Treatment results of randomized patients
. | R1 . | . | R2 . | . | R3 + R4 . | . | All . | . | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
. | MTX-4h . | MTX-24h . | MTX-4h . | MTX-24h . | MTX-4h . | MTX-24h . | MTX-4h . | MTX-24h . | ||||
| No. patients | 21 | 19 | 93 | 96 | 66 | 69 | 180 | 184 | ||||
| Toxic death, no. | 0 | 0 | 1 | 0 | 3 | 3 | 4 | 3 | ||||
| Tumor failure, no. (no. alive after rescue) | 1 (1) | 0 | 4 (2) | 4 (0) | 12 (2) | 2 (0) | 17 (5) | 6 (0) | ||||
| Second malignancy, no. | 0 | 1 | 2 | 0 | 0 | 0 | 2 | 1 | ||||
| Late event, no. | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | ||||
| pFFS at 1 y, ± SE, % | 95 ± 5 | 100 | 95 ± 2 | 96 ± 2 | 77 ± 5 | 93 ± 3 | 88 ± 2 | 95 ± 2 | ||||
. | R1 . | . | R2 . | . | R3 + R4 . | . | All . | . | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
. | MTX-4h . | MTX-24h . | MTX-4h . | MTX-24h . | MTX-4h . | MTX-24h . | MTX-4h . | MTX-24h . | ||||
| No. patients | 21 | 19 | 93 | 96 | 66 | 69 | 180 | 184 | ||||
| Toxic death, no. | 0 | 0 | 1 | 0 | 3 | 3 | 4 | 3 | ||||
| Tumor failure, no. (no. alive after rescue) | 1 (1) | 0 | 4 (2) | 4 (0) | 12 (2) | 2 (0) | 17 (5) | 6 (0) | ||||
| Second malignancy, no. | 0 | 1 | 2 | 0 | 0 | 0 | 2 | 1 | ||||
| Late event, no. | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | ||||
| pFFS at 1 y, ± SE, % | 95 ± 5 | 100 | 95 ± 2 | 96 ± 2 | 77 ± 5 | 93 ± 3 | 88 ± 2 | 95 ± 2 | ||||
Intent-to-treat analysis. Log-rank P = .34 for R1, .72 for R2, .0077 for R3 + R4, and .015 for all.