Introduction
Methods and patients
Patient population
Statistical analysis
Variable | Subjects with available data {% missing} | Overall (n = 406) | CVE during follow-up (n = 23) | No CVE during follow-up (n = 383) |
p* |
---|---|---|---|---|---|
Demographic characteristics | |||||
Age | 406 {0.0%} | 37.3 [32.4 to 44.1] | 46.7 [42.0 to 54.1] | 37.0 [32.0 to 43.5] | 0.0002 |
BMI | 298 {26.6%} | 25.3 [23.1 to 27.5] | 25.3 [24.2 to 29.4] | 25.2 [23.0 to 27.5] | 0.353 |
Family history of TGCT** | 282 {30.5%} | 28 (9.9%) | 28 (9.9%) | 28 (10.3%) | 0.999 |
Smoker or ex-smoker | 329 {19.0%} | 147 (44.7%) | 13 (86.7%) | 134 (42.7%) | 0.001 |
Karnofsky index <100% | 364 {10.3%} | 17 (4.7%) | 2 (12.5%) | 15 (4.3%) | 0.168 |
Diabetes pretreatment | 369 {9.1%} | 9 (2.4%) | 5 (25.0%) | 4 (1.2%) | <0.0001 |
Hypertension pretreatment | 368 {9.4%} | 20 (5.4%) | 3 (16.7%) | 17 (4.9%) | 0.066 |
Hyperlipidemia pretreatment | 366 {9.9%} | 5 (1.4%) | 0 (0.0%) | 5 (1.4%) | 0.990 |
Diabetes posttreatment | 367 {9.6%} | 6 (1.6%) | 1 (5.9%) | 5 (1.4%) | 0.249 |
Hypertension posttreatment | 368 {9.4%} | 22 (6.0%) | 8 (44.4%) | 14 (4.0%) | <0.0001 |
Hyperlipidemia posttreatment | 366 {9.9%} | 37 (10.11%) | 8 (47.1%) | 29 (8.3%) | <0.0001 |
Clinicopathological variables | |||||
TU size > 4 cm | 352 {13.3%} | 135 (38.4%) | 7 (43.8%) | 128 (38.1%) | 0.649 |
Rete testis invasion | 232 {43.0%} | 101 (43.5%) | 1 (33.3%) | 100 (43.7%) | 0.597 |
LVI | 352 {13.3%} | 651 (19.5%) | 3 (17.7%) | 62 (19.6%) | 0.568 |
T stage | 406 {0.0%} | / | / | / | 0.277 |
pTis | / | 2 (0.5%) | 0 (00.0%) | 2 (0.5%) | / |
pT1 | / | 299 (73.7%) | 14 (60.8%) | 285 (74.4%) | / |
pT2 | / | 70 (17.2%) | 5 (21.7%) | 65 (17.0%) | / |
pT3 | / | 34 (8.4%) | 4 (17.4%) | 30 (7.8%) | / |
pT4 | 1 (0.3%) | 0 (00.0%) | 1 (0.3%) | ||
Laboratory parameters (preoperative) | |||||
Hemoglobin | 239 {41.1%} | 15.4 [14.8 to 16.3] | 14.6 [14.1 to 15.4] | 15.4 [14.9 to 16.4] | 0.047 |
Leukocytes | 238 {41.4%} | 7.3 [5.7 to 8.8] | 10.2 [7.4 to 12.0] | 7.2 [5.7 to 8.7] | 0.016 |
Thrombocytes | 238 {41.4%} | 225.0 [198.0 to 264.0] | 230.0 [196.0 to 282.0] | 224.0 [198.0 to 264.0] | 0.75 |
CRP | 209 {48.5%} | 1.4 [1.0 to 3.2] | 2.5 [1.4 to 8.2] | 1.3 [0.9 to 3.2] | 0.13 |
Fibrinogen | 207 {49.0%} | 293.0 [246.0 to 343.0] | 385.0 [346.0 to 1000.0] | 293.0 [246.0 to 337.0] | 0.003 |
LDH | 238 {41.4%} | 199.0 [167.0 to 248.0] | 218.0 [140.0 to 225.0] | 198.0 [167.0 to 248.0] | 0.809 |
Laboratory parameters (postoperative) | |||||
CRP | 195 {52.0%} | 1.0 [1.0 to 2.3] | 3.8 [2.3 to 4.4] | 1.0 [0.9 to 2.1] | 0.008 |
Laboratory parameters (1 year posttreatment) | |||||
CRP | 208 {48.8%} | 1.0 [0.8 to 2.3] | 2.8 [1.5 to 7.9] | 1.0 [0.7 to 2.2] | 0.008 |
Results
Analysis at baseline
Variable | Subjects with available data {% missing} | Overall (n = 406) | Active surveillance (n = 312) | Adjuvant carboplatin (n = 37) | Adjuvant radiotherapy (n = 57) |
