Table 3.
Overall Improvement (2006 IWG criteria) to Decitabine by Subgroup
| Subgroup | Patients With Overall Improvement (CR + mCR + PR + HI) | Total No. of Patients in Subgroup | % |
|---|---|---|---|
| Time from diagnosis to first dose, years | |||
| < 1 | 35§ | 63 | 56 |
| > 1 | 15 | 36 | 42 |
| Type of MDS | |||
| De novo | 45§ | 88 | 51 |
| Secondary | 5 | 11 | 45 |
| Patients with prior disease-modifying MDS therapy* | |||
| No | 38§ | 72 | 53 |
| Yes | 12 | 27 | 44 |
| FAB classification† | |||
| RA + RARS‡ | 15§ | 37 | 40 |
| RAEB + RAEB-T | 27 | 51 | 53 |
| CMML | 8 | 11 | 73 |
| IPSS risk group‖¶ | |||
| Intermediate-1 | 26§ | 52 | 50 |
| Intermediate-2 | 14 | 23 | 61 |
| High | 10 | 23 | 43 |
| Cytogenetic classification of risk | |||
| Good | 26§ | 49 | 53 |
| Intermediate | 10 | 15 | 67 |
| Poor | 12 | 29 | 41 |
Abbreviations: IWG, International Working Group; CR, complete response; mCR, marrow CR; PR, partial response; HI, hematologic improvement; MDS, myelodysplastic syndrome; FAB, French-American-British; RA, refractory anemia; RARS, refractory anemia with ringed sideroblasts; RAEB, refractory anemia with excess blasts; RAEB-T, refractory anemia with excess blasts in transformation; CMML, chronic myelomonocytic leukemia; IPSS, International Prognostic Scoring System.
Patients could have received more than one type of prior disease-modifying therapy.
Improvement rates by expert reviewer's FAB classification: RA+RARS (30%), RAEB+RAEB-T (56%), CMML (75%).
Patients with RA or RARS were required to have been red cell transfusion dependent to enroll.
Observed differences in overall improvement rates between subgroups did not achieve statistical significance.
IPSS was assigned to all patients, including those with secondary MDS or prior therapy.
Improvement rates by expert reviewer's IPSS classification: Intermediate-1 (46%), Intermediate-2 (59%), High (50%).