Difference between revisions of "Colorectal 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The purpose of this page is to provide references to regimens that are obsolete, outdated, or of historical interest only. As a general rule, this includes the inferior arm(s) of a randomized study, unless said regimens continue to be recommended by trustworthy sources such as the [http://www.nccn.org/professionals/physician_gls/f_guidelines.asp NCCN Guidelines]. Is there a regimen missing from this list? See the [[Colorectal_cancer|main colorectal cancer page]] for current regimens.
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[[#top|Back to Top]]
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The purpose of this page is to provide references to regimens that are obsolete, outdated, or of historical interest only.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 [[Colorectal_cancer|main colorectal cancer page]] for current regimens.
 
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|-
 
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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: #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}}]] |?Variant |limit=10000|format=sum}} [[Tutorial#Variants|variants]] 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>
 
|}  
 
|}  
 
{{TOC limit|limit=3}}
 
{{TOC limit|limit=3}}
 
=Metastatic disease, first-line=
 
=Metastatic disease, first-line=
 
==Fluorouracil & Methotrexate (MF) {{#subobject:bcd024|Regimen=1}}==
 
==Fluorouracil & Methotrexate (MF) {{#subobject:bcd024|Regimen=1}}==
<div class="toccolours" style="background-color:#eeeeee">
+
MF: '''<u>M</u>'''ethotrexate & '''<u>F</u>'''luorouracil
 +
<div class="toccolours" style="background-color:#ee6b6e">
 
===Regimen {{#subobject:909280|Variant=1}}===
 
===Regimen {{#subobject:909280|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%"|Years of enrollment
+
!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 20: Line 25:
 
|1992-1994
 
|1992-1994
 
|style="background-color:#1a9851"|Phase 3 (C)
 
|style="background-color:#1a9851"|Phase 3 (C)
|[[#MF_.26_PALA_77|MF & PALA]]
+
|[[#MF_.26_PALA_999|MF & PALA]]
 
| style="background-color:#ffffbf" |Did not meet endpoints of RR/PFS/OS
 
| style="background-color:#ffffbf" |Did not meet endpoints of RR/PFS/OS
 
|-
 
|-
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<div class="toccolours" style="background-color:#b3e2cd">
 
<div class="toccolours" style="background-color:#b3e2cd">
 
====Chemotherapy====
 
====Chemotherapy====
*[[Fluorouracil (5-FU)]]
+
*[[Fluorouracil (5-FU)]] 30 mg/kg/day IV continuous infusion over 48 hours, started on day 1 (total dose per cycle: 60 mg/kg)
*[[Methotrexate (MTX)]]
+
*[[Methotrexate (MTX)]] 40 mg/m<sup>2</sup> IV once on day 1, '''given first'''
 +
'''7-day cycle for 3 cycles, then 14-day cycles'''
 
</div></div>
 
</div></div>
 
===References===
 
===References===
# Wils J, Blijham GH, Wagener T, De Greve J, Jansen RL, Kok TC, Nortier JW, Bleiberg H, Couvreur ML, Genicot B, Baron B; [[Study_Groups#EORTC|EORTC]] Gastrointestinal Group. High-dose 5-fluorouracil plus low dose methotrexate plus or minus low-dose PALA in advanced colorectal cancer: a randomised phase II-III trial of the EORTC Gastrointestinal Group. Eur J Cancer. 2003 Feb;39(3):346-52. [https://doi.org/10.1016/s0959-8049(02)00662-7 link to original article] [https://pubmed.ncbi.nlm.nih.gov/12565987 PubMed]
+
# Wils J, Blijham GH, Wagener T, De Greve J, Jansen RL, Kok TC, Nortier JW, Bleiberg H, Couvreur ML, Genicot B, Baron B; [[Study_Groups#EORTC|EORTC]] Gastrointestinal Group. High-dose 5-fluorouracil plus low dose methotrexate plus or minus low-dose PALA in advanced colorectal cancer: a randomised phase II-III trial of the EORTC Gastrointestinal Group. Eur J Cancer. 2003 Feb;39(3):346-52. [https://doi.org/10.1016/s0959-8049(02)00662-7 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/12565987/ PubMed]
 +
 
