | <div class="noprint" style="background-color:LightGray; position:fixed; bottom:2%; right:0.25%; padding-left:5px; padding-right:5px; margin: 15px; opacity:0.8; border-style: solid; border-color:DarkGray; border-width: 1px"> | |
+ | [[#top|Back to Top]] | ||
+ | </div> | ||
+ | The purpose of this page is to provide references to regimens that are obsolete, outdated, or of historical interest only. Is there a regimen missing from this list? See the [[Gastric_cancer|main gastric cancer page]] for current regimens. | ||
{| class="wikitable" style="float:right; margin-right: 5px;" | {| class="wikitable" style="float:right; margin-right: 5px;" | ||
|- | |- | ||
− | |<div style="background-color: #fee0d1; border: 1px solid #808000; padding: 5px; {{border-radius|16px}}" align="right"><font size="4"><b>{{#ask: [[-Has subobject::{{FULLPAGENAME}}]] | + | |<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> |
− | <div style="background-color: #deebf6; border: 1px solid #808000; padding: 5px; {{border-radius|16px}}"><font size="4"><b>{{#ask: [[-Has subobject::{{FULLPAGENAME}}]] | + | <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> |
|} | |} | ||
{{TOC limit|limit=3}} | {{TOC limit|limit=3}} | ||
− | |||
=Adjuvant therapy= | =Adjuvant therapy= | ||
==Doxifluridine & Mitomycin {{#subobject:958354|Regimen=1}}== | ==Doxifluridine & Mitomycin {{#subobject:958354|Regimen=1}}== | ||
− | + | <div class="toccolours" style="background-color:#ee6b6e"> | |
− | |||
− | |||
− | |||
===Regimen {{#subobject:895ddd|Variant=1}}=== | ===Regimen {{#subobject:895ddd|Variant=1}}=== | ||
{| 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]] | ||
|- | |- | ||
− | |[https:// | + | |[https://doi.org/10.1007/s00280-013-2332-5 Kang et al. 2013 (AMC0101)] |
|2001-2007 | |2001-2007 | ||
− | |style="background-color:#1a9851"|Phase | + | |style="background-color:#1a9851"|Phase 3 (C) |
− | |iceMFP | + | |[[#iceMFP_888|iceMFP]] |
| style="background-color:#fc8d59" |Seems to have inferior OS | | style="background-color:#fc8d59" |Seems to have inferior OS | ||
|- | |- | ||
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3619263/ Kang et al. 2013 (AMC0201)] | |[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3619263/ Kang et al. 2013 (AMC0201)] | ||
|2002-2006 | |2002-2006 | ||
− | |style="background-color:#1a9851"|Phase | + | |style="background-color:#1a9851"|Phase 3 (C) |
− | |MFP | + | |[[#MFP_999|MFP]] |
| style="background-color:#ffffbf" |Did not meet primary endpoint of RFS36 | | style="background-color:#ffffbf" |Did not meet primary endpoint of RFS36 | ||
|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#cbd5e8"> | ||
====Preceding treatment==== | ====Preceding treatment==== | ||
− | *[[Surgery#Gastrectomy|Gastrectomy]] | + | *[[Surgery#Gastrectomy|Gastrectomy]], 3 to 6 weeks prior |
− | + | </div> | |
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
− | *[[Doxifluridine (Didox)]] | + | *[[Doxifluridine (Didox)]] as follows: |
− | *[[Mitomycin (Mutamycin)]] | + | **Cycle 2: 460 mg/m<sup>2</sup> PO once per day |
− | + | *[[Mitomycin (Mutamycin)]] as follows: | |
+ | **Cycle 1: 20 mg/m<sup>2</sup> IV once on day 1 | ||
+ | '''28-day course, then 3-month course''' | ||
+ | </div></div> | ||
===References=== | ===References=== | ||
− | # '''AMC0201:''' Kang YK, Chang HM, Yook JH, Ryu MH, Park I, Min YJ, Zang DY, Kim GY, Yang DH, Jang SJ, Park YS, Lee JL, Kim TW, Oh ST, Park BK, Jung HY, Kim BS. Adjuvant chemotherapy for gastric cancer: a randomised phase 3 trial of mitomycin-C plus either short-term doxifluridine or long-term doxifluridine plus cisplatin after curative D2 gastrectomy (AMC0201). Br J Cancer. 2013 Apr 2;108(6):1245-51. Epub 2013 Feb 28. [https:// | + | # '''AMC0201:''' Kang YK, Chang HM, Yook JH, Ryu MH, Park I, Min YJ, Zang DY, Kim GY, Yang DH, Jang SJ, Park YS, Lee JL, Kim TW, Oh ST, Park BK, Jung HY, Kim BS. Adjuvant chemotherapy for gastric cancer: a randomised phase 3 trial of mitomycin-C plus either short-term doxifluridine or long-term doxifluridine plus cisplatin after curative D2 gastrectomy (AMC0201). Br J Cancer. 2013 Apr 2;108(6):1245-51. Epub 2013 Feb 28. [https://doi.org/10.1038/bjc.2013.86 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3619263/ link to PMC article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/23449357/ PubMed] [https://clinicaltrials.gov/study/NCT00296335 NCT00296335] |
− | # '''AMC0101:''' Kang YK, Yook JH, Chang HM, Ryu MH, Yoo C, Zang DY, Lee JL, Kim TW, Yang DH, Jang SJ, Park YS, Lee YJ, Jung HY, Kim JH, Kim BS. Enhanced efficacy of postoperative adjuvant chemotherapy in advanced gastric cancer: results from a phase 3 randomized trial (AMC0101). Cancer Chemother Pharmacol. 2014 Jan;73(1):139-49. Epub 2013 Oct 27. [https:// | + | # '''AMC0101:''' Kang YK, Yook JH, Chang HM, Ryu MH, Yoo C, Zang DY, Lee JL, Kim TW, Yang DH, Jang SJ, Park YS, Lee YJ, Jung HY, Kim JH, Kim BS. Enhanced efficacy of postoperative adjuvant chemotherapy in advanced gastric cancer: results from a phase 3 randomized trial (AMC0101). Cancer Chemother Pharmacol. 2014 Jan;73(1):139-49. Epub 2013 Oct 27. [https://doi.org/10.1007/s00280-013-2332-5 link to original article] [https://pubmed.ncbi.nlm.nih.gov/24162381/ PubMed] [https://clinicaltrials.gov/study/NCT00296322 NCT00296322] |
==FA {{#subobject:9a8ca4|Regimen=1}}== | ==FA {{#subobject:9a8ca4|Regimen=1}}== | ||
− | |||
− | |||
− | |||
− | |||
FA: '''<u>F</u>'''luorouracil & '''<u>A</u>'''driamycin (Doxorubicin) | FA: '''<u>F</u>'''luorouracil & '''<u>A</u>'''driamycin (Doxorubicin) | ||
+ | <div class="toccolours" style="background-color:#ee6b6e"> | ||
===Regimen {{#subobject:89ccc3|Variant=1}}=== | ===Regimen {{#subobject:89ccc3|Variant=1}}=== | ||
{| 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 63: | Line 64: | ||
|NR | |NR | ||
|style="background-color:#1a9851"|Randomized (C) | |style="background-color:#1a9851"|Randomized (C) | ||
− | |FA & poly A:U | + | |[[#FA_.26_poly_A-U_888|FA & poly A:U]] |
| style="background-color:#fc8d59" |Seems to have inferior OS | | style="background-color:#fc8d59" |Seems to have inferior OS | ||
|- | |- | ||
|} | |} | ||
− | ''Note: to our knowledge, this regimen was not tested as an experimental arm in an RCT prior to becoming a standard comparator arm.'' | + | ''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:#cbd5e8"> | ||
====Preceding treatment==== | ====Preceding treatment==== | ||
