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Background

Capecitabine plus oxaliplatin (XELOX) as adjuvant therapy for stage III colon cancer: Final results of NO16968. H-J. Schmoll, J. Tabernero, J. Maroun, F. de Braud T. Price, E. Van Cutsem, M. Hill, S. Hoersch K. Rittweger, D. Haller. Background.

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Background

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  1. Capecitabine plus oxaliplatin (XELOX) as adjuvant therapy forstage III colon cancer:Final results of NO16968 H-J. Schmoll, J. Tabernero, J. Maroun, F. de Braud T. Price, E. Van Cutsem, M. Hill, S. HoerschK. Rittweger, D. Haller

  2. Background • Oxaliplatin in combination with a fluoropyrimidine is the accepted standard adjuvant regimen for patients with stage III colon cancer following curative resection1,2 • This recommendation is based on the DFS findings of three large randomized controlled trials – MOSAIC,3 NSABP C-07,4 and NO169685 • All three trials showed that adding oxaliplatin to a fluoropyrimidine significantly prolongs DFS compared with 5-FU/LV in patients with stage III colon cancer3–5 1. Labianca et al. Ann Oncol 2010;21 (Suppl 5):70–7; 2. NCCN Guidelines: Colon cancer 2012, vs 2 3. André et al. NEJM 2004;350:2343–51; 4. Kuebler et al. JCO 2007;25:2198–204; 5. Haller et al. JCO 2011;29:1465–71

  3. Background • Mature survival data are now available for all three trials • In MOSAIC, a significant improvement in OS was observed with FOLFOX4 vs infusional 5-FU/LV in patients with stage III disease (median follow-up of 6.8 years)1 • In NSABP C-07, the difference in OS between FLOX and bolus 5-FU/LV did not reach statistical significance after a median follow-up of 8 years in patients with stage II/III disease2 1. André et al. JCO 2009;27:3109–16 2. Yothers et al. JCO 2011;28:3768–74

  4. NO16968: Final OS analysis • NO16968 compared capecitabine plus oxaliplatin (XELOX) with bolus 5-FU/LV in patients with stage III colon cancer • We present here the pre-specified final analysis from this trial, which was performed after a median follow-up of 7 years

  5. NO16968: Trial design RANDO MIS ATION XELOX (6 months) Capecitabine 1000 mg/m2 bid d1–14Oxaliplatin 130 mg/m2 d1 q3w8 cycles n=944 Chemo/radiotherapy-naive stage III colon cancer ≤8 weeks since resection N=1886 Bolus 5-FU/LV (6 months) Mayo Clinic (n=664)orRoswell Park (n=278) n=942 • Primary endpoint: DFS • Secondary endpoints: OS, RFS, tolerability Haller et al. Eur J Cancer Suppl, Vol.7, No3, Sept 2009, s4

  6. Patient demographics ITT population Haller et al. Eur J Cancer Suppl, Vol.7, No3, Sept 2009, s4

  7. Disease-free survival HR 0.80 (95% CI 0.69–0.93) p=0.0038 Survival 5–FU/LV XELOX 1.0 0.9 0.8 0.7 0.6 0.5 0.4 0.3 0.2 0.1 0.0 0 6 12 18 24 30 36 42 48 54 60 66 72 78 84 Study month No. left 5–FU/LV XELOX 655 677 758 784 610 647 476 526 235 268 942 944 522 577 437 481 694 722 579 622 74 92 859 865 501 557 334 393 535 599 Updated from: Haller et al. JCO 2011;29:1465–71 ITT population

  8. Overall survival Follow-up: median 7y / minimum 6.6y HR 0.83 (95% CI 0.70–0.99) p=0.0367 Survival 5–FU/LV XELOX 1.0 0.9 0.8 0.7 75% 0.6 0.5 ∆ 6% 0.4 0.3 0.2 0.1 0.0 0 6 12 18 24 30 36 42 48 54 60 66 72 78 84 Study month No. left 5–FU/LV XELOX 817 807 881 875 787 790 647 668 516 572 942 944 693 703 625 659 852 835 758 770 258 281 904 902 661 683 591 641 726 738 Updated from: Haller et al. JCO 2011;29:1465–71 ITT population

  9. Overall survival Follow-up: median 7y / minimum 6.6y HR 0.83 (95% CI 0.70–0.99) p=0.0367 Survival 5–FU/LV XELOX 1.0 0.9 0.8 0.7 75% 0.6 0.5 ∆ 6% 0.4 0.3 0.2 0.1 0.0 0 6 12 18 24 30 36 42 48 54 60 66 72 78 84 Study month No. left 5–FU/LV XELOX 817 807 881 875 787 790 647 668 516 572 942 944 693 703 625 659 852 835 758 770 258 281 904 902 661 683 591 641 726 738 Updated from: Haller et al. JCO 2011;29:1465–71 ITT population

  10. NO16968: Conclusions • XELOX improves DFS versus bolus 5-FU/LV in patients with stage III colon cancer • DFS benefits observed with XELOX translate into a significant OS gain after a median follow-up of 7 years • Benefit is less in patients ≥70 years than in younger patients • Translational research programme underway • XELOX should be considered a standard adjuvant treatment option in patients with stage III colon cancer

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