| Methods |
Phase III open‐label RCT; n = 1186 |
| Participants |
People with mCRC, with 1 prior chemotherapy regimen |
| Interventions |
FOLFIRI with panitumumab vs FOLFIRI |
| Outcomes |
Primary outcomes: PFS, OS. Secondary outcomes: TRR, duration of response, safety |
| Notes |
Supported by Amgen. Peeters: consultancy (Amgen), honoraria (Amgen), research funding (Amgen). Gansert: employment/leadership (Amgen), stock ownership (Amgen). Median follow‐up time was 13.3 months (range 0.2 to 31.7 months) in the KRAS exon 2 WT panitumumab‐FOLFIRI arm, 10.2 months (range 0.5 to 32.9 months) in the
KRAS exon 2 WT FOLFIRI arm, 10.5 months (range 0.2 to 30.1 months) in the KRAS exon 2 MT panitumumab‐FOLFIRI arm, and 9.5 months (range 0 to 31.7 months) in the KRAS exon 2 MT FOLFIRI arm. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
No details specified. |
| Allocation concealment (selection bias) |
Unclear risk |
No details specified. |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Open label (but assessment of endpoints blinded for PFS and not affected for OS) |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Tumour response was assessed by the investigator and by an independent central radiology review blinded to treatment and outcomes. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
No attrition data available, but PFS occurred in 178/303 (59%) of participants in the FOLFIRI with panitumumab arm and 203/294 (69%) of participants in the FOLFIRI arm, with median follow‐up 13.3 months. |
| Selective reporting (reporting bias) |
Low risk |
All stated outcomes reported. |
| Other bias |
Low risk |
No other significant bias present; funders did not have inappropriate influence. |