*[[Surgery#Gastrectomy|Gastrectomy]] | *[[Surgery#Gastrectomy|Gastrectomy]] | ||
+ | </div> | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
+ | ====Chemotherapy==== | ||
+ | *[[Fluorouracil (5-FU)]] 12 mg/kg IV once per day on days 1, 8, 15 | ||
+ | *[[Doxorubicin (Adriamycin)]] 40 mg/m<sup>2</sup> IV once on day 1 | ||
+ | '''21-day cycles''' | ||
+ | </div></div> | ||
+ | ===References=== | ||
+ | # Youn JK, Kim BS, Min JS, Lee KS, Choi HJ, Lee YB, Lee DW, Park IS, Roh JK, Chung JB, Koh EH, Park YJ, Kim HI, Lee JB. Adjuvant treatment of operable stomach cancer with polyadenylic-polyuridylic acid in addition to chemotherapeutic agents: a preliminary report. Int J Immunopharmacol. 1990;12(3):289-95. [https://doi.org/10.1016/0192-0561(90)90084-z link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/2184135/ PubMed] | ||
+ | ## '''Update:''' Jeung HC, Moon YW, Rha SY, Yoo NC, Roh JK, Noh SH, Min JS, Kim BS, Chung HC. Phase III trial of adjuvant 5-fluorouracil and adriamycin versus 5-fluorouracil, adriamycin, and polyadenylic-polyuridylic acid (poly A:U) for locally advanced gastric cancer after curative surgery: final results of 15-year follow-up. Ann Oncol. 2008 Mar;19(3):520-6. Epub 2007 Nov 20. [https://doi.org/10.1093/annonc/mdm536 link to original article] [https://pubmed.ncbi.nlm.nih.gov/18029971/ PubMed] | ||
+ | ==FAM {{#subobject:5a147b|Regimen=1}}== | ||
+ | FAM: '''<u>F</u>'''luorouracil, '''<u>A</u>'''driamycin (Doxorubicin), '''<u>M</u>'''itomycin | ||
+ | <div class="toccolours" style="background-color:#ee6b6e"> | ||
+ | ===Regimen {{#subobject:6ecb8e|Variant=1}}=== | ||
+ | {| 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/10.1002/%28SICI)1097-0142%2819981115%2983%3A10%3C2054%3A%3AAID-CNCR2%3E3.0.CO%3B2-1 Kim et al. 1998] | ||
+ | |1988-1991 | ||
+ | | style="background-color:#1a9851" |Phase 3 (C) | ||
+ | |[[#FAM-P_888|FAM-P]] | ||
+ | | style="background-color:#fc8d59" |Seems to have inferior OS | ||
+ | |- | ||
+ | |} | ||
+ | ''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:#cbd5e8"> | ||
+ | ====Preceding treatment==== | ||
+ | *[[Surgery#Gastrectomy|Gastrectomy]] | ||
+ | </div> | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
− | *[[Fluorouracil (5-FU)]] | + | *[[Fluorouracil (5-FU)]] 750 mg/m<sup>2</sup> IV once per day on days 1, 8, 29, 36 |
− | *[[Doxorubicin (Adriamycin)]] | + | *[[Doxorubicin (Adriamycin)]] 30 mg/m<sup>2</sup> IV once per day on days 1 & 29 |
− | + | *[[Mitomycin (Mutamycin)]] 10 mg/m<sup>2</sup> IV once on day 1 | |
+ | '''8-week cycle for 5 cycles''' | ||
+ | </div></div> | ||
===References=== | ===References=== | ||
− | # | + | # Kim SY, Park HC, Yoon C, Yoon HJ, Choi YM, Cho KS. OK-432 and 5-fluorouracil, doxorubicin, and mitomycin C (FAM-P) versus FAM chemotherapy in patients with curatively resected gastric carcinoma: a randomized Phase III trial. Cancer. 1998 Nov 15;83(10):2054-9. [https://doi.org/10.1002/%28SICI)1097-0142%2819981115%2983%3A10%3C2054%3A%3AAID-CNCR2%3E3.0.CO%3B2-1 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/9827708/ PubMed] |
− | |||
==Fluorouracil monotherapy {{#subobject:7b6f1c|Regimen=1}}== | ==Fluorouracil monotherapy {{#subobject:7b6f1c|Regimen=1}}== | ||
− | + | <div class="toccolours" style="background-color:#ee6b6e"> | |
− | |||
− | |||
− | |||
===Regimen {{#subobject:da7bba|Variant=1}}=== | ===Regimen {{#subobject:da7bba|Variant=1}}=== | ||
{| 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 94: | Line 128: | ||
|[https://doi.org/10.1093/annonc/mdf302 Chang et al. 2002] | |[https://doi.org/10.1093/annonc/mdf302 Chang et al. 2002] | ||
|1990-1993 | |1990-1993 | ||
− | | style="background-color:#1a9851" |Phase | + | | style="background-color:#1a9851" |Phase 3 (C) |
− | |1. 5-FU & Mitomycin<br> 2. 5-FU, Doxorubicin, Mitomycin | + | |1. [[#Fluorouracil_.26_Mitomycin|5-FU & Mitomycin]]<br>2. [[#Doxorubicin.2C_Fluorouracil.2C_Mitomycin_999|5-FU, Doxorubicin, Mitomycin]] |
− | | style="background-color:#ffffbf" | | + | | style="background-color:#ffffbf" |Did not meet primary endpoint of OS |
|- | |- | ||
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2855100/ Lee et al. 2004a] | |[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2855100/ Lee et al. 2004a] | ||
|1996-1999 | |1996-1999 | ||
− | | style="background-color:#1a9851" |Phase | + | | style="background-color:#1a9851" |Phase 3 (C) |
|[[Stub#PELF|PELF]] | |[[Stub#PELF|PELF]] | ||
− | | style="background-color:#ffffbf" | | + | | style="background-color:#ffffbf" |Did not meet primary endpoint of DFS60 |
|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#cbd5e8"> | ||
====Preceding treatment==== | ====Preceding treatment==== | ||
*[[Surgery#Gastrectomy|Gastrectomy]] | *[[Surgery#Gastrectomy|Gastrectomy]] | ||
− | + | </div> | |
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
− | *[[Fluorouracil (5-FU)]] | + | *[[Fluorouracil (5-FU)]] 500 mg/m<sup>2</sup> IV once per day on days 1 to 4 |
+ | '''21-day cycle for 6 cycles''' | ||
+ | </div></div> | ||
===References=== | ===References=== | ||
− | # Lee JJ, Kim SY, Shin IS, Cho KS, Joo HZ, Yoon C, Kim YW, Yoon HJ. Randomized phase III trial of cisplatin, epirubicin, leucovorin, 5-fluorouracil (PELF) combination versus 5-fluorouracil alone as adjuvant chemotherapy in curative resected stage III gastric cancer. Cancer Res Treat. 2004 Apr;36(2):140-5. Epub 2004 Apr 30. [https://doi.org/10.4143/crt.2004.36.2.140 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2855100/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/20396554 PubMed] | + | # Lee JJ, Kim SY, Shin IS, Cho KS, Joo HZ, Yoon C, Kim YW, Yoon HJ. Randomized phase III trial of cisplatin, epirubicin, leucovorin, 5-fluorouracil (PELF) combination versus 5-fluorouracil alone as adjuvant chemotherapy in curative resected stage III gastric cancer. Cancer Res Treat. 2004 Apr;36(2):140-5. Epub 2004 Apr 30. [https://doi.org/10.4143/crt.2004.36.2.140 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2855100/ link to PMC article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/20396554/ PubMed] |
