Table 4.
Response in Myelodysplastic Syndromes and Chronic Myelomonocytic Leukemia Patients
| Response | Previously Treated Patientsa |
First-Line Treatment |
Duration of Response:Range (days) | ||||
|---|---|---|---|---|---|---|---|
| Responders | Evaluable Patients | % | Responders | Evaluable Patients | % | ||
| Overall responseb | 6 | 17 | 35 | 11 | 15 | 73 | 30-483c |
| CRd | 0 | 17 | 0 | 6 | 15 | 40 | 30-152 |
| Any HIe | 6 | 16 | 38 | 5 | 9 | 56 | 56-483c |
| HI-E | 3 | 10 | 30 | 2 | 4 | 50 | 56-483c |
| HI-N | 0 | 10 | 0 | 2 | 7 | 29 | 82-321c |
| HI-P | 5 | 14 | 36 | 2 | 6 | 33 | 58-351c |
| TI | 0 | 5 | 0 | 1 | 3 | 33 | 76 |
| Red blood cell | 0 | 3 | 0 | 1 | 3 | 33 | 76 |
| Platelet | 0 | 4 | 0 | 0 | NA | ||
| mCRe,f | 6 | 9 | 67 | 2 | 6 | 33 | 63-422g |
NOTE. At any cycle of azacitidine, International Working Group 2006 criteria were used with modifications as described in the Patients and Methods section.
Abbreviations: CR, complete remission; E, erythroid; HI, hematologic improvement; mCR, bone marrow complete remission; N, neutrophil; NA, not applicable; P, platelet; TI, transfusion independence.
Includes erythropoiesis-stimulating agents, chemotherapy, hypomethylating agents, and investigational and/or other agents.
Overall response rate does not include patients achieving mCR only.
One or more responses, including that at upper limit of range, are ongoing. Data were censored as of last visit entered into the clinical database.
Patients achieving CR were not included in any other categories.
One patient with mCR in the previously treated group also achieved HI (both HI-E and HI-P). Two patients with mCR in the first-line treatment group also achieved HI (one patient with HI-P and one patient with both HI-E and HI-N). These patients have been included in both the mCR and HI categories.
In the eight patients who achieved mCR, the response began in cycle 1 of subcutaneous (SC) dosing (n = 4) or very early in cycle 2 of oral dosing (n = 4). Therefore, the contribution of a single SC azacitidine cycle to the induction of these responses is likely relevant.
Bone marrow aspirates were not required after 6 cycles of oral azacitidine treatment, therefore follow-up data were not available to confirm upper limit of duration. Data were censored as of last visit entered into the clinical database.