Table 4.
Early severe fluoropyrimidine‐related AEs
| Genotype‐guided cohort | Retrospective sample | |||||||
|---|---|---|---|---|---|---|---|---|
| Noncarrier (N = 1347) | Carrier (N = 47) | P value a | c.1905+1G>A (N = 9) | c.2846A>T (N = 19) | c.1679T>G (N = 1) | c.1236G>A (N = 18) | c.1236 G>A (N = 41) | |
|
Early severe AEs b (cycles 1–2), N (%) |
N (%) | N (%) | N (%) | |||||
| Global c | 284 (21.1) | 6 (13) | 0.167 | 2 (22) | 3 (16) | 0 (0) | 1 (5) | 10 (24) |
| Gastrointestinal | 131 (9.7) | 3 (6) | 0.616 | 1 (11) | 1 (5) | 0 (0) | 1 (5) | 5 (12) |
| Myelosuppression | 102 (7.6) | 5 (11) | 0.401 | 2 (22) | 2 (11) | 0 (0) | 1 (5) | 1 (2) |
| Cardiac | 26 (1.9) | 0 (0) | >0.99 | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| HFS | 13 (1.0) | 0 (0) | >0.99 | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 2 (5) |
| Other d | 68 (5.0) | 2 (4) | >0.99 | 1 (11) | 1 (5) | 0 (0) | 0 (0) | 3 (7) |
| AE‐related death e | 8 (0.6) | 0 (0) | >0.99 | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Discontinued treatment f | 137 (10.2) | 5 (11) | 0.808 | 2 (22) | 1 (5) | 0 (0) | 2 (11) | 4 (10) |
Abbreviations: AEs, adverse events; HFS, hand‐foot syndrome.
P values for fluoropyrimidine‐related AEs calculated using the following tests: Global utilized χ2 test; Gastrointestinal, Myelosuppression, Cardiac, HFS, Other, AE‐related death, and Discontinued Treatment utilized Fisher’s Exact Test.
Grade ≥3 by Common Terminology Criteria for Adverse Events version 5.0.
Global includes all fluoropyrimidine‐related AEs grade ≥3 and fluoropyrimidine‐related deaths. This does not include discontinuation.
Other AEs included: fatigue, infections, neurotoxicities, and laboratory abnormalities.
At least one fluoropyrimidine‐related AE contributed significantly to death.
Patients discontinuing treatment with fluoropyrimidines due to a fluoropyrimidine‐related AE of any grade.