Table 2:
Proportion of patients with an objective response or haematological improvement
| Guadecitabine dose |
Disease cohort |
All patients (n=102) | |||
|---|---|---|---|---|---|
| 60 mg/m2 (n=53) | 90 mg/m2 (n=49) | Treatment-naive (n=49) | Relapsed or refractory (n=53) | ||
| Overall response* | 21 (40%; 26·5–54·0) | 27 (55%; 40·2–69·3) | 25 (51%; 36·3–65·6) | 23 (43%; 29·8–57·7) | 48 (47%; 37·1–57·2) |
|
| |||||
| Complete response | 6 (11%) | 7 (14%) | 11 (22%) | 2 (4%) | 13 (13%) |
|
| |||||
| Partial response | 0 | 0 | 0 | 0 | 0 |
|
| |||||
| Marrow complete response | 6 (11%) | 16 (33%) | 7 (14%) | 15 (28%) | 22 (22%) |
|
| |||||
| HI | 18 (34%) | 18 (37%) | 21 (43%) | 15 (28%) | 36 (35%) |
| HI-neutrophil | 7 (13%) | 6 (12%) | 7 (14%) | 6 (11%) | 13 (13%) |
| HI-platelet | 10 (19%) | 13 (27%) | 13 (27%) | 10 (19%) | 23 (23%) |
| HI-erythroid | 10 (19%) | 8 (16%) | 13 (27%) | 5 (9%) | 18 (18%) |
| Single-lineage HI | 11 (21%) | 10 (20%) | 11 (22%) | 10 (19%) | 21 (21%) |
| Bilineage HI | 5 (9%) | 7 (14%) | 8 (16%) | 4 (8%) | 12 (12%) |
| Trilineage HI | 2 (4%) | 1 (2%) | 2 (4%) | 1 (2%) | 3 (3%) |
|
| |||||
| No response | 29 (55%) | 20 (41%) | 20 (41%) | 29 (55%) | 49 (48%) |
|
| |||||
| Not evaluable | 3 (6%) | 2 (4%) | 4 (8%) | 1 (2%) | 5 (5%) |
Data are n (%; 95% CI) or n (%). Responses are based on modified 2006 International Working Group Response Criteria in Myelodysplasia.22
HI=haematological improvement.
*
Defined as complete response, partial response, marrow complete response, or HI. Some patients in the HI category have also been counted in one of the other response categories (ie, complete, partial, or marrow complete response). Patients were counted only once for overall response.