 
==Fluorouracil & Mitomycin {{#subobject:29baf5|Regimen=1}}==
 
==Fluorouracil & Mitomycin {{#subobject:29baf5|Regimen=1}}==
<div class="toccolours" style="background-color:#eeeeee">
+
<div class="toccolours" style="background-color:#ee6b6e">
 
===Regimen {{#subobject:e41b97|Variant=1}}===
 
===Regimen {{#subobject:e41b97|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%"|Years of enrollment
+
!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://www.clinical-colorectal-cancer.com/article/S1533-0028(11)70094-9 Price et al. 2004]
+
|[https://doi.org/10.3816/ccc.2004.n.004 Price et al. 2004]
 
|1996-1998
 
|1996-1998
 
|style="background-color:#1a9851"|Phase 3 (C)
 
|style="background-color:#1a9851"|Phase 3 (C)
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<div class="toccolours" style="background-color:#b3e2cd">
 
<div class="toccolours" style="background-color:#b3e2cd">
 
====Chemotherapy====
 
====Chemotherapy====
*[[Fluorouracil (5-FU)]]
+
*[[Fluorouracil (5-FU)]] 300 mg/m<sup>2</sup>/day IV continuous infusion over 42 days, started on day 1 (total dose per cycle: 12,600 mg/m<sup>2</sup>)
*[[Mitomycin (Mutamycin)]]
+
*[[Mitomycin (Mutamycin)]] 7 mg/m<sup>2</sup> (maximum dose of 14 mg) IV once on day 1
 +
'''42-day cycle for up to 4 cycles'''
 
</div></div>
 
</div></div>
 
===References===
 
===References===
# Price TJ, Ross PJ, Hickish T, Tait D, Norman AR, Ford HE, Middleton G, Sumpter K, Hill M, Oates J, Cunningham D. Phase III study of mitomycin-C with protracted venous infusion or circadian-timed infusion of 5-fluorouracil in advanced colorectal carcinoma. Clin Colorectal Cancer. 2004 Feb;3(4):235-42. [https://www.clinical-colorectal-cancer.com/article/S1533-0028(11)70094-9 link to original article] [https://pubmed.ncbi.nlm.nih.gov/15025796 PubMed]
+
# Price TJ, Ross PJ, Hickish T, Tait D, Norman AR, Ford HE, Middleton G, Sumpter K, Hill M, Oates J, Cunningham D. Phase III study of mitomycin-C with protracted venous infusion or circadian-timed infusion of 5-fluorouracil in advanced colorectal carcinoma. Clin Colorectal Cancer. 2004 Feb;3(4):235-42. [https://doi.org/10.3816/ccc.2004.n.004 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/15025796/ PubMed]
 +
 
 
==Fluorouracil & Semustine {{#subobject:ddfd74|Regimen=1}}==
 
==Fluorouracil & Semustine {{#subobject:ddfd74|Regimen=1}}==
<div class="toccolours" style="background-color:#eeeeee">
+
<div class="toccolours" style="background-color:#ee6b6e">
 
===Regimen {{#subobject:4df123|Variant=1}}===
 
===Regimen {{#subobject:4df123|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%"|Years of enrollment
+
!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
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|-
 
|-
 
|[https://doi.org/10.1002/1097-0142(197607)38:1%3C1::AID-CNCR2820380102%3E3.0.CO;2-S Baker et al. 1976]
 
|[https://doi.org/10.1002/1097-0142(197607)38:1%3C1::AID-CNCR2820380102%3E3.0.CO;2-S Baker et al. 1976]
|1973-1974
+
|1973-03 to 1974-10
 
|style="background-color:#1a9851"|Phase 3 (C)
 
|style="background-color:#1a9851"|Phase 3 (C)
 
|[[Colon_cancer#Fluorouracil_monotherapy|5-FU]]
 
|[[Colon_cancer#Fluorouracil_monotherapy|5-FU]]
Line 72: Line 81:
 
|-
 
|-
 
|[https://doi.org/10.1002/1097-0142(19820415)49:8%3C1555::AID-CNCR2820490807%3E3.0.CO;2-C Engstrom et al. 1982 (ECOG E4275)]
 
