Table 2 Primary endpoint ORR and secondary endpoints PFS and OS of FIRE-3 in RAS WT patients grouped in age cohorts and tumour sidedness.

From: Efficacy of FOLFIRI plus cetuximab vs FOLFIRI plus bevacizumab in 1st-line treatment of older patients with RAS wild-type metastatic colorectal cancer: an analysis of the randomised trial FIRE-3

ORR

n

RAS WT

n

RAS WT right-sided

n

RAS WT left-sided

All

353

FOLFIRI + cet

FOLFIRI + bev

p-value

77

FOLFIRI + cet

FOLFIRI + bev

p-value

276

FOLFIRI + cet

FOLFIRI + bev

p-value

Patients <65 years

181

n = 84 ORR 76.2%

n = 97 ORR 62.9%

0.076

32

n = 11 ORR 63.6%

n = 21 ORR 52.4%

0.71

149

n = 73 ORR 78.1 %

n = 76 ORR 65.8 %

0.11

Patients ≥65 years

172

n = 86 ORR 77.9%

n = 86 ORR 66.3%

0.13

45

n = 19 ORR 68.4%

n = 26 57.7%

0.54

127

n = 67 ORR 80.6%

n = 60 ORR 70.0 %

0.22

PFS (months, 95% CI)

 

RAS WT

 

RAS WT right-sided

 

RAS WT left-sided

All

400

FOLFIRI + cet

FOLFIRI + bev

p-value

HR

90

FOLFIRI + cet

FOLFIRI + bev

p-value

HR

308

FOLFIRI + cet

FOLFIRI + bev

p-value

HR

Patients <65 years

201

11.1 (9.3–13)

10.2 (8.7–11.7)

0.46

0.9 (0.67–1.2)

36

7.2 (3.5–11)

7.2 (4.3–10.0)

0.19

1.6 (0.78–3.32)

164

12 (9.5–14.6)

10.3 (8.8–11.9)

0.3

0.85 (0.62–1.16)

Patients ≥65 years

199

9.9 (8.4–11.4)

11.0 (9.6–12.6)

0.82

1.03 (0.7–1.4)

54

8.0 (6.1–9.8)

9.3 (6.6–12.1)

0.44

1.2 (0.71–2.17)

144

10.4 (9.4–11.4)

11.1 (9.6–12.6)

0.94

0.99 (0.70–1.4)

OS (months, 95% CI)

 

RAS WT

 

RAS WT right-sided

 

RAS WT left-sided

All

400

FOLFIRI + cet

FOLFIRI + bev

p-value

HR

90

FOLFIRI + cet

FOLFIRI + bev

p-value

HR

308

FOLFIRI + cet

FOLFIRI + bev

p-value

HR

Patients <65 years

201

33.1 (26.9–39.2)

25.6 (19.1–32.2)

0.012

0.67 (0.5–0.91)

36

21.9 (14.6–29.2)

16.4 (8.3–24.7)

0.31

0.68 (0.32–1.44)

164

38.2 (30.9–45.4)

28.2 (22.7–33.7)

0.006

0.62 (0.44–0.88)

Patients ≥65 years

199

27.1 (18.9–35.3)

26.0 (23.0–28.7)

0.46

0.89 (0.66–1.2)

54

16.6 (11.6–20.5)

23.6 (19.3–27.9)

0.87

1.1 (0.6–1.87)

144

33.2 (21.3–45.1)

27.5 (24.0-31-0)

0.38

0.86 (0.60–1.2)

  1. For survival times Kaplan–Meier estimation medians and 95% CIs are given.
  2. FOLFIRI fluorouracil, leucovorin and irinotecan, cet Cetuximab, bev Bevacizumab, HR hazard ratio, OS overall survival, PFS progression-free survival, wt wild-type.
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