− | # Chang HM, Jung KH, Kim TY, Kim WS, Yang HK, Lee KU, Choe KJ, Heo DS, Bang YJ, Kim NK. A phase III randomized trial of 5-fluorouracil, doxorubicin, and mitomycin C versus 5-fluorouracil and mitomycin C versus 5-fluorouracil alone in curatively resected gastric cancer. Ann Oncol. 2002 Nov;13(11):1779-85. [https://doi.org/10.1093/annonc/mdf302 link to original article] [https://pubmed.ncbi.nlm.nih.gov/12419751 PubMed] | + | # Chang HM, Jung KH, Kim TY, Kim WS, Yang HK, Lee KU, Choe KJ, Heo DS, Bang YJ, Kim NK. A phase III randomized trial of 5-fluorouracil, doxorubicin, and mitomycin C versus 5-fluorouracil and mitomycin C versus 5-fluorouracil alone in curatively resected gastric cancer. Ann Oncol. 2002 Nov;13(11):1779-85. [https://doi.org/10.1093/annonc/mdf302 link to original article] [https://pubmed.ncbi.nlm.nih.gov/12419751/ PubMed] |
==Fluorouracil & Mitomycin {{#subobject:958354|Regimen=1}}== | ==Fluorouracil & Mitomycin {{#subobject:958354|Regimen=1}}== | ||
− | + | <div class="toccolours" style="background-color:#ee6b6e"> | |
− | |||
− | |||
− | |||
===Regimen {{#subobject:895ddd|Variant=1}}=== | ===Regimen {{#subobject:895ddd|Variant=1}}=== | ||
{| 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]] | ||
|- | |- | ||
− | |[https:// | + | |[https://doi.org/10.1016/S0140-6736(89)91607-3 Allum et al. 1989] |
|1976-NR | |1976-NR | ||
− | | style="background-color:#1a9851" |Phase | + | | style="background-color:#1a9851" |Phase 3 (E-esc) |
|[[Gastric_cancer_-_null_regimens#Observation|Observation]] | |[[Gastric_cancer_-_null_regimens#Observation|Observation]] | ||
− | | style="background-color:#ffffbf" | | + | | style="background-color:#ffffbf" |Did not meet primary endpoint of OS |
|- | |- | ||
− | |[https:// | + | |[https://doi.org/10.1016/s0140-6736(94)90233-x Nakazato et al. 1994] |
|1985-1987 | |1985-1987 | ||
− | |style="background-color:#1a9851"|Phase | + | |style="background-color:#1a9851"|Phase 3 (C) |
− | |5-FU, Mitomycin, PSK | + | |[[#Fluorouracil.2C_Mitomycin.2C_PSK_777|5-FU, Mitomycin, PSK]] |
| style="background-color:#fc8d59" |Seems to have inferior OS | | style="background-color:#fc8d59" |Seems to have inferior OS | ||
|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#cbd5e8"> | ||
====Preceding treatment==== | ====Preceding treatment==== | ||
*[[Surgery#Gastrectomy|Gastrectomy]] | *[[Surgery#Gastrectomy|Gastrectomy]] | ||
− | + | </div> | |
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
− | *[[Fluorouracil (5-FU)]] | + | *[[Fluorouracil (5-FU)]] 15 mg/kg IV once on day 1 |
− | *[[Mitomycin (Mutamycin)]] | + | *[[Mitomycin (Mutamycin)]] 0.15 mg/kg IV once on day 1 |
− | + | '''21-day cycle for up to 35 cycles (2 years)''' | |
+ | </div></div> | ||
===References=== | ===References=== | ||
− | # Allum WH, Hallissey MT, Kelly KA; British Stomach Cancer Group. Adjuvant chemotherapy in operable gastric cancer: 5 year follow-up of first British Stomach Cancer Group trial. Lancet. 1989 Mar 18;1(8638):571-4. [https:// | + | # Allum WH, Hallissey MT, Kelly KA; British Stomach Cancer Group. Adjuvant chemotherapy in operable gastric cancer: 5 year follow-up of first British Stomach Cancer Group trial. Lancet. 1989 Mar 18;1(8638):571-4. [https://doi.org/10.1016/S0140-6736(89)91607-3 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/2564109/ PubMed] |
− | # Nakazato H, Koike A, Saji S, Ogawa N, Sakamoto J; Study Group of Immunochemotherapy with PSK for Gastric Cancer. Efficacy of immunochemotherapy as adjuvant treatment after curative resection of gastric cancer. Lancet. 1994 May 7;343(8906):1122-6. [https:// | + | # Nakazato H, Koike A, Saji S, Ogawa N, Sakamoto J; Study Group of Immunochemotherapy with PSK for Gastric Cancer. Efficacy of immunochemotherapy as adjuvant treatment after curative resection of gastric cancer. Lancet. 1994 May 7;343(8906):1122-6. [https://doi.org/10.1016/s0140-6736(94)90233-x link to original article] [https://pubmed.ncbi.nlm.nih.gov/7910230/ PubMed] |
=Metastatic or locally advanced disease, first-line= | =Metastatic or locally advanced disease, first-line= | ||
==FAM {{#subobject:5a147b|Regimen=1}}== | ==FAM {{#subobject:5a147b|Regimen=1}}== | ||
− | |||
− | |||
− | |||
− | |||
FAM: '''<u>F</u>'''luorouracil, '''<u>A</u>'''driamycin (Doxorubicin), '''<u>M</u>'''itomycin | FAM: '''<u>F</u>'''luorouracil, '''<u>A</u>'''driamycin (Doxorubicin), '''<u>M</u>'''itomycin | ||
− | ===Regimen {{#subobject:6ecb8e|Variant=1}}=== | + | <div class="toccolours" style="background-color:#ee6b6e"> |
+ | ===Regimen variant #1, "Georgetown regimen" {{#subobject:6ecb8e|Variant=1}}=== | ||
{| 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]] | ||
|- | |- | ||
− | |[https:// | + | |[https://doi.org/10.1002/1097-0142(197907)44:1%3C42::AID-CNCR2820440108%3E3.0.CO;2-X MacDonald et al. 1979] |
|1974-1977 | |1974-1977 | ||
− | | style="background-color:#91cf61" |Phase | + | | style="background-color:#91cf61" |Phase 2 |
| style="background-color:#d3d3d3" | | | style="background-color:#d3d3d3" | | ||
| style="background-color:#d3d3d3" | | | style="background-color:#d3d3d3" | | ||
|- | |- | ||
− | |[https:// | + | |[https://doi.org/10.1001/jama.1985.03350380077025 Cullinan et al. 1985] |
|NR | |NR | ||
− | | style="background-color:#1a9851" |Phase | + | | style="background-color:#1a9851" |Phase 3 (C) |
− | |1. [[Gastric_cancer#Fluorouracil_monotherapy|5-FU]]<br> 2. [[Stub#FA|FA]] | + | |1. [[Gastric_cancer#Fluorouracil_monotherapy|5-FU]]<br>2. [[Stub#FA|FA]] |
− | | style="background-color:#ffffbf" | | + | | style="background-color:#ffffbf" |Did not meet primary endpoint of OS |
|- | |- | ||
|[https://doi.org/10.1200/JCO.1991.9.5.827 Wils et al. 1991] | |[https://doi.org/10.1200/JCO.1991.9.5.827 Wils et al. 1991] | ||
|NR-1989 | |NR-1989 | ||
− | | style="background-color:#1a9851" |Phase | + | | style="background-color:#1a9851" |Phase 3 (C) |
|[[#FAMTX|FAMTX]] | |[[#FAMTX|FAMTX]] | ||
| style="background-color:#d73027" |Inferior OS | | style="background-color:#d73027" |Inferior OS | ||
|- | |- | ||
− | |[https:// | + | |} |
+ | ''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:#b3e2cd"> | ||
+ | ====Chemotherapy==== | ||
+ | *[[Fluorouracil (5-FU)]] 600 mg/m<sup>2</sup> IV once per day on days 1, 8, 29, 36 | ||
+ | *[[Doxorubicin (Adriamycin)]] 30 mg/m<sup>2</sup> IV once per day on days 1 & 29 | ||
+ | *[[Mitomycin (Mutamycin)]] 10 mg/m<sup>2</sup> IV once on day 1 | ||
+ | '''8-week cycles''' | ||
+ | </div></div><br> | ||
+ | <div class="toccolours" style="background-color:#ee6b6e"> | ||
+ | ===Regimen variant #2 {{#subobject:6ecjr3|Variant=1}}=== | ||
+ | {| 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/10.1002/1097-0142%2819930615%2971%3A12%3C3813%3A%3AAID-CNCR2820711205%3E3.0.CO%3B2-5 Kim et al. 1993] | ||
