Difference between revisions of "Colon cancer - historical"
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| − | ==Fluorouracil & Methotrexate {{#subobject:bcd024|Regimen=1}}== | + | ==Fluorouracil & Methotrexate (MF) {{#subobject:bcd024|Regimen=1}}== |
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|style="background-color:#1a9851"|Phase III (C) | |style="background-color:#1a9851"|Phase III (C) | ||
| − | | | + | |MF & PALA |
| style="background-color:#ffffbf" |Seems not superior | | style="background-color:#ffffbf" |Seems not superior | ||
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Revision as of 14:18, 12 March 2021
The purpose of this page is to provide references to regimens that are obsolete, outdated, or of historical interest only.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 NCCN Guidelines. Is there a regimen missing from this list? See the main colon cancer page for current regimens.
6 regimens on this page
10 variants on this page
|
Adjuvant therapy
Bacillus Calmette-Guérin (BCG) monotherapy
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Regimen
| Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Mavligit et al. 1976 | 1973-1975 | Phase III (C) | 5-FU & BCG | Not reported |
Immunotherapy
References
- Mavligit GM, Gutterman JU, Burgess MA, Khankhanian N, Seibert GB, Speer JF, Jubert AV, Martin RC, McBride CM, Copeland EM, Gehan EA, Hersh EM. Prolongation of postoperative disease-free interval and survival in human colorectal cancer by BCG or BCG plus 5-fluorouracil. Lancet. 1976 Apr 24;1(7965):871-6. link to original article PubMed
- NSABP C-01: Wolmark N, Fisher B, Rockette H, Redmond C, Wickerham DL, Fisher ER, Jones J, Glass A, Lerner H, Lawrence W, Prager D, Wexler M, Evans J, Cruz A, Dimitrov N, Jochimsen P; NSABP. Postoperative adjuvant chemotherapy or BCG for colon cancer: results from NSABP protocol C-01. J Natl Cancer Inst. 1988 Mar 2;80(1):30-6. link to original article PubMed
- Update: Smith RE, Colangelo L, Wieand HS, Begovic M, Wolmark N. Randomized trial of adjuvant therapy in colon carcinoma: 10-year results of NSABP protocol C-01. J Natl Cancer Inst. 2004 Aug 4;96(15):1128-32. link to original article PubMed
- Pooled update: Wilkinson NW, Yothers G, Lopa S, Costantino JP, Petrelli NJ, Wolmark N. Long-term survival results of surgery alone versus surgery plus 5-fluorouracil and leucovorin for stage II and stage III colon cancer: pooled analysis of NSABP C-01 through C-05: a baseline from which to compare modern adjuvant trials. Ann Surg Oncol. 2010 Apr;17(4):959-66. link to original article link to PMC article PubMed
Edrecolomab monotherapy
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Regimen
| Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Riethmüller et al. 1994 | 1985-1990 | Phase III (E-esc) | Observation | Seems to have superior OS |
| Punt et al. 2002 (Study 157-002) | 1995-1999 | Phase III (E-switch-ooc) | 1. FULV | Seems to have inferior OS |
| 2. FULV & Edrecolomab | Not reported | |||
| Niedzwiecki et al. 2011 (CALGB 9581) | 1997-2002 | Phase III (E-esc) | Observation | Seems not superior |
Note: this was the first monoclonal antibody approved (in Germany) for the therapeutic treatment of cancer; it was never FDA approved and was subsequently removed from the German market.