|[https://doi.org/10.1002/1097-0142(19820415)49:8%3C1555::AID-CNCR2820490807%3E3.0.CO;2-C Engstrom et al. 1982 (ECOG E4275)]
|NR
+
|Not reported
 
|style="background-color:#1a9851"|Phase 3 (E-switch-ic)
 
|style="background-color:#1a9851"|Phase 3 (E-switch-ic)
|1. [[#Fluorouracil.2C_Semustine.2C_Vincristine_99|5-FU, Semustine, Vincristine]]<br>2. [[#Dacarbazine.2C_Fluorouracil.2C_Semustine_99|5-FU, Dacarbazine, Semustine]]<br> 3. [[#Dacarbazine.2C_Fluorouracil.2C_Semustine.2C_Vincristine_99|5-FU, Dacarbazine, Semustine, Vincristine]]<br> 4. [[#Fluorouracil_.26_Hydroxyurea_88|5-FU & Hydrea]]
+
|1. [[#Fluorouracil.2C_Semustine.2C_Vincristine_999|5-FU, Semustine, Vincristine]]<br>2. [[#Dacarbazine.2C_Fluorouracil.2C_Semustine_999|5-FU, Dacarbazine, Semustine]]<br>3. [[#Dacarbazine.2C_Fluorouracil.2C_Semustine.2C_Vincristine_999|5-FU, Dacarbazine, Semustine, Vincristine]]<br>4. [[#Fluorouracil_.26_Hydroxyurea_999|5-FU & Hydrea]]
 
| style="background-color:#ffffbf" |Did not meet endpoints of RR/OS
 
| style="background-color:#ffffbf" |Did not meet endpoints of RR/OS
 
|-
 
|-
Line 80: Line 89:
 
<div class="toccolours" style="background-color:#b3e2cd">
 
<div class="toccolours" style="background-color:#b3e2cd">
 
====Chemotherapy====
 
====Chemotherapy====
*[[Fluorouracil (5-FU)]]
+
*[[Fluorouracil (5-FU)]] 400 mg/m<sup>2</sup> IV once per day on days 1, 8, 15, 22, 29, 36
*[[Semustine (MeCCNU)]]
+
*[[Semustine (MeCCNU)]] 175 mg/m<sup>2</sup> PO once on day 1
 +
'''42-day cycles'''
 
</div></div>
 
</div></div>
 
===References===
 
===References===
# Baker LH, Talley RW, Matter R, Lehane DE, Ruffner BW, Jones SE, Morrison FS, Stephens RL, Gehan EA, Vaitkevicius VK; Southwest Oncology Group. Phase III comparison of the treatment of advanced gastrointestinal cancer with bolus weekly 5-FU vs methyl-CCNU plus bolus weekly 5-FU: a Southwest Oncology Group study. Cancer. 1976 Jul;38(1):1-7. [https://doi.org/10.1002/1097-0142(197607)38:1%3C1::AID-CNCR2820380102%3E3.0.CO;2-S link to original article] [https://pubmed.ncbi.nlm.nih.gov/779949 PubMed]
+
# Baker LH, Talley RW, Matter R, Lehane DE, Ruffner BW, Jones SE, Morrison FS, Stephens RL, Gehan EA, Vaitkevicius VK; Southwest Oncology Group. Phase III comparison of the treatment of advanced gastrointestinal cancer with bolus weekly 5-FU vs methyl-CCNU plus bolus weekly 5-FU: a Southwest Oncology Group study. Cancer. 1976 Jul;38(1):1-7. [https://doi.org/10.1002/1097-0142(197607)38:1%3C1::AID-CNCR2820380102%3E3.0.CO;2-S link to original article] '''dosing details in abstract have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/779949/ PubMed]
# '''ECOG E4275:''' Engstrom PF, MacIntyre JM, Douglass HO Jr, Muggia F, Mittelman A. Combination chemotherapy of advanced colorectal cancer utilizing 5-fluorouracil, semustine, dacarbazine, vincristine, and hydroxyurea: a phase III trial by the Eastern Cooperative Oncology Group (EST: 4275). Cancer. 1982 Apr 15;49(8):1555-60. [https://doi.org/10.1002/1097-0142(19820415)49:8%3C1555::AID-CNCR2820490807%3E3.0.CO;2-C link to original article] [https://pubmed.ncbi.nlm.nih.gov/7039814 PubMed]
+
# '''ECOG E4275:''' Engstrom PF, MacIntyre JM, Douglass HO Jr, Muggia F, Mittelman A. Combination chemotherapy of advanced colorectal cancer utilizing 5-fluorouracil, semustine, dacarbazine, vincristine, and hydroxyurea: a phase III trial by the Eastern Cooperative Oncology Group (EST: 4275). Cancer. 1982 Apr 15;49(8):1555-60. [https://doi.org/10.1002/1097-0142(19820415)49:8%3C1555::AID-CNCR2820490807%3E3.0.CO;2-C link to original article] [https://pubmed.ncbi.nlm.nih.gov/7039814/ PubMed]
 +
 
