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Adding the EGFR antibody cetuximab to chemotherapy after surgery did not help, even in patients whose tumours had no KRAS mutation.
PETACC-8 randomised 2,559 patients with resected stage III colon cancer in 340 European centres to FOLFOX4 with or without cetuximab. In the 1,602 patients with KRAS exon 2 wild-type tumours, disease-free survival was no different (hazard ratio 1.05, 95% CI 0.85 to 1.29, p=0.66), and there was no benefit in the KRAS exon 2 and BRAF wild-type subgroup either (0.99, 0.76 to 1.28). Grade 3 or 4 acne-like rash affected 27 percent of the cetuximab group. With N0147 reaching the same conclusion in North America, the two trials closed the question: anti-EGFR antibodies work in metastatic left-sided RAS wild-type disease and have no place in the adjuvant setting.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
2,559 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Disease-free survival (KRAS exon 2 wild-type)primary | FOLFOX4 plus cetuximab | 791 | 1.05 hazard ratio | 1.05 (0.85 to 1.29) | 0.66 | link |
| FOLFOX4 | 811 | 1 hazard ratio |
Shares Colorectal cancer: the failed and stopped programmes, and why, Oxaliplatin, Cetuximab, FOLFOX (5-FU, leucovorin, oxaliplatin).
Shares Oxaliplatin, Cetuximab, FOLFOX (5-FU, leucovorin, oxaliplatin), EGFR.
Shares Oxaliplatin, Cetuximab, FOLFOX (5-FU, leucovorin, oxaliplatin), EGFR.
Shares Cetuximab, FOLFOX (5-FU, leucovorin, oxaliplatin), Monoclonal antibodies, Colon cancer (adenocarcinoma of the colon).
Shares Oxaliplatin, Cetuximab, FOLFOX (5-FU, leucovorin, oxaliplatin), EGFR.
Shares Cetuximab, FOLFOX (5-FU, leucovorin, oxaliplatin), Monoclonal antibodies, Colon cancer (adenocarcinoma of the colon).
Shares Cetuximab, FOLFOX (5-FU, leucovorin, oxaliplatin), Monoclonal antibodies, Colon cancer (adenocarcinoma of the colon).
Shares Colorectal cancer: the failed and stopped programmes, and why, Oxaliplatin, FOLFOX (5-FU, leucovorin, oxaliplatin), Colon cancer (adenocarcinoma of the colon).