Table 1.
Baseline characteristics of 722 cancer patients treated at Odense University Hospital
| Overall N = 722a |
Intervention (DPYD guided) n = 230a | Control n = 492a | |
|---|---|---|---|
| Sex | |||
| Male | 456 (63) | 137 (60) | 319 (65) |
| Female | 266 (37) | 93 (40) | 173 (35) |
| Age at inclusion, years | 66.7 (9.4) | 66.8 (10.0) | 66.7 (9.1) |
| Tumor type | |||
| Upper gastrointestial (adenocarcinoma) | 221 (31) | 54 (23) | 167 (34) |
| Colorectal | 195 (27) | 66 (29) | 129 (26) |
| Pancreas | 138 (19) | 44 (19) | 94 (19) |
| Bile duct | 61 (8.4) | 23 (10) | 38 (7.7) |
| Breast | 43 (6.0) | 27 (12) | 16 (3.3) |
| Esophageal (squamous cell carcinoma) | 26 (3.6) | 7 (3.0) | 19 (3.9) |
| Head and neck | 16 (2.2) | 0 (0) | 16 (3.3) |
| Duodenal cancer | 13 (1.8) | 5 (2.2) | 8 (1.6) |
| Neuroendocrine carcinoma | 7 (1.0) | 3 (1.3) | 4 (0.8) |
| Carcinoma of unknown primary | 2 (0.3) | 1 (0.4) | 1 (0.2) |
| First treatment with fluoropyrimidine | |||
| S-1 [teysuno, (tegafur)] | 321 (44) | 92 (40) | 229 (47) |
| Capecitabine | 271 (38) | 97 (42) | 174 (35) |
| 5-FU | 130 (18) | 41 (18) | 89 (18) |
| Number of treatment cycles with FP | |||
| 4 | 575 (80) | 175 (76) | 400 (81) |
| 3 | 66 (9.1) | 22 (9.6) | 44 (8.9) |
| 2 | 38 (5.3) | 14 (6.1) | 24 (4.9) |
| 1 | 43 (6.0) | 19 (8.3) | 24 (4.9) |
| First FP dose intensity, % | |||
| 100 | 607 (84) | 167 (73) | 440 (89) |
| 51-85 | 92 (13) | 41 (18) | 51 (10) |
| 50 | 22 (3.1) | 21 (9.2) | 1 (0.2) |
| <50 | 1 (0.1) | 1 (0.4) | 0 (0) |
| Treatment target | |||
| Curative | 469 (65) | 123 (53) | 346 (70) |
| Palliative | 253 (35) | 107 (47) | 146 (30) |
| Performance status (WHO) | |||
| 0 | 347 (48) | 110 (48) | 237 (48) |
| 1 | 305 (42) | 94 (41) | 211 (43) |
| 2 | 69 (9.6) | 26 (11) | 43 (8.7) |
| 3 | 1 (0.1) | 0 (0) | 1 (0.2) |
| DPYD genotype | |||
| Wild type | 658 (91) | 207 (90) | 450 (91) |
| DPYD variants | |||
| Heterozygous (HapB3) | 39 (5.4) | 12 (5.2) | 27 (5.5) |
| Heterozygous (D949V) | 9 (1.1) | 5 (2.2) | 4 (0.8) |
| Heterozygous (DPYD∗2A) | 8 (1.1) | 1 (0.4) | 7 (1.4) |
| Heterozygous (DPYD∗13) | 4 (0.6) | 3 (1.3) | 1 (0.2) |
| Homozygous | |||
| HapB3/HapB3 | 2 (0.3%) | 0 (0%) | 2 (0.4%) |
| Compound heterozygous | |||
| D949V and HapB3 | 1 (0.1%) | 1 (0.4%) | 0 (0%) |
| DPYD2∗Aand HapB3 | 1 (0.1%) | 0 (0%) | 1 (0.2%) |
| Comorbidity | |||
| Chronic obstructive pulmonary disease | 24 (3.3%) | 6 (2.6%) | 18 (3.7%) |
| Type 1 diabetes | 14 (1.9%) | 6 (2.6%) | 8 (1.6%) |
| Type 2 diabetes | 84 (12%) | 25 (11%) | 59 (12%) |
| eGFR interval (ml/min/1.73 m2) | |||
| >90 | 291 (42) | 98 (44) | 193 (41) |
| 60-89 | 338 (49) | 105 (47) | 233 (0) |
| 30-59 | 63 (9.1) | 21 (9.4) | 42 (9.0) |
| <30 | 0 (0) | 0 (0) | 0 (0) |
| Unknown | 30 | 6 | 24 |
| Radiotherapy during FP treatment | 49 (6.8) | 12 (5.2) | 37 (7.5) |
| Combination chemotherapy | 577 (80) | 179 (78) | 398 (81) |
| Other drugs during first treatment cycle | |||
| Oxaliplatin | 397 (55) | 122 (53) | 275 (56) |
| Docetaxel | 137 (19) | 25 (11) | 112 (23) |
| Gemcitabine | 144 (20) | 54 (23) | 90 (18) |
| Calcium folinate(folinic acid) | 105 (15) | 35 (15) | 70 (14) |
| Bevacizumab | 9 (1.2) | 4 (1.7) | 5 (1.0) |
| Cisplatin | 11 (1.5) | 1 (0.4) | 10 (2.0) |
| Cyclophosphamide | 3 (0.4) | 1 (0.4) | 2 (0.4) |
| Irinotecan | 64 (8.9) | 23 (10) | 41 (8.3) |
| Methotrexate | 3 (0.4) | 1 (0.4) | 2 (0.4) |
| Cetuximab | 15 (2.1) | 5 (2.2) | 10 (2.0) |
| Paclitaxel | 18 (2.5) | 0 (0) | 18 (3.7) |
| Pembrolizumab | 1 (0.1) | 1 (0.4) | 0 (0) |
| Temozolomide | 3 (0.4) | 2 (0.9) | 1 (0.2) |
| Uracil concentration (ng/ml) | n = 200 | ||
| Mean uracil concentration (SD) | 8.9 (4.1) | ||
| <16 | 187 (94) | ||
| ≥16 <150 | 12 (6.0) |
FP, (5-fluorouracil, capecitabine, tegafur(S-1));
eGFR, estimated glomerular filtration rate; 5-FU, 5-fluoruracil; SD, standard deviation; WHO, World Health Organization.
a
n (%).