|1986-1990 | |1986-1990 | ||
− | | style="background-color:#1a9851" |Phase | + | | style="background-color:#1a9851" |Phase 3 (C) |
− | |1. [[Gastric_cancer#Fluorouracil_monotherapy|5-FU]]<br> 2. | + | |1. [[Gastric_cancer#Fluorouracil_monotherapy|5-FU]]<br>2. [[Gastric_cancer#Cisplatin_.26_Fluorouracil_.28CF.29_3|FP]] |
− | + | | style="background-color:#ffffbf" |Did not meet endpoint of OS | |
− | |||
− | |||
− | |||
− | | style="background-color:# | ||
− | |||
− | |||
|- | |- | ||
|} | |} | ||
− | ''Note: to our knowledge, this regimen was not tested as an experimental arm in an RCT prior to becoming a standard comparator arm.'' | + | ''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:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
− | *[[Fluorouracil (5-FU)]] | + | *[[Fluorouracil (5-FU)]] 800 mg/m<sup>2</sup> IV over 12 hours once per day on days 1 to 5 |
− | *[[Doxorubicin (Adriamycin)]] | + | *[[Doxorubicin (Adriamycin)]] 30 mg/m<sup>2</sup> IV once on day 1 |
− | *[[Mitomycin (Mutamycin)]] | + | *[[Mitomycin (Mutamycin)]] 8 mg/m<sup>2</sup> IV once on day 1 |
− | + | '''4-week cycles''' | |
+ | </div></div> | ||
===References=== | ===References=== | ||
− | # MacDonald JS, Woolley PV, Smythe T, Ueno W, Hoth D, Schein PS. 5-fluorouracil, adriamycin, and mitomycin-C (FAM) combination chemotherapy in the treatment of advanced gastric cancer. Cancer. 1979 Jul;44(1):42-7. [https:// | + | # MacDonald JS, Woolley PV, Smythe T, Ueno W, Hoth D, Schein PS. 5-fluorouracil, adriamycin, and mitomycin-C (FAM) combination chemotherapy in the treatment of advanced gastric cancer. Cancer. 1979 Jul;44(1):42-7. [https://doi.org/10.1002/1097-0142(197907)44:1%3C42::AID-CNCR2820440108%3E3.0.CO;2-X link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/455263/ PubMed] |
− | # Cullinan SA, Moertel CG, Fleming TR, Rubin JR, Krook JE, Everson LK, Windschitl HE, Twito DI, Marschke RF, Foley JF, Pfeifle DM, Barlow JF. A comparison of three chemotherapeutic regimens in the treatment of advanced pancreatic and gastric carcinoma: fluorouracil vs fluorouracil and doxorubicin vs fluorouracil, doxorubicin, and mitomycin. JAMA. 1985 Apr 12;253(14):2061-7. [https:// | + | # Cullinan SA, Moertel CG, Fleming TR, Rubin JR, Krook JE, Everson LK, Windschitl HE, Twito DI, Marschke RF, Foley JF, Pfeifle DM, Barlow JF. A comparison of three chemotherapeutic regimens in the treatment of advanced pancreatic and gastric carcinoma: fluorouracil vs fluorouracil and doxorubicin vs fluorouracil, doxorubicin, and mitomycin. JAMA. 1985 Apr 12;253(14):2061-7. [https://doi.org/10.1001/jama.1985.03350380077025 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/2579257/ PubMed] |
− | # Wils JA, Klein HO, Wagener DJ, Bleiberg H, Reis H, Korsten F, Conroy T, Fickers M, Leyvraz S, Buyse M, Duez N; European Organisation for Research and Treatment of Cancer Gastrointestinal Tract Cooperative Group. Sequential high-dose methotrexate and fluorouracil combined with doxorubicin--a step ahead in the treatment of advanced gastric cancer: a trial of the European Organisation for Research and Treatment of Cancer Gastrointestinal Tract Cooperative Group. J Clin Oncol. 1991 May;9(5):827-31. [https://doi.org/10.1200/JCO.1991.9.5.827 link to original article] [https://pubmed.ncbi.nlm.nih.gov/2016625 PubMed] | + | # Wils JA, Klein HO, Wagener DJ, Bleiberg H, Reis H, Korsten F, Conroy T, Fickers M, Leyvraz S, Buyse M, Duez N; European Organisation for Research and Treatment of Cancer Gastrointestinal Tract Cooperative Group. Sequential high-dose methotrexate and fluorouracil combined with doxorubicin--a step ahead in the treatment of advanced gastric cancer: a trial of the European Organisation for Research and Treatment of Cancer Gastrointestinal Tract Cooperative Group. J Clin Oncol. 1991 May;9(5):827-31. [https://doi.org/10.1200/JCO.1991.9.5.827 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/2016625/ PubMed] |
− | # Kim NK, Park YS, Heo DS, Suh C, Kim SY, Park KC, Kang YK, Shin DB, Kim HT, Kim HJ, Kang WK, Suh CI, Bang YJ. A phase III randomized study of 5-fluorouracil and cisplatin versus 5-fluorouracil, doxorubicin, and mitomycin C versus 5-fluorouracil alone in the treatment of advanced gastric cancer. Cancer. 1993 Jun 15;71(12):3813-8. [https:// | + | # Kim NK, Park YS, Heo DS, Suh C, Kim SY, Park KC, Kang YK, Shin DB, Kim HT, Kim HJ, Kang WK, Suh CI, Bang YJ. A phase III randomized study of 5-fluorouracil and cisplatin versus 5-fluorouracil, doxorubicin, and mitomycin C versus 5-fluorouracil alone in the treatment of advanced gastric cancer. Cancer. 1993 Jun 15;71(12):3813-8. [https://doi.org/10.1002/1097-0142%2819930615%2971%3A12%3C3813%3A%3AAID-CNCR2820711205%3E3.0.CO%3B2-5 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/8508349/ PubMed] |
− | |||
==FAMTX {{#subobject:53382f|Regimen=1}}== | ==FAMTX {{#subobject:53382f|Regimen=1}}== | ||
− | |||
− | |||
− | |||
− | |||
FAMTX: '''<u>F</u>'''luorouracil, '''<u>A</u>'''driamycin (Doxorubicin), '''<u>MTX</u>''' (Methotrexate) | FAMTX: '''<u>F</u>'''luorouracil, '''<u>A</u>'''driamycin (Doxorubicin), '''<u>MTX</u>''' (Methotrexate) | ||
+ | <div class="toccolours" style="background-color:#ee6b6e"> | ||
===Regimen {{#subobject:1f4ecf|Variant=1}}=== | ===Regimen {{#subobject:1f4ecf|Variant=1}}=== | ||
{| 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 226: | Line 271: | ||
|[https://doi.org/10.1200/JCO.1991.9.5.827 Wils et al. 1991] | |[https://doi.org/10.1200/JCO.1991.9.5.827 Wils et al. 1991] | ||
|NR-1989 | |NR-1989 | ||
− | | style="background-color:#1a9851" |Phase | + | | style="background-color:#1a9851" |Phase 3 (E-switch-ic) |
|[[#FAM|FAM]] | |[[#FAM|FAM]] | ||
| style="background-color:#1a9850" |Superior OS | | style="background-color:#1a9850" |Superior OS | ||
Line 234: | Line 279: | ||
| style="background-color:#1a9851" |Randomized (E-switch-ic) | | style="background-color:#1a9851" |Randomized (E-switch-ic) | ||
|[[Stub#EAP|EAP]] | |[[Stub#EAP|EAP]] | ||
− | | style="background-color:#ffffbf" | | + | | style="background-color:#ffffbf" |Did not meet secondary endpoint of OS |
|- | |- | ||
|[https://doi.org/10.1200/JCO.2000.18.14.2648 Vanhoefer et al. 2000 (EORTC 40902)] | |[https://doi.org/10.1200/JCO.2000.18.14.2648 Vanhoefer et al. 2000 (EORTC 40902)] | ||
|1991-1995 | |1991-1995 | ||
− | | style="background-color:#1a9851" |Phase | + | | style="background-color:#1a9851" |Phase 3 (C) |