Preceding treatment
Targeted therapy
References
- Riethmüller G, Schneider-Gädicke E, Schlimok G, Schmiegel W, Raab R, Höffken K, Gruber R, Pichlmaier H, Hirche H, Pichlmayr R, Buggisch P, Witte J; German Cancer Aid 17-1A Study Group. Randomised trial of monoclonal antibody for adjuvant therapy of resected Dukes' C colorectal carcinoma. Lancet. 1994 May 14;343(8907):1177-83. link to original article PubMed
- Study 157-002: Punt CJ, Nagy A, Douillard JY, Figer A, Skovsgaard T, Monson J, Barone C, Fountzilas G, Riess H, Moylan E, Jones D, Dethling J, Colman J, Coward L, MacGregor S. Edrecolomab alone or in combination with fluorouracil and folinic acid in the adjuvant treatment of stage III colon cancer: a randomised study. Lancet. 2002 Aug 31;360(9334):671-7. link to original article PubMed
- CALGB 9581: Niedzwiecki D, Bertagnolli MM, Warren RS, Compton CC, Kemeny NE, Benson AB 3rd, Eckhardt SG, Alberts S, Porjosh GN, Kerr DJ, Fields A, Rougier P, Pipas JM, Schwartz JH, Atkins J, O'Rourke M, Perry MC, Goldberg RM, Mayer RJ, Colacchio TA. Documenting the natural history of patients with resected stage II adenocarcinoma of the colon after random assignment to adjuvant treatment with edrecolomab or observation: results from CALGB 9581. J Clin Oncol. 2011 Aug 10;29(23):3146-52. Epub 2011 Jul 11. link to original article link to PMC article PubMed
Fluorouracil monotherapy
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Regimen
| Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Li & Ross 1976 | 1965-1970 | Phase III (E-esc) | Observation | Superior DFS |
| De Placido et al. 2005 (IGCS-COL) | 1991-1998 | Phase III (C) | 1. FULV 2. 5-FU & LEV 3. FULV & LEV |
Seems not superior |
Preceding treatment
Chemotherapy
References
- Li MC, Ross ST. Chemoprophylaxis for patients with colorectal cancer: prospective study with five-year follow-up. JAMA. 1976 Jun 28;235(26):2825-8. link to original article PubMed
- IGCS-COL: De Placido S, Lopez M, Carlomagno C, Paoletti G, Palazzo S, Manzione L, Iannace C, Ianniello GP, De Vita F, Ficorella C, Farris A, Pistillucci G, Gemini M, Cortesi E, Adamo V, Gebbia N, Palmeri S, Gallo C, Perrone F, Persico G, Bianco AR. Modulation of 5-fluorouracil as adjuvant systemic chemotherapy in colorectal cancer: the IGCS-COL multicentre, randomised, phase III study. Br J Cancer. 2005 Oct 17;93(8):896-904. link to original article link to PMC article PubMed
Fluorouracil & Levamisole
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Regimen
| Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Moertel et al. 1990 | 1984-1987 | Phase III (E-esc) | Observation | Superior OS |
| O'Connell et al. 1998 | NR | Phase III (C) | FULV & Levamisole | Inferior OS |
| Wolmark et al. 1999 (NSABP C-04) | 1989-1990 | Phase III (C) | 1. FULV | Might have inferior OS |
| 2. FULV & Levamisole | Not reported | |||
| Taal et al. 2001 | 1991-1996 | Phase III (E-esc) | Observation | Superior OS |
| Glimelius et al. 2005 | 1991-1997 | Phase III (E-esc) | Observation | Seems not superior |
| Schippinger et al. 2005 (ABCSG Study 90) | 1991-1999 | Phase III (E-esc) | 1. 5-FU 2. 5-FU & IFN alfa |
Inferior OS |
| 3. 5-FU, IFN alfa, Levamisole | Seems not superior | |||
| Martenson et al. 2004 (INT-0130) | 1992-1996 | Phase III (C) | 5-FU, LEV, RT | Seems not superior |
| Dencausse et al. 2002 | 1993-1997 | Randomized (C) | FULV | Seems not superior |
| Nordlinger et al. 2005 (FFCD 9204) | 1993-1998 | Phase III (C) | 5-FU, LEV, regional chemotherapy | Seems not superior |
Note: there was no statistical difference in the overall population of Glimelius et al. 2005; stage III patients appeared to derive benefit.
