Capecitabine plus oxaliplatin compared with fluorouracil and folinic acid as adjuvant therapy for stage III colon cancer Full Text
Journal of Clinical Oncology, 03/11/2011
Clinical Article
Haller DG et al. – The addition of oxaliplatin to capecitabine improves DFS in patients with stage III colon cancer. XELOX is an additional adjuvant treatment option for these patients.
Methods- Patients who had undergone curative resection randomly assigned to XELOX (oxaliplatin 130 mg/m2 on day 1 plus capecitabine 1,000 mg/m2 twice daily on days 1 to 14 every 3 weeks for 24 weeks) or standard bolus FU/FA adjuvant regimen (Mayo Clinic for 24 weeks or Roswell Park for 32 weeks)
- Primary study end point DFS
- Intention-to-treat population comprised 1,886 patients; 944 patients randomly assigned to XELOX and 942 to FU/FA (Mayo Clinic, n = 664; Roswell Park, n = 278)
- After 57 months of follow-up for primary analysis, 295 patients (31.3%) in XELOX group had relapsed, developed new primary colon cancer, or died compared with 353 patients (37.5%) in FU/FA group (HR for DFS, 0.80; 95% CI, 0.69 to 0.93; P = .0045)
- 3-year DFS rate 70.9% with XELOX and 66.5% with FU/FA
- HR for OS for XELOX compared to FU/FA 0.87 (95% CI, 0.72 to 1.05; P = .1486)
- 5-year OS for XELOX and FU/FA 77.6% and 74.2%
- Follow-up ongoing
- Preplanned multivariate and subgroup analyses supported robustness of these findings
