Table 1.
Baseline characteristics of included (post)pubertal and pre-pubertal boys.
| (Post)pubertal boysa | Pre-pubertal boys | |
|---|---|---|
| (n = 73) | (n = 28) | |
| Age at diagnosis (years), median (IQR) | 15.4 [14.4; 16.6] | 9.6 [6.6; 11.4] |
| Ann Arbor stage of disease | ||
| 1 | 1 (1.4%) | 0 (0.0%) |
| 2 | 33 (45.2%) | 7 (25.0%) |
| 3 | 22 (30.1%) | 11 (39.3%) |
| 4 | 17 (23.3%) | 10 (35.7%) |
| B symptomsb | 31 (42.5%) | 12 (42.9%) |
| ESR ≥ 30 mm/h | 44 (61.1%) | 17 (60.7%) |
| Bulky diseasec | 36 (50.7%) | 8 (28.6%) |
| Involved tumour sites in infradiaphragmatic regiond | 23 (31.5%) | 17 (60.7%) |
| Assigned treatment level and consolidation scheme | ||
| TL1 | 10 (13.7%) | 4 (14.3%) |
| TL2, COPDAC-28 | 17 (23.3%) | 3 (10.7%) |
| TL2, DECOPDAC-21 | 12 (16.4%) | 4 (14.3%) |
| TL3, COPDAC-28 | 22 (30.1%) | 6 (21.4%) |
| TL3, DECOPDAC-21 | 12 (16.4%) | 11 (39.3%) |
| Radiotherapy | ||
| Received radiotherapy | 18 (24.7%) | 7 (25.0%) |
| Assigned but not given | 2 (2.7%) | 1 (3.6%) |
| Ended study participation before end of treatment | 1 (1.4%) | 0 (0.0%) |
| Pelvic radiotherapye | 4 (5.5%) | 2 (7.1%) |
| Median follow-up, months (IQR) | 24.0 [23.0; 28.0] | 24.5 [22.0; 26.2] |
| End of study | ||
| Recurrence | 5 (6.8%) | 3 (10.7%) |
| Secondary malignancy | 1 (1.4%) | 0 (0.0%) |
| Death | 2 (2.7%) | 0 (0.0%) |
| Lost to follow-up | 2 (2.7%) | 0 (0.0%) |
Results are presented as median (IQR) or number (%).
Assigned treatment was according to the EuroNet-PHL-C2 protocol. TL1 patients receive 2× OEPA induction followed by either 1× COPDAC-28 or involved node radiotherapy depending on adequate or inadequate treatment-response.TL2/TL3 patients are randomized between the COPDAC-28 and DECOPDAC-21 treatment-arm and receive 2× OEPA induction followed by 2× (TL2) or 4× (TL3) (DE)COPDAC consolidation. Indication for radiotherapy depends on treatment response and treatment-arm.
OEPA, vincristine, etoposide, prednisone, doxorubicin; COPDAC-28, cyclophosphamide, vincristine, prednisone, and dacarbazine; DECOPDAC-21, doxorubicin, etoposide, cyclophosphamide, vincristine, prednisone, and dacarbazine; ESR, erythrocyte sedimentation rate; IQR, interquartile range; TL, treatment level.
(Post)pubertal is defined as testicular volume (measured by Prader orchidometer) ≥4 ml or tanner stage (genital) >1.
B symptoms, i.e. unexplained fever >38.5°C, weight loss of 10% during the past 6 months and drenching night sweats.
Bulky disease is defined as contiguous tumour volume of at least 200 ml.
Including tumour sites in the porta hepatis, splenic hilum, mesenteric, upper para-aortic, lower para-aortic, iliac, and inguinal area.
All patients who received pelvic radiotherapy were within the COPDAC-28 treatment-arm and target dose was 19.8 Gy. None of the boys were irradiated in the inguinal or testicular area, expected radiation directed towards the testes was <0.5–1 Gy.