Colon cancer - null regimens

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The purpose of this page is to provide references to "null therapy" such as placebo and observation. These references provide further insight into the historical development of the treatment landscape. See the main colon cancer page for regimens that include active anticancer treatment.


Adjuvant therapy, stage II

Observation

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Moertel et al. 1995 (INT-0035) 1984-1987 Phase 3 (C) 5-FU & Levamisole Did not meet primary endpoint of OS
Laffer et al. 2008 (SAKK 40/87) 1987-1993 Phase 3 (C) 1. Portal venous 5-FU & Mitomycin
2. 5-FU & Mitomycin 		Did not meet primary endpoint of OS
Kemeny et al. 2022 (ECOG-ACRIN E1292) 1993-2000 Phase 3 (C) Peri-operative 5-FU Did not meet primary endpoint of OS
Schippinger et al. 2007 1993-2003 Phase 3 (C) FULV Did not meet primary endpoint of OS
Hartung et al. 2005 1997-2000 Phase 3 (C) Edrecolomab Did not meet primary endpoint of OS
Niedzwiecki et al. 2011 (CALGB 9581) 1997-2002 Phase 3 (C) Edrecolomab Did not meet primary endpoint of OS

No systemic treatment after surgery for stage II colon cancer.

Preceding treatment

References

  1. INT-0035: Moertel CG, Fleming TR, Macdonald JS, Haller DG, Laurie JA, Tangen CM, Ungerleider JS, Emerson WA, Tormey DC, Glick JH, Veeder MH, Mailliard JA; North Central Cancer Treatment Group; SWOG; ECOG. Intergroup study of fluorouracil plus levamisole as adjuvant therapy for stage II/Dukes' B2 colon cancer. J Clin Oncol. 1995 Dec;13(12):2936-43. link to original article PubMed
  2. Hartung G, Hofheinz RD, Dencausse Y, Sturm J, Kopp-Schneider A, Dietrich G, Fackler-Schwalbe I, Bornbusch D, Gonnermann M, Wojatschek C, Lindemann W, Eschenburg H, Jost K, Edler L, Hochhaus A, Queisser W. Adjuvant therapy with edrecolomab versus observation in stage II colon cancer: a multicenter randomized phase III study. Onkologie. 2005 Jun;28(6-7):347-50. Epub 2005 Jun 2. link to original article PubMed
  3. Schippinger W, Samonigg H, Schaberl-Moser R, Greil R, Thödtmann R, Tschmelitsch J, Jagoditsch M, Steger GG, Jakesz R, Herbst F, Hofbauer F, Rabl H, Wohlmuth P, Gnant M, Thaler J; ABCSG. A prospective randomised phase III trial of adjuvant chemotherapy with 5-fluorouracil and leucovorin in patients with stage II colon cancer. Br J Cancer. 2007 Oct 22;97(8):1021-7. Epub 2007 Sep 25. link to original article link to PMC article PubMed
  4. SAKK 40/87: Laffer U, Metzger U, Aeberhard P, Lorenz M, Harder F, Maibach R, Zuber M, Herrmann R. Adjuvant perioperative portal vein or peripheral intravenous chemotherapy for potentially curative colorectal cancer: long-term results of a randomized controlled trial. Int J Colorectal Dis. 2008 Dec;23(12):1233-41. Epub 2008 Aug 8. link to original article PubMed
  5. 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 NCT00002968
  6. ECOG-ACRIN E1292: Kemeny MM, Zhao F, Forastiere AA, Catalano P, Hamilton SR, Miedema BW, Dawson NA, Weiner LM, Smith BD, Mason BA, Graziano SL, Gilman PB, Venook AP, Pinto HA, Whitehead RP, O'Dwyer PJ, Benson AB. Phase III Prospectively Randomized Trial of Perioperative 5-FU After Curative Resection for Colon Cancer: An Intergroup Trial of the ECOG-ACRIN Cancer Research Group (E1292). Ann Surg Oncol. 2023 Feb;30(2):1099-1109. Epub 2022 Oct 28. link to original article link to PMC article PubMed NCT00002525
  7. PanDRa-BD: jRCTs031190186

Placebo

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Midgley et al. 2010 (VICTOR) 2002-2004 Phase 3 (C) Rofecoxib Did not meet primary endpoint of OS

No active antineoplastic treatment.

