Table 1.
Patient demographics and clinical characteristics of 303 patients randomized to two studies
| Variables | Training data set, n (%) (N=73) | Testing data set, n (%) (N=230) | Total, n (%) (N=303) |
|---|---|---|---|
| Sex | |||
| Male | 58 (79) | 172 (75) | 230 (76) |
| Female | 15 (21) | 58 (25) | 73 (24) |
| Median age, years | 54 | 58 | 56 |
| Q25–Q75 | 48–58 | 51–62 | 50–62 |
| Time since initial diagnosis, years | 2.08 | 1.86 | 1.91 |
| Q25–Q75 | 1.03–2.55 | 0.83–2.28 | 0.91–2.31 |
| ECOG PS | |||
| 0 | 4 (5) | 57 (25) | 61 (20) |
| 1 | 69 (95) | 173 (75) | 242 (80) |
| Prior surgery of primary tumor | |||
| Yes | 57 (78) | 164 (71) | 221 (73) |
| No | 16 (22) | 66 (29) | 82 (27) |
| Stage | |||
| II | 1 (1) | 2 (1) | 3 (1) |
| III | 3 (4) | 12 (5) | 15 (5) |
| IV | 69 (95) | 213 (93) | 282 (93) |
| Metastatic sites | |||
| ≤2 | 60 (82) | 164 (71) | 224 (74) |
| >2 | 13 (18) | 66 (29) | 79 (26) |
| Previous lines of chemotherapy | |||
| 2 | 52 (71) | 152 (66) | 204 (67) |
| ≥3 | 21 (29) | 78 (34) | 99 (33) |
| Prior radiotherapy | 10 (14) | 35 (15) | 45 (15) |
| Hemoglobin, g/dL | |||
| Median | 11.4 | 11.4 | 11.4 |
| Q25–Q75 | 10.7–12.6 | 10.3–12.6 | 10.4–12.6 |
| AST, IU/L | |||
| Median | 23 | 25 | 24 |
| Q25–Q75 | 19–27 | 18–37.03 | 18.1–34.2 |
| BUN, mmol/L | |||
| Median | 4.80 | 5 | 5 |
| Q25–Q75 | 3.91–5.96 | 3.91–5.88 | 3.91–5.895 |
| Alkaline phosphatase, U/L | |||
| Median | 89 | 98 | 97 |
| Q25–Q75 | 71.5–122 | 74.5–137 | 73.75–133 |
| LDH, U/L | |||
| Median | 192 | 186 | 187.5 |
| Q25–Q75 | 148–223.5 | 155.5–247.5 | 154–243.25 |
| Creatinine, μmol/L | |||
| Median | 63.5 | 65.6 | 65 |
| Q25–Q75 | 53–73 | 55.75–77 | 54.53–76.05 |
| Albumin, g/L | |||
| Median | 41.4 | 40.6 | 40.8 |
| Q25–Q75 | 38.1–45.78 | 37.1–43.65 | 37.7–44 |
| CEA, μg/mL | |||
| Median | 10.2 | 10.58 | 10.46 |
| Q25–Q75 | 2.58–65.21 | 3.45–78.83 | 3.4–76.51 |
| Treatment arm | |||
| Placebo | 31 (42) | 76 (33) | 107 (35) |
| Apatinib | 42 (58) | 154 (67) | 196 (65) |
Abbreviations: ECOG, Eastern Cooperative Oncology Group; PS, performance status; AST, aspartate aminotransferase; BUN, blood urea nitrogen; LDH, lactate dehydrogenase; CEA, carcinoembryonic antigen.