Preceding treatment
Chemotherapy
Immunotherapy
References
- Moertel CG, Fleming TR, Macdonald JS, Haller DG, Laurie JA, Goodman PJ, Ungerleider JS, Emerson WA, Tormey DC, Glick JH, Veeder MH, Mailliard JA. Levamisole and fluorouracil for adjuvant therapy of resected colon carcinoma. N Engl J Med. 1990 Feb 8;322(6):352-8. link to original article PubMed
- Update: Moertel CG, Fleming TR, Macdonald JS, Haller DG, Laurie JA, Tangen CM, Ungerleider JS, Emerson WA, Tormey DC, Glick JH, Veeder MH, Mailliard JA. Fluorouracil plus levamisole as effective adjuvant therapy after resection of stage III colon carcinoma: a final report. Ann Intern Med. 1995 Mar 1;122(5):321-6. link to original article PubMed
- O'Connell MJ, Laurie JA, Kahn M, Fitzgibbons RJ Jr, Erlichman C, Shepherd L, Moertel CG, Kocha WI, Pazdur R, Wieand HS, Rubin J, Vukov AM, Donohue JH, Krook JE, Figueredo A. Prospectively randomized trial of postoperative adjuvant chemotherapy in patients with high-risk colon cancer. J Clin Oncol. 1998 Jan;16(1):295-300. link to original article PubMed
- NSABP C-04: Wolmark N, Rockette H, Mamounas E, Jones J, Wieand S, Wickerham DL, Bear HD, Atkins JN, Dimitrov NV, Glass AG, Fisher ER, Fisher B. Clinical trial to assess the relative efficacy of fluorouracil and leucovorin, fluorouracil and levamisole, and fluorouracil, leucovorin, and levamisole in patients with Dukes' B and C carcinoma of the colon: results from National Surgical Adjuvant Breast and Bowel Project C-04. J Clin Oncol. 1999 Nov;17(11):3553-9. link to original article PubMed
- Pooled update: Wilkinson NW, Yothers G, Lopa S, Costantino JP, Petrelli NJ, Wolmark N. Long-term survival results of surgery alone versus surgery plus 5-fluorouracil and leucovorin for stage II and stage III colon cancer: pooled analysis of NSABP C-01 through C-05: a baseline from which to compare modern adjuvant trials. Ann Surg Oncol. 2010 Apr;17(4):959-66. link to original article link to PMC article PubMed
- Taal BG, Van Tinteren H, Zoetmulder FA; NACCP group. Adjuvant 5FU plus levamisole in colonic or rectal cancer: improved survival in stage II and III. Br J Cancer. 2001 Nov 16;85(10):1437-43. link to original article link to PMC article PubMed
- Dencausse Y, Hartung G, Sturm J, Kopp-Schneider A, Hagmüller E, Wojatschek C, Lindemann H, Fritze D, Queisser W. Adjuvant chemotherapy in stage III colon cancer with 5-fluorouracil and levamisole versus 5-fluorouracil and leucovorin. Oncology. 2002 Oct; 25 (5): 426-30. link to original article PubMed
- INT-0130: Martenson JA Jr, Willett CG, Sargent DJ, Mailliard JA, Donohue JH, Gunderson LL, Thomas CR Jr, Fisher B, Benson AB 3rd, Myerson R, Goldberg RM. Phase III study of adjuvant chemotherapy and radiation therapy compared with chemotherapy alone in the surgical adjuvant treatment of colon cancer: results of intergroup protocol 0130. J Clin Oncol. 2004 Aug 15;22(16):3277-83. Epub 2004 Jul 12. link to original article PubMed
- Glimelius B, Dahl O, Cedermark B, Jakobsen A, Bentzen SM, Starkhammar H, Grönberg H, Hultborn R, Albertsson M, Påhlman L, Tveit KM; Nordic Gastrointestinal Tumour Adjuvant Therapy Group. Adjuvant chemotherapy in colorectal cancer: a joint analysis of randomised trials by the Nordic Gastrointestinal Tumour Adjuvant Therapy Group. Acta Oncol. 2005;44(8):904-12. Erratum in: Acta Oncol. 2006;45(1):110. link to original article PubMed
