Table 2.
Univariate analysis of effect of clinical variables on survival outcomes
| Progression-free survival | Overall survival | ||||||
|---|---|---|---|---|---|---|---|
| Variable | No. of patients | Median, months (95% CI) | HR (95% CI) | p-value | Median, months (95% CI) | HR (95% CI) | p-value |
| Age | 0.409 | 0.891 | |||||
| <65 years | 94 | 1.4 (1.3–2.2) | 1.00* | 5.1 (3.6–8.6) | 1.00* | ||
| ≥65 years | 67 | 2.0 (1.6–2.7) | 0.87 (0.6–1.2) | 4.6 (3.7–9.1) | 1.03 (0.7–1.5) | ||
| Gender | 0.614 | 0.948 | |||||
| Male | 124 | 1.68 (1.4–2.2) | 1.00* | 5.1 (3.9–8.4) | 1.00* | ||
| Female | 37 | 2.01 (1.3–2.7) | 1.1 (0.8–1.6) | 4.9 (2.9–20.4) | 0.99 (0.6–1.5) | ||
| ECOG | 0.002 | <0.001 | |||||
| 0–1 | 123 | 1.8 (1.6–2.5) | 1.00* | 6.4 (4.8–9.1) | 1.00 | ||
| ≥2 | 38 | 1.2 (0.8–2.2) | 1.81 (1.2–2.6) | 2.0 (1.0–3.7) | 2.23 | ||
| Primary site | 0.73 | 0.9 | |||||
| Esophageal | 25 | 1.4 (1.2–4.1) | 1.00* | 5.9 (3.91-NR) | 1.00* | ||
| GE junction | 60 | 1.8 (1.5–2.7) | 0.98 (0.6–1.6) | 4.5 (3.1–8.3) | 1.1 (0.7–1.9) | ||
| Gastric | 76 | 1.7 (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 sites | 0.006 | <0.001 | |||||
| 1–2 ≥3 |
105 | 2.1 (1.6–2.7) | 1.00* | 8.4 (5.8–11.8) | 1.00* | ||
| ≥3 | 56 | 1.4 (1.2–1.9) | 1.6 (1.1–2.3) | 3.6 (2.9–4.6) | 2.1 (1.5–3.0) | ||
| Liver metastases | 0.016 | <0.001 | |||||
| No | 102 | 2.1 (1.7–2.7) | 1.00* | 8.2 (5.1–12.5) | 1.00* | ||
| Yes | 59 | 1.4 (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 therapies | 0.003 | <0.001 | |||||
| 1–2 | 112 | 1.8 (1.6–2.6) | 1.00* | 7.2 (4.9–9.9) | 1.00* | ||
| ≥3 | 49 | 1.4 (1.1–2.2) | 1.7 (1.2–2.4) | 3.4 (2.2–4.8) | 2.0 (1.4–3.0) | ||
| Type of ICI | 0.208 | 0.008 | |||||
| Single-agent anti-PD-1/PD-L1 | 110 | 1.6 (1.3–2.2) | 1.00* | 4.3 (3.6–6.0) | 1.00* | ||
| Anti-CTLA-4 + anti-PD-1/PD-L1 | 51 | 1.9 (1.6–3.3) | 0.8 (0.6–1.9) | 8.8 (5.8–20.6) | 0.6 (0.4–0.9) | ||
| PD-L1 status$ | 0.001 | 0.004 | |||||
| PD-L1 positive | 45 | 2.7 (2.0–4.3) | 1.00* | 6.7 (3.9–19.9) | 1.00* | ||
| PD-L1 negative | 24 | 1.3 (1.0–2.2) | 2.47 (1.4–4.2) | 2.9 (2.0–6.2) | 2.3 (1.3–4.0) | ||
HR, hazard ratio; CI, confidence interval;
*
Denotes reference HR; GE junction, gastroesophageal junction, ICI, immune checkpoint inhibitors; anti-PD-1, anti-programmed cell death protein-1; PD-L1, PD-ligand-1; anti-CTLA-4, anti-cytotoxic T-lymphocyte-associated protein-4; NR, not reached;
$
patients with unknown PD-L1 status (n=92) were excluded from analysis; TMB, tumor mutation burden;
¥
Among patients who underwent genomic profiling (n=89); NA, not applicable; significant values highlighted in bold