p* |
---|---|---|---|---|---|---|
Demographic characteristics | ||||||
Age | 406 {00.0%} | 37.3 [32.4 to 44.1] | 36.9 [32.0 to 43.1] | 37.2 [31.3 to 46.1] | 41.1 [34.9 to 46.5] | 0.02 |
BMI | 298 {26.6%} | 25.3 [23.1 to 27.5] | 25.3 [23.1 to 27.4] | 24.9 [23.0 to 27.5] | 25.5 [23.7 to 29.2] | 0.603 |
Family history of TGCT** | 282 {30.5%} | 28 (9.9%) | 22 (10.2%) | 1 (3.3%) | 5 (13.5%) | 0.402 |
Smoker or ex-smoker | 329 {19.0%} | 147 (44.7%) | 106 (42.1%) | 20 (58.8%) | 21 (48.8%) | 0.153 |
Karnofsky index <100% | 364 {10.3%} | 17 (4.7%) | 9 (3.3%) | 1 (2.7%) | 7 (14.0%) | 0.01 |
Diabetes pretreatment | 369 {9.1%} | 9 (2.4%) | 5 (1.8%) | 0 (0.0%) | 4 (7.4%) | 0.06 |
Hyperlipidemia pretreatment | 366 {9.9%} | 5 (1.4%) | 4 (1.4%) | 0 (0.0%) | 1 (1.9%) | 0.745 |
Hypertension pretreatment | 368 {9.4%} | 20 (5.4%) | 13 (4.6%) | 2 (5.6%) | 5 (9.6%) | 0.291 |
Diabetes posttreatment | 367 {9.6%} | 6 (1.6%) | 6 (2.2%) | 0 (0.0%) | 0 (0.0%) | 0.783 |
Hypertension posttreatment | 368 {9.4%} | 22 (6.0%) | 18 (6.4%) | 0 (0.0%) | 4 (7.7%) | 0.256 |
Hyperlipidemia posttreatment | 366 {9.9%} | 37 (10.1%) | 26 (9.3%) | 1 (2.9%) | 10 (19.2%) | 0.04 |
Clinicopathological variables | ||||||
TU size > 4 cm | 352 {13.3%} | 135 (38.4%) | 77 (28.6%) | 26 (72.2%) | 32 (68.1%) | <0.0001 |
Rete testis invasion | 232 {43.0%} | 101 (43.5%) | 59 (33.9%) | 19 (61.3%) | 23 (85.2%) | <0.0001 |
Rete testis invasion and TU size > 4 cm | 226 {44.3%} | 40 (17.7%) | 14 (8.3%) | 11 (36.7%) | 15 (55.6%) | <0.0001 |
T stage | 406 {00.0%} | / | / | / | / | <0.277 |
pTis | / | 2 (0.5%) | 2 (0.6%) | 0 (0.0%) | 0 (0.0%) | / |
pT1 | / | 299 (73.7%) | 266 (85.3%) | 6 (16.2%) | 27 (47.4%) | / |
pT2 | / | 70 (17.2%) | 32 (10.3%) | 19 (51.4%) | 19 (33.3%) | / |
pT3 | / | 34 (8.4%) | 12 (3.9%) | 12 (32.4%) | 10 (17.5%) | / |
pT4 | 1 (0.3%) | 0 (0.0%) | 0 (0.0%) | 1 (1.8%) | ||
Laboratory parameters (preoperative) | ||||||
Hemoglobin | 239 {41.1%} | 15.4 [14.8 to 16.3] | 15.4 [14.9 to 16.4] | 15.9 [15.2 to 16.5] | 15.0 [13.9 to 15.6] | 0.002 |
Leukocytes | 238 {41.4%} | 7.3 [5.7 to 8.8] | 7.4 [5.8 to 8.8] | 7.2 [6.1 to 8.0] | 6.9 [5.0 to 10.0] | 0.866 |
Thrombocytes | 238 {41.4%} | 225.0 [198.0 to 264.0] | 227.0 [203.0 to 264.0] | 223.0 [199.0 to 271.0] | 211.0 [187.0 to 249.0] | 0.382 |
CRP | 209 {48.5%} | 1.4 [1.0 to 3.2] | 1.3 [0.7 to 3.2] | 1.1 [1.0 to 2.2] | 2.4 [1.3 to 5.1] | 0.022 |
Fibrinogen | 207 {49.0%} | 293.0 [246.0 to 343.0] | 291.0 [245.0 to 337.0] | 282.0 [248.0 to 336.0] | 325.0 [288.0 to 419.0] | 0.048 |
LDH | 238 {41.4%} | 199 [167 to 248] | 195.0 [164.0 to 237.0] | 215.0 [187.0 to 288.0] | 246.0 [191.0 to 381.0] | 0.002 |
Laboratory parameters (postoperative) | ||||||
CRP | 195 {52.0%} | 1.0 [1.0 to 2.3] | 1.0 [0.9 to 2.3] | 1.0 [0.9 to 2.3] | 1.4 [1.0 to 2.1] | 0.195 |
Laboratory parameters (1 year posttreatment) | ||||||
