Table 2.
Selected clinical studies from targeted literature review.
| Trial alias | Author (year) | Treatment | Trial design | N | Included or not included in meta-analysis |
|---|---|---|---|---|---|
| CECOG | Brodowicz et al. (2013) | CET (Q1W) + FOLFOX vs CET (Q2W) + FOLFOX | Ph2, randomized | Q1W = 75 Q2W = 77 |
Included; randomized trial with sufficient sample size to provide the highest quality evidence to support Q2W vs Q1W CET |
| OPTIMIX-ACROSS | Fernandez-Plana et al. (2014) | CET + FOLFOX4 | Ph2, single-arm | Q2W = 99 | Includeda |
| APEC | Cheng et al. (2016) | CET + FOLFIRI or CET + FOLFOX |
Ph2, single-arm | Q2W = 101 (CET + FOLFIRI) Q2W=188 (CET + FOLFOX) |
Includeda |
| CELINE | Kotake et al. (2017) | CET + 5-FU + FOLFOX6 | Ph2, single-arm | Q2W = 60 | Includeda |
| NORDIC 7.5 | Pfeiffer et al. (2015) | FLOX + CET for 16 weeks then Maintenance CET (Q1W vs Q2W) | Ph2, single-arm | Q1W = 109 Q2W = 152 |
Included; Inclusion criteria allowed for comparison of NORDIC 7.5 to NORDIC VII |
| Tabernero et al. (2010) | CET monotherapy or CET + FOLFIRI | 62 | Not Included; Phase 1 trial, limited patient data at 500 mg/m2 dosing | ||
| FLEET2 | Hazama et al. (2016) | CET + XELOX | Ph2, single-arm | Q1W = 14 Q2W = 26 |
Not included; small sample size, patient characteristics are significantly different between Q1W and Q2W cohorts |
Abbreviations: CET = cetuximab; Ph = phase; Q1W = weekly; Q2W = biweekly.