Table 3.
Intervention group (DPYD guided)a |
Control groupa |
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CH (D949V, HapB3), n = 1 | HT (D949V), n = 5 | HT (DPYD13), n = 3 | HT (DPYD2A), n = 1 | HT (HapB3), n = 12 | Wild type, n = 208 | CH (DPYD2A-HapB3), n = 1 | HT (D949V), n = 4 | HT (DPYD13), n = 1 | HT (DPYD2A), n = 7 | HT (HapB3), n = 27 | HO (HapB3), n = 2 | Wild type, n = 450 | |
Relative dose intensity first cycleb | 50 (50-50) | 50 (50-50) | 50 (50-50) | 50 (50-50) | 49 (38-50) | 96 (75-100) | 100 (100-100) | 94 (75-100) | 80 (80-80) | 100 (100-100) | 98 (75-100) | 100 (100-100) | 98 (50-100) |
Overall grade ≥3 toxicity | 0 | 1 (20) | 1 (33) | 1 (100) | 2 (17) | 58 (28) | 1 (100) | 0 | 0 | 5 (71) | 6 (22) | 0 | 100 (22) |
Stop of FP treatment due to toxicity | 0 | 0 | 0 | 0 | 0 | 14 (6.7) | 1 (100) | 0 | 0 | 1 (14) | 1 (3.7) | 0 | 27 (6.0) |
FP-related hospitalization | 0 | 0 | 0 | 0 | 0 | 23 (11) | 1 (100) | 0 | 0 | 5 (71) | 2 (7.4) | 0 | 32 (7.1) |
Worst FP grade registered. | |||||||||||||
Grade 3 toxicity | 0 | 1 (20) | 1 (33) | 1 (100) | 2 (17) | 51 (25) | 0 | 0 | 0 | 2 (29) | 5 (19) | 0 | 87 (19) |
Grade 4 toxicity | 0 | 0 | 0 | 0 | 0 | 6 (2.9) | 1 (100) | 0 | 0 | 1 (14) | 1 (3.7) | 0 | 9 (2.0) |
Grade 5 toxicity (death) | 0 | 0 | 0 | 0 | 0 | 1 (0.5) | 0 | 0 | 0 | 2 (29) | 0 | 0 | 4 (0.9) |
Grade ≥3 gastrointestinal toxicity | 0 | 0 | 0 | 1 (100) | 2 (17) | 31 (15) | 0 | 0 | 0 | 4 (57) | 5 (19) | 0 | 51 (11) |
Grade ≥3 hematological toxicity | 0 | 0 | 0 | 0 | 0 | 11 (5.3) | 1 (100) | 0 | 0 | 2 (29) | 1 (3.7) | 0 | 22 (4.9) |
Grade ≥3 cardiac toxicity | 0 | 1 (20) | 0 | 0 | 0 | 7 (3.4) | 0 | 0 | 0 | 0 | 0 | 0 | 10 (2.2) |
Grade 3 PPE | 0 | 0 | 1 (33) | 0 | 0 | 8 (3.8) | 0 | 0 | 0 | 0 | 1 (3.7) | 0 | 13 (2.9) |
Grade ≥3 other toxicity | 0 | 0 | 0 | 0 | 0 | 2 (1.0) | 0 | 0 | 0 | 0 | 0 | 0 | 2 (0.4) |
FP, (5-fluorouracil, capecitabine, tegafur(S-1));
PPE, palmar plantar erythrodysesthesia; CH, compound heterozygous; HT, heterozygous; HO, homozygous.
n (%).
Mean in % of normal dose of FP drug relative to regimen. (min-max); all toxicity reported in this table is related to FP.