Characteristics of 123 patients monitored with serial PML-RARα NQ determinations compared with 344 overall adult patients on protocol INT0129
| Characteristic . | Study group . | Total adults* . |
|---|---|---|
| Age, y, median (range) | 41 (16-77) | 41 (15-81) |
| Sex, M/F, % | 55/45 | 53/47 |
| Pretreatment WBC count, cells/μL, median (range) | 1700 (300-550 000) | 2100 (200-550 000) |
| DFS follow-up | ||
| Months, median no. | 69 | 66 |
| Patients in CCR, no. | 66 | 129 |
| Induction Rx, ATRA/DA, no. patients | 68/55 | 171/173 |
| Postconsolidation Rx, ATRA/no-ATRA, no. patients | 47/64† | 93/130‡ |
| PML-RARα type, L-form/S-form, % | 61/38 | 60/401-153 |
| Characteristic . | Study group . | Total adults* . |
|---|---|---|
| Age, y, median (range) | 41 (16-77) | 41 (15-81) |
| Sex, M/F, % | 55/45 | 53/47 |
| Pretreatment WBC count, cells/μL, median (range) | 1700 (300-550 000) | 2100 (200-550 000) |
| DFS follow-up | ||
| Months, median no. | 69 | 66 |
| Patients in CCR, no. | 66 | 129 |
| Induction Rx, ATRA/DA, no. patients | 68/55 | 171/173 |
| Postconsolidation Rx, ATRA/no-ATRA, no. patients | 47/64† | 93/130‡ |
| PML-RARα type, L-form/S-form, % | 61/38 | 60/401-153 |
Rx indicates treatment.
Data based on randomized adult cases, as described in Tallman et al.1 26
ATRA patients were randomized to ATRA maintenance therapy for 1 year per protocol; the no-ATRA group did not receive any further therapy, whether by official protocol randomization (50 cases) or for other reasons (14 cases).
These values deviate from the anticipated 50:50 protocol distribution, because they have been corrected for patients who did not register for maintenance randomization and, thus, did not receive further treatment in the postconsolidation period and for patients who were randomized to maintenance treatment (7 to ATRA, 3 to observation) without confirmed CR.
Based on 203 clinically eligible adult cases positive for the L- or S-form of PML-RARα from Gallagher et al.19