Preceding treatment

References

  1. VICTOR: Midgley RS, McConkey CC, Johnstone EC, Dunn JA, Smith JL, Grumett SA, Julier P, Iveson C, Yanagisawa Y, Warren B, Langman MJ, Kerr DJ. Phase III randomized trial assessing rofecoxib in the adjuvant setting of colorectal cancer: final results of the VICTOR trial. J Clin Oncol. 2010 Oct 20;28(30):4575-80. Epub 2010 Sep 13. link to original article PubMed NCT00031863

Adjuvant therapy, stage III

Observation

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Panettiere et al. 1988 (SWOG S7510) 1975-1977 Phase 3 (C) 1. 5-FU & Semustine
2. 5-FU, Semustine, BCG 		Did not meet primary endpoint
Lessner et al. 1984 1975-1979 Phase 3 (C) 1. 5-FU & Semustine
2. 5-FU, Semustine, BCG
3. BCG 		Did not meet primary endpoint of OS
Wolmark et al. 1988 (NSABP C-01) 1977-1983 Phase 3 (C) 1. MOF
2. BCG 		Did not meet primary endpoint of OS1
Laffer et al. 1995 (SAKK 40/81) 1981-1987 Phase 3 (C) Portal venous chemotherapy Seems to have inferior OS
Moertel et al. 1990 (SWOG S8591) 1984-1987 Phase 3 (C) 1. 5-FU & Levamisole Inferior OS
2. Levamisole Not reported
Wolmark et al. 1990 (NSABP C-02) 1984-1988 Phase 3 (C) Portal venous chemotherapy Might have inferior OS
Laurie et al. 1989 NR Phase 3 (C) 1. 5-FU & Levamisole Seems to have inferior OS
2. Levamisole Not reported
Fielding et al. 1992 (AXIS-CRC) NR Phase 3 (C) Portal venous chemotherapy Did not meet primary endpoint of OS
Riethmüller et al. 1994 1985-1990 Phase 3 (C) Edrecolomab Seems to have inferior OS
Marsoni et al. 1995 (SITAC-01) NR Phase 3 (C) FULV Seems to have inferior OS
Marsoni et al. 1995 (NCIC-CTG C-03) NR Phase 3 (C) FULV Seems to have inferior OS
Marsoni et al. 1995 (FFCD 8802) NR Phase 3 (C) FULV Seems to have inferior OS
Vaillant et al. 2000 1986-1991 Phase 3 (C) 5-FU; IP Did not meet co-primary endpoints of DFS60/OS60
Rougier et al. 1998 1987-1993 Phase 3 (C) Portal venous chemotherapy Did not meet primary endpoint of OS
Laffer et al. 2008 (SAKK 40/87) 1987-1993 Phase 3 (C) 1. Portal venous 5-FU & Mitomycin
2. 5-FU & Mitomycin 		Did not meet primary endpoint of OS
O'Connell et al. 1997 (CALGB 8896) 1988-02 to 1989-08 Phase 3 (C) FULV Seems to have inferior OS

1Reported efficacy for NSABP C-01 is based on the 2004 update.
No systemic treatment after surgery. The AXIS trial is named "AXIS-CRC" here so as not to confuse it with the AXIS trial in renal cell carcinoma. Note that Marsoni et al. 1995 (IMPACT) is a pooled report of three RCTs.

