Table 3.

Prognostic analysis based on additive and dominant genetic models in the BSC arm only

Univariable analysisMultivariable analysisa
Dataset/BiomarkerAmino acidNMedian survival (months)HRb (95% CI)PcHRb (95% CI)Pc
OS
All
FCGR2AH/H414.1111
H/R685.550.71 (0.6–0.9)0.010.72 (0.5–1.0)0.03
R/R405.820.51 (0.3–0.9)0.51 (0.3–0.9)
R/-1085.65052 (0.3–0.8)<0.00010.48 (0.3–0.7)<0.0001
FCGR3AF/F764.8311
F/V565.451.00 (0.8–1.3)0.991.00 (0.8–1.3)0.99
V/V183.981.00 (0.6–1.7)1.00 (0.6–1.8)
V/-744.990.99 (0.7–1.4)0.951.03 (0.7–1.5)0.87
WT KRAS
FCGR2AH/H214.8310.3410.55
H/R285.600.85 (0.6–1.2)0.87 (0.6–1.4)
R/R265.340.72 (0.4,-1.4)0.76 (0.3–1.8)
R/-545.490.65 (0.4–1.2)0.150.59 (0.3–1.2)0.13
FCGR3AF/F374.7610.4810.40
F/V285.590.88 (0.6–1.3)0.82 (0.5–1.3)
V/V115.030.77 (0.4–1.6)0.68 (0.3–1.7)
V/-395.450.91 (0.6–1.5)0.730.90 (0.5–1.7)0.77
Mutated KRAS
FCGR2AH/H133.6110.0110.05
H/R345.550.49 (0.3–0.8)0.55 (0.3–1.0)
R/R117.360.24 (0.1- 0.7)0.30 (0.1–1.0)
R/-455.820.31 (0.2–0.6)<0.00010.44 (0.2–1.0)0.05
FCGR3AF/F335.4910.1310.02
F/V194.701.39 (0.9–2.1)1.88 (1.1–3.2)
V/V63.251.92 (0.8–4.5)3.52 (1.2–10.0)
R/-253.881.36 (0.8–2.4)0.281.92 (1.0–3.8)0.07
PFS
All
FCGR2AH/H411.8110.4610.30
H/R681.871.09 (0.9–1.4)1.14 (0.9–1.5)
R/R401.791.20 (0.8–1.9)1.31 (0.8–2.2)
R/-1081.841.10 (0.8–1.6)0.611.01 (0.7–1.5)0.97
FCGR3AF/F761.8410.2210.29
F/V561.840.87 (0.7–1.1)0.87 (0.7–1.1)
V/V181.840.75 (0.5–1.2)0.76 (0.5–1.3)
V/-741.840.85 (0.6–1.2)0.520.85 (0.-1.5)0.57
WT KRAS
FCGR2AH/H211.8410.3710.92
H/R282.041.16 (0.8–1.6)1.02 (0.7–1.5)
R/R261.841.34 (0.7–2.5)1.04 (0.5–2.2)
R/-541.911.20 (0.8–1.7)0.881.02 (0.7–1.6)0.61
FCGR3AF/F371.8710.1610.26
F/V281.840.79 (0.6–1.1)0.80 (0.5–1.2)
V/V111.910.62 (0.3–1.2)0.64 (0.3–1.4)
V/-391.870.75 (0.5–1.2)0.230.78 (0.5–1.4)0.42
Mutated KRAS
FCGR2AH/H131.6810.7110.53
H/R341.811.09 (0.7–1.7)1.19 (0.7–2.1)
R/R111.541.19 (0.5–3.0)1.42 (0.5–4.2)
R/-451.771.10 (0.4–1.6)0.571.20 (0.7–2.3)0.79
FCGR3AF/F331.8110.6410.60
F/V191.681.09 (0.8–1.6)1.12 (0.7–1.7)
V/V61.681.18 (0.6–2.4)1.25 (0.5–2.9)
V/-251.681.10 (0.8–1.6)0.391.15 (0.6–1.9)0.47
  • NOTE: In each section, the codominant model is presented in the first three rows. Then, the dominant model is presented in indented format (R/-, at least one R allele; V/-, at least one V allele). As the wild-type (H/H or F/F) data remain unchanged in either model, they are only presented with the codominant model.

  • Abbreviations: BSC, best supportive care; CI, confidence interval; WT, wild type.

  • aCox regression adjusted for the following factors: ECOG performance status (0–1 vs. 2), gender (male vs. female), age (65 years or older vs. younger than 65 years), baseline lactate dehydrogenase level [higher than the upper limit of the normal (ULN) range vs. ULN or lower], baseline alkaline phosphatase (higher than ULN vs. ULN or less), baseline hemoglobin [common toxicity criteria (CTC) grade 1 or higher vs. CTC grade 0], number of disease sites (more than 2 vs. 2 or less), number of previous chemotherapy drug classes (more than 2 vs. 2 or less), primary tumor site (rectum only vs. colon), and presence of liver metastases (yes vs. no) as covariates. These variables were included as covariates of the multivariate models in the original clinical trial analysis.

  • bHR comparing each group over first category, the reference, which is labeled “1.”

  • cFrom the global test for the polymorphism variable.