Table 2.
Primary and secondary efficacy measures (ITT population)
| Efficacy outcomes | Arm A (N = 62) | Arm B (N = 31) |
|---|---|---|
| Median PFS (months) (90% CI)a | 2.0 (1.9, 3.4) | 3.1 (1.9, 4.2) |
| Q25, Q75a | (1.8, 5.7) | (1.8, 4.4) |
| 6-month PFS rate, % (90% CI)a | 20.1 (11.3, 30.6) | 15.2 (6.0, 28.2) |
| 1-year PFS rate, % (90% CI)a | 15.0 (7.5, 25.0) | 7.6 (1.9, 18.7) |
| 2-year PFS rate, % (90% CI)a | 3.0 (0.4, 10.8) | NR |
| Best overall response, n (%) | ||
| CR | 0 (0.0) | 0 (0.0) |
| PR | 1 (1.6) | 0 (0.0) |
| SD | 24 (38.7) | 16 (51.6) |
| Progressive disease | 32 (51.6) | 15 (48.4) |
| Not evaluable/available | 5 (8.1) | 0 (0.0) |
| Objective response rate (CR+PR), % (95% CI)b | 1.6 (0.0, 8.7) | 0.0 (0.0, 11.2) |
| Disease control (CR+PR+SD), % (95% CI)b | 40.3 (28.1, 53.6) | 51.6 (33.1, 69.8) |
| Median OS (months) (90% CI)a | 20.3 (11.5, NR) | NR (17.8, NR) |
| Q25, Q75a | (6.2, NR) | (17.8, NR) |
| 6-month OS rate, % (90% CI)a | 76.7 (66.3, 84.3) | 96.8 (84.4, 99.4) |
| 1-year OS rate, % (90% CI)a | 60.8 (49.4, 70.4) | 80.4 (65.2, 89.5) |
| 2-year OS rate, % (90% CI)a | 46.6 (29.4, 62.1) | 62.5 (38.9, 79.2) |
Abbreviations: Arm A, cixutumumab + antiestrogen; Arm B, cixutumumab; N, number of patients for each treatment; n, number of patients; NR, not reached; Q25, 25th quartile; Q75, 75th quartile.
a
Estimated by the Kaplan–Meier method.
b
Estimated using binomial distribution.