− | |1. [[Stub#ELF|ELF]]<br> 2. FP | + | |1. [[Stub#ELF|ELF]]<br>2. [[Gastric_cancer#Cisplatin_.26_Fluorouracil_.28CF.29_3|FP]] |
− | | style="background-color:#ffffbf" | | + | | style="background-color:#ffffbf" |Did not meet primary endpoint of ORR |
|- | |- | ||
|[https://doi.org/10.1200/JCO.1997.15.1.261 Webb et al. 1997] | |[https://doi.org/10.1200/JCO.1997.15.1.261 Webb et al. 1997] | ||
Line 249: | Line 294: | ||
|- | |- | ||
|} | |} | ||
+ | ''Note: Vanhoefer et al. 2000 stated that cycles were repeated every 29 days which is likely a mistake.'' | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
− | *[[Fluorouracil (5-FU)]] | + | *[[Fluorouracil (5-FU)]] 1500 mg/m<sup>2</sup> IV once on day 1, '''given second, one hour after methotrexate''' |
− | *[[Doxorubicin (Adriamycin)]] | + | *[[Doxorubicin (Adriamycin)]] 30 mg/m<sup>2</sup> IV once on day 15 |
− | *[[Methotrexate (MTX)]] | + | *[[Methotrexate (MTX)]] 1500 mg/m<sup>2</sup> IV once on day 1, '''given first''' |
− | + | '''28-day cycles''' | |
+ | </div></div> | ||
===References=== | ===References=== | ||
− | # Wils JA, Klein HO, Wagener DJ, Bleiberg H, Reis H, Korsten F, Conroy T, Fickers M, Leyvraz S, Buyse M, Duez N; European Organisation for Research and Treatment of Cancer Gastrointestinal Tract Cooperative Group. Sequential high-dose methotrexate and fluorouracil combined with doxorubicin--a step ahead in the treatment of advanced gastric cancer: a trial of the European Organisation for Research and Treatment of Cancer Gastrointestinal Tract Cooperative Group. J Clin Oncol. 1991 May;9(5):827-31. [https://doi.org/10.1200/JCO.1991.9.5.827 link to original article] [https://pubmed.ncbi.nlm.nih.gov/2016625 PubMed] | + | # Wils JA, Klein HO, Wagener DJ, Bleiberg H, Reis H, Korsten F, Conroy T, Fickers M, Leyvraz S, Buyse M, Duez N; European Organisation for Research and Treatment of Cancer Gastrointestinal Tract Cooperative Group. Sequential high-dose methotrexate and fluorouracil combined with doxorubicin--a step ahead in the treatment of advanced gastric cancer: a trial of the European Organisation for Research and Treatment of Cancer Gastrointestinal Tract Cooperative Group. J Clin Oncol. 1991 May;9(5):827-31. [https://doi.org/10.1200/JCO.1991.9.5.827 link to original article] [https://pubmed.ncbi.nlm.nih.gov/2016625/ PubMed] |
− | # Kelsen D, Atiq OT, Saltz L, Niedzwiecki D, Ginn D, Chapman D, Heelan R, Lightdale C, Vinciguerra V, Brennan M. FAMTX versus etoposide, doxorubicin, and cisplatin: a random assignment trial in gastric cancer. J Clin Oncol. 1992 Apr;10(4):541-8. [https://doi.org/10.1200/JCO.1992.10.4.541 link to original article] [https://pubmed.ncbi.nlm.nih.gov/1548519 PubMed] | + | # Kelsen D, Atiq OT, Saltz L, Niedzwiecki D, Ginn D, Chapman D, Heelan R, Lightdale C, Vinciguerra V, Brennan M. FAMTX versus etoposide, doxorubicin, and cisplatin: a random assignment trial in gastric cancer. J Clin Oncol. 1992 Apr;10(4):541-8. [https://doi.org/10.1200/JCO.1992.10.4.541 link to original article] [https://pubmed.ncbi.nlm.nih.gov/1548519/ PubMed] |
− | # Webb A, Cunningham D, Scarffe JH, Harper P, Norman A, Joffe JK, Hughes M, Mansi J, Findlay M, Hill A, Oates J, Nicolson M, Hickish T, O'Brien M, Iveson T, Watson M, Underhill C, Wardley A, Meehan M. Randomized trial comparing epirubicin, cisplatin, and fluorouracil versus fluorouracil, doxorubicin, and methotrexate in advanced esophagogastric cancer. J Clin Oncol. 1997 Jan;15(1):261-7. [https://doi.org/10.1200/JCO.1997.15.1.261 link to original article] [https://pubmed.ncbi.nlm.nih.gov/8996151 PubMed] | + | # Webb A, Cunningham D, Scarffe JH, Harper P, Norman A, Joffe JK, Hughes M, Mansi J, Findlay M, Hill A, Oates J, Nicolson M, Hickish T, O'Brien M, Iveson T, Watson M, Underhill C, Wardley A, Meehan M. Randomized trial comparing epirubicin, cisplatin, and fluorouracil versus fluorouracil, doxorubicin, and methotrexate in advanced esophagogastric cancer. J Clin Oncol. 1997 Jan;15(1):261-7. [https://doi.org/10.1200/JCO.1997.15.1.261 link to original article] [https://pubmed.ncbi.nlm.nih.gov/8996151/ PubMed] |
− | ## '''Update:''' Waters JS, Norman A, Cunningham D, Scarffe JH, Webb A, Harper P, Joffe JK, Mackean M, Mansi J, Leahy M, Hill A, Oates J, Rao S, Nicolson M, Hickish T. Long-term survival after epirubicin, cisplatin and fluorouracil for gastric cancer: results of a randomized trial. Br J Cancer. 1999 Apr;80(1-2):269-72. [https:// | + | ## '''Update:''' Waters JS, Norman A, Cunningham D, Scarffe JH, Webb A, Harper P, Joffe JK, Mackean M, Mansi J, Leahy M, Hill A, Oates J, Rao S, Nicolson M, Hickish T. Long-term survival after epirubicin, cisplatin and fluorouracil for gastric cancer: results of a randomized trial. Br J Cancer. 1999 Apr;80(1-2):269-72. [https://doi.org/10.1038/sj.bjc.6690350 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2363002/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/10390007/ PubMed] |
− | # '''EORTC 40902:''' Vanhoefer U, Rougier P, Wilke H, Ducreux MP, Lacave AJ, Van Cutsem E, Planker M, Santos JG, Piedbois P, Paillot B, Bodenstein H, Schmoll HJ, Bleiberg H, Nordlinger B, Couvreur ML, Baron B, Wils JA; European Organisation for Research and Treatment of Cancer Gastrointestinal Tract Cooperative Group. Final results of a randomized phase III trial of sequential high-dose methotrexate, fluorouracil, and doxorubicin versus etoposide, leucovorin, and fluorouracil versus infusional fluorouracil and cisplatin in advanced gastric cancer: a trial of the European Organisation for Research and Treatment of Cancer Gastrointestinal Tract Cancer Cooperative Group. J Clin Oncol. 2000 Jul;18(14):2648-57. [https://doi.org/10.1200/JCO.2000.18.14.2648 link to original article] [https://pubmed.ncbi.nlm.nih.gov/10894863 PubMed] | + | # '''EORTC 40902:''' Vanhoefer U, Rougier P, Wilke H, Ducreux MP, Lacave AJ, Van Cutsem E, Planker M, Santos JG, Piedbois P, Paillot B, Bodenstein H, Schmoll HJ, Bleiberg H, Nordlinger B, Couvreur ML, Baron B, Wils JA; European Organisation for Research and Treatment of Cancer Gastrointestinal Tract Cooperative Group. Final results of a randomized phase III trial of sequential high-dose methotrexate, fluorouracil, and doxorubicin versus etoposide, leucovorin, and fluorouracil versus infusional fluorouracil and cisplatin in advanced gastric cancer: a trial of the European Organisation for Research and Treatment of Cancer Gastrointestinal Tract Cancer Cooperative Group. J Clin Oncol. 2000 Jul;18(14):2648-57. [https://doi.org/10.1200/JCO.2000.18.14.2648 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/10894863/ PubMed] |
