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N ational S urgical A djuvant B reast and B owel P roject

N ational S urgical A djuvant B reast and B owel P roject. Oxaliplatin, Fluorouracil, and Leucovorin as Adjuvant Treatment for Colon Cancer

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N ational S urgical A djuvant B reast and B owel P roject

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  1. National Surgical Adjuvant Breast and Bowel Project

  2. Oxaliplatin, Fluorouracil, and Leucovorin as Adjuvant Treatment for Colon Cancer Thierry André, M.D., Corrado Boni, M.D., Lamia Mounedji-Boudiaf, M.D.,Matilde Navarro, M.D., Josep Tabernero, M.D., Tamas Hickish, M.D.,Clare Topham, M.D., Marta Zaninelli, M.D., Philip Clingan, M.D., John Bridgewater, M.D., Isabelle Tabah-Fisch, M.D.,and Aimery de Gramont, M.D., for the Multicenter International Study of Oxaliplatin/5-Fluorouracil/Leucovorin in the Adjuvant Treatment of Colon Cancer (MOSAIC) Investigators

  3. 1993-2003: A Decade of Decadence Mayo v. RPMI Bolus v. Infusion of 5FU Efficacy of levamisole High v. Low dose levamisole, LV Dukes’ B v C American v. European Advocacy neglect Consensus statement abstinence Paucity of trials

  4. EDITORIAL New England Journal of Medicine Two Steps Forward in the Treatment of Colorectal Cancer

  5. Curative Options for Colorectal Cancer: Folklore, fables, and mythes

  6. Variations on a theme of B (minor)

  7. On November 4, 2004, the FDA approved oxaliplatin in combination with infusionalFULV for adjuvant stage III colon cancer.

  8. The Global test for interaction between treatment and tumor stage (II+III) was not significant (p=0.71)

  9. INT 0035 ’85-’87 DukesBDukesC Control Control FU+LEV FU+LEV LEV n=318n=929

  10. NSABP Pooled analysis of NSABP C-01 through C-04 Death Recurrence DFS event All patients Stage II Stage III 0.5 1 2.0 0.5 1 2.0 0.5 1 2.0

  11. INT 0035 Dukes BRFS 78 70 % Cont FuLev 159 159 45 32 P = 0.10 Yrs. 31% reduction in recurrence Source: Moertel CG et al. J Clin Oncol 1995;13(12):2936-43.

  12. COMBINED ANALYSIS 11.77-12.90 Treatment 1 Treatment 2 MOF PVI FU+LV FU+LV C-01 C-02 C-03 C-04 0.05 0.02 <0.001 0.03 OP OP MOF FU+LEV Vs Vs Vs Vs N = 1924 N = 1896 JCO 1999;17:1349

  13. PATIENT POPULATION • DUKES’ B 1567 • DUKES’ C 2254 JCO 1999;17:1349

  14. American Society of Clinical Oncology Recommendations on Adjuvant Chemotherapy for Stage II Colon Cancer Al B. Benson III, Deborah Schrag, Mark R. Somerfield, Alfred M. Cohen, Alvaro T. Figueredo, Patrick J. Flynn, Monika K. Krzyzanowska, Jean Maroun, Pamela McAllister, Eric Van Cutsem, Melissa Brouwers, Manya Charette, and Daniel G. Haller

  15. Quick & Simple & Reliable 'Uncertain indication' for chemotherapy (3239 patients ’94 -’03 MTS 4.6 yrs) Randomize Observation (n=1617) FULV ± Lev (n=1622) 92% Dukes B Richard G. Gray MS

  16. Quasar Survival n dths 5yS p Chemo 1622 281 80.3 0.02 None 1617 328 77.4 Source: With permission. Gray RG et al. Presentation. ASCO 2004. Abstract 3501.

  17. Quasar Dukes B Survival dths p Chemo 224 0.04 None 262 Source: With permission. Gray RG et al. Presentation. ASCO 2004. Abstract 3501.

  18. Stage II: Putative Prognostic Discriminates MSI Allelic instability (18q del) Venous invasion T differentiation Number N examined (ignored or absent) High Risk Stage II Mayo algorithm

  19. Gene Identification: C-01/C-02 • Univariate analysis • 142 of 757 genes were associated with RFS (p<0.05)

  20. Gene Identification: C-01/C-02 • Multivariate analysis • Individual Genes • # Pos Nodes • Tumor Grade • Tumor Location • 66 of the 142 genes retained independent significance (p<0.05)

  21. Survey: N=150 pt with CRC Cum % rec treatment % risk reduction Love N. Asco GI 2006

  22. None 1% None 1% FFox 68% FU 10% FFox 87% 6% 6% Cape 21% Stage II Stage III Survey: N=150 pt with CRC Love N. Asco GI 2006 # 373

  23. Survey: N=100 Medical Oncologists Breast CRC % likely to treat % risk reduction Love N. Asco GI 2006

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