Table 3.
Subgroup analyses of overall response rate (ITT analysis set)
| Subgroups | Total number of patients in subgroup | Patients with ORR (CR + PR + mCR) | ORR, % (95% CI) |
|---|---|---|---|
| Age category | |||
| ≥18–60 years | 92 | 18 | 19.6 (12.0, 29.1)a |
| ≥60 years | 40 | 17 | 42.5 (27.0, 59.1)b |
| Sex | |||
| Men | 78 | 22 | 28.2 (18.6, 39.5)b |
| Women | 54 | 13 | 24.1 (13.5, 37.6)a |
| Treatment group | |||
| 3-day group | 34 | 10 | 29.4 (15.1, 47.5)c |
| 5-day group | 98 | 25 | 25.5 (17.2, 35.3)b |
| FAB classification | |||
| RA | 27 | 3 | 18.2 (2.3, 51.8) |
| RARS | 4 | 0 | 0 |
| RAEB | 83 | 27 | 32.5 (22.6, 43.7)b |
| RAEB-t | 11 | 2 | 25.0 (0.6, 80.6) |
| CMML | 7 | 3 | 50.0 (1.3, 98.7) |
| IPSS risk group | |||
| Intermediate-1 | 55 | 14 | 18.8 (4.0, 45.6)b |
| Intermediate-2 | 57 | 15 | 63.6 (30.8, 89.1)b |
| High | 20 | 6 | 42.9 (9.9, 81.6) |
ORR = CR + PR + mCR
P value calculated using single sample test using exact binomial proportion test, p 0 = 10%
ITT analysis set included all patients who received at least 1 dose of decitabine
CI confidence interval, CMML chronic myelomonocytic leukemia, CR complete response, IPSS International Prognostic Scoring System, ITT intent to treat, mCR marrow complete response, ORR overall response rate, PR partial response, RA refractory anemia, RAEB refractory anemia with excess blasts, RAEB-t refractory anemia with excess blasts in transformation, RARS refractory anemia with ringed sideroblasts
a P < 0.05
b P < 0.001
c P = 0.003