The rate of treatment discontinuation for treatment failure, study failure, and other causes
| Cause of discontinuation of study treatment . | IFN-α + LDAC, no. (%) . | IFN-α, no. (%) . |
|---|---|---|
| Treatment failure | ||
| No HR (less than partial) at 6 mo | 23 (8.4) | 15 (5.7) |
| Loss of complete HR | 23 (8.4) | 7 (2.7) |
| No CgR at 12 mo or less than minor CgR at 24 mo | 24 (8.7) | 18 (6.8) |
| Loss of MCgR | 16 (5.8) | 8 (3.0) |
| Progression to ABP | 22 (8.0) | 41 (15.6) |
| Death in CP | 1 (0.4) | 4 (1.5) |
| Treatment failure total | 109 (39.6) | 93 (35.4) |
| Study failure | ||
| Adverse events, toxicity | 32 (11.6) | 42 (16.0) |
| Refusal to continue | 25 (9.1) | 20 (7.6) |
| Study failure, total | 57 (20.7) | 62 (23.6) |
| Other causes | ||
| AlloBMT in CP | 49 (17.8) | 56 (21.3) |
| Other cancers | 2 (0.7) | 3 (1.1) |
| Other, or undefined | 20 (7.3) | 24 (9.1) |
| Total other causes | 71 (25.8) | 83 (31.5) |
| Total causes | 237 (86.2) | 238 (90.5) |
| Cause of discontinuation of study treatment . | IFN-α + LDAC, no. (%) . | IFN-α, no. (%) . |
|---|---|---|
| Treatment failure | ||
| No HR (less than partial) at 6 mo | 23 (8.4) | 15 (5.7) |
| Loss of complete HR | 23 (8.4) | 7 (2.7) |
| No CgR at 12 mo or less than minor CgR at 24 mo | 24 (8.7) | 18 (6.8) |
| Loss of MCgR | 16 (5.8) | 8 (3.0) |
| Progression to ABP | 22 (8.0) | 41 (15.6) |
| Death in CP | 1 (0.4) | 4 (1.5) |
| Treatment failure total | 109 (39.6) | 93 (35.4) |
| Study failure | ||
| Adverse events, toxicity | 32 (11.6) | 42 (16.0) |
| Refusal to continue | 25 (9.1) | 20 (7.6) |
| Study failure, total | 57 (20.7) | 62 (23.6) |
| Other causes | ||
| AlloBMT in CP | 49 (17.8) | 56 (21.3) |
| Other cancers | 2 (0.7) | 3 (1.1) |
| Other, or undefined | 20 (7.3) | 24 (9.1) |
| Total other causes | 71 (25.8) | 83 (31.5) |
| Total causes | 237 (86.2) | 238 (90.5) |
The rate of treatment discontinuation for treatment failure, study failure, and other causes was the same in the 2 treatment arms. However, while all the patients who failed IFN-α plus LDAC went off treatment, 29 patients who failed IFN-α were crossed to IFN-α plus LDAC.
HR indicates hematologic response; CgR, cytogenetic response; MCgR, major cytogenetic response; ABP, accelerated or blast phase; CP, chronic phase; alloBMT, allogeneic bone marrow transplantation. Other abbreviations are explained in Table 1.