Prospective DAC or AZA studies in AML patients
| Reference . | AML type . | Median age (range), y . | Drug dose and schedule . | Patients, N . | CR/PR (%) . | ORR* (%) . | Median OS, mo . |
|---|---|---|---|---|---|---|---|
| 31 | |||||||
| CALGB 8421 | AML (20%-30% BM blasts) | 65 (35-81) | AZA 75 mg/m2 per day for 7 d, IV | 25 | 4 (12) | 12 (48) | — |
| CALG 8921 | AML (20%-30% BM blasts) | 66 (23-82) | AZA 75 mg/m2 per day for 7 d, SC | 26 | 3 (12) | 9 (35) | — |
| CALGB 9221 | AML (20%-30% BM blasts) | 69 (1-82) | Two randomization arms | ||||
| AZA 75 mg/m2 per day for 7 d, SC | 27 | 2 (7) | 10 (37%) | 19.3 | |||
| BSC | 25† | 0 | 2 (8)† | 12.9 | |||
| 32 | WHO-AML | 74 (61-87) | DAC 20 mg/m2 per day for 5 d, IV | 55 | 13 (24)‡ | 14 (25) | 7.7 |
| 33 | WHO-AML | 74 (60-85) | DAC 20 mg/m2 per day for 10 d, IV | 53 | 25 (47)‡ | 34 (64) | 12.6 |
| 34 | AML (20%-30% BM blasts) | 70 (62-80) | Two randomization arms | ||||
| AZA 75 mg/m2 per day for 7 d, SC | 55 | 10 (18)‡ | — | 24.5 | |||
| BSC, LDAC, or ICT | 58 | 9 (16)‡ | — | 16 | |||
| 35 | WHO-AML | 72 (56-86) | DAC 15 mg/m2 per 8 hours for 3 d, IV | 227 | 59 (26)§ | — | 5.5 |
| 36 | WHO-AML | 73 (64-91) | Two randomization arms | ||||
| DAC 20 mg/m2 per day for 5 d, IV | 242 | 44 (18) | 73 (30) | 7.7 | |||
| BSC or LDAC | 243 | 27 (11) | 34 (14) | 5 | |||
| 37 | AML (20%-30% BM blasts) | 69.5 (61-90) | Two randomization arms | ||||
| DAC 15 mg/m2 per 8 hours for 3 d, IV | 40 | 6 (15) | 12 (30) | 8 | |||
| BSC | 35 | 0 | 0 | 6 | |||
| 38 | WHO-AML‖ | 75 (64-91) | Two randomization arms | ||||
| AZA, 75 mg/m2 per day for 7 d, SC | 231 | 50 (22) | 70 (30) | 10.4 | |||
| BSC, LDAC, or ICT | 247 | 57 (23) | 65 (26) | 6.5 |
| Reference . | AML type . | Median age (range), y . | Drug dose and schedule . | Patients, N . | CR/PR (%) . | ORR* (%) . | Median OS, mo . |
|---|---|---|---|---|---|---|---|
| 31 | |||||||
| CALGB 8421 | AML (20%-30% BM blasts) | 65 (35-81) | AZA 75 mg/m2 per day for 7 d, IV | 25 | 4 (12) | 12 (48) | — |
| CALG 8921 | AML (20%-30% BM blasts) | 66 (23-82) | AZA 75 mg/m2 per day for 7 d, SC | 26 | 3 (12) | 9 (35) | — |
| CALGB 9221 | AML (20%-30% BM blasts) | 69 (1-82) | Two randomization arms | ||||
| AZA 75 mg/m2 per day for 7 d, SC | 27 | 2 (7) | 10 (37%) | 19.3 | |||
| BSC | 25† | 0 | 2 (8)† | 12.9 | |||
| 32 | WHO-AML | 74 (61-87) | DAC 20 mg/m2 per day for 5 d, IV | 55 | 13 (24)‡ | 14 (25) | 7.7 |
| 33 | WHO-AML | 74 (60-85) | DAC 20 mg/m2 per day for 10 d, IV | 53 | 25 (47)‡ | 34 (64) | 12.6 |
| 34 | AML (20%-30% BM blasts) | 70 (62-80) | Two randomization arms | ||||
| AZA 75 mg/m2 per day for 7 d, SC | 55 | 10 (18)‡ | — | 24.5 | |||
| BSC, LDAC, or ICT | 58 | 9 (16)‡ | — | 16 | |||
| 35 | WHO-AML | 72 (56-86) | DAC 15 mg/m2 per 8 hours for 3 d, IV | 227 | 59 (26)§ | — | 5.5 |
| 36 | WHO-AML | 73 (64-91) | Two randomization arms | ||||
| DAC 20 mg/m2 per day for 5 d, IV | 242 | 44 (18) | 73 (30) | 7.7 | |||
| BSC or LDAC | 243 | 27 (11) | 34 (14) | 5 | |||
| 37 | AML (20%-30% BM blasts) | 69.5 (61-90) | Two randomization arms | ||||
| DAC 15 mg/m2 per 8 hours for 3 d, IV | 40 | 6 (15) | 12 (30) | 8 | |||
| BSC | 35 | 0 | 0 | 6 | |||
| 38 | WHO-AML‖ | 75 (64-91) | Two randomization arms | ||||
| AZA, 75 mg/m2 per day for 7 d, SC | 231 | 50 (22) | 70 (30) | 10.4 | |||
| BSC, LDAC, or ICT | 247 | 57 (23) | 65 (26) | 6.5 |
ORR, overall response rate; PR, partial remission; SC, subcutaneous.
ORR including CR/PR, CR with incomplete blood count recovery, and/or hematologic improvements.
Thirteen patients received study drug after crossover.
CR only.
PR criteria were used in this study, and it included patients with persistent cytopenia.
If >30% marrow blasts and WBC < 15 G/L.