NO16968
Trial question
What is the role of capecitabine plus oxaliplatin in patients with resected stage III colon cancer?
Study design
Multi-center
Open label
RCT
Population
1886 patients.
Inclusion criteria: patients with resected stage III colon cancer.
Key exclusion criteria: pregnancy or lactation; sexually active males and females unwilling to practice contraception during the study; previous cytotoxic chemotherapy, radiotherapy, or immunotherapy for currently treated colon cancer; patients not completely recovering from surgery.
Interventions
N=944 XELOX (oxaliplatin 130 mg/m² on day 1 plus capecitabine 1,000 mg/m² BID on days 1-14 every 3 weeks for 6 months).
N=942 FU/FA (bolus fluorouracil/folinic acid for 6 months).
Primary outcome
Disease-free survival at 7 years
63%
56%
63.0 %
47.3 %
31.5 %
15.8 %
0.0 %
XELOX
FU/FA
Significant
increase ▲
NNT = 14
Significant increase in disease-free survival at 7 years (63% vs. 56%; HR 1.25, 95% CI 1.07 to 1.45).
Secondary outcomes
Significant increase in overall survival at 7 years (73% vs. 67%; HR 1.2, 95% CI 1.01 to 1.43).
Significant increase in relapse-free survival at 7 years (66% vs. 58%; HR 1.28, 95% CI 1.1 to 1.5).
Significant decrease in median time from relapse to death (21.6 months vs. 24.8 months; HR 0.9, 95% CI 0.75 to 0.92).
Conclusion
In patients with resected stage III colon cancer, XELOX was superior to FU/FA with respect to a disease-free survival at 7 years.
Reference
Hans-Joachim Schmoll, Josep Tabernero, Jean Maroun et al. Capecitabine Plus Oxaliplatin Compared With Fluorouracil / Folinic Acid As Adjuvant Therapy for Stage III Colon Cancer: Final Results of the NO16968 Randomized Controlled Phase III Trial. J Clin Oncol. 2015 Nov 10;33(32):3733-40.
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