Table 2.
Selection of studies reporting the association between the e14a2 transcript and molecular response and/or TFR as clinical outcome
| Ref | N | Outcome measure | Results | P |
|---|---|---|---|---|
| Bonifacio et al. (2015) [48] | 320 | Rate of stable MR4 (among pts with optimal response to IM) | ||
| At 3 months |
e13a2: 23.2% e14a2: 47.8% both: 21% |
0.003a | ||
| At 6 months |
e13a2: 28.8% e14a2: 48.6% both: 33.3% |
0.027a | ||
| At 12 months |
e13a2: 25.9% e14a2: 53.7% both: 40% |
0.037a | ||
| Jain et al. (2016) [49] |
e13a2: 200 e14a2: 196 both: 85 |
Cumulative rate of MMR |
e13a2: 79% e14a2: 91% both: 95% |
0.0001 |
| Cumulative rate of MR4.5 |
e13a2: 57% e14a2: 79% both: 80% |
0.00001 | ||
| MMR at 12 months: OR for e14a2 (95%CI) |
e14a2: 5.85 (3.01–11.37) both: 3.29 (1.61–6.75) |
< 0.001 | ||
| Castagnetti et al. (2017) [50] |
e13a2: 203 e14a2: 290 |
Median time to MMR |
e13a2: 12 months e14a2: 6 months |
0.001 |
| Overall estimated probability of MMR |
e13a2: 83% e14a2: 88% |
< 0.001 | ||
| Median time to MR4.0 |
e13a2: 61 months e14a2: 41 months |
|||
| Overall estimated probability of MR4.0 |
e13a2: 52% e14a2: 67% |
0.001 | ||
| Claudiani et al. (2017) [51] |
e13a2: 27 e14a2: 37 |
Cumulative incidence of loosing MR3 (95%CI) |
e13a2: 64% (50–77) e14a2: 35% (15–56) |
- |
| Cumulative incidence of MR3 loss over time for e14a2: HR (95%CI) | ||||
| Univariate analysis | 0.4 (0.18–0.85) | 0.019 | ||
| Multivariate analysis | 0.38 (0.18–0.84) | 0.016 | ||
| Pagnano KBB et al. (2017) [52] |
e13a2: 56 e14a2: 94 both: 20 |
Rate of optimal MR (BCR-ABL levels <10%) at 3 months |
e13a2: 60% e14a2: 84% both: 75% |
0.02 |
|
Breccia M et al. 2018 [41] |
e13a2: 97 e14a2: 108 both: 3 |
Rate of MR4.5 |
e13a2: 31% e14a2: 43% both: 42% |
0.02 |
| Probability to achieve MR4.5—Multivariate analysis: HR (95%CI) of e14a2 vs e13a2 | 1.6 (1.3–2.0) | 0.03 | ||
| Shanmuganathan et al. (2018) [53] |
e13a2: 35 e14a2: 42 both: 18 |
Rate of TFR at 12 months |
e13a2: 34% e14a2: 65% |
0.008 |
| Probability to remain in TFR at 12 months—Multivariate analysis, HR (95%CI) of e14a2/both vs e13a2 | 2.24 (1.07–4.67) | 0.032 | ||
| D’Adda et al. (2019) [54] |
e13a2: 67 e14a2: 106 |
Rate of MR4 at 60 months |
e13a2: 52.4% e14a2: 82.2% |
0.008 |
| Rate of sustained DMR at 60 months |
e13a2: 26.9% e14a2: 47.2% |
0.003 | ||
| Rate of TFR after 12 months |
e13a2: 22±14% e14a2: 61±8% |
0.005 | ||
| Genthon A et al. (2020) [55] |
e13a2: 51 e14a2: 63 |
Rate of MMR at 12 months |
e13a2: 50.1% e14a2: 66.7% |
0.048 |
| OR (95%CI) | 3.25 (1.30–8.18) | 0.01 |
Bold indicates statistically significant P-values (< 0.05)
ae14a2 vs e13a2 or e13a2/e14a2
N number of patients, MR4 a 4-log decrease in BCR-ABL1 transcript based on the International Scale, IM imatinib mesylate, MMR major molecular response, OR odds ratio, 95%CI 95% confidence interval, HR hazard ratio, MR molecular response, TFR treatment-free remission, DMR deep molecular response