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Clinical Trial
. 2011 Jun 28;105(1):58-64.
doi: 10.1038/bjc.2011.201. Epub 2011 Jun 14.

XELOX vs FOLFOX-4 as first-line therapy for metastatic colorectal cancer: NO16966 updated results

J Cassidy  1 , S Clarke, E Díaz-Rubio, W Scheithauer, A Figer, R Wong, S Koski, K Rittweger, F Gilberg, L Saltz
Affiliations
Clinical Trial

XELOX vs FOLFOX-4 as first-line therapy for metastatic colorectal cancer: NO16966 updated results

J Cassidy et al. Br J Cancer. .

Abstract

Background: We report updated overall survival (OS) data from study NO16966, which compared capecitabine plus oxaliplatin (XELOX) vs 5-fluorouracil/folinic acid plus oxaliplatin (FOLFOX4) as first-line therapy in metastatic colorectal cancer.

Methods: NO16966 was a randomised, two-arm, non-inferiority, phase III comparison of XELOX vs FOLFOX4, which was subsequently amended to a 2 × 2 factorial design with further randomisation to bevacizumab or placebo. A planned follow-up exploratory analysis of OS was performed.

Results: The intent-to-treat (ITT) population comprised 2034 patients (two-arm portion, n=634; 2 × 2 factorial portion, n=1400). For the whole NO16966 study population, median OS was 19.8 months in the pooled XELOX/XELOX-placebo/XELOX-bevacizumab arms vs 19.5 months in the pooled FOLFOX4/FOLFOX4-placebo/FOLFOX4-bevacizumab arms (hazard ratio 0.95 (97.5% CI 0.85-1.06)). In the pooled XELOX/XELOX-placebo arms, median OS was 19.0 vs 18.9 months in the pooled FOLFOX4/FOLFOX4-placebo arms (hazard ratio 0.95 (97.5% CI 0.83-1.09)). FOLFOX4 was associated with more grade 3/4 neutropenia/granulocytopenia and febrile neutropenia than XELOX, and XELOX with more grade 3 diarrhoea and grade 3 hand-foot syndrome than FOLFOX4.

Conclusion: Updated survival data from study NO16966 show that XELOX is similar to FOLFOX4, confirming the primary analysis of progression-free survival. XELOX can be considered as a routine first-line treatment option for patients with metastatic colorectal cancer.

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Figures

Figure 1
Figure 1
The CONSORT flowchart.
Figure 2
Figure 2
Overall survival for FOLFOX4/FOLFOX4-placebo/FOLFOX4-bevacizumab vs XELOX/XELOX-placebo/XELOX-bevacizumab (A), FOLFOX4/FOLFOX4-placebo vs XELOX/XELOX-placebo (B), FOLFOX4-bevacizumab vs XELOX-bevacizumab (C) and FOLFOX4 vs XELOX (D) (ITT population).
See this image and copyright information in PMC

References

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