Preceding treatment

References

  1. Lessner HE, Mayer RJ, Ellenberg SS, Holyoke ED; Gastrointestinal Tumor Study Group. Adjuvant therapy of colon cancer--results of a prospectively randomized trial. N Engl J Med. 1984 Mar 22;310(12):737-43. link to original article PubMed
  2. 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
    1. 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
    2. 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
  3. SWOG S7510: Panettiere FJ, Goodman PJ, Costanzi JJ, Cruz AB Jr, Vaitkevicius VK, McCracken JD, Brownlee RW, Laufman L, Stephens RL, Bonnet J, Bottomley R, Rivkin S, Fletcher W, Oishi N, Chen TT. Adjuvant therapy in large bowel adenocarcinoma: long-term results of a Southwest Oncology Group Study. J Clin Oncol. 1988 Jun;6(6):947-54. link to original article PubMed
  4. Laurie JA, Moertel CG, Fleming TR, Wieand HS, Leigh JE, Rubin J, McCormack GW, Gerstner JB, Krook JE, Malliard J, Twito DI, Morton RF, Tschetter LK, Barlow JF; The North Central Cancer Treatment Group and the Mayo Clinic. Surgical adjuvant therapy of large-bowel carcinoma: an evaluation of levamisole and the combination of levamisole and fluorouracil. J Clin Oncol. 1989 Oct;7(10):1447-56. link to original article PubMed
  5. 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
    1. 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
  6. SWOG S8591: 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
    1. 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
  7. NSABP C-02: Wolmark N, Rockette H, Wickerham DL, Fisher B, Redmond C, Fisher ER, Potvin M, Davies RJ, Jones J, Robidoux A, Wexler M, Gordon P, Cruz AB, Horsley S, Nims TA, Thirlwell M, Phillips WA, Prager D, Stern HS, Lerner HJ, Frazier TG. Adjuvant therapy of Dukes' A, B, and C adenocarcinoma of the colon with portal-vein fluorouracil hepatic infusion: preliminary results of National Surgical Adjuvant Breast and Bowel Project protocol C-02. J Clin Oncol. 1990 Sep;8(9):1466-75. link to original article PubMed
    1. 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
  8. AXIS: Fielding LP, Hittinger R, Grace RH, Fry JS. Randomised controlled trial of adjuvant chemotherapy by portal-vein perfusion after curative resection for colorectal adenocarcinoma. Lancet. 1992 Aug 29;340(8818):502-6. link to original article PubMed
  9. 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
  10. SAKK 40/81: Laffer U, Metzger U, Aeberhard P, Maibach R, Castiglione M, Goldhirsch A; Swiss Group for Clinical Cancer Research. Long-term results of single course of adjuvant intraportal chemotherapy for colorectal cancer. Lancet. 1995 Feb 11;345(8946):349-53. link to original article PubMed
  11. IMPACT: Marsoni S, Labianca R, Pancera G, Torri V, Zaniboni A, Erlichman C, Pater J, Shepherd L, Zee B, Seitz JF, Milan C, Pignon JP; International Multicentre Pooled Analysis of Colon Cancer Trials (IMPACT) investigators. Efficacy of adjuvant fluorouracil and folinic acid in colon cancer. Lancet. 1995 Apr 15;345(8955):939-44. link to original article PubMed
    1. Update: Zaniboni A, Labianca R, Marsoni S, Torri V, Mosconi P, Grilli R, Apolone G, Cifani S, Tinazzi A; Gruppo Italiano Valutazione Interventi in Oncologia. GIVIO-SITAC 01: A randomized trial of adjuvant 5-fluorouracil and folinic acid administered to patients with colon carcinoma--long term results and evaluation of the indicators of health-related quality of life. Cancer. 1998 Jun 1;82(11):2135-44. link to original article PubMed
  12. CALGB 8896: O'Connell MJ, Mailliard JA, Kahn MJ, Macdonald JS, Haller DG, Mayer RJ, Wieand HS. Controlled trial of fluorouracil and low-dose leucovorin given for 6 months as postoperative adjuvant therapy for colon cancer. J Clin Oncol. 1997 Jan;15(1):246-50. link to original article PubMed
    1. Pooled update: Erlichman C, O'Connell M, Kahn M, Marsoni S, Torri V, Tardio B, Zaniboni A, Pancera G, Martignoni G, Labianca R, Barni A, Seitz JF, Milan C, Bedenne L, Giovannini M, Letreut YP, Skillings J, Shepard L, Zee B, Petrioli R, Francini G; International Multicentre Pooled Analysis of B2 Colon Cancer Trials (IMPACT B2) Investigators. Efficacy of adjuvant fluorouracil and folinic acid in B2 colon cancer. J Clin Oncol. 1999 May;17(5):1356-63. link to original article PubMed
  13. Rougier P, Sahmoud T, Nitti D, Curran D, Doci R, De Waele B, Nakajima T, Rauschecker H, Labianca R, Pector JC, Marsoni S, Apolone G, Lasser P, Couvreur ML, Wils J; EORTC Gastrointestinal Tract Cancer Cooperative Group; Gruppo Interdisciplinare Valutazione Interventi in Oncologia; Japanese Foundation for Cancer Research. Adjuvant portal-vein infusion of fluorouracil and heparin in colorectal cancer: a randomised trial. Lancet. 1998 Jun 6;351(9117):1677-81. link to original article PubMed
  14. Vaillant JC, Nordlinger B, Deuffic S, Arnaud JP, Pelissier E, Favre JP, Jaeck D, Fourtanier G, Grandjean JP, Marre P, Letoublon C. Adjuvant intraperitoneal 5-fluorouracil in high-risk colon cancer: a multicenter phase III trial. Ann Surg. 2000 Apr;231(4):449-56. link to original article link to PMC article PubMed
  15. SAKK 40/87: Laffer U, Metzger U, Aeberhard P, Lorenz M, Harder F, Maibach R, Zuber M, Herrmann R. Adjuvant perioperative portal vein or peripheral intravenous chemotherapy for potentially curative colorectal cancer: long-term results of a randomized controlled trial. Int J Colorectal Dis. 2008 Dec;23(12):1233-41. Epub 2008 Aug 8. link to original article PubMed
  16. ADAGE: NCT02355379
  17. POLEM: NCT03827044

Placebo

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Midgley et al. 2010 (VICTOR) 2002-2004 Phase 3 (C) Rofecoxib Did not meet primary endpoint of OS

No active antineoplastic treatment.

Preceding treatment

References

  1. VICTOR: Midgley RS, McConkey CC, Johnstone EC, Dunn JA, Smith JL, Grumett SA, Julier P, Iveson C, Yanagisawa Y, Warren B, Langman MJ, Kerr DJ. Phase III randomized trial assessing rofecoxib in the adjuvant setting of colorectal cancer: final results of the VICTOR trial. J Clin Oncol. 2010 Oct 20;28(30):4575-80. Epub 2010 Sep 13. link to original article PubMed NCT00031863
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