Table 2.
Main outcome results in 161 patients with Ph− ALL also according to patient age (≤55 vs. >55 years) and ALL subset (B-ALL vs. T-ALL) (95% CI in brackets for time-dependent variables).
| All patients (n = 161) |
Age groups | ALL subsets | |||||
|---|---|---|---|---|---|---|---|
| ≤55 years (n = 135) | >55 years (n = 26) | P valuea | B-ALL (n = 117) |
T-ALL (n = 44) |
P valuea | ||
| CR induction | |||||||
| CR, no. (%) | 140 (86.9) | 124 (91.9) | 16 (61.5) | 0.0002 | 97 (82.9) | 43 (97.7) | 0.02 |
| NR, no. (%) | 7 (4.3) | 7 (5.2) | 0 (0) | 0.60 | 6 (5.1) | 1 (2.3) | 0.67 |
| ED, no. (%) | 14 (8.6) | 4 (2.9) | 10 (38.5) | <0.0001 | 14 (12.0) | 0 (0) | 0.01 |
| Treatment-related mortalityb | |||||||
| No. (%) | 28 (17.4) | 14 (10.4) | 14 (53.8) | <0.0001 | 25 (21.4) | 3 (6.8) | 0.02 |
| 5–10 years (%) | 18 (12–24) | 10 (6–16) | 55 (33–72) | 22 (15–29) | 7 (2–17) | ||
| Cumulative incidence of relapsec | |||||||
| No. (%) | 54 (33.5) | 49 (36.3) | 5 (19.2) | 0.70 | 40 (24.2) | 14 (31.8) | 0.24 |
| 5 years (%) | 36 (28–44) | 36 (28–45) | 32 (11–56) | 38 (28–48) | 30 (17–44) | ||
| 10 years (%) | 40 (32–49) | 41 (32–50) | N/A | 44 (33–54) | 33 (19–48) | ||
| Relapse-free survivalc | |||||||
| Median (years) | 6.3 | 7.2 | 2.0 | 0.06 | 4.9 | N/A | 0.16 |
| 5 years (%) | 53 (45–62) | 56 (47–65) | 28 (12–64) | 49 (40–60) | 60 (47–77) | ||
| 10 years (%) | 45 (37–55) | 48 (39–58) | N/A | 43 (33–54) | 50 (35–73) | ||
| CR durationc | |||||||
| Median (years) | N/A | N/A | N/A | 0.96 | N/A | N/A | 0.19 |
| 5 years (%) | 62 (54–71) | 62 (54–71) | 61 (39–96) | 59 (49–70) | 68 (55–84) | ||
| 10 years (%) | 56 (48–66) | 56 (48–67) | N/A | 52 (42–65) | 64 (51–82) | ||
| Event-free survivald | |||||||
| Median (years) | 3.4 | 5.4 | 0.5 | <0.0001 | 1.9 | 8.9 | 0.02 |
| 5 years (%) | 46 (39–55) | 52 (44–61) | 17 (7–41) | 42 (33–52) | 59 (46–75) | ||
| 10 years (%) | 39 (32–49) | 44 (35–54) | N/A | 35 (27–46) | 49 (34–71) | ||
| Overall survival | |||||||
| Median (years) | 7.4 | N/A | 0.6 | <0.0001 | 3.8 | N/A | 0.002 |
| 5 years (%) | 52 (45–62) | 60 (52–69) | 21 (9–45) | 47 (38–57) | 73 (61–87) | ||
| 10 years (%) | 46 (38–56) | 52 (44–63) | N/A | 40 (32–51) | 63 (48–84) | ||
ALL acute lymphoblastic leukemia, CI confidence interval, CR complete remission, NR non-responsive, ED early death, N/A not achieved.
aFisher test, Log-rank test, or Gray test, as appropriate.
bCumulative: sum of CR induction mortality and non-relapse mortality in CR patients (with censoring of 2 patients who died of an illness unrelated to ALL and its management).
cCalculated on 140 CR patients, including 4 patients with MRD relapse in relapse incidence and relapse-free survival analysis, with censoring of treatment-related deaths and secondary myeloid malignancies (n = 3) in CR duration analysis.
dCalculated on all study patients from diagnosis to induction death/resistance/recurrence/death in CR or last follow-up, whichever occurred first, with censoring of secondary AML/MDS (n = 3).