Difference between revisions of "Colorectal cancer - historical"

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m (Text replacement - "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]. " to "")
 
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The purpose of this page is to provide references to regimens that are obsolete, outdated, or of historical interest only.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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<span id="BackToTop"></span>
 
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[[#top|Back to Top]]
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</div>
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The purpose of this page is to provide references to regimens that are obsolete, outdated, or of historical interest only.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.
 
{| 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}}]] |?Regimen |limit=10000|format=sum}} [[Tutorial#Regimens|regimens]] on this page</b></font></div>
+
|<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>
+
<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}}==
 
+
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
 
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
|-
 
|-
|[https://www.ejcancer.com/article/S0959-8049(02)00662-7/fulltext Wils et al. 2003]
+
|[https://doi.org/10.1016/s0959-8049(02)00662-7 Wils et al. 2003]
 
|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" |Seems not superior
+
| style="background-color:#ffffbf" |Did not meet endpoints of RR/PFS/OS
 
|-
 
|-
 
|}
 
|}
 +
<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>
 
===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://www.ejcancer.com/article/S0959-8049(02)00662-7/fulltext 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] '''contains dosing details in manuscript''' [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:#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/pdf 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)
 
|[[#Fluorouracil_.26_Mitomycin|Fluorouracil & Mitomycin]]; chronomodulated
 
|[[#Fluorouracil_.26_Mitomycin|Fluorouracil & Mitomycin]]; chronomodulated
| style="background-color:#ffffbf" |Seems not superior
+
| style="background-color:#ffffbf" |Did not meet endpoints of FFS/OS
 
|-
 
|-
 
|}
 
|}
 +
<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>
 
===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/pdf 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] '''contains dosing details in manuscript''' [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:#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
 
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
|-
 
|-
|[https://onlinelibrary.wiley.com/doi/abs/10.1002/1097-0142(197607)38:1<1::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]]
 
| style="background-color:#1a9850" |Superior ORR
 
| style="background-color:#1a9850" |Superior ORR
 
|-
 
|-
|[https://onlinelibrary.wiley.com/doi/abs/10.1002/1097-0142(19820415)49:8<1555::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
 
|NR
 
|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" |Seems not superior
+
| style="background-color:#ffffbf" |Did not meet endpoints of RR/OS
 
|-
 
|-
 
|}
 
|}
 +
<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>
 
===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://onlinelibrary.wiley.com/doi/abs/10.1002/1097-0142(197607)38:1<1::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] '''contains dosing details in abstract''' [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://onlinelibrary.wiley.com/doi/abs/10.1002/1097-0142(19820415)49:8<1555::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 (Leucovorin), '''<u>F</u>'''luorouracil, '''<u>OX</u>'''aliplatin
FOLFOX: '''<u>FOL</u>'''inic acid, '''<u>F</u>'''luorouracil, '''<u>OX</u>'''aliplatin
+
<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://www.thelancet.com/journals/lancet/article/PIIS0140673697033588/fulltext 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
 
|-
 
|-
 
|}
 
|}
''This schedule is "chronomodulated"; see paper for details.''
+
''Note: This schedule is "chronomodulated"; see paper for details.''
 +
<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'''
 +
'''21-day cycles'''
 +
</div></div>
 +
===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/s0140-6736(97)03358-8 link to original article] '''contains dosing details in manuscript''' [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'''
 
'''21-day cycles'''
 +
</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://www.thelancet.com/journals/lancet/article/PIIS0140673697033588/fulltext link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/9291901 PubMed]
+
#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] '''contains dosing details in manuscript''' [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] '''contains dosing details in manuscript''' [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://www.karger.com/Article/Abstract/94357 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 11:35, 13 May 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 contains dosing details in manuscript 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 contains dosing details in manuscript 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) NR 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 contains dosing details in abstract 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 contains dosing details in manuscript 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 contains dosing details in manuscript 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 contains dosing details in manuscript 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