Comparison of MTX-associated toxicities between the stage-changed and nonstage-changed groups.
| MTX-associated Toxicity, n | Stage-changed Group, n = 130 | Nonstage-changed Group, n = 306 | P |
|---|---|---|---|
| Total events, n = 103 | 40 (30.7) | 63 (20.6) | 0.02 |
| Alopecia, n = 6 | 1 (0.8) | 5 (1.6) | 0.48 |
| Anemia, n = 6 | 4 (3.1) | 2 (0.6) | 0.04 |
| Flushing, n = 1 | 1 (0.8) | 0 (0) | 0.13 |
| Headache, n = 1 | 1 (0.8) | 0 (0) | 0.13 |
| Hepatotoxicity, n = 25 | 11 (8.5) | 14 (4.6) | 0.11 |
| All respiratory events assumed to be related to MTX, n = 5 | 2 (1.5) | 3 (1) | 0.62 |
| Serious Infection, n = 3 | 1 (0.8) | 2 (0.6) | 0.89 |
| Leukopenia, n = 9 | 6 (4.6) | 3 (0.9) | 0.02 |
| Malignancy, n = 3 | 0 (0) | 3 (0.9) | 0.26 |
| GI symptoms, n = 31 | 5 (3.8) | 26 (8.5) | 0.08 |
| Nephrotoxicity n = 5 | 4 (3.1) | 1 (0.3) | 0.01 |
| Stomatitis, n = 4 | 2 (1.5) | 2 (0.6) | 0.38 |
| Thrombocytopenia, n = 4 | 2 (1.5) | 2 (0.6) | 0.38 |
Data are presented as n (%). Values in bold are statistically significant. GI: gastrointestinal; MTX: methotrexate.