==FEMTX {{#subobject:412e7b|Regimen=1}}== | ==FEMTX {{#subobject:412e7b|Regimen=1}}== | ||
− | |||
− | |||
− | |||
− | |||
FEMTX: '''<u>F</u>'''luorouracil, '''<u>E</u>'''pirubicin, '''<u>MTX</u>''' (Methotrexate) | FEMTX: '''<u>F</u>'''luorouracil, '''<u>E</u>'''pirubicin, '''<u>MTX</u>''' (Methotrexate) | ||
+ | <div class="toccolours" style="background-color:#ee6b6e"> | ||
===Regimen {{#subobject:700bc8|Variant=1}}=== | ===Regimen {{#subobject:700bc8|Variant=1}}=== | ||
{| 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 277: | Line 322: | ||
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2033628/ Pyrhönen et al. 1995] | |[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2033628/ Pyrhönen et al. 1995] | ||
|1986-1992 | |1986-1992 | ||
− | | style="background-color:#1a9851" |Phase | + | | style="background-color:#1a9851" |Phase 3 (E-esc) |
|[[Gastric_cancer_-_null_regimens#Best_supportive_care|Best supportive care]] | |[[Gastric_cancer_-_null_regimens#Best_supportive_care|Best supportive care]] | ||
| style="background-color:#1a9850" |Superior OS | | style="background-color:#1a9850" |Superior OS | ||
|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
− | *[[Fluorouracil (5-FU)]] | + | *[[Fluorouracil (5-FU)]] 1500 mg/m<sup>2</sup> IV once on day 1, '''given second''' |
− | *[[Epirubicin (Ellence)]] | + | *[[Epirubicin (Ellence)]] 60 mg/m<sup>2</sup> IV once on day 15 |
− | *[[Methotrexate (MTX)]] | + | *[[Methotrexate (MTX)]] 1500 mg/m<sup>2</sup> IV once on day 1, '''given first''' |
− | + | ====Supportive therapy==== | |
+ | *[[Leucovorin (Folinic acid)]] 30 mg PO once every 6 hours on days 2 & 3 | ||
+ | '''28-day cycles''' | ||
+ | </div></div> | ||
===References=== | ===References=== | ||
− | # Pyrhönen S, Kuitunen T, Nyandoto P, Kouri M. Randomised comparison of fluorouracil, epidoxorubicin and methotrexate (FEMTX) plus supportive care with supportive care alone in patients with non-resectable gastric cancer. Br J Cancer. 1995 Mar;71(3):587-91. [https:// | + | # Pyrhönen S, Kuitunen T, Nyandoto P, Kouri M. Randomised comparison of fluorouracil, epidoxorubicin and methotrexate (FEMTX) plus supportive care with supportive care alone in patients with non-resectable gastric cancer. Br J Cancer. 1995 Mar;71(3):587-91. [https://doi.org/10.1038/bjc.1995.114 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2033628/ link to PMC article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/7533517/ PubMed] |
==Fluorouracil & RT {{#subobject:52e768|Regimen=1}}== | ==Fluorouracil & RT {{#subobject:52e768|Regimen=1}}== | ||
− | |||
− | |||
− | |||
− | |||
5-FU & RT: '''<u>5-F</u>'''luoro'''<u>U</u>'''racil & '''<u>R</u>'''adiation '''<u>T</u>'''herapy | 5-FU & RT: '''<u>5-F</u>'''luoro'''<u>U</u>'''racil & '''<u>R</u>'''adiation '''<u>T</u>'''herapy | ||
+ | <div class="toccolours" style="background-color:#ee6b6e"> | ||
===Regimen {{#subobject:f8576f|Variant=1}}=== | ===Regimen {{#subobject:f8576f|Variant=1}}=== | ||
− | {| class="wikitable" style="width: | + | {| class="wikitable sortable" style="width: 60%; text-align:center;" |
− | !style="width: | + | !style="width: 33%"|Study |
− | !style="width: | + | !style="width: 33%"|Dates of enrollment |
+ | !style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
|- | |- | ||
− | |[https:// | + | |[https://doi.org/10.1016/S0140-6736(69)92326-5 Moertel et al. 1969] |
+ | |NR | ||
| style="background-color:#91cf61" |Non-randomized | | style="background-color:#91cf61" |Non-randomized | ||
|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
*[[Fluorouracil (5-FU)]] | *[[Fluorouracil (5-FU)]] | ||
====Radiotherapy==== | ====Radiotherapy==== | ||
*Concurrent [[External_beam_radiotherapy|radiation therapy]] | *Concurrent [[External_beam_radiotherapy|radiation therapy]] | ||
+ | </div></div> | ||
+ | ===References=== | ||
+ | # Moertel CG, Childs DS Jr, Reitemeier RJ, Colby MY Jr, Holbrook MA. Combined 5-fluorouracil and supervoltage radiation therapy of locally unresectable gastrointestinal cancer. Lancet. 1969 Oct 25;2(7626):865-7. [https://doi.org/10.1016/S0140-6736(69)92326-5 link to original article] [https://pubmed.ncbi.nlm.nih.gov/4186452/ PubMed] | ||
+ | |||
+ | =Metastatic or locally advanced disease, subsequent lines of therapy= | ||
+ | ==Apatinib monotherapy {{#subobject:ao594c|Regimen=1}}== | ||
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
+ | ===Regimen {{#subobject:913ap2|Variant=1}}=== | ||
+ | {| 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://www.ncbi.nlm.nih.gov/pmc/articles/pmc10896803/ Kang et al. 2024 (ANGEL)] | ||
+ | |2017-03-14 to 2018-10-31 | ||
+ | | style="background-color:#1a9851" |Phase 3 (E-esc) | ||
+ | |[[Gastric cancer_-_null_regimens#Placebo|Placebo]] | ||
+ | | style="background-color:#ffffbf" |Did not meet primary endpoint of OS | ||
+ | |- | ||
+ | |} | ||
+ | ''Note: ANGEL included patients with GEJ malignancy'' | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
+ | ====Targeted therapy==== | ||
+ | *[[Apatinib (Aitan)]] 700 mg PO once per day on days 1 to 28 | ||
+ | '''28-day cycles''' | ||
+ | </div></div> | ||
===References=== | ===References=== | ||
− | # | + | #'''ANGEL:''' Kang YK, Ryu MH, Di Bartolomeo M, Chau I, Yoon H, Kim JG, Lee KW, Oh SC, Takashima A, Kryzhanivska A, Chao Y, Evesque L, Schenker M, McGinn A, Zhao Y, Lee J, Wyrwicz L, Boku N. Rivoceranib, a VEGFR-2 inhibitor, monotherapy in previously treated patients with advanced or metastatic gastric or gastroesophageal junction cancer (ANGEL study): an international, randomized, placebo-controlled, phase 3 trial. Gastric Cancer. 2024 Mar;27(2):375-386. Epub 2024 Jan 28. [https://doi.org/10.1007/s10120-023-01455-5 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc10896803/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/38281295/ PubMed] [https://clinicaltrials.gov/study/NCT03042611 NCT03042611] |
[[Category:Gastric cancer regimens]] | [[Category:Gastric cancer regimens]] |
Latest revision as of 17:36, 28 June 2024
The purpose of this page is to provide references to regimens that are obsolete, outdated, or of historical interest only. Is there a regimen missing from this list? See the main gastric cancer page for current regimens.
