Table 2.
Five-year survival estimates and cumulative incidence estimates from time of initiation of trastuzumab and sensitivity analysis 14 months after initiation of trastuzumab
| Study outcome | Primary analysis, % (95% CI) | Sensitivity analysis, % (95% CI) |
|---|---|---|
| 5-year survival estimates | ||
| DFS | ||
| Group Aa | 94.1 (93.3 to 94.9) | 92.6 (91.6 to 93.5) |
| Group Bb | 80.2 (74.8 to 84.6) | 80.6 (74.7 to 85.3) |
| Group Cc | 81.4 (76.7 to 85.2) | 84.9 (79.7 to 88.8) |
| Group Dd | 82.4 (79.7 to 84.8) | 84.7 (81.7 to 87.2) |
| OS | ||
| Group A | 95.0 (94.3 to 95.7) | 93.7 (92.9 to 94.5) |
| Group B | 84.4 (79.6 to 88.2) | 86.2 (81.2 to 89.9) |
| Group C | 82.8 (78.4 to 86.4) | 86.7 (82.0 to 90.3) |
| Group D | 83.7 (81.2 to 86.0) | 86.3 (83.5 to 88.7) |
| 5-year cumulative incidence estimates | ||
| Cancer-specific death | ||
| Group A | 2.7 (2.2 to 3.3) | 3.1 (2.5 to 3.7) |
| Group B | 6.5 (4.0 to 9.7) | 6.0 (3.5 to 9.3) |
| Group C | 9.2 (6.5 to 12.5) | 6.5 (4.0 to 9.8) |
| Group D | 10.2 (8.3 to 12.2) | 7.7 (5.8 to 9.8) |
| Cardiovascular-specific death | ||
| Group A | 0.3 (0.1 to 0.5) | 0.3 (0.1 to 0.5) |
| Group B | 2.0 (0.7 to 4.4) | 2.1 (0.8 to 4.6) |
| Group C | 0.6 (0.1 to 1.9) | 0.3 (0.0 to 1.7) |
| Group D | 0.4 (0.2 to 1.1) | 0.7 (0.2 to 1.8) |
a
Group A received a full course of trastuzumab (17-18 cycles) without any cardiac events between day 1, cycle 1, and 90 days after the final cycle. CI = confidence interval; DFS = disease-free survival; OS = overall survival.
b
Group B had a cardiac event within the study period.
c
Group C had 16 or fewer cycles of trastuzumab, had no cardiac events, and stopped treatment within 30 days of the last cardiac imaging test.
d
Group D had 16 or fewer cycles of trastuzumab, had no cardiac events, and stopped treatment more than 30 days after the last cardiac imaging test.