 
==FOLFOX chronotherapy {{#subobject:7239a0|Regimen=1}}==
 
==FOLFOX chronotherapy {{#subobject:7239a0|Regimen=1}}==
FOLFOX: '''<u>FOL</u>'''inic acid, '''<u>F</u>'''luorouracil, '''<u>OX</u>'''aliplatin
+
FOLFOX: '''<u>FOL</u>'''inic acid (Leucovorin), '''<u>F</u>'''luorouracil, '''<u>OX</u>'''aliplatin
<div class="toccolours" style="background-color:#eeeeee">
+
<div class="toccolours" style="background-color:#ee6b6e">
 
===Regimen {{#subobject:0af678|Variant=1}}===
 
===Regimen {{#subobject:0af678|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%"|Years of enrollment
+
!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://doi.org/10.1016/S0140673697033588 Lévi et al. 1997]
+
|[https://doi.org/10.1016/s0140-6736(97)03358-8 Lévi et al. 1997]
 
|1991-1993
 
|1991-1993
 
|style="background-color:#1a9851"|Phase 3 (E-switch-ic)
 
|style="background-color:#1a9851"|Phase 3 (E-switch-ic)
|[[#FOLFOX_88|FOLFOX]]; CI
+
|[[#FOLFOX_888|FOLFOX]]; CI
 
| style="background-color:#1a9850" |Superior TTF
 
| style="background-color:#1a9850" |Superior TTF
 
|-
 
|-
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<div class="toccolours" style="background-color:#b3e2cd">
 
<div class="toccolours" style="background-color:#b3e2cd">
 
====Chemotherapy====
 
====Chemotherapy====
*[[Folinic acid (Leucovorin)]] 300 mg/m<sup>2</sup> IV over 12 hours once per day on days 1 to 5, '''given second, with 5-FU'''
+
*[[Leucovorin (Folinic acid)]] 300 mg/m<sup>2</sup> IV over 12 hours once per day on days 1 to 5, '''given second, with 5-FU'''
 
*[[Fluorouracil (5-FU)]] 600 mg/m<sup>2</sup> IV over 12 hours once per day on days 1 to 5, '''given second, with leucovorin'''
 
*[[Fluorouracil (5-FU)]] 600 mg/m<sup>2</sup> IV over 12 hours once per day on days 1 to 5, '''given second, with leucovorin'''
 
*[[Oxaliplatin (Eloxatin)]] 20 mg/m<sup>2</sup> IV over 12 hours once per day on days 1 to 5, '''given first'''
 
*[[Oxaliplatin (Eloxatin)]] 20 mg/m<sup>2</sup> IV over 12 hours once per day on days 1 to 5, '''given first'''
Line 113: Line 124:
 
