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Bending the Curve Trial by Trial
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N0147

A Randomized Phase III Trial of Oxaliplatin (OXAL) Plus 5-Fluorouracil (5-FU)/Leucovorin (CF) With or Without Cetuximab (C225) After Curative Resection for Patients With Stage III Colon Cancer

Phase 3N = 2,686NCT00079274

Population
2686 patients aged 18 or older; 1863 with wild-type KRAS tumours at the interim analysis (2070 planned), 717 with mutated KRAS and 106 with indeterminate KRAS. ClinicalTrials.gov lists a larger actual enrolment (3397).
Design
Randomised phase III trial in North America of 12 biweekly cycles of mFOLFOX6 with or without cetuximab after resection of stage III colon cancer; KRAS status centrally determined. The trial was halted after a planned interim analysis at 48 percent of predicted events in patients with wild-type KRAS. Primary outcome disease-free survival in patients with wild-type KRAS.
Primary endpoint
DFS
Arms
  • mFOLFOX6 (control): 12 biweekly cycles of mFOLFOX6
  • mFOLFOX6 plus cetuximab (experimental): 12 biweekly cycles of mFOLFOX6 plus cetuximab
People
Alberts SR
DFSHR 1.21 (95% CI 0.98–1.49)Δ 36-month DFS−3.1 pointsDFSHR 1.12 (95% CI 0.86–1.46)Δ 36-month DFS−2.1 pointsΔ Grade 3 or worse adverse events+20.2 points
Show the numbers
Results reported for N0147
EndpointAnalysismFOLFOX6 plus cetuximabmFOLFOX6Effect
DFSPatients with wild-type KRAS tumours (1,863 at the interim analysis)primarymedian follow-up 28 monthsAlberts 201271.5% at 3 y74.6% at 3 yHR 1.21 (95% CI 0.98–1.49)P=0.08Hazard ratio above 1 indicates a numerically shorter DFS with cetuximab. Trial halted after a planned interim analysis at 48 percent of predicted events (246 of 515).
DFSPatients with mutated KRAS tumours (717)exploratorymedian follow-up 28 monthsAlberts 201265% at 3 y67.1% at 3 yHR 1.12 (95% CI 0.86–1.46)P=0.38
Grade 3 or worse adverse eventsAll patients (among all patients, as stated in the abstract)primaryAlberts 201272.5%52.3%P<0.001Odds ratio 2.4 (95% CI 2.1 to 2.8) for cetuximab versus mFOLFOX6 alone. Failure to complete 12 cycles 33 percent versus 23 percent (P < .001).
Results reported for N0147
EndpointAnalysismFOLFOX6 plus cetuximabmFOLFOX6Effect
DFSPatients with wild-type KRAS tumours (1,863 at the interim analysis)primarymedian follow-up 28 monthsAlberts 201271.5% at 3 y74.6% at 3 yHR 1.21 (95% CI 0.98–1.49)P=0.08Hazard ratio above 1 indicates a numerically shorter DFS with cetuximab. Trial halted after a planned interim analysis at 48 percent of predicted events (246 of 515).
DFSPatients with mutated KRAS tumours (717)exploratorymedian follow-up 28 monthsAlberts 201265% at 3 y67.1% at 3 yHR 1.12 (95% CI 0.86–1.46)P=0.38
Grade 3 or worse adverse eventsAll patients (among all patients, as stated in the abstract)primaryAlberts 201272.5%52.3%P<0.001Odds ratio 2.4 (95% CI 2.1 to 2.8) for cetuximab versus mFOLFOX6 alone. Failure to complete 12 cycles 33 percent versus 23 percent (P < .001).
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
DFSDFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
DFS1.210.98–1.49
DFS1.120.86–1.46
Primary publication: Alberts SR, Sargent DJ, Nair S, Mahoney MR, Mooney M, Thibodeau SN, et al. Effect of oxaliplatin, fluorouracil, and leucovorin with or without cetuximab on survival among patients with resected stage III colon cancer: a randomized trial. JAMA. 2012;307(13):1383-93. PubMedDOI

Appears in

Sources

  1. Alberts SR, Sargent DJ, Nair S, Mahoney MR, Mooney M, Thibodeau SN, et al. Effect of oxaliplatin, fluorouracil, and leucovorin with or without cetuximab on survival among patients with resected stage III colon cancer: a randomized trial. JAMA. 2012;307(13):1383-93.

    PubMedDOI