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. Author manuscript; available in PMC: 2012 Sep 14.
Published in final edited form as: JAMA. 2012 Apr 4;307(13):1383–1393. doi: 10.1001/jama.2012.385

Table 2.

Patient Outcomes Within the Wild-Type KRAS and Mutated KRAS Patient Groups by Treatment and Age Groupa

mFOLFOX6
mFOLFOX6 + Cetuximab
Event Age
Group, y
No. of
Events/
Total No.
3-Year %
Event-Free
(95% CI)b
No. of
Events/
Total No.
3-Year %
Event-Free
(95% CI)b
Hazard Ratio
(95% CI)c
P
Valuec,d
Wild-type KRAS
   Disease-free survival All ages 163/909 74.6 (71.1–78.3) 192/954 71.5 (67.8–75.4) 1.21 (0.98–1.49) .08

<70 141/797 74.5 (70.7–78.5) 152/807 72.7 (68.8–76.9) 1.13 (0.90–1.42) .29

≥70 22/112 75.3 (66.4–85.5) 40/147 64.5 (55.3–75.4) 1.59 (0.93–2.70) .09

   Overall survival All ages 78/909 87.3 (84.3–90.3) 94/954 85.6 (82.7–88.7) 1.25 (0.92–1.68) .15

<70 64/797 87.4 (84.2–90.7) 62/807 88.4 (85.5–91.5) 1.02 (0.72–1.44) .92

≥70 14/112 86.2 (78.9–94.1) 32/147 72.5 (64.0–82.0) 2.00 (1.05–3.78) .03

   Time-to-recurrence All ages 146/909 76.9 (73.4–80.4) 165/954 74.4 (70.8–78.3) 1.17 (0.93–1.46) .18

<70 128/797 76.6 (72.9–80.4) 137/807 75.1 (71.2–79.2) 1.13 (0.89–1.44) .31

≥70 18/112 79.0 (70.3–88.8) 28/147 70.8 (61.3–81.6) 1.36 (0.74–2.50) .32

Mutated KRAS
   Disease-free survival All ages 112/374 67.1 (61.8–72.8) 111/343 65.0 (59.8–70.7) 1.12 (0.86–1.46) .38

<70 91/320 67.5 (61.9–73.6) 94/296 65.7 (60.1–71.8) 1.14 (0.85–1.52) .38

≥70 21/54 64.3 (50.9–81.3) 17/47 60.4 (46.8–78.0) 1.23 (0.64–2.37) .53

   Overall survival All ages 44/374 87.9 (84.0–91.9) 49/343 82.7 (78.0–87.6) 1.27 (0.85–1.92) .25

<70 34/320 88.5 (84.3–92.8) 37/296 84.7 (79.9–89.8) 1.24 (0.77–1.98) .38

≥70 10/54 84.9 (75.1–96.0) 12/47 68.9 (54.5–87.2) 1.73 (0.74–4.07) .21

   Time-to-recurrence All ages 107/374 67.9 (62.6–73.6) 101/343 67.0 (61.7–72.7) 1.07 (0.81–1.40) .63

<70 87/320 68.5 (62.9–74.6) 87/296 67.2 (61.6–73.3) 1.10 (0.81–1.48) .55

≥70 20/54 64.3 (50.9–81.3) 14/47 65.5 (51.6–83.1) 1.05 (0.52–2.11) .90

Mutated BRAF
   Disease-free survival All ages 41/155 67.3 (59.3–76.3) 51/192 68.9 (61.7–76.9) 1.15 (0.76–1.75) .50

   Overall survival All ages 30/155 74.8 (67.2–83.2) 38/192 73.7 (66.4–81.9) 1.21 (0.75–1.97) .43

   Time-to-recurrence All ages 36/155 71.2 (63.4–79.9) 44/192 71.9 (64.8–79.8) 1.13 (0.72–1.76) .59

Wild-type BRAF and wild-type KRAS
   Disease-free survival All ages 119/736 76.0 (72.0–80.2) 138/743 72.0 (67.7–76.6) 1.22 (0.96–1.56) .11

   Overall survival All ages 47/736 90.1 (86.9–93.4) 54/743 89.3 (86.3–92.4) 1.22 (0.82–1.81) .32

   Time-to-recurrence All ages 108/736 77.8 (73.9–81.8) 119/743 74.9 (70.7–79.4) 1.17 (0.90–1.52) .23

Abbreviation: mFOLFOX6, the modified sixth version of the leucovorin, fluorouracil, and oxaliplatin regimen.

a

Within all patients having wild-type KRAS, 74.6% (95% CI, 71.1%–78.3%) and 71.5% (95% CI, 67.8%–75.4%) of patients were event free for disease-free survival following treatment with mFOLFOX6 and mFOLFOX6 with cetuximab, respectively. HR of more than 1 indicates the increase in risk associated with the addition of cetuximab and for the event listed for each row. The addition of cetuximab failed to reach statistical significance (disease-free survival: hazard ratio, 1.21; 95% CI, 0.98–1.49; P=.08).

b

Kaplan-Meier method estimate of the percentage of patients event-free (eg, disease-free, alive) at 3 years, with corresponding 95% CI.

c

Hazard ratio and P value reported from a multivariate Cox proportional hazards regression model, adjusted for number of nodes, histologic grade, and T stage.

d

By Wald statistic.

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