Table 2.

Univariate analysis of effect of clinical variables on survival outcomes

PFSOverall survival
VariableNo. of patientsMedian, months (95% CI)HR (95% CI)PMedian, months (95% CI)HR (95% CI)P
Age0.4090.891
 <65 years941.4 (1.3–2.2)1.00a5.1 (3.6–8.6)1.00a
 ≥65 years672.0 (1.6–2.7)0.87 (0.6–1.2)4.6 (3.7–9.1)1.03 (0.7–1.5)
Gender0.6140.948
 Male1241.68 (1.4–2.2)1.00a5.1 (3.9–8.4)1.00a
 Female372.01 (1.3–2.7)1.1 (0.8–1.6)4.9 (2.9–20.4)0.99 (0.6–1.5)
ECOG0.002<0.001
 0–11231.8 (1.6–2.5)1.00a6.4 (4.8–9.1)1.00
 ≥2381.2 (0.8–2.2)1.81 (1.2–2.6)2.0 (1.0–3.7)2.23
Primary site0.730.9
 Esophageal251.4 (1.2–4.1)1.00a5.9 (3.91–NR)1.00a
 GE junction601.8 (1.5–2.7)0.98 (0.6–1.6)4.5 (3.1–8.3)1.1 (0.7–1.9)
 Gastric761.7 (1.4–2.5)1.1 (0.7–1.8)4.9 (3.6–9.2)1.1 (0.7–1.9)
No. of metastatic sites0.006<0.001
 1–21052.1 (1.6–2.7)1.00a8.4 (5.8–11.8)1.00a
 ≥3561.4 (1.2–1.9)1.6 (1.1–2.3)3.6 (2.9–4.6)2.1 (1.5–3.0)
Liver metastases0.016<0.001
 No1022.1 (1.7–2.7)1.00a8.2 (5.1–12.5)1.00a
 Yes591.4 (1.2–1.8)1.5 (1.1–2.1)3.1 (2.2–4.6)2.11 (1.5–3.0)
No. of prior therapies0.003<0.001
 1–21121.8 (1.6–2.6)1.00a7.2 (4.9–9.9)1.00a
 ≥3491.4 (1.1–2.2)1.7 (1.2–2.4)3.4 (2.2–4.8)2.0 (1.4–3.0)
Type of ICI0.2080.008
 Single-agent anti–PD-1/PD-L11101.6 (1.3–2.2)1.00a4.3 (3.6–6.0)1.00a
 Anti–CTLA-4 + anti–PD-1/PD-L1511.9 (1.6–3.3)0.8 (0.6–1.9)8.8 (5.8–20.6)0.6 (0.4–0.9)
PD-L1 statusb0.0010.004
 PD-L1–positive452.7 (2.0–4.3)1.00a6.7 (3.9–19.9)1.00a
 PD-L1–negative241.3 (1.0–2.2)2.47 (1.4–4.2)2.9 (2.0–6.2)2.3 (1.3–4.0)
 TMB (log-scale)c89NA0.97 (0.95–0.99)0.003NA0.72 (0.5–0.9)0.016
  • NOTE: Significant values highlighted in bold.

  • Abbreviations: NA, not applicable; NR, not reached.

  • aDenotes reference HR.

  • bPatients with unknown PD-L1 status (n = 92) were excluded from analysis.

  • cAmong patients who underwent genomic profiling (n = 89).