</div></div>
 
</div></div>
 
===References===
 
===References===
# Lévi F, Zidani R, Misset JL; International Organization for Cancer Chronotherapy. Randomised multicentre trial of chronotherapy with oxaliplatin, fluorouracil, and folinic acid in metastatic colorectal cancer. Lancet. 1997 Sep 6;350(9079):681-6. [https://doi.org/10.1016/S0140673697033588 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/9291901 PubMed]
+
# Lévi F, Zidani R, Misset JL; International Organization for Cancer Chronotherapy. Randomised multicentre trial of chronotherapy with oxaliplatin, fluorouracil, and folinic acid in metastatic colorectal cancer. Lancet. 1997 Sep 6;350(9079):681-6. [https://doi.org/10.1016/s0140-6736(97)03358-8 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/9291901/ PubMed]
 +
 
 +
==Raltitrexed monotherapy {{#subobject:rclb7e|Regimen=1}}==
 +
<div class="toccolours" style="background-color:#ee6b6e">
 +
===Regimen {{#subobject:3dcd8b|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/10.1016/0959-8049(95)00502-1 Cunningham et al. 1995]
 +
|1993-11 to 1994-06
 +
| style="background-color:#1a9851" |Phase 3 (E-switch-ooc)
 +
|[[Colorectal_cancer#FULV_3|FULV]]; Mayo Clinic regimen (LDLV)
 +
| style="background-color:#ffffbf" |Did not meet primary endpoint of TTP
 +
|-
 +
|[https://doi.org/10.1200/jco.1998.16.9.2943 Cocconi et al. 1998]
 +
|1995-07 to 1996-02
 +
| style="background-color:#1a9851" |Phase 3 (E-switch-ooc)
 +
|[[Colorectal_cancer#FULV_3|FULV]]; HDLV
 +
| style="background-color:#d73027" |Inferior TTP
 +
|-
 +
|}
 +
<div class="toccolours" style="background-color:#b3e2cd">
 +
====Chemotherapy====
 +
*[[Raltitrexed (Tomudex)]] 3 mg/mg<sup>2</sup> IV once on day 1
 +
'''21-day cycles'''
 +
</div></div>
 +
 
 +
===References===
 +
#Cunningham D, Zalcberg JR, Rath U, Olver I, Van Cutsem E, Svensson C, Seitz JF, Harper P, Kerr D, Perez-Manga G, Azab M, Seymour L, Lowery K; The 'Tomudex' Colorectal Cancer Study Group. 'Tomudex' (ZD1694): results of a randomised trial in advanced colorectal cancer demonstrate efficacy and reduced mucositis and leucopenia. Eur J Cancer. 1995 Nov;31A(12):1945-54. [https://doi.org/10.1016/0959-8049(95)00502-1 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/8562146/ PubMed]
 +
##'''Update:''' Cunningham D, Zalcberg JR, Rath U, Oliver I, van Cutsem E, Svensson C, Seitz JF, Harper P, Kerr D, Perez-Manga G; "Tomudex" Colorectal Cancer Study Group. Final results of a randomised trial comparing 'Tomudex' (raltitrexed) with 5-fluorouracil plus leucovorin in advanced colorectal cancer. Ann Oncol. 1996 Nov;7(9):961-5. Erratum in: Ann Oncol 1997 Apr;8(4):407. [https://doi.org/10.1093/oxfordjournals.annonc.a010800 link to original article] [https://pubmed.ncbi.nlm.nih.gov/9006748/ PubMed]
 +
#Cocconi G, Cunningham D, Van Cutsem E, Francois E, Gustavsson B, van Hazel G, Kerr D, Possinger K, Hietschold SM; Tomudex Colorectal Cancer Study Group. Open, randomized, multicenter trial of raltitrexed versus fluorouracil plus high-dose leucovorin in patients with advanced colorectal cancer. J Clin Oncol. 1998 Sep;16(9):2943-52. [https://doi.org/10.1200/jco.1998.16.9.2943 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/9738562/ PubMed]
 +
#'''MRC CR06:''' Maughan TS, James RD, Kerr DJ, Ledermann JA, McArdle C, Seymour MT, Cohen D, Hopwood P, Johnston C, Stephens RJ; British MRC Colorectal Cancer Working Party. Comparison of survival, palliation, and quality of life with three chemotherapy regimens in metastatic colorectal cancer: a multicentre randomised trial. Lancet. 2002 May 4;359(9317):1555-63. [https://doi.org/10.1016/S0140-6736(02)08514-8 link to original article] [https://pubmed.ncbi.nlm.nih.gov/12047964/ PubMed] [https://clinicaltrials.gov/study/NCT00002893 NCT00002893]
 +
#'''FFCD 9601:''' Ducreux M, Bouche O, Pignon JP, Mousseau M, Raoul JL, Cassan P, Leduc B, Berger C, Dunant A, Fournet J, Bedenne L; FFCD. Randomised trial comparing three different schedules of infusional 5FU and raltitrexed alone as first-line therapy in metastatic colorectal cancer: final results of the Fédération Francophone de Cancérologie Digestive (FFCD) 9601 trial. Oncology. 2006;70(3):222-30. Epub 2006 Jun 30. [https://doi.org/10.1159/000094357 link to original article] [https://pubmed.ncbi.nlm.nih.gov/16816536/ PubMed]
 
