Table 1. Characteristics of Patients Enrolled in the Children’s Oncology Group AAML0631 and AAML1331 Studies.
| Characteristic | Standard-risk APL cohort, No./total No. (%)a | P value | High-risk APL cohort, No./total No. (%)b | P value | ||
|---|---|---|---|---|---|---|
| AAML0631 (n = 66) | AAML1331 (n = 98) | AAML0631 (n = 35) | AAML1331 (n = 56) | |||
| Sex | ||||||
| Female | 35/66 (53.0) | 48/98 (49.0) | .61 | 22/35 (62.9) | 25/56 (44.6) | .09 |
| Male | 31/66 (47.0) | 50/98 (51.0) | 13/35 (37.1) | 31/56 (55.4) | ||
| Age, median (range), y | 14.8 (2.4-21.3) | 15.4 (2.3-21.7) | .62 | 15.2 (2.0-19.0) | 12.6 (1.1-20.8) | .22 |
| Racec | ||||||
| American Native | 2/63 (3.2) | 3/82 (3.7) | >.99 | 0 | 0 | NA |
| Asian | 0 | 3/82 (3.7) | .26 | 3/35 (8.6) | 3/49 (6.1) | .69 |
| Black | 7/63 (11.1) | 13/82 (15.9) | .41 | 3/35 (8.6) | 13/49 (26.5) | .04 |
| White | 51/63 (81.0) | 59/82 (72.0) | .21 | 27/35 (77.1) | 33/49 (67.3) | .33 |
| Otherd | 3/63 (4.8) | 4/82 (4.9) | >.99 | 2/35 (5.7) | 0 | .17 |
| Ethnicitye | ||||||
| Hispanic | 14/64 (21.9) | 32/86 (37.2) | .04 | 5/34 (14.7) | 14/50 (28.0) | .15 |
| Non-Hispanic | 50/64 (78.1) | 54/86 (62.8) | 29/34 (85.3) | 36/50 (72.0) | ||
| M3v | 6/66 (9.1) | 16/98 (16.3) | .18 | 14/35 (40.0) | 24/56 (42.9) | .79 |
| Cytogenetic complexityf | ||||||
| Chromosomal translocation t(15;17) only | 38/66 (57.6) | 62/95 (65.3) | .32 | 24/32 (75.0) | 39/49 (80.0) | .63 |
| Additional abnormalities | 28/66 (42.4) | 33/95 (34.7) | 8/32 (25.0) | 10/49 (20.4) | ||
| ECOG scoreg | ||||||
| 0 | 39/64 (60.9) | 62/98 (63.3) | .70 | 9/33 (27.3) | 27/56 (48.2) | .04 |
| 1 | 14/64 (21.9) | 22/98 (22.4) | .91 | 11/33 (33.3) | 17/56 (30.4) | .86 |
| 2 | 6/64 (9.4) | 6/98 (6.1) | .54 | 8/33 (24.2) | 5/56 (8.9) | .07 |
| 3 | 1/64 (1.6) | 5/98 (5.1) | .40 | 2/33 (6.1) | 2/56 (3.6) | .63 |
| 4 | 4/64 (6.3) | 2/98 (2.0) | .22 | 3/33 (9.1) | 3/56 (5.4) | .67 |
| WBCs, median (range), ×1000/μL | 1.8 (0.4-9.5) | 2.4 (0.2-8.9) | .21 | 25.2 (11.2-173.8) | 41.1 (10.2-255.1) | .17 |
| Platelets, median (range), ×1000/μL | 19.0 (3.0-198.0) | 21.0 (2.0-650.0) | .65 | 24.0 (5.0-107.0) | 18.5 (5.0-99.0) | .42 |
Abbreviations: APL, acute promyelocytic leukemia; ECOG, Eastern Cooperative Oncology Group; M3v, microgranular variant; NA, not applicable; WBC, white blood cell.
Standard-risk APL was defined as a WBC count of less than 10 000/μL.
High-risk APL was defined as a WBC count of 10 000/μL or greater.
In the AAML0631 study, race was unknown for 3 patients in the standard-risk cohort. In the AAML1331 study, race was unknown for 16 patients in the standard-risk and 7 patients in the high-risk cohort.
Races in this category included Native Hawaiian, other Pacific Islander, and multiple races (not specified).
In the AAML0631 study, ethnicity was unknown for 2 patients in the standard-risk cohort and 1 patient in the high-risk cohort. In the AAML1331 study, ethnicity was unknown for 12 patients in the standard-risk cohort and 6 patients in the high-risk cohort.
In the AAML0631 study, data were missing for 3 patients in the high-risk cohort. In the AAML1331 study, data were missing for 3 patients in the standard-risk cohort and 7 patients in the high-risk cohort.
In the AAML0631 study, 2 patients in the standard-risk cohort and 2 patients in the high-risk cohort were not evaluated. In the AAML1331 study, 1 patient in the standard-risk cohort and 2 patients in the high-risk cohort were not evaluated.