Table 2.
Response rates – at 3, 6, 12, 18, 24 and 30 months of dasatinib at 50mg daily*
| No. Response/Total (%) | 3 months | 6 months | 12 months | 18 months | 24 months | 30 months |
|---|---|---|---|---|---|---|
| BCR-ABL1 transcripts (IS) ≤10% | 78/81 (96) | 79/81 (98) | --- | --- | --- | --- |
| PCR ≤1% | 62/81 (77) | 73/81 (88) | --- | --- | --- | --- |
| CCyR | 40/81 (49) | 70/81 (86) | 76/81 (94) | 61/65 (94) | 44/47 (94) | 18/18 (100) |
| MMR | 27/81 (33) | 53/81 (65) | 65/81 (80) | 57/65 (88) | 41/47 (87) | 18/18 (100) |
| MR4.0 | 5/81 (6) | 28/81 (35) | 48/81 (59) | 48/65 (74) | 31/47 (66) | 15/18 (83) |
| MR4.5 | 3/81 (4) | 21/81 (26) | 40/81 (49) | 44/65 (68) | 27/47 (57) | 14/18 (78) |
CCyR=complete cytogenetic response; MMR=major molecular response (BCR-ABL1 transcripts [IS] ≤0.1%); MR4.0 = BCR-ABL transcripts (IS) ≤0.01%; MR4.5 = BCR-ABL transcripts (IS) ≤0.0032%
As the data matured showing discrepancy between PCR and FISH testing at 3 months, BCR-ABL1 transcripts (IS) ≤1% was used to define CCyR. In addition cytogenetic assessment by conventional cytogenetics was mandated at 6 months, starting patient 19 and onwards.