Table 2.

The U.S. cohort characteristics and clinical outcome: TTR and OS

TTROS
Characteristicsn (%)Median TTR, y (95% CI)HR (95% CI)PaMedian OS, y (95% CI)HR (95% CI)Pa
Age, y0.420.65
 <6080 (58%)2.2 (1.5–14.5b)14.7 (3.8–14.6b)1
 ≥6057 (42%)3.7 (2.1–12.3b)0.81 (0.48–1.36)4.5 (3.3–7.3)1.14 (0.64–2.05)
Sex0.850.32
 Male83 (61%)2.3 (1.8–7.0)14.1 (3.3–7.3)1
 Female54 (39%)7.0 (1.5–8.3b)0.95 (0.56–1.63)7.3 (3.8–8.3b)0.72 (0.37–1.39)
Race0.0850.040
 White63 (46%)1.7 (1.2–4.4)13.8 (2.7–5.5)1
 African American1 (1%)0.5bc0.5bc
 Asian28 (20%)7.0 (2.3–14.5b)0.45 (0.23–0.91)7.3 (3.3–14.6b)0.45 (0.20–1.03)
 Hispanic45 (33%)3.7 (2.1–10.7b)0.63 (0.34–1.17)10.7b (3.6–10.7b)0.36 (0.15–0.85)
Stage0.0300.32
 IB12 (9%)4.3b (2.2–4.3b)14.4bc
 II36 (26%)7.0 (2.9–10.7b)1.56 (0.35–6.98)5.4 (4.1–10.7b)1
 III71 (52%)1.8 (1.4–2.8)3.24 (0.78–13.5)3.8 (2.8–7.3)1.31 (0.69–2.50)
 IV18 (13%)1.6 (1.2–3.8b)4.00 (0.86–18.5)7.3b (1.4–7.3b)1.33 (0.43–4.09)
Tumor stage0.0130.30
 T1d4 (3%)
 T2d44 (32%)8.3b (2.9–8.3b)15.4 (4.1–8.3b)1
 T3e79 (58%)1.7 (1.4–4.4)2.04 (1.14–3.67)4.5 (3.3–7.3)1.40 (0.73–2.68)
 T4e10 (7%)
N0.0040.088
 N027 (20%)7.0 (1.8–10.7b)17.3 (3.4–10.7b)1
 N164 (47%)4.4 (2.2–14.5b)0.99 (0.47–2.11)5.5 (4.1–14.6b)1.07 (0.46–2.47)
 N231 (23%)1.3 (1.1–2.3)2.62 (1.15–5.94)3.3 (2.0–5.7b)2.27 (0.85–6.07)
 N315 (11%)1.6 (1.0–3.8b)1.96 (0.73–5.32)2.4 (1.1–3.8b)2.35 (0.66–8.41)
PS0.770.25
 ECOG 062 (45%)2.5 (1.7–10.7b)14.5 (2.8–10.7b)1
 ECOG 165 (47%)2.3 (1.6–14.5b)1.00 (0.60–1.68)5.7 (3.8–14.6b)0.68 (0.37–1.25)
 ECOG 210 (7%)2.2b (1.7–2.2b)0.60 (0.14–2.53)2.2b (1.2–2.2b)1.67 (0.36–7.75)
Differentiation0.150.098
 Moderate27 (20%)2.1 (1.1–3.8b)14.1 (2.7–4.7)1
 Poor/moderatee10 (7%)3.7 (2.1–14.5b)0.65 (0.36–1.19)7.3 (3.8–14.6b)0.59 (0.31–1.13)
 Poore97 (71%)
Lauren0.870.74
 Diffuse40 (29%)3.7 (1.8–8.9b)17.3 (5.4–8.9b)1
 Intestinal50 (36%)7.0 (2.1–14.5b)0.87 (0.45–1.67)5.7 (3.8–14.6b)1.10 (0.48–2.51)
 Mixed21 (15%)12.3b (1.7–12.3b)1.04 (0.45–2.41)3.6 (1.9–12.3b)1.52 (0.51–4.58)
Tumor site0.0200.003
 Stomach88 (64%)4.4 (2.1–14.5b)1 (Reference)7.3 (3.8–14.6b)1 (Reference)
 GEJ38 (28%)1.6 (1.1–2.9)1.97 (1.15–3.37)3.4 (2.4–4.5)2.50 (1.35–4.60)
 Unknown11 (8%)4.4b (3.2–4.4b)0.77 (0.24–2.54)4.4b (3.3–4.4b)0.51 (0.07–3.89)
Type of chemotherapy<0.0010.009
 5-FU/LV70 (51%)7.0 (2.8–10.6b)17.3 (3.8–10.6b)1
 5-FU/LV/oxaliplatin19 (14%)1.6 (1.1–2.9)2.65 (1.22–5.75)2.4 (1.2–4.5b)4.07 (1.62–10.19)
 5-FU, CDDP, CPT-1123 (17%)14.5 (1.2–14.5)1.25 (0.58–2.69)4.1 (2.2–14.6b)1.32 (0.57–3.05)
 None25 (18%)2.1 (0.8–2.5)2.99 (1.62–5.51)4.7 (2.8–5.7)1.95 (0.93–4.07)
Radiation0.920.68
 Yes88 (64%)2.5 (1.8–14.5b)14.5 (3.3–14.6b)1
 No48 (35%)3.7 (1.7–12.3b)1.03 (0.60–1.76)5.4 (3.8–12.3b)0.89 (0.48–1.63)

Abbreviations: CDDP, cisplatin; ECOG, Eastern Cooperative Oncology Group; 5-FU, fluorouracil; LV, Leucovorin; PS, performance status.

  • aOn the basis of log-rank test.

  • bEstimates were not reached.

  • cNo events occurred and estimates were not obtained.

  • d,eGrouped together for the estimates of HR.