Tournigand DREAM 2015.
Methods | Phase III RCT; n = 452 | |
Participants | People with unresectable mCRC after initial bevacizumab‐including therapy (mFOLFOX7 with bevacizumab, CAPOX with bevacizumab, or FOLFIRI with bevacizumab) | |
Interventions | Arm A: maintenance combination of bevacizumab and erlotinib. Arm B: maintenance bevacizumab | |
Outcomes | Primary endpoint: maintenance PFS. Secondary endpoints: PFS from inclusion, OS, safety | |
Notes | Sponsored by GERCOR and F. Hoffmann‐La Roche. Tournigand: grants from Roche, Sanofi, Merck, Amgen, Bayer. de Gramont: personal fees for talks and participation in advisory boards from Roche and Sanofi‐Aventis Median follow‐up: 48 to 51 months |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | The random allocation sequence was generated through a computer random number generator. |
Allocation concealment (selection bias) | Unclear risk | An unblinded randomisation (1:1) was done with a minimisation technique. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Open‐label study |
Blinding of outcome assessment (detection bias) All outcomes | High risk | No statement of central or blinded review of imaging to determine PFS ‐ awaiting response from authors |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Not stated, but 6/228 participants in bevacizumab arm and 4/224 participants in bevacizumab + erlotinib arm discontinued treatment due to "patient choice". In addition, long median follow‐up and balance of participants characteristics make significant attrition bias unlikely. |
Selective reporting (reporting bias) | Low risk | All outcomes reported. |
Other bias | Low risk | No other potential biases detected. |