Table 3.
Sensitivity analyses of best overall response, progression-free survival, and time to progression, intent-to-treat population
| Cohort 1: pertuzumab, trastuzumab, and vinorelbine | ||
|---|---|---|
| Sensitivity analyses | ||
| Excluding tumor assessments after intake of any new anticancer therapy N = 106 | Including progressive disease due to symptomatic deterioration N = 106 | |
| Best overall response | NDa | |
| Patients with measurable disease at baseline | 89 (84.0%) | |
| Overall response rate | 57 (64.0%) [53.2–73.9] | |
| Complete response | 10 (11.2%) [5.5–19.7] | |
| Partial response | 47 (52.8%) [41.9–63.5] | |
| Stable disease | 17 (19.1%) [11.5–28.8] | |
| Progressive disease | 5 (5.6%) [1.8–12.6] | |
| Not evaluable | 10 (11.2%) [5.5–19.7] | |
| Progression-free survival | ||
| Median | 12.5 months [10.4–16.8] | 13.8 months [11.0–17.3] |
| Number of patients with events | 65 (61.3%) | 74 (69.8%) |
| Number of patients censored | 41 (38.7%) | 32 (30.2%) |
| Time to progression | ||
| Median | 12.9 months [10.5–16.8] | 14.3 months [11.2–17.5] |
| Number of patients with events | 62 (58.5%) | 72 (67.9%) |
| Number of patients censored | 44 (41.5%) | 34 (32.1%) |
Data are reported number (%) [95% CI] for best overall response and median number of months [95% CI] or number (%) for progression-free survival and time to progression. Best overall response was assessed only in patients of the intent-to-treat population with measurable disease at baseline. Progression-free survival and time to progression were assessed in the intent-to-treat population
aA sensitivity analysis including progressive disease due to symptomatic deterioration was not performed for best overall response