Table 2.
Cumulative cytogenetic response rates by 1 year in patients with Ph + CP CML: total cohort, by line of therapy, and by TKI resistance or intolerance (overall and excluding patients with the respective baseline response).
| Total N = 156 | By line of therapy | By TKI resistance or intolerance | ||||
|---|---|---|---|---|---|---|
| Second-line n = 46 | Third-line n = 61 | Fourth-line n = 49 | Resistant n = 83 | Intolerant n = 73 | ||
| Cumulative cytogenetic response, % (95% CI) | ||||||
| Evaluable patients, n | 144 | 43 | 56 | 45 | 77 | 67 |
| MCyR | 83.3 (76.2–89.0) | 88.4 (74.9–96.1) | 83.9 (71.7–92.4) | 77.8 (62.9–88.8) | 79.2 (68.5–87.6) | 88.1 (77.8–94.7) |
| CCyR | 80.6 (73.1–86.7) | 83.7 (69.3–93.2) | 83.9 (71.7–92.4) | 73.3 (58.1–85.4) | 75.3 (64.2–84.4) | 86.6 (76.0–93.7) |
| Cumulative cytogenetic response in patients without the respective baseline response, % (95% CI) | ||||||
| Evaluable patients, n | 32 | 10 | 10 | 12 | 23 | 9 |
| MCyR | 59.4 (40.6–76.3) | 80.0 (44.4–97.5) | 60.0 (26.2–87.8) | 41.7 (15.2–72.3) | 56.5 (34.5–76.8) | 66.7 (29.9–92.5) |
| Evaluable patients, n | 52 | 16 | 19 | 17 | 34 | 18 |
| CCyR | 63.5 (49.0–76.4) | 75.0 (47.6–92.7) | 68.4 (43.4–87.4) | 47.1 (23.0–72.2) | 58.8 (40.7–75.4) | 72.2 (46.5–90.3) |
Evaluable cytogenetic population. To be considered a responder, the patient must have maintenance of baseline response while on-treatment or an improvement from baseline. Patients with MMR or better are counted as CCyR if a valid cytogenetic assessment is not available on a specific date. Associated two-sided 95% CI based on the exact method by Clopper–Pearson.
CCyR complete cytogenetic response, CI confidence interval, CML chronic myeloid leukemia, CP chronic phase, MCyR major cytogenetic response, Ph Philadelphia chromosome, TKI tyrosine kinase inhibitor.