- Update: Dahl O, Fluge Ø, Carlsen E, Wiig JN, Myrvold HE, Vonen B, Podhorny N, Bjerkeset O, Eide TJ, Halvorsen TB, Tveit KM; Norwegian Gastrointestinal Cancer Group. Final results of a randomised phase III study on adjuvant chemotherapy with 5 FU and levamisol in colon and rectum cancer stage II and III by the Norwegian Gastrointestinal Cancer Group. Acta Oncol. 2009;48(3):368-76. link to original article PubMed
- ABCSG Study 90: Schippinger W, Jagoditsch M, Sorré C, Gnant M, Steger G, Hausmaninger H, Mlineritsch B, Schaberl-Moser R, Mischinger HJ, Hofbauer F, Holzberger P, Mittlböck M, Jakesz R; ABCSG. A prospective randomised trial to study the role of levamisole and interferon alfa in an adjuvant therapy with 5-FU for stage III colon cancer. Br J Cancer. 2005 May 9;92(9):1655-62. link to original article link to PMC article PubMed
- FFCD 9204: Nordlinger B, Rougier P, Arnaud JP, Debois M, Wils J, Ollier JC, Grobost O, Lasser P, Wals J, Lacourt J, Seitz JF, Guimares dos Santos J, Bleiberg H, Mackiewickz R, Conroy T, Bouché O, Morin T, Baila L, van Cutsem E, Bedenne L. Adjuvant regional chemotherapy and systemic chemotherapy versus systemic chemotherapy alone in patients with stage II-III colorectal cancer: a multicentre randomised controlled phase III trial. Lancet Oncol. 2005 Jul;6(7):459-68. link to original article PubMed
FULV & Levamisole
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FULV & Levamisole: 5-FU, LeucoVorin (Folinic acid), Levamisole
Regimen
| Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| O'Connell et al. 1998 | NR | Phase III (E-esc) | 5-FU & Levamisole | Superior OS |
| Poplin et al. 2005 (SWOG S9415) | 1994-1999 | Phase III (C) | CIFU & Levamisole | Seems not superior |
Preceding treatment
Chemotherapy
Immunotherapy
References
- O'Connell MJ, Laurie JA, Kahn M, Fitzgibbons RJ Jr, Erlichman C, Shepherd L, Moertel CG, Kocha WI, Pazdur R, Wieand HS, Rubin J, Vukov AM, Donohue JH, Krook JE, Figueredo A. Prospectively randomized trial of postoperative adjuvant chemotherapy in patients with high-risk colon cancer. J Clin Oncol. 1998 Jan;16(1):295-300. link to original article PubMed
- NSABP C-04: Wolmark N, Rockette H, Mamounas E, Jones J, Wieand S, Wickerham DL, Bear HD, Atkins JN, Dimitrov NV, Glass AG, Fisher ER, Fisher B. Clinical trial to assess the relative efficacy of fluorouracil and leucovorin, fluorouracil and levamisole, and fluorouracil, leucovorin, and levamisole in patients with Dukes' B and C carcinoma of the colon: results from National Surgical Adjuvant Breast and Bowel Project C-04. J Clin Oncol. 1999 Nov;17(11):3553-9. link to original article PubMed
- Pooled update: Wilkinson NW, Yothers G, Lopa S, Costantino JP, Petrelli NJ, Wolmark N. Long-term survival results of surgery alone versus surgery plus 5-fluorouracil and leucovorin for stage II and stage III colon cancer: pooled analysis of NSABP C-01 through C-05: a baseline from which to compare modern adjuvant trials. Ann Surg Oncol. 2010 Apr;17(4):959-66. link to original article link to PMC article PubMed