CRP | 208 {48.8%} | 1.0 [0.8 to 2.3] | 1.0 [0.7 to 2.2] | 1.0 [0.6 to 1.8] | 1.7 [1.0 to 2.9] | 0.001 |
Change in CRP (mg/dl) (from postoperative to 1 year posttreatment) | 185 {54.4%} | 0.0 [−0.4 to 0.4] | 0.0 [−0.4 to 0.2] | 0.0 [−0.5 to 0.5] | 0.1 [−0.3 to 3.16] | 0.002 |
Analysis of arterial cardiovascular complications
Cardiovascular event (N = 23) | No. of patients (N = 406) | Percentage (5.7%) |
---|---|---|
Subtype of cardiovascular event | ||
Myocardial infarction | 10 | 43.5 |
Corononary heart disease | 6 | 26.1 |
Cerebrovascular event | 4 | 17.4 |
Peripheral arterial disease | 3 | 13.0 |
Predictors of cardiovascular events
Variable | Univariable HR | 95% CI |
p
| Multivariable HR adjusted for age and smoking | 95% CI |
p
|
---|---|---|---|---|---|---|
Demographic characteristics | ||||||
Age (per 5 years increase above 35 years) | 1.62 | 1.35 to 1.94 | <0.0001 | N/A | N/A | N/A |
BMI (for 5 kg/m2 increase above 25 kg/m2) | 1.61 | 0.82 to 3.16 | 0.171 | 1.29 | 0.61 to 2.73 | 0.501 |
Smoker or ex-smoker | 8.43 | 1.88 to 37.84 | 0.005 | N/A | N/A | N/A |
Karnofsky index <100% | 2.65 | 0.70 to 9.99 | 0.151 | 2.28 | 0.59 to 8.87 | 0.233 |
Diabetes pretreatment | 6.16 | 2.67 to 14.22 | <0.0001 | 2.92 | 0.96 to 8.89 | 0.06 |
Hypertension pretreatment | 4.84 | 1.37 to 17.16 | 0.015 | 1.35 | 0.15 to 11.86 | 0.79 |
Hyperlipidemia pretreatment | N/E | N/E | N/E | N/E | N/E | N/E |
Diabetes posttreatment | 16.1 | 1.50 to 172.70 | 0.022 | 2.62 | 0.19 to 35.17 | 0.468 |
Hypertension posttreatment | 37.0 | 12.78 to 107.17 | <0.0001 | 42.13 | 9.35 to 189.94 | <0.0001 |
Hyperlipidemia posttreatment | 4.12 | 1.49 to 11.39 | 0.006 | 3.95 | 1.24 to 12.62 | 0.021 |
Clinicopathological variables | ||||||
TU size > 4 cm | 1.36 | 0.52 to 3.59 | 0.531 | 0.95 | 0.34 to 2.68 | 0.919 |
Rete testis invasion | 0.53 | 0.06 to 4.87 | 0.575 | 1.01 | 0.08 to 11.96 | 0.995 |
Rete testis invasion plus TU size > 4 cm | 1.39 | 0.18 to 10.98 | 0.755 | 0.60 | 0.07 to 4.76 | 0.626 |
Laboratory parameters (preoperative) | ||||||
Hemoglobin (per 1 g/dl increase) | 0.77 | 0.62 to 0.96 | 0.020 | 0.88 | 0.62 to 1.24 | 0.461 |
Leukocytes | 1.37 | 1.13 to 1.66 | 0.001 | 1.51 | 1.15 to 1.98 | 0.003 |
Thrombocytes (per 100 g/l increase) | 1.77 | 0.58 to 5.31 | 0.320 | 2.07 | 0.63 to 6.83 | 0.233 |
CRP (per 10 mg/dl increase) | 1.19 | 1.12 to 1.26 | <0.0001 | 0.89 | 0.56 to 1.40 | 0.607 |
Fibrinogen (per 100 mg/dl) | 1.78 | 1.53 to 2.07 | <0.0001 | 1.54 | 1.23 to 1.94 | 0.0001 |
Preoperative LDH (per 100 U/l increase) | 1.12 | 0.93 to 1.35 | 0.244 | 0.62 | 0.28 to 1.39 | 0.248 |
Laboratory parameters (postoperative) | ||||||
CRP (per 10 mg/dl increase) | 2.18 | 1.12 to 4.24 | 0.022 | 2.31 | 0.85 to 6.27 | 0.099 |
Laboratory parameters (1 year posttreatment) | ||||||
CRP 1a (per 10 mg/dl increase) | 23.8 | 4.08 to 139.21 | <0.0001 | 6.45 | 0.74 to 56.22 | 0.092 |