Table 1.
Ref | N | Outcome measure | Disease risk | |||
---|---|---|---|---|---|---|
Low | Intermediate | High | P | |||
TWISTER [6] (Sokal) | 40 | Rate of TFR 3 years after stopping IM | 51.1% | 36.5% | 25.0% | |
STIM1 long term [4] (Sokal) | 100 | Cumulative incidence of molecular recurrence (SHR [95%CI])—Univariate analysis | Low + intermediate | 2.01 (0.98–4.11) | 0.05 | |
Cumulative incidence of molecular recurrence (SHR [95%CI])Multivariate analysis | Low + intermediate | 2.22 (1.11–4.442) | 0.024 | |||
Cumulative incidence of molecular recurrence over time | ≈5 8% | ≈ 82% | ≈ 82% | 0.048 | ||
ENESTfreedom 96 weeks [22] (Sokal) | Rate of TFR (95%CI) | 61.3% (48.1–73.4) | 50.0% (35.5–64.5) | 28.6% (13.2–48.7) | ||
EURO-SKI [14] (Sokal and ELTS) | 758 | Probability of maintaining MMR 6 months after TKI discontinuation (OR [95%CI]) | ||||
Sokal | Ref. | 0.91 (0.60–1.37) | 0.90 (0.52–1.55) | 0.88 | ||
ELTS | Ref. | 0.86 (0.54–1.37) | 0.79 (0.36–1.77) | 0.72 | ||
Castagnetti et al. (2018) [43] (Sokal and ELTS) | All patients | |||||
Rate of MMR | ||||||
Sokal | 89% | 86% | 70% | < 0.001 | ||
ELTS | 89% | 83% | 65% | < 0.001 | ||
Rate of DMR | ||||||
Sokal | 68% | 63% | 49% | < 0.001 | ||
ELTS | 73% | 53% | 42% | < 0.001 | ||
Elderly (> 65 years) | ||||||
Rate of MMR | ||||||
Sokal | 94% | 88% | 83% | 0.471 | ||
ELTS | 100% | 87% | 75% | 0.001 | ||
Rate of DMR | ||||||
Sokal | 67% | 60% | 74% | 0.245 | ||
ELTS | 82% | 61% | 50% | 0.005 | ||
Italian observational study [26] (Sokal) | 293 |
Predictive value for molecular relapse HR (95% CI)—Univariate analysis |
Ref. | 0.74 (0.47-1.17) | 0.19 | |
1.66 (0.98-2.81) | 0.06 | |||||
Predictive value for molecular relapse HR (95% CI)—Multivariate analysis |
Ref. | 0.92 (0.54-1.97) | 0.76 | |||
2.07 (1.16-3.71) | 0.01 | |||||
Sato et al. 2020 [44] (Sokal and ELTS) | Rate of MMR by 12 months | |||||
Sokal | 53.3% | 56.2% | 45.5% | 0.409 | ||
ELTS | 56.3% | 52.1% | 11.8% | 0.00137 | ||
Rate of DMR at any time | ||||||
Sokal | 63.3% | 56.2% | 50.9% | 0.223 | ||
ELTS | 65.0% | 43.7% | 23.5% | 0.000057 |
Bold indicates statistically significant P-values (< 0.05)
N number of patients, TFR treatment-free remission, IM imatinib mesylate, SHR sub distribution hazard ratio, 95%CI 95% confidence interval, MMR major molecular response, ELTS European Treatment and Outcome Study long-term survival, OR odds ratio, pts patients, HR hazard ratio