8 regimens on this page
9 variants on this page
|
Adjuvant therapy
Doxifluridine & Mitomycin
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Kang et al. 2013 (AMC0101) | 2001-2007 | Phase 3 (C) | iceMFP | Seems to have inferior OS |
Kang et al. 2013 (AMC0201) | 2002-2006 | Phase 3 (C) | MFP | Did not meet primary endpoint of RFS36 |
Preceding treatment
- Gastrectomy, 3 to 6 weeks prior
Chemotherapy
- Doxifluridine (Didox) as follows:
- Cycle 2: 460 mg/m2 PO once per day
- Mitomycin (Mutamycin) as follows:
- Cycle 1: 20 mg/m2 IV once on day 1
28-day course, then 3-month course
References
- AMC0201: Kang YK, Chang HM, Yook JH, Ryu MH, Park I, Min YJ, Zang DY, Kim GY, Yang DH, Jang SJ, Park YS, Lee JL, Kim TW, Oh ST, Park BK, Jung HY, Kim BS. Adjuvant chemotherapy for gastric cancer: a randomised phase 3 trial of mitomycin-C plus either short-term doxifluridine or long-term doxifluridine plus cisplatin after curative D2 gastrectomy (AMC0201). Br J Cancer. 2013 Apr 2;108(6):1245-51. Epub 2013 Feb 28. link to original article link to PMC article contains dosing details in manuscript PubMed NCT00296335
- AMC0101: Kang YK, Yook JH, Chang HM, Ryu MH, Yoo C, Zang DY, Lee JL, Kim TW, Yang DH, Jang SJ, Park YS, Lee YJ, Jung HY, Kim JH, Kim BS. Enhanced efficacy of postoperative adjuvant chemotherapy in advanced gastric cancer: results from a phase 3 randomized trial (AMC0101). Cancer Chemother Pharmacol. 2014 Jan;73(1):139-49. Epub 2013 Oct 27. link to original article PubMed NCT00296322
FA
FA: Fluorouracil & Adriamycin (Doxorubicin)
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Youn et al. 1990 | NR | Randomized (C) | FA & poly A:U | Seems to have inferior OS |
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.
Preceding treatment
Chemotherapy
- Fluorouracil (5-FU) 12 mg/kg IV once per day on days 1, 8, 15
- Doxorubicin (Adriamycin) 40 mg/m2 IV once on day 1
21-day cycles
References
- Youn JK, Kim BS, Min JS, Lee KS, Choi HJ, Lee YB, Lee DW, Park IS, Roh JK, Chung JB, Koh EH, Park YJ, Kim HI, Lee JB. Adjuvant treatment of operable stomach cancer with polyadenylic-polyuridylic acid in addition to chemotherapeutic agents: a preliminary report. Int J Immunopharmacol. 1990;12(3):289-95. link to original article contains dosing details in abstract PubMed
- Update: Jeung HC, Moon YW, Rha SY, Yoo NC, Roh JK, Noh SH, Min JS, Kim BS, Chung HC. Phase III trial of adjuvant 5-fluorouracil and adriamycin versus 5-fluorouracil, adriamycin, and polyadenylic-polyuridylic acid (poly A:U) for locally advanced gastric cancer after curative surgery: final results of 15-year follow-up. Ann Oncol. 2008 Mar;19(3):520-6. Epub 2007 Nov 20. link to original article PubMed
FAM
FAM: Fluorouracil, Adriamycin (Doxorubicin), Mitomycin
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Kim et al. 1998 | 1988-1991 | Phase 3 (C) | FAM-P | Seems to have inferior OS |
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.
Preceding treatment
Chemotherapy
- Fluorouracil (5-FU) 750 mg/m2 IV once per day on days 1, 8, 29, 36
- Doxorubicin (Adriamycin) 30 mg/m2 IV once per day on days 1 & 29
- Mitomycin (Mutamycin) 10 mg/m2 IV once on day 1
8-week cycle for 5 cycles
References
- Kim SY, Park HC, Yoon C, Yoon HJ, Choi YM, Cho KS. OK-432 and 5-fluorouracil, doxorubicin, and mitomycin C (FAM-P) versus FAM chemotherapy in patients with curatively resected gastric carcinoma: a randomized Phase III trial. Cancer. 1998 Nov 15;83(10):2054-9. link to original article contains dosing details in manuscript PubMed
Fluorouracil monotherapy
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Chang et al. 2002 | 1990-1993 | Phase 3 (C) | 1. 5-FU & Mitomycin 2. 5-FU, Doxorubicin, Mitomycin |
Did not meet primary endpoint of OS |
Lee et al. 2004a | 1996-1999 | Phase 3 (C) | PELF | Did not meet primary endpoint of DFS60 |
Preceding treatment
References
- Lee JJ, Kim SY, Shin IS, Cho KS, Joo HZ, Yoon C, Kim YW, Yoon HJ. Randomized phase III trial of cisplatin, epirubicin, leucovorin, 5-fluorouracil (PELF) combination versus 5-fluorouracil alone as adjuvant chemotherapy in curative resected stage III gastric cancer. Cancer Res Treat. 2004 Apr;36(2):140-5. Epub 2004 Apr 30. link to original article link to PMC article contains dosing details in manuscript PubMed
- Chang HM, Jung KH, Kim TY, Kim WS, Yang HK, Lee KU, Choe KJ, Heo DS, Bang YJ, Kim NK. A phase III randomized trial of 5-fluorouracil, doxorubicin, and mitomycin C versus 5-fluorouracil and mitomycin C versus 5-fluorouracil alone in curatively resected gastric cancer. Ann Oncol. 2002 Nov;13(11):1779-85. link to original article PubMed
Fluorouracil & Mitomycin
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Allum et al. 1989 | 1976-NR | Phase 3 (E-esc) | Observation | Did not meet primary endpoint of OS |
Nakazato et al. 1994 | 1985-1987 | Phase 3 (C) | 5-FU, Mitomycin, PSK | Seems to have inferior OS |
Preceding treatment
Chemotherapy
- Fluorouracil (5-FU) 15 mg/kg IV once on day 1
- Mitomycin (Mutamycin) 0.15 mg/kg IV once on day 1
21-day cycle for up to 35 cycles (2 years)
References
- Allum WH, Hallissey MT, Kelly KA; British Stomach Cancer Group. Adjuvant chemotherapy in operable gastric cancer: 5 year follow-up of first British Stomach Cancer Group trial. Lancet. 1989 Mar 18;1(8638):571-4. link to original article contains dosing details in manuscript PubMed
- Nakazato H, Koike A, Saji S, Ogawa N, Sakamoto J; Study Group of Immunochemotherapy with PSK for Gastric Cancer. Efficacy of immunochemotherapy as adjuvant treatment after curative resection of gastric cancer. Lancet. 1994 May 7;343(8906):1122-6. link to original article PubMed
Metastatic or locally advanced disease, first-line
FAM
FAM: Fluorouracil, Adriamycin (Doxorubicin), Mitomycin
Regimen variant #1, "Georgetown regimen"
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
MacDonald et al. 1979 | 1974-1977 | Phase 2 | ||
Cullinan et al. 1985 | NR | Phase 3 (C) | 1. 5-FU 2. FA |
Did not meet primary endpoint of OS |
Wils et al. 1991 | NR-1989 | Phase 3 (C) | FAMTX | Inferior OS |
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.
Chemotherapy
- Fluorouracil (5-FU) 600 mg/m2 IV once per day on days 1, 8, 29, 36
- Doxorubicin (Adriamycin) 30 mg/m2 IV once per day on days 1 & 29
- Mitomycin (Mutamycin) 10 mg/m2 IV once on day 1
8-week cycles
Regimen variant #2
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Kim et al. 1993 | 1986-1990 | Phase 3 (C) | 1. 5-FU 2. FP |
Did not meet endpoint of OS |
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.
