Table 1.
Baseline characteristics of the 123 treated patients with advanced esophageal squamous cell carcinoma (intention-to-treat population)
| Characteristic | Treatment groups | P value | |
|---|---|---|---|
| Irinotecan plus S-1 [cases (%)] | S-1 monotherapy [cases (%)] | ||
| Age | 0.877 | ||
| Median years (range) | 60 (39.1–70.0) | 57 (42.0–70.0) | |
| ≤ 65 years | 46 (75.4) | 46 (74.2) | |
| > 65 years | 15 (24.6) | 16 (25.8) | |
| Sex | 0.774 | ||
| Male | 56 (91.8) | 56 (90.3) | |
| Female | 5 (8.2) | 6 (9.7) | |
| ECOG performance score | 0.593 | ||
| 0 | 23 (37.7) | 18 (29.0) | |
| 1 | 33 (54.1) | 38 (61.3) | |
| 2 | 5 (8.2) | 6 (9.7) | |
| Tumor grade | 0.792# | ||
| Poorly differentiated | 28 (45.9) | 29 (46.8) | |
| Moderately differentiated | 29 (47.5) | 31 (50.0) | |
| Well differentiated | 4 (6.6) | 2 (3.2) | |
| Number of metastatic sites | 0.409 | ||
| 1 | 23 (37.7) | 19 (30.6) | |
| ≥ 2 | 38 (62.3) | 43 (69.4) | |
| Previous treatmenta | |||
| Surgery | 28 (45.9) | 19 (30.6) | 0.082 |
| Local radiation | 32 (52.5) | 32 (51.6) | 0.925 |
| Disease status | 1.000# | ||
| Local recurrence | 3 (4.9) | 4 (6.5) | |
| Distant metastasis | 58 (95.1) | 58 (93.5) | |
| Prior lines of chemotherapy | 0.668 | ||
| First-line | 51 (83.6) | 50 (80.6) | |
| Second-line | 10 (16.4) | 12 (19.4) | |
ECOG Eastern Cooperative Oncology Group
#Tested by Fisher’s exact test
aSome of the patients presented with metastatic disease at their initial diagnosis, therefore they did not receive either surgery or radiation