Table 2 Efficacy in the FAS

From: First-line treatment of anti-EGFR monoclonal antibody cetuximab β plus FOLFIRI versus FOLFIRI alone in Chinese patients with RAS/BRAF wild-type metastatic colorectal cancer: a randomized, phase 3 trial

Efficacy

Cetuximab β plus FOLFIRI (n = 257)

FOLFIRI (n = 248)

PFS

 No. of events (PD or death), n (%)a

96 (37.4)

79 (31.9)

 Median (95% CI), monthsb

13.1 (11.2, 14.0)

9.6 (7.9, 11.3)

 HR (95% CI)

0.639 (0.468, 0.872)

 

 P valuec

0.004

 

OS

 No. of events (death), n (%)

102 (39.7)

103 (41.5)

 Median (95% CI), monthsb

28.3 (24.0, 38.1)

23.1 (19.6, 24.5)

 HR (95% CI)

0.729 (0.551, 0.965)

 

 P valuec

0.024

 

Best overall response, n (%)

 Complete response

0 (0.0)

3 (1.3)

 Partial response

161 (69.1)

93 (41.0)

 Stable disease

44 (18.9)

108 (47.6)

 Progressive disease

20 (8.6)

19 (8.4)

 Not evaluable

8 (3.4)

4 (1.8)

ORR, n (%)

161 (69.1)

96 (42.3)

 95% CI

63.2, 75.0

35.9, 48.7

 OR (95% CI)

3.090 (2.280, 4.189)

 

 P valuec

<0.001

 

DCR, n (%)

205 (88.0)

204 (89.9)

 95% CI

83.8, 92.2

85.9, 93.8

 OR (95% CI)

0.814 (0.477, 1.389)

 

 P valuec

0.520

 
  1. Except for OS, all other efficacy endpoints were based on BIRC-assessed data
  2. BIRC blinded independent review committee, CI confidence interval, DCR disease control rate, FAS full analysis set, HR hazard ratio, OR odds ratio, ORR objective response rate, OS overall survival, PD progressive disease, PFS progression-free survival
  3. aDeath occurring within 90 days following the last tumor response evaluation or the date of randomization
  4. bKaplan–Meier estimates
  5. cP values were calculated with the use of the log-rank test or, in the case of ORR, the Cochran–Mantel–Haenszel test
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