Univariable and multivariable analyses of risk factors for any delay of ≥7 d during frontline therapy
| Risk factor . | Univariable . | Multivariable . | |||
|---|---|---|---|---|---|
| Events/n . | OR (95% CI) . | P . | OR (95% CI) . | P . | |
| ≥7-d delay (all patients) | |||||
| HD-MTX approach | |||||
| Intercalated | 196/743 | 1.00 | <.0001 | 1.00 | <.0001 |
| EOT | 79/616 | 0.41 (0.31-0.55) | 0.44 (0.33-0.59) | ||
| Age (for an increase of 10 y) | 275/1359 | 0.96 (0.87-1.06) | .37 | 0.92 (0.82-1.04) | .20 |
| Sex | |||||
| Male | 166/825 | 1.00 | .90 | 1.00 | .95 |
| Female | 109/534 | 1.02 (0.78-1.33) | 0.99 (0.75-1.32) | ||
| Advanced stage | |||||
| Stage 1-2 | 46/221 | 1.00 | .82 | 1.00 | .90 |
| Stage 3-4 | 229/1138 | 0.96 (0.67-1.37) | 0.97 (0.63-1.50) | ||
| ECOG | |||||
| 0-1 | 210/1004 | 1.00 | .32 | 1.00 | .43 |
| 2+ | 65/353 | 0.85 (0.63-1.16) | 0.88 (0.63-1.22) | ||
| 2+ extranodal sites | |||||
| <2 | 115/576 | 1.00 | .83 | 1.00 | .62 |
| 2+ | 160/783 | 1.03 (0.79-1.35) | 1.08 (0.79-1.48) | ||
| LDH | |||||
| Normal | 93/401 | 1.00 | .12 | 1.00 | .088 |
| >ULN | 180/925 | 0.80 (0.60-1.06) | 0.76 (0.56-1.04) | ||
| Baseline CrCl | 272/1321 | 0.94 (0.68-1.30) | .71 | 0.73 (0.49-1.10) | .14 |
| Risk factor . | Univariable . | Multivariable . | |||
|---|---|---|---|---|---|
| Events/n . | OR (95% CI) . | P . | OR (95% CI) . | P . | |
| ≥7-d delay (all patients) | |||||
| HD-MTX approach | |||||
| Intercalated | 196/743 | 1.00 | <.0001 | 1.00 | <.0001 |
| EOT | 79/616 | 0.41 (0.31-0.55) | 0.44 (0.33-0.59) | ||
| Age (for an increase of 10 y) | 275/1359 | 0.96 (0.87-1.06) | .37 | 0.92 (0.82-1.04) | .20 |
| Sex | |||||
| Male | 166/825 | 1.00 | .90 | 1.00 | .95 |
| Female | 109/534 | 1.02 (0.78-1.33) | 0.99 (0.75-1.32) | ||
| Advanced stage | |||||
| Stage 1-2 | 46/221 | 1.00 | .82 | 1.00 | .90 |
| Stage 3-4 | 229/1138 | 0.96 (0.67-1.37) | 0.97 (0.63-1.50) | ||
| ECOG | |||||
| 0-1 | 210/1004 | 1.00 | .32 | 1.00 | .43 |
| 2+ | 65/353 | 0.85 (0.63-1.16) | 0.88 (0.63-1.22) | ||
| 2+ extranodal sites | |||||
| <2 | 115/576 | 1.00 | .83 | 1.00 | .62 |
| 2+ | 160/783 | 1.03 (0.79-1.35) | 1.08 (0.79-1.48) | ||
| LDH | |||||
| Normal | 93/401 | 1.00 | .12 | 1.00 | .088 |
| >ULN | 180/925 | 0.80 (0.60-1.06) | 0.76 (0.56-1.04) | ||
| Baseline CrCl | 272/1321 | 0.94 (0.68-1.30) | .71 | 0.73 (0.49-1.10) | .14 |
A more conservative analysis which excluded any patient in the iHDMTX group given <6 cycles of treatment (ie, a patient group who may not have been given EOT MTX even if it was the intention) found very similar results for treatment approach: HR: 0.44 (0.33-0.59), P < .001 (UVA); and HR 0.47 (0.35-0.64), P < .001 (MVA).
CI, confidence interval; CrCl, creatinine clearance; ECOG, Eastern Cooperative Group performance status; EOT, intercalated; HD-MTX, high-dose methotrexate; LDH, lactate dehydrogenase; OR, odds ratio; ULN, upper limit of normal.