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Table 3 Sensitivity analyses of best overall response, progression-free survival, and time to progression, intent-to-treat population

From: 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

  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%)
  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
  2. aA sensitivity analysis including progressive disease due to symptomatic deterioration was not performed for best overall response