Table 2.
Patient characteristics.
| Patients randomised | All (n = 497) | VC (n = 249) | VCE (n = 248) |
|---|---|---|---|
| Gender (f/m) | 231/266 | 118/131 | 113/135 |
| Age at randomisation | |||
| Mean | 4.98 | 4.96 | 5.01 |
| Median | 4.26 | 4.42 | 4.13 |
| Median range (q1–q3) | 2.02–7.06 | 1.99–7.06 | 2.14–7.07 |
| Age group – strata at randomisation | |||
| <1 year | 73 (14.7%) | 38 | 35 |
| ≥1 and <8 years | 328 (66.0%) | 163 | 165 |
| ≥8 years | 96 (19.3%) | 48 | 48 |
| Localisation – strata at randomisation | |||
| Supratentorial midline | |||
| Dodge II (chiasmatic) | 47 (9.5%) | 25 | 22 |
| Dodge III and other locations | 268 (53.9%) | 133 | 135 |
| All other locations | 182 (36.6%) | 91 | 91 |
| Primary tumour site | |||
| Cerebral hemispheres | 32 (6.4%) | 16 | 16 |
| Supratentorial midline | 315 (63.4%) | 158 | 157 |
| Dodge II | 47 | 25 | 22 |
| Dodge III | 121 | 64 | 57 |
| Others | 147 | 69 | 78 |
| Cerebellum | 30 (6.0%) | 16 | 14 |
| Brainstem | 80 (16.1%) | 41 | 39 |
| Spinal cord | 40 (8.0%) | 18 | 22 |
| Extent of all surgeries prior to start of chemotherapy | |||
| Complete resection | 6 (1.2%) | 4 | 2 |
| Subtotal/near total | 32 (6.4%) | 19 | 13 |
| Partial resectiona | 184 (37.0%) | 85 | 99 |
| Biopsy (open, stereotactic, endoscopic)a | 195 (39.2%) | 94 | 101 |
| Not evaluable | 12 (2.4%) | 6 | 6 |
| No surgeryb | 68 (13.7%) | 41 | 27 |
| Tumour histology/WHO grade | |||
| Pilocytic astrocytoma I | 289 (67.4%) | 141 | 148 |
| Pilomyxoid astrocytoma II | 36 (8.4%) | 17 | 19 |
| Diffuse glioma II | 49 (11.2%) | 25 | 24 |
| Glioneuronal tumours I | 30 (7.0%) | 15 | 15 |
| All others (LGG nos, Astrocytoma nos, RGNT, other mixed glioma) | 25 (5.8%) | 10 | 15 |
| Dissemination prior to treatmentc (M1/M2/M3/M4/not known) | 69 (13.9%) (1/30/30/5/13) | 27 (0/10/8/2/7) | 42 (1/20/22/3/6) |
| Interval from diagnosis to start of chemotherapy | |||
| ≤3.0 months | 299 (60.2%) | 148 | 151 |
| 3–6 months | 49 (9.9%) | 28 | 21 |
| 6–12 months | 54 (10.9%) | 27 | 27 |
| 12–24 months | 51 (10.2%) | 24 | 27 |
| >24 months | 44 (8.9%) | 22 | 22 |
| Indication to treatment (multiple recordings/patient possible) | |||
| Diencephalic syndrome | 59 | 28 | 31 |
| Severe/progressive neurologic symptoms | 218 | 107 | 111 |
| Severe/progressive visual impairment | 183 | 85 | 98 |
| Visual deterioration | 119 | 55 | 64 |
| Borderline vision | 107 | 51 | 56 |
| Nystagmus in infants | 79 | 32 | 47 |
| Loss of vision in second eye with first eye blind | 22 | 12 | 10 |
| Pressure effect of tumour mass | 74 | 34 | 40 |
| Symptomatic/progressive metastases | 20 | 6 | 14 |
| Radiological tumour progression | 198 | 99 | 99 |
| Radiological progression only | 97 | 54 | 43 |
| Radiological progression + symptoms | 101 | 45 | 56 |
a
The proportions of partial resection + biopsy are different between the VC- and VCE-arm, p 0.0218.
b
There is no significant difference between the proportions without histological diagnosis, p 0.0704. Tumours were located in the VP 58, other supratentorial midline structures 7, cerebellum 2, and caudal brainstem 1.
c
The proportions of dissemination between the VC- and VCE-arm are different of borderline significance p 0.0495. Primaries were located: 60.9% supratentorial midline, 13.0% brainstem, and 8.7% each for cerebrum, cerebellum, and spinal cord.