Table 1.
Patient characteristics, treatment regimens and treatment responses
|
Cohort A (n = 81) |
Cohort B (n = 245) |
|
|---|---|---|
| Age at diagnosis (year), median (range) | 33 (16 – 66) | 34 (17 – 69) |
| Histological subtype in primary tumor, number (%)a | ||
| Pure seminoma | 41 (50.6%) | 72 (29.4%) |
| Non-seminoma / mixed germ cell tumor | 40 (49.4%) | 161 (65.7%) |
| Pure Teratoma | 0 | 10 (4.1%) |
| Serum tumor markers prior to treatment, number (%)b | ||
| AFP median (range) | 3.1 (n – 104) | 4.5 (n – 63951) |
| < 1000 ng/ml | 71 (100%) | 210 (91.7%) |
| > 1000 and < 10000 ng/ml | 0 | 14 (6.1%) |
| > 10000 ng/ml | 0 | 5 (2.2%) |
| Missing values | 10/81 (12.3%) | 16/245 (6.5%) |
| HCG median (range) | 0 (n – 549) | 8 (n-1′995′937) |
| < 5000 IU/l | 73 (100%) | 200 (86.6%) |
| > 5000 and < 50′000 IU/l | 0 | 14 (6.1%) |
| > 50′000 IU/l | 0 | 17 (7.4%) |
| Missing values | 8/81 (9.9%) | 14/245 (5.7%) |
| LDH median (range) | 360.5 (n – 1038) | 416 (n – 5666) |
| < 1.5 × ULN | 40 (60.6%) | 73 (34.8%) |
| > 1.5 × and < 10 × ULN | 26 (39.4%) | 129 (61.4%) |
| > 10 × ULN | 0 | 8 (3.9%) |
| Missing values | 15/81 (18.5%) | 35/245 (14.3%) |
| IGCCCG risk classification, number (%)c | ||
| Good prognosis | 70 (86.4%) | 135 (55.1%) |
| Intermediate prognosis | 11 (13.6%)d | 73 (29.8%) |
| Poor prognosis | 0 | 34 (13.9%) |
| Treatment for metastatic disease | ||
| BEP | 55 (67.9%) | 174 (71.0%) |
| EP | 7 (8.6%) | 27 (11.0%) |
| VIP / TIP | 3 (3.7%) | 17 (6.9%) |
| Othere | 9 (11.1%) | 14 (5.7%) |
| Surgery | 7 (8.6%) | 0 |
| Missing data | 0 | 9 (3.7%) |
| Residual tumor resection post chemotherapy | 12 (14.8%) | 82 (34.5%) |
| Radiotherapy post chemotherapy | 10 (13.2%) | 13 (5.4%) |
| Treatment response | ||
| Complete response (CR) | 54 (68.4%) | 77 (33.2%) |
| CR after residual tumor resection (CRar) | 13 (16.4%) | 59 (25.4%) |
| Partial response (PR) | 11 (13.9%) | 90 (38.8%) |
| Stable disease (SD) / Progressive disease (PD) | 0 | 6 (2.6%) |
| Missing data | 1 (1.2%) | 13 (5.3%) |
Abbreviations: AFP alpha-fetoprotein, BEP bleomycin, etoposide, cisplatin, EP etoposide, cisplatin, TIP paclitaxel, ifosfamide, cisplatin, ULN upper limit of normal, VIP cisplatin, etoposide, ifosfamide
aUnknown / burned out tumor: cohort A: n = 0, cohort B: n = 2 (0.8%)
b“n” indicates a normal value
cIGCCCG classification not possible: cohort A: 7/70 NSem patients did not have a known LDH-value and were classified as good prognosis due to favorable clinical parameters; cohort B: 3/245 (1.2%) patients not able to be classified into IGCCCG prognosis group due to missing information
d250 U/l was selected as upper limit of normal (ULN) for serum-LDH. A cut-off of 1.5 × ULN was selected for classification into IGCCCG intermediate risk group
eOther: Cohort A: n = 6 patients defined as treated in SAKK trials (SAKK 01/10 and SAKK 01/18) with 1 cycle of EP + RT or 1 cycle of carboplatin + RT, 2 patients with RT alone and 1 patient with not further specified radiochemotherapy. Cohort B had 4 patients with primary high-dose chemotherapy, 2 patients being treated with multiple cycles of POMB/ACE after 1 cycle of EP, multiple patients treated within clinical trials (SAKK) and some regimes not further specified