[[Category:Colorectal cancer regimens]]
 
[[Category:Colorectal cancer regimens]]
 
[[Category:Historical regimens]]
 
[[Category:Historical regimens]]
 
[[Category:Disease-specific pages]]
 
[[Category:Disease-specific pages]]
 
[[Category:Gastrointestinal cancers]]
 
[[Category:Gastrointestinal cancers]]

Latest revision as of 23:34, 15 July 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 colorectal cancer page for current regimens.

5 regimens on this page
5 variants on this page


Metastatic disease, first-line

Fluorouracil & Methotrexate (MF)

MF: Methotrexate & Fluorouracil

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Wils et al. 2003 1992-1994 Phase 3 (C) MF & PALA Did not meet endpoints of RR/PFS/OS

Chemotherapy

7-day cycle for 3 cycles, then 14-day cycles

References

  1. Wils J, Blijham GH, Wagener T, De Greve J, Jansen RL, Kok TC, Nortier JW, Bleiberg H, Couvreur ML, Genicot B, Baron B; EORTC Gastrointestinal Group. High-dose 5-fluorouracil plus low dose methotrexate plus or minus low-dose PALA in advanced colorectal cancer: a randomised phase II-III trial of the EORTC Gastrointestinal Group. Eur J Cancer. 2003 Feb;39(3):346-52. link to original article dosing details in manuscript have been reviewed by our editors PubMed

Fluorouracil & Mitomycin

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Price et al. 2004 1996-1998 Phase 3 (C) Fluorouracil & Mitomycin; chronomodulated Did not meet endpoints of FFS/OS

Chemotherapy

42-day cycle for up to 4 cycles

References

  1. Price TJ, Ross PJ, Hickish T, Tait D, Norman AR, Ford HE, Middleton G, Sumpter K, Hill M, Oates J, Cunningham D. Phase III study of mitomycin-C with protracted venous infusion or circadian-timed infusion of 5-fluorouracil in advanced colorectal carcinoma. Clin Colorectal Cancer. 2004 Feb;3(4):235-42. link to original article dosing details in manuscript have been reviewed by our editors PubMed

Fluorouracil & Semustine

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Baker et al. 1976 1973-03 to 1974-10 Phase 3 (C) 5-FU Superior ORR
Engstrom et al. 1982 (ECOG E4275) Not reported Phase 3 (E-switch-ic) 1. 5-FU, Semustine, Vincristine
2. 5-FU, Dacarbazine, Semustine
3. 5-FU, Dacarbazine, Semustine, Vincristine
4. 5-FU & Hydrea
Did not meet endpoints of RR/OS

Chemotherapy

42-day cycles

References

  1. Baker LH, Talley RW, Matter R, Lehane DE, Ruffner BW, Jones SE, Morrison FS, Stephens RL, Gehan EA, Vaitkevicius VK; Southwest Oncology Group. Phase III comparison of the treatment of advanced gastrointestinal cancer with bolus weekly 5-FU vs methyl-CCNU plus bolus weekly 5-FU: a Southwest Oncology Group study. Cancer. 1976 Jul;38(1):1-7. link to original article dosing details in abstract have been reviewed by our editors PubMed
  2. ECOG E4275: Engstrom PF, MacIntyre JM, Douglass HO Jr, Muggia F, Mittelman A. Combination chemotherapy of advanced colorectal cancer utilizing 5-fluorouracil, semustine, dacarbazine, vincristine, and hydroxyurea: a phase III trial by the Eastern Cooperative Oncology Group (EST: 4275). Cancer. 1982 Apr 15;49(8):1555-60. link to original article PubMed

