Safety and efficacy of vinorelbine in combination with pertuzumab and trastuzumab for first-line treatment of patients with HER2-positive locally advanced or metastatic breast cancer: VELVET Cohort 1 final results

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		ND^a
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

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