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
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Discussion
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Implication
Randomized phase III trial demonstrates superior survival with capecitabine plus oxaliplatin in stage III colon cancer, supporting its role as standard adjuvant chemotherapy.
Key Points
- To report the final efficacy outcomes and predictive biomarker findings after nearly seven years of follow-up in patients receiving adjuvant chemotherapy for resected stage III colon cancer.
- In an open-label, randomized phase III trial, 1,886 patients with resected stage III colon cancer were randomly assigned to receive either adjuvant XELOX (oxaliplatin and oral capecitabine; n = 944) or bolus FU/FA (fluorouracil/folinic acid; n = 942) for 6 months.
- The primary endpoint was disease-free survival (DFS), secondary endpoints included overall survival (OS), and 498 consenting patients underwent tumor biomarker analysis including dihydropyrimidine dehydrogenase expression.
- XELOX significantly improved 7-year DFS compared with FU/FA (63% vs 56%; HR 0.80, 95% CI, 0.69 to 0.93; P = .004).
- XELOX significantly improved 7-year OS compared with FU/FA (73% vs 67%; HR 0.83, 95% CI, 0.70 to 0.99; P = .04).
- In the XELOX arm, high versus low tumor expression of dihydropyrimidine dehydrogenase correlated with worse DFS (HR 2.45, 95% CI, 1.55 to 3.86; P < .001) and OS (HR 2.75, 95% CI, 1.65 to 4.59; P < .001).
Cite This Study
Schmoll et al. (2015) studied this question.