| Methods |
Phase III randomised, open‐label trial |
| Participants |
People with mCRC |
| Interventions |
All participants received first‐line XELOX/XELIRI/mFOLFOX6/FOLFIRI with bevacizumab as well as KRAS testing; those with stable disease or better after 18 weeks were randomised ‐ if KRAS exon 2 WT, to maintenance bevacizumab and erlotinib; if KRAS exon 2 MT, to bevacizumab or continuous capecitabine (500 mg twice daily). |
| Outcomes |
Primary endpoint: PFS at 3 months. Secondary endpoints: PFS, OS, toxicity |
| Notes |
Investigator‐sponsored trial, supported by Roche, Skane County Council, Sweden, Futurm, and John and Augusta Persson's Trust, Lund, Sweden. AJ: honoraria from Genentech. Median follow‐up 34.5 months |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Block randomisation was used (2 arms, 2 strata = 4 strata groups), each block 4 participants, double block size. |
| Allocation concealment (selection bias) |
Low risk |
Allocation concealment was ensured as randomisation procedure was conducted by a central co‐ordinated randomising service provided by the regional cancer centre in Skane/Lund, Sweden. |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Open‐label trial |
| Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
Whilst assessment of tumour response was undertaken using RECIST criteria, measurement of lesions was performed in an open‐label fashion by local radiologists at the participating site. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Not stated, but only 2/233 participants withdrew consent. As 184/233 participants had documented death by time of publication, we feel that there is low risk of attrition bias. |
| Selective reporting (reporting bias) |
Low risk |
All endpoints reported. |
| Other bias |
Unclear risk |
Hagman and Johnsson: No declared conflicts of interest. |
