Table 1.
Patient characteristics of ITT and PP population
| ITT population | PP population | ||||||
|---|---|---|---|---|---|---|---|
| Control group (n = 43) |
Experimental group (n = 38) |
p-value | Control group (n = 36) |
Experimental group (n = 32) |
p-value | ||
| Patient demographic | Patient demographic | ||||||
| Age (years) | Age (years) | ||||||
| Mean ± sd | 55.5 ± 11.8 | 55.9 ± 10.6 | 0.992 | Mean ± sd | 55.3 ± 12.6 | 55.1 ± 10.9 | 0.64 |
| Median (IQR) | 57.0 (48.0–64.0) | 56.5 (50.0–63.0) | Median (IQR) | 57.5 (46.0-64.5) | 55.5 (49.5–61.0) | ||
| <65 | 33 (76.7) | 32 (84.2) | 0.4 | <65 | 27 (75.0) | 28 (87.5) | 0.191 |
| ≥65 | 10 (23.3) | 6 (15.8) | ≥65 | 9 (25.0) | 4 (12.5) | ||
| sex | sex | ||||||
| Male | 21 (48.8) | 22 (57.9) | 0.415 | Male | 17 (47.2) | 20 (62.5) | 0.207 |
| Female | 22 (51.2) | 16 (42.1) | Female | 19 (52.8) | 12 (37.5) | ||
| Physical examination | Physical mxamination | ||||||
| Height (cm) | Height (cm) | ||||||
| Mean ± sd | 164.7 ± 9.6 | 164.6 ± 11.2 | 0.773 | mean ± sd | 164.5 ± 9.2 | 165.0 ± 11.8 | 0.522 |
| Median (IQR) | 163.0 (157.0-173.0) | 166.5 (156.0-173.0) | median (IQR) | 163.0 (157.0-172.5) | 170.0 (157.5–174.0) | ||
| Weight (kg) | Weight (kg) | ||||||
| Mean ± sd | 62.6 ± 12.4 | 68.0 ± 12.9 | 0.052 | mean ± sd | 62.4 ± 11.7 | 69.2 ± 13.4 | 0.038 |
| Median (IQR) | 62.0(52.0–73.0) | 66.0(59.0–81.0) | median (IQR) | 63.0(52.0–73.0) | 69.5(59.5–81.0) | ||
| Karnofsky Performance Status (KPS) | Karnofsky performance status (KPS) | ||||||
| 60 | 9 (20.9) | 4 (10.5) | 0.103 | 60 | 8 (22.2) | 2 (6.3) | 0.18 |
| 70 | 4 (9.3) | 11 (28.9) | 70 | 4 (11.1) | 9 (28.1) | ||
| 80 | 14 (32.6) | 9 (23.7) | 80 | 12 (33.3) | 9 (28.1) | ||
| 90 | 12 (27.9) | 13 (34.2) | 90 | 10 (27.8) | 11 (34.4) | ||
| 100 | 4 (9.3) | 1 (2.6) | 100 | 2 (5.6) | 1 (3.1) | ||
| MGMT methylation | MGMT methylation | ||||||
| No | 24 (57.1) | 29 (78.4) | 0.045 | No | 19 (54.3) | 24 (77.4) | 0.049 |
| Yes | 18 (42.9) | 8 (21.6) | Yes | 16 (45.7) | 7 (22.6) | ||
ITT intention-to-treat; PP per-protocol population; sd standard deviation; IQR interquartile range; cm centimeters; kg kilograms; MGMT O6-methylguanine-DNA methyltransferase