Table 2. Patient Survival in the Children’s Oncology Group AAML0631 and AAML1331 Studies.
| Variable | AAML0631 participants, No./total No. (%) | AAML1331 participants, No./total No. (%) [90% CI] | P value |
|---|---|---|---|
| Total patients, No. | 101 | 154 | NA |
| Standard-risk APL | 66/101 (65.3) | 98/154 (63.6) [NA] | NA |
| High-risk APL | 35/101 (34.7) | 56/154 (36.4) [NA] | NA |
| Early death | |||
| Standard-risk APL | 0 | 1/98 (1.0) [NA] | .16 |
| High-risk APL | 4/35 (11.4) | 0 | .02 |
| 2-year EFS rate | |||
| Standard-risk APL | 64/66 (97.0) | 96/98 (98.0) [93.4-99.3] | .71a |
| High-risk APL | 29/35 (82.9) | 54/56 (96.4) [88.2-98.8] | .05a |
| 2-year OS rate | |||
| Standard-risk APL | 65/66 (98.5) | 97/98 (99.0) [94.8-99.8] | .78 |
| High-risk APL | 30/35 (85.7) | 56/56 (100) [93.0-100] | .02 |
Abbreviations: APL, acute promyelocytic leukemia; EFS, event-free survival; NA, not applicable; OS, overall survival.
a
The 2-year EFS in the AAML1331 study met protocol-prespecified noninferiority assessments compared with the AAML0631 study for both the standard-risk and high-risk APL cohorts.