Table 1.
Baseline characteristics of the patients
| Characteristics | N-IRI arm (n = 40) | IRI arm (n = 42) | Total (n = 82) | |||
|---|---|---|---|---|---|---|
| n | % | n | % | n | % | |
| Age (years) | ||||||
| Median | 60.0 | 63.5 | 61.5 | |||
| Range | 27–75 | 32–75 | 27–75 | |||
| Sex | ||||||
| Male | 33 | 82.5 | 33 | 78.6 | 66 | 80.5 |
| Female | 7 | 17.5 | 9 | 21.4 | 16 | 19.5 |
| ECOG performance status | ||||||
| 0 | 19 | 47.5 | 17 | 40.5 | 36 | 43.9 |
| 1 | 21 | 52.5 | 25 | 59.5 | 46 | 56.1 |
| Body weight (kg) | ||||||
| Median | 56.3 | 54.2 | 56.0 | |||
| Range | 42.0–81.4 | 37.5–107.0 | 37.5–107.0 | |||
| Resection status of the primary tumor | ||||||
| Inoperable advanced | 22 | 55.0 | 23 | 54.8 | 45 | 54.9 |
| Postoperative recurrent | 18 | 45.0 | 19 | 45.2 | 37 | 45.1 |
| Histological diagnosis, n | ||||||
| Well/moderately differentiated adenocarcinoma | 15 | 37.5 | 19 | 45.2 | 34 | 41.5 |
| Poorly differentiated adenocarcinoma | 21 | 52.5 | 17 | 40.5 | 38 | 46.3 |
| Others | 4 | 10.0 | 6 | 14.3 | 10 | 12.2 |
| Primary tumor site | ||||||
| Absent | 18 | 45.0 | 16 | 38.1 | 34 | 41.5 |
| Present | 22 | 55.0 | 26 | 61.9 | 48 | 58.5 |
| Gastroesophageal junction | 4 | 18.2 | 1 | 3.8 | 5 | 10.4 |
| Gastric region | 18 | 81.8 | 25 | 96.2 | 43 | 89.6 |
| Metastatic focus site | ||||||
| No | 1 | 2.5 | 0 | 0.0 | 1 | 1.2 |
| Yes | 39 | 97.5 | 42 | 100.0 | 81 | 98.8 |
| Lymph node | 25 | 64.1 | 25 | 59.5 | 50 | 61.7 |
| Liver | 13 | 33.3 | 19 | 45.2 | 32 | 39.5 |
| Lung | 3 | 7.7 | 6 | 14.3 | 9 | 11.1 |
| Other | 19 | 48.7 | 18 | 42.9 | 37 | 45.7 |
| UGT1A1 gene polymorphism | ||||||
| *1/*1, *1/*6, *1/*28 | 38 | 95.0 | 39 | 92.9 | 77 | 93.9 |
| *6/*6, *28/*28, *6/*28 | 2 | 5.0 | 3 | 7.1 | 5 | 6.1 |
N-IRI nimotuzumab plus irinotecan, IRI irinotecan alone, n number of patients, ECOG Eastern Cooperative Oncology Group