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Table 2 Best overall response and progression-free survival for all patients, and by prior trastuzumab therapy and by hormone-receptor status, 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