- SWOG S9415: Poplin EA, Benedetti JK, Estes NC, Haller DG, Mayer RJ, Goldberg RM, Weiss GR, Rivkin SE, Macdonald JS. Phase III Southwest Oncology Group 9415/Intergroup 0153 randomized trial of fluorouracil, leucovorin, and levamisole versus fluorouracil continuous infusion and levamisole for adjuvant treatment of stage III and high-risk stage II colon cancer. J Clin Oncol. 2005 Mar 20;23(9):1819-25. link to original article PubMed
- IGCS-COL: De Placido S, Lopez M, Carlomagno C, Paoletti G, Palazzo S, Manzione L, Iannace C, Ianniello GP, De Vita F, Ficorella C, Farris A, Pistillucci G, Gemini M, Cortesi E, Adamo V, Gebbia N, Palmeri S, Gallo C, Perrone F, Persico G, Bianco AR. Modulation of 5-fluorouracil as adjuvant systemic chemotherapy in colorectal cancer: the IGCS-COL multicentre, randomised, phase III study. Br J Cancer. 2005 Oct 17;93(8):896-904. link to original article link to PMC article PubMed
mFOLFOX6-B
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mFOLFOX6-B: FOLinic acid, Fluorouracil, OXaliplatin, Bevacizumab
Regimen
| Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Allegra et al. 2009 (NSABP C-08) | 2004-2006 | Phase III (E-esc) | mFOLFOX6 | Seems not superior |
Note: this was a negative experimental arm but is included for historic reference. Some guidelines do not recommend using bevacizumab as adjuvant therapy outside of a clinical trial.
Preceding treatment
Chemotherapy
- Fluorouracil (5-FU) 400 mg/m2 IV bolus once on day 1, then 2400 mg/m2 IV continuous infusion over 46 to 48 hours (total dose per cycle: 2800 mg/m2)
- Folinic acid (Leucovorin) 400 mg/m2 IV over 2 hours once on day 1
- Oxaliplatin (Eloxatin) 85 mg/m2 IV over 2 hours once on day 1
Targeted therapy
- Bevacizumab (Avastin) 5 mg/kg IV once on day 1
14-day cycle for 12 cycles, to start within 10 weeks of surgery
References
- NSABP C-08: Allegra CJ, Yothers G, O'Connell MJ, Sharif S, Colangelo LH, Lopa SH, Petrelli NJ, Goldberg RM, Atkins JN, Seay TE, Fehrenbacher L, O'Reilly S, Chu L, Azar CA, Wolmark N. Initial safety report of NSABP C-08: A randomized phase III study of modified FOLFOX6 with or without bevacizumab for the adjuvant treatment of patients with stage II or III colon cancer. J Clin Oncol. 2009 Jul 10;27(20):3385-90. Epub 2009 May 4. link to original article contains verified protocol link to PMC article PubMed
- Update: Allegra CJ, Yothers G, O'Connell MJ, Sharif S, Petrelli NJ, Colangelo LH, Atkins JN, Seay TE, Fehrenbacher L, Goldberg RM, O'Reilly S, Chu L, Azar CA, Lopa S, Wolmark N. Phase III trial assessing bevacizumab in stages II and III carcinoma of the colon: results of NSABP protocol C-08. J Clin Oncol. 2011 Jan 1;29(1):11-6. link to original article link to PMC article PubMed
- Update: Allegra CJ, Yothers G, O'Connell MJ, Sharif S, Petrelli NJ, Lopa SH, Wolmark N. Bevacizumab in stage II-III colon cancer: 5-year update of the National Surgical Adjuvant Breast and Bowel Project C-08 trial. J Clin Oncol. 2013 Jan 20;31(3):359-64. link to original article link to PMC article PubMed
MOF
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MOF: MeCCNU (Semustine), Oncovin (Vincristine), Fluorouracil
Regimen
| Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Wolmark et al. 1988 (NSABP C-01) | 1977-1983 | Phase III (E-esc) | 1. Observation 2. BCG |
Seems not superior (*) |
| Wolmark et al. 1993 (NSABP C-03) | 1987-1989 | Phase III (C) | FULV | Inferior OS |
Note: Reported efficacy for NSABP C-01 is based on the 2004 update.
