Table 1 Baseline demographics and disease characteristics

From: Encorafenib, cetuximab and chemotherapy in BRAF-mutant colorectal cancer: a randomized phase 3 trial

 

EC + mFOLFOX6 (n = 236)

SOC (n = 243)

Total (n = 479)

Median age (range), years

60.0 (24–81)

62.0 (28–84)

61.0 (24–84)

Male, n (%)

123 (52.1)

119 (49.0)

242 (50.5)

Female, n (%)

113 (47.9)

124 (51.0)

237 (49.5)

Race, n (%)

 White

141 (59.7)

144 (59.3)

285 (59.5)

 Asian

88 (37.3)

91 (37.4)

179 (37.4)

 Multiracial

0

2 (0.8)

2 (0.4)

 Black or African American

0

1 (0.4)

1 (0.2)

 Not reported

7 (3.0)

5 (2.1)

12 (2.5)

Body site, n (%)

 Colon

191 (80.9)

192 (79.0)

383 (80.0)

 Rectum

24 (10.2)

27 (11.1)

51 (10.6)

 Cecum

21 (8.9)

24 (9.9)

45 (9.4)

Side of tumor, n (%)

 Left

89 (37.7)

98 (40.3)

187 (39.0)

 Right

147 (62.3)

145 (59.7)

292 (61.0)

Stage at initial diagnosis, n (%)

 I

3 (1.3)

2 (0.8)

5 (1.0)

 II

13 (5.5)

10 (4.1)

23 (4.8)

 III

37 (15.7)

43 (17.7)

80 (16.7)

 IV

183 (77.5)

188 (77.4)

371 (77.5)

Primary tumor resection, n (%)

 Complete

116 (49.2)

105 (43.2)

221 (46.1)

 Partial

14 (5.9)

13 (5.3)

27 (5.6)

 None

106 (44.9)

125 (51.4)

231 (48.2)

No. of organs involved, n (%)a

 ≤2

122 (51.7)

129 (53.1)

251 (52.4)

 ≥3

114 (48.3)

114 (46.9)

228 (47.6)

 Liver metastases, n (%)a

144 (61.0)

156 (64.2)

300 (62.6)

Eastern Cooperative Oncology Group performance status, n (%)

 0

129 (54.7)

131 (53.9)

260 (54.3)

 1

103 (43.6)

98 (40.3)

201 (42.0)

 Missing

4 (1.7)

14 (5.8)

18 (3.8)

Central BRAF V600E status (tumor tissue), n (%)

 Detected

226 (95.8)

224 (92.2)

450 (93.9)

 Indeterminate

0

1 (0.4)

1 (0.2)

 Not detected

4 (1.7)

2 (0.8)

6 (1.3)

 Not available

6 (2.5)

16 (6.6)

22 (4.6)

Local microsatellite instability/mismatch repair deficiency status, n (%)

 High microsatellite instability/mismatch repair deficiency

1 (0.4)

0

1 (0.2)

 Microsatellite stable/proficient mismatch repair

229 (97.0)

227 (93.4)

456 (95.2)

 Not available

6 (2.5)

16 (6.6)

22 (4.6)

Carcinoembryonic antigen at baseline, n (%)

 ≤5 μg liter-1

65 (27.5)

63 (25.9)

128 (26.7)

 >5 μg liter-1

166 (70.3)

163 (67.1)

329 (68.7)

 Missing

5 (2.1)

17 (7.0)

22 (4.6)

C-reactive protein at baseline, n (%)

 ≤10 mg liter-1

125 (53.0)

119 (49.0)

244 (50.9)

 >10 mg liter-1

105 (44.5)

107 (44.0)

212 (44.3)

 Missing

6 (2.5)

17 (7.0)

23 (4.8)

  1. EC+mFOLFOX6, encorafenib and cetuximab plus oxaliplatin, leucovorin and 5-FU.
  2. aNumber of organs and presence of liver metastases are based on blinded independent central review data for the phase 3 portion of the study.