Chemotherapy
- Fluorouracil (5-FU) 800 mg/m2 IV over 12 hours once per day on days 1 to 5
- Doxorubicin (Adriamycin) 30 mg/m2 IV once on day 1
- Mitomycin (Mutamycin) 8 mg/m2 IV once on day 1
4-week cycles
References
- MacDonald JS, Woolley PV, Smythe T, Ueno W, Hoth D, Schein PS. 5-fluorouracil, adriamycin, and mitomycin-C (FAM) combination chemotherapy in the treatment of advanced gastric cancer. Cancer. 1979 Jul;44(1):42-7. link to original article contains dosing details in manuscript PubMed
- Cullinan SA, Moertel CG, Fleming TR, Rubin JR, Krook JE, Everson LK, Windschitl HE, Twito DI, Marschke RF, Foley JF, Pfeifle DM, Barlow JF. A comparison of three chemotherapeutic regimens in the treatment of advanced pancreatic and gastric carcinoma: fluorouracil vs fluorouracil and doxorubicin vs fluorouracil, doxorubicin, and mitomycin. JAMA. 1985 Apr 12;253(14):2061-7. link to original article contains dosing details in manuscript PubMed
- Wils JA, Klein HO, Wagener DJ, Bleiberg H, Reis H, Korsten F, Conroy T, Fickers M, Leyvraz S, Buyse M, Duez N; European Organisation for Research and Treatment of Cancer Gastrointestinal Tract Cooperative Group. Sequential high-dose methotrexate and fluorouracil combined with doxorubicin--a step ahead in the treatment of advanced gastric cancer: a trial of the European Organisation for Research and Treatment of Cancer Gastrointestinal Tract Cooperative Group. J Clin Oncol. 1991 May;9(5):827-31. link to original article contains dosing details in manuscript PubMed
- Kim NK, Park YS, Heo DS, Suh C, Kim SY, Park KC, Kang YK, Shin DB, Kim HT, Kim HJ, Kang WK, Suh CI, Bang YJ. A phase III randomized study of 5-fluorouracil and cisplatin versus 5-fluorouracil, doxorubicin, and mitomycin C versus 5-fluorouracil alone in the treatment of advanced gastric cancer. Cancer. 1993 Jun 15;71(12):3813-8. link to original article contains dosing details in manuscript PubMed
FAMTX
FAMTX: Fluorouracil, Adriamycin (Doxorubicin), MTX (Methotrexate)
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Wils et al. 1991 | NR-1989 | Phase 3 (E-switch-ic) | FAM | Superior OS |
Kelsen et al. 1992 | 1988-1990 | Randomized (E-switch-ic) | EAP | Did not meet secondary endpoint of OS |
Vanhoefer et al. 2000 (EORTC 40902) | 1991-1995 | Phase 3 (C) | 1. ELF 2. FP |
Did not meet primary endpoint of ORR |
Webb et al. 1997 | 1992-1995 | Randomized (C) | ECF | Inferior OS |
Note: Vanhoefer et al. 2000 stated that cycles were repeated every 29 days which is likely a mistake.
Chemotherapy
- Fluorouracil (5-FU) 1500 mg/m2 IV once on day 1, given second, one hour after methotrexate
- Doxorubicin (Adriamycin) 30 mg/m2 IV once on day 15
- Methotrexate (MTX) 1500 mg/m2 IV once on day 1, given first
28-day cycles
References
- Wils JA, Klein HO, Wagener DJ, Bleiberg H, Reis H, Korsten F, Conroy T, Fickers M, Leyvraz S, Buyse M, Duez N; European Organisation for Research and Treatment of Cancer Gastrointestinal Tract Cooperative Group. Sequential high-dose methotrexate and fluorouracil combined with doxorubicin--a step ahead in the treatment of advanced gastric cancer: a trial of the European Organisation for Research and Treatment of Cancer Gastrointestinal Tract Cooperative Group. J Clin Oncol. 1991 May;9(5):827-31. link to original article PubMed
- Kelsen D, Atiq OT, Saltz L, Niedzwiecki D, Ginn D, Chapman D, Heelan R, Lightdale C, Vinciguerra V, Brennan M. FAMTX versus etoposide, doxorubicin, and cisplatin: a random assignment trial in gastric cancer. J Clin Oncol. 1992 Apr;10(4):541-8. link to original article PubMed
- Webb A, Cunningham D, Scarffe JH, Harper P, Norman A, Joffe JK, Hughes M, Mansi J, Findlay M, Hill A, Oates J, Nicolson M, Hickish T, O'Brien M, Iveson T, Watson M, Underhill C, Wardley A, Meehan M. Randomized trial comparing epirubicin, cisplatin, and fluorouracil versus fluorouracil, doxorubicin, and methotrexate in advanced esophagogastric cancer. J Clin Oncol. 1997 Jan;15(1):261-7. link to original article PubMed
- Update: Waters JS, Norman A, Cunningham D, Scarffe JH, Webb A, Harper P, Joffe JK, Mackean M, Mansi J, Leahy M, Hill A, Oates J, Rao S, Nicolson M, Hickish T. Long-term survival after epirubicin, cisplatin and fluorouracil for gastric cancer: results of a randomized trial. Br J Cancer. 1999 Apr;80(1-2):269-72. link to original article link to PMC article PubMed
- EORTC 40902: Vanhoefer U, Rougier P, Wilke H, Ducreux MP, Lacave AJ, Van Cutsem E, Planker M, Santos JG, Piedbois P, Paillot B, Bodenstein H, Schmoll HJ, Bleiberg H, Nordlinger B, Couvreur ML, Baron B, Wils JA; European Organisation for Research and Treatment of Cancer Gastrointestinal Tract Cooperative Group. Final results of a randomized phase III trial of sequential high-dose methotrexate, fluorouracil, and doxorubicin versus etoposide, leucovorin, and fluorouracil versus infusional fluorouracil and cisplatin in advanced gastric cancer: a trial of the European Organisation for Research and Treatment of Cancer Gastrointestinal Tract Cancer Cooperative Group. J Clin Oncol. 2000 Jul;18(14):2648-57. link to original article contains dosing details in manuscript PubMed
FEMTX
FEMTX: Fluorouracil, Epirubicin, MTX (Methotrexate)
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Pyrhönen et al. 1995 | 1986-1992 | Phase 3 (E-esc) | Best supportive care | Superior OS |
Chemotherapy
- Fluorouracil (5-FU) 1500 mg/m2 IV once on day 1, given second
- Epirubicin (Ellence) 60 mg/m2 IV once on day 15
- Methotrexate (MTX) 1500 mg/m2 IV once on day 1, given first
Supportive therapy
- Leucovorin (Folinic acid) 30 mg PO once every 6 hours on days 2 & 3
28-day cycles
References
- Pyrhönen S, Kuitunen T, Nyandoto P, Kouri M. Randomised comparison of fluorouracil, epidoxorubicin and methotrexate (FEMTX) plus supportive care with supportive care alone in patients with non-resectable gastric cancer. Br J Cancer. 1995 Mar;71(3):587-91. link to original article link to PMC article contains dosing details in manuscript PubMed
Fluorouracil & RT
5-FU & RT: 5-FluoroUracil & Radiation Therapy
Regimen
Study | Dates of enrollment | Evidence |
---|---|---|
Moertel et al. 1969 | NR | Non-randomized |
References
- Moertel CG, Childs DS Jr, Reitemeier RJ, Colby MY Jr, Holbrook MA. Combined 5-fluorouracil and supervoltage radiation therapy of locally unresectable gastrointestinal cancer. Lancet. 1969 Oct 25;2(7626):865-7. link to original article PubMed
Metastatic or locally advanced disease, subsequent lines of therapy
Apatinib monotherapy
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Kang et al. 2024 (ANGEL) | 2017-03-14 to 2018-10-31 | Phase 3 (E-esc) | Placebo | Did not meet primary endpoint of OS |
Note: ANGEL included patients with GEJ malignancy
References
- ANGEL: Kang YK, Ryu MH, Di Bartolomeo M, Chau I, Yoon H, Kim JG, Lee KW, Oh SC, Takashima A, Kryzhanivska A, Chao Y, Evesque L, Schenker M, McGinn A, Zhao Y, Lee J, Wyrwicz L, Boku N. Rivoceranib, a VEGFR-2 inhibitor, monotherapy in previously treated patients with advanced or metastatic gastric or gastroesophageal junction cancer (ANGEL study): an international, randomized, placebo-controlled, phase 3 trial. Gastric Cancer. 2024 Mar;27(2):375-386. Epub 2024 Jan 28. link to original article link to PMC article PubMed NCT03042611