FOLFOX chronotherapy

FOLFOX: FOLinic acid (Leucovorin), Fluorouracil, OXaliplatin

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Lévi et al. 1997 1991-1993 Phase 3 (E-switch-ic) FOLFOX; CI Superior TTF

Note: This schedule is "chronomodulated"; see paper for details.

Chemotherapy

21-day cycles

References

  1. Lévi F, Zidani R, Misset JL; International Organization for Cancer Chronotherapy. Randomised multicentre trial of chronotherapy with oxaliplatin, fluorouracil, and folinic acid in metastatic colorectal cancer. Lancet. 1997 Sep 6;350(9079):681-6. link to original article dosing details in manuscript have been reviewed by our editors PubMed

Raltitrexed monotherapy

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Cunningham et al. 1995 1993-11 to 1994-06 Phase 3 (E-switch-ooc) FULV; Mayo Clinic regimen (LDLV) Did not meet primary endpoint of TTP
Cocconi et al. 1998 1995-07 to 1996-02 Phase 3 (E-switch-ooc) FULV; HDLV Inferior TTP

Chemotherapy

21-day cycles

References

  1. Cunningham D, Zalcberg JR, Rath U, Olver I, Van Cutsem E, Svensson C, Seitz JF, Harper P, Kerr D, Perez-Manga G, Azab M, Seymour L, Lowery K; The 'Tomudex' Colorectal Cancer Study Group. 'Tomudex' (ZD1694): results of a randomised trial in advanced colorectal cancer demonstrate efficacy and reduced mucositis and leucopenia. Eur J Cancer. 1995 Nov;31A(12):1945-54. link to original article dosing details in manuscript have been reviewed by our editors PubMed
    1. Update: Cunningham D, Zalcberg JR, Rath U, Oliver I, van Cutsem E, Svensson C, Seitz JF, Harper P, Kerr D, Perez-Manga G; "Tomudex" Colorectal Cancer Study Group. Final results of a randomised trial comparing 'Tomudex' (raltitrexed) with 5-fluorouracil plus leucovorin in advanced colorectal cancer. Ann Oncol. 1996 Nov;7(9):961-5. Erratum in: Ann Oncol 1997 Apr;8(4):407. link to original article PubMed
  2. Cocconi G, Cunningham D, Van Cutsem E, Francois E, Gustavsson B, van Hazel G, Kerr D, Possinger K, Hietschold SM; Tomudex Colorectal Cancer Study Group. Open, randomized, multicenter trial of raltitrexed versus fluorouracil plus high-dose leucovorin in patients with advanced colorectal cancer. J Clin Oncol. 1998 Sep;16(9):2943-52. link to original article dosing details in manuscript have been reviewed by our editors PubMed
  3. MRC CR06: Maughan TS, James RD, Kerr DJ, Ledermann JA, McArdle C, Seymour MT, Cohen D, Hopwood P, Johnston C, Stephens RJ; British MRC Colorectal Cancer Working Party. Comparison of survival, palliation, and quality of life with three chemotherapy regimens in metastatic colorectal cancer: a multicentre randomised trial. Lancet. 2002 May 4;359(9317):1555-63. link to original article PubMed NCT00002893
  4. FFCD 9601: Ducreux M, Bouche O, Pignon JP, Mousseau M, Raoul JL, Cassan P, Leduc B, Berger C, Dunant A, Fournet J, Bedenne L; FFCD. Randomised trial comparing three different schedules of infusional 5FU and raltitrexed alone as first-line therapy in metastatic colorectal cancer: final results of the Fédération Francophone de Cancérologie Digestive (FFCD) 9601 trial. Oncology. 2006;70(3):222-30. Epub 2006 Jun 30. link to original article PubMed