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The trial that proved an EGFR antibody on its own lengthens life in bowel cancer, and whose stored tumour blocks then proved that only KRAS-normal tumours benefit.
CO.17 randomised 572 patients with pretreated EGFR-positive metastatic colorectal cancer to cetuximab with best supportive care or best supportive care alone. Cetuximab improved overall survival (hazard ratio for death 0.77, 95% CI 0.64 to 0.92, p=0.005) and progression-free survival (hazard ratio 0.68, 0.57 to 0.80) while preserving quality-of-life measures. Its lasting importance is the retrospective biomarker analysis of the trial's tumour blocks, published a year later, which found the survival benefit confined to KRAS wild-type tumours and absent, with a trend to harm, in KRAS-mutant ones: the first negative predictive biomarker in solid-tumour oncology and the reason RAS testing became mandatory before any EGFR antibody.
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.
572 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survivalprimary | Cetuximab plus best supportive care | - | 0.77 hazard ratio | 0.77 (0.64 to 0.92) | 0.005 | link |
| Best supportive care | - | 1 hazard ratio |
Shares Canadian Cancer Trials Group (CCTG), Cetuximab, Colorectal cancer.
Shares CRYSTAL & FIRE-3, Cetuximab, EGFR, KRAS.
Shares CRYSTAL & FIRE-3, Cetuximab, EGFR, KRAS.
Shares Cetuximab, EGFR, KRAS, Colorectal cancer.
Shares CRYSTAL & FIRE-3, Cetuximab, EGFR, KRAS.
Shares Cetuximab, EGFR, KRAS, Monoclonal antibodies.
Shares CRYSTAL & FIRE-3, Cetuximab, EGFR, KRAS.
Shares Cetuximab, EGFR, KRAS, Monoclonal antibodies.