Table 3.
CR in patients with AML
| Overall population | de novo AML | Secondary AML | ||||
|---|---|---|---|---|---|---|
| Glasdegib + LDAC | LDAC alone | Glasdegib + LDAC | LDAC alone | Glasdegib + LDAC | LDAC alone | |
| n = 78 | n = 38 | n = 38 | n = 18 | n = 40 | n = 20 | |
| Patients with CR, n (%) | 15 (19.2) | 1 (2.6) | 7 (18.4) | 1 (5.6) | 8 (20.0)b | 0 |
| 95% CIa | 10.5–28.0 | 0.0–7.7 | 6.1–30.7 | 0.0–16.1 | 7.6–32.4 | N/A |
| Duration of remission, days | ||||||
| Median (range) | 302 (1–1262) | 91 (91–91) | 175 (1–533) | 91 (91–91) | 532 (64–1262) | 0 |
| Cytogenetic risk | ||||||
| Good/intermediate risk | n = 49 | n = 21 | n = 24 | n = 14 | n = 25 | n = 7 |
| Patients with CR, n (%) | 11 (22.4) | 0 | 5 (20.8) | 0 | 6 (24.0) | 0 |
| 95% exact CIc | 11.8–36.6 | 0.0–16.1 | 7.1–42.2 | 0.0–23.2 | 9.4–45.1 | 0.0–41.0 |
| Poor cytogenetic risk | n = 29 | n = 17 | n = 14 | n = 4 | n = 15 | n = 13 |
| Patients with CR, n (%) | 4 (13.8) | 1 (5.9) | 2 (14.3) | 1 (25.0) | 2 (13.3) | 0 |
| 95% exact CIc | 3.9–31.7 | 0.1–28.7 | 1.8–42.8 | 0.6–80.6 | 1.7–40.5 | 0.0–24.7 |
| Combination vs LDAC | ||||||
| Pearson Chi-square test (unstratified), p value | 0.0150 | 0.1988 | 0.0317 | |||
| CMH test stratified by CRF prognosis factor | ||||||
| Odds ratio (95% CI) | 4.3762 (1.3296–14.4037) | 1.8306 (0.4931–6.7962) | 4.5370 (1.0712–19.2173) | |||
| p value | 0.0184 | 0.2207 | 0.0662 | |||
AML, acute myeloid leukemia; CI, confidence interval; CMH, Cochran–Mantel–Haenszel; CR, complete remission; CRF, case report form; LDAC, low-dose cytarabine; MDS, myelodysplastic syndrome; N/A, not applicable
aUsing normal approximation
bSecondary AML developed from prior MDS (n = 7) or from prior chemotherapy/radiotherapy treatment (n = 1)
cUsing exact method based on binomial distribution