Table 1. Randomized controlled trials (OXA+anti-EGFR vs OXA alone).
Studies | Intervention | Patients (KRASwild typepopulation) | Median follow-up(mo) | Median OS and95%CI(mo) | HR and 95%CI for OS | Median PFSand 95%CI(mo) | HR and 95%CI for PFS | ORR | KRAS test | Jadadscore |
COIN [13] | FOLFOX/XELOX | 367 | 21 | 17.9(no report) | 1.04 [0.88, 1.22] | 8.6(no report) | 0.96 [0.82, 1.12] | 57% | Prospective | 3 |
FOLFOX/XELOX+Cetuximab | 362 | 23 | 17.0(no report) | 8.6(no report) | 64% | |||||
Nordic VII [14] | FLOX | 97 | No report | 22.0(17.9 to 26.1) | 1.14 [0.80, 1.62] | 8.7(7.4 to 9.9) | 1.07 [0.79, 1.45] | 47% | Prospective | 3 |
FLOX+Cetuximab | 97 | No report | 20.1(14.5 to 25.7) | 7.9(6.3 to 9.5) | 46% | |||||
OPUS [11], [12] | FOLFOX4 | 97 | No report | 18.5(no report) | 0.85 [0.60, 1.22] | 7.2(no report) | 0.57 [0.38, 0.86] | 37% | Retrospective | 3 |
FOLFOX4+Cetuximab | 82 | No report | 22.8(no report) | 8.3(no report) | 59% | |||||
PRIME [15], [16] | FOLFOX4 | 325 | 12.5 | 19.7(17.6 to 22.7) | 0.88 [0.73, 1.06] | 8.6(7.5 to 9.5) | 0.80 [0.67, 0.95] | 48% | Prospective | 3 |
FOLFOX4+Panitumumab | 331 | 13.2 | 23.9(20.3 to 27.7) | 10.0(9.3 to 11.4) | 55% |
FOLFOX in COIN study: oxaliplatin 85 mg/m2 on day 1, L-folinic acid 175 mg or D,L-folinic acid 350 mg on day 1, FU 400 mg/m2 bolus and FU 2400 mg/m2 infusion over 46 h. Every 2 weeks.
XELOX in COIN study: oxaliplatin 130 mg/m2 on day 1, capecitabine 850 mg/m2 twice a day on day 1 to 14. Every 3 weeks.
Cetuximab in COIN study: an initial dose of 400 mg/m2 and thereafter 250 mg/m2. Every week.
FLOX in NORDIC VII study: oxaliplatin 85 mg/m2 on day 1, FU 500 mg/m2 bolus +FA 60 mg/m2 bolus on days 1 and 2. Every 2 weeks.
Cetuximab in NORDIC VII study: an initial dose of 400 mg/m2 and thereafter 250 mg/m2. Every week.
FOLFOX4 in OPUS study: oxaliplatin 85 mg/m2 on day 1, leucovorin 200 mg/m2 followed by FU 400 mg/m2 bolus and 600 mg/m2 22-hour continuous infusion on days 1 and 2. Every 2 weeks.
Cetuximab in OPUS study: an initial dose of 400 mg/m2 and thereafter 250 mg/m2. Every week.
FOLFOX4 in PRIME study: oxaliplatin 85 mg/m2 on day 1, leucovorin 200 mg/m2 followed by FU 400 mg/m2 bolus and 600 mg/m2 22-hour continuous infusion on days 1 and 2. Every 2 weeks.
Panitumumab in PRIME study: 6 mg/kg. Every 2 weeks.