Skip to main content
. 2017 Jun 27;2017(6):CD007047. doi: 10.1002/14651858.CD007047.pub2

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
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.