Preceding treatment
Chemotherapy
References
- NSABP C-01: Wolmark N, Fisher B, Rockette H, Redmond C, Wickerham DL, Fisher ER, Jones J, Glass A, Lerner H, Lawrence W, Prager D, Wexler M, Evans J, Cruz A, Dimitrov N, Jochimsen P; NSABP. Postoperative adjuvant chemotherapy or BCG for colon cancer: results from NSABP protocol C-01. J Natl Cancer Inst. 1988 Mar 2;80(1):30-6. link to original article PubMed
- Update: Smith RE, Colangelo L, Wieand HS, Begovic M, Wolmark N. Randomized trial of adjuvant therapy in colon carcinoma: 10-year results of NSABP protocol C-01. J Natl Cancer Inst. 2004 Aug 4;96(15):1128-32. link to original article PubMed
- Pooled update: Wilkinson NW, Yothers G, Lopa S, Costantino JP, Petrelli NJ, Wolmark N. Long-term survival results of surgery alone versus surgery plus 5-fluorouracil and leucovorin for stage II and stage III colon cancer: pooled analysis of NSABP C-01 through C-05: a baseline from which to compare modern adjuvant trials. Ann Surg Oncol. 2010 Apr;17(4):959-66. link to original article link to PMC article PubMed
- NSABP C-03: Wolmark N, Rockette H, Fisher B, Wickerham DL, Redmond C, Fisher ER, Jones J, Mamounas EP, Ore L, Petrelli NJ, Spurr CL, Dimitrov N, Romond EH, Sutherland CM, Kardinal CG, DeFusco PA, Jochimsen P. The benefit of leucovorin-modulated fluorouracil as postoperative adjuvant therapy for primary colon cancer: results from National Surgical Adjuvant Breast and Bowel Project protocol C-03. J Clin Oncol. 1993 Oct;11(10):1879-87. link to original article contains verified protocol PubMed
Metastatic disease, first-line
Fluorouracil & Methotrexate (MF)
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Regimen
| Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Wils et al. 2003 | 1992-1994 | Phase III (C) | MF & PALA | Seems not superior |
Chemotherapy
References
- 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 PubMed
Fluorouracil & Mitomycin
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Regimen
| Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Price et al. 2004 | 1996-1998 | Phase III (C) | Chronomodulated 5-FU & MMC | Seems not superior |
Chemotherapy
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. link to original article PubMed
Fluorouracil & Semustine
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Regimen
| Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Baker et al. 1976 | 1973-1974 | Phase III (C) | 5-FU | Superior ORR |
| Engstrom et al. 1982 (ECOG E4275) | NR | Phase III (E-switch-ic) | 1. 5-FU, Semustine, Vincristine 2. 5-FU, Dacarbazine, Semustine 3. 5-FU, Dacarbazine, Semustine, Vincristine 4. 5-FU & Hydrea |
Seems not superior |
Chemotherapy
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. link to original article 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. link to original article PubMed
FOLFOX chronotherapy
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FOLFOX: FOLinic acid, Fluorouracil, OXaliplatin
Regimen
| Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Lévi et al. 1997 | 1991-1993 | Phase III (E-switch-ic) | FOLFOX CI | Superior TTF |
This schedule is "chronomodulated"; see paper for details.
Chemotherapy
- Folinic acid (Leucovorin) 300 mg/m2 IV over 12 hours once per day on days 1 to 5, given second, with 5-FU
- Fluorouracil (5-FU) 600 mg/m2 IV over 12 hours once per day on days 1 to 5, given second, with leucovorin
- Oxaliplatin (Eloxatin) 20 mg/m2 IV over 12 hours once per day on days 1 to 5, given first
21-day cycles
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. link to original article contains verified protocol PubMed