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The purpose of this page is to provide references to regimens that are obsolete, outdated, or of historical interest only. Is there a regimen missing from this list? See the main gastric cancer page for current regimens.
Last updated on 2024-07-23:10 regimens on this page
11 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 shorter 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 dosing details in manuscript have been reviewed by our editors EuroPMC 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 EuroPMC NCT00296322
==FA==
FA: Fluorouracil & Adriamycin (Doxorubicin)
===Regimen===
Study 	Dates of enrollment	Evidence 	Comparator 	Comparative Efficacy
Youn et al. 1990	Not reported 	Randomized (C)	FA & poly A:U	Seems to have shorter 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====
*Gastrectomy
====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 dosing details in abstract have been reviewed by our editors EuroPMC
## 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 EuroPMC
==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 shorter 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====
*Gastrectomy
====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 dosing details in manuscript have been reviewed by our editors EuroPMC
==Fluorouracil monotherapy==
===Regimen===
Study 	Dates of enrollment	Evidence 	Comparator 	Comparative Efficacy
Chang et al. 2002	1990-1993 	Phase 3 (C)	1. 5-FU & Mitomycin2. 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====
*Gastrectomy
====Chemotherapy====
*Fluorouracil (5-FU) 500 mg/m2 IV once per day on days 1 to 4
21-day cycle for 6 cycles
===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 dosing details in manuscript have been reviewed by our editors EuroPMC
# 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 EuroPMC
==Fluorouracil & Mitomycin==
===Regimen===
Study 	Dates of enrollment 	Evidence 	Comparator 	Comparative Efficacy
Allum et al. 1989 	1976 to not reported	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 shorter OS
====Preceding treatment====
*Gastrectomy
====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 dosing details in manuscript have been reviewed by our editors EuroPMC
# 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 EuroPMC
=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 	Not reported 	Phase 3 (C)	1. 5-FU2. FA	Did not meet primary endpoint of OS
Wils et al. 1991 	Not reported to 1989	Phase 3 (C)	FAMTX 	Shorter 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-FU2. 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 dosing details in manuscript have been reviewed by our editors EuroPMC
# 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 dosing details in manuscript have been reviewed by our editors EuroPMC
# 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 dosing details in manuscript have been reviewed by our editors EuroPMC
# 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 dosing details in manuscript have been reviewed by our editors EuroPMC
==FAMTX==
FAMTX: Fluorouracil, Adriamycin (Doxorubicin), MTX (Methotrexate)
===Regimen===
Study 	Dates of enrollment 	Evidence 	Comparator 	Comparative Efficacy
Wils et al. 1991 	Not reported to 1989	Phase 3 (E-switch-ic) 	FAM 	Longer 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. ELF2. FP	Did not meet primary endpoint of ORR
Webb et al. 1997 	1992-1995 	Randomized (C) 	ECF 	Shorter 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 EuroPMC
# 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 EuroPMC
# 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 EuroPMC
## 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 EuroPMC
# 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 dosing details in manuscript have been reviewed by our editors EuroPMC
==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	Longer 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 dosing details in manuscript have been reviewed by our editors EuroPMC
==Fluorouracil & RT==
5-FU & RT: 5-FluoroUracil & Radiation Therapy
===Regimen===
Study 	Dates of enrollment	Evidence
Moertel et al. 1969	Not reported 	Non-randomized
====Chemotherapy====
*Fluorouracil (5-FU)
====Radiotherapy====
*Concurrent radiation therapy
===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 EuroPMC
=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
====Targeted therapy====
*Apatinib (Aitan) 700 mg PO once per day on days 1 to 28
28-day cycles
===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 EuroPMC NCT03042611
Category:Gastric cancer regimens
Category:Historical regimens
Category:Disease-specific pages
Category:Gastroesophageal cancers