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Bending the Curve Trial by Trial
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PETACC-8

Oxaliplatin, fluorouracil, and leucovorin with or without cetuximab in patients with resected stage III colon cancer (PETACC-8): an open-label, randomised phase 3 trial

Phase 3N = 2,559NCT00265811

Population
2559 patients randomised at 340 sites; 1602 had KRAS exon 2 wild-type tumours (intention-to-treat population).
Design
Open-label, randomised phase 3 trial in nine European countries: 12 cycles of FOLFOX4 with or without cetuximab after R0 resection of stage III colon cancer. A protocol amendment in June 2008, after 2096 patients had been randomised, restricted enrolment to KRAS exon 2 wild-type tumours. Primary endpoint disease-free survival, analysed by intention to treat in patients with KRAS exon 2 wild-type tumours. Also registered as EudraCT 2005-003463-23.
Primary endpoint
DFS
Arms
  • FOLFOX4 (control, n = 811): 12 cycles of FOLFOX4
  • FOLFOX4 plus cetuximab (experimental, n = 791): 12 cycles of FOLFOX4 plus cetuximab
People
Taieb J, PETACC-8 Study Investigators
DFSHR 1.05 (95% CI 0.85–1.29)DFSHR 0.99 (95% CI 0.76–1.28)DFSHR 1.06 (95% CI 0.82–1.37)
Show the numbers
Results reported for PETACC-8
EndpointAnalysisFOLFOX4 plus cetuximabFOLFOX4Effect
DFSprimarymedian follow-up 3.3 yearsTaieb 2014——HR 1.05 (95% CI 0.85–1.29)P=0.66Population: patients with KRAS exon 2 wild-type tumours (1602). Grade 3 or 4 acne-like rash 27 percent versus under 1 percent, diarrhoea 14 percent versus 9 percent, mucositis 8 percent versus 1 percent with FOLFOX4 plus cetuximab versus FOLFOX4.
DFSPatients with KRAS exon 2 and BRAF wild-type tumours (984)exploratorymedian follow-up 3.3 yearsTaieb 2014——HR 0.99 (95% CI 0.76–1.28)The authors describe heterogeneous responses in preplanned subgroup analyses.
DFSPatients with KRAS exon 2-mutated tumours (742)exploratorymedian follow-up 3.3 yearsTaieb 2014——HR 1.06 (95% CI 0.82–1.37)
Results reported for PETACC-8
EndpointAnalysisFOLFOX4 plus cetuximabFOLFOX4Effect
DFSprimarymedian follow-up 3.3 yearsTaieb 2014——HR 1.05 (95% CI 0.85–1.29)P=0.66Population: patients with KRAS exon 2 wild-type tumours (1602). Grade 3 or 4 acne-like rash 27 percent versus under 1 percent, diarrhoea 14 percent versus 9 percent, mucositis 8 percent versus 1 percent with FOLFOX4 plus cetuximab versus FOLFOX4.
DFSPatients with KRAS exon 2 and BRAF wild-type tumours (984)exploratorymedian follow-up 3.3 yearsTaieb 2014——HR 0.99 (95% CI 0.76–1.28)The authors describe heterogeneous responses in preplanned subgroup analyses.
DFSPatients with KRAS exon 2-mutated tumours (742)exploratorymedian follow-up 3.3 yearsTaieb 2014——HR 1.06 (95% CI 0.82–1.37)
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
DFSDFSDFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
DFS1.050.85–1.29
DFS0.990.76–1.28
DFS1.060.82–1.37
Primary publication: Taieb J, Tabernero J, Mini E, Subtil F, Folprecht G, Van Laethem JL, et al. Oxaliplatin, fluorouracil, and leucovorin with or without cetuximab in patients with resected stage III colon cancer (PETACC-8): an open-label, randomised phase 3 trial. Lancet Oncol. 2014;15(8):862-73. PubMedDOI

Appears in

Sources

  1. Taieb J, Tabernero J, Mini E, Subtil F, Folprecht G, Van Laethem JL, et al. Oxaliplatin, fluorouracil, and leucovorin with or without cetuximab in patients with resected stage III colon cancer (PETACC-8): an open-label, randomised phase 3 trial. Lancet Oncol. 2014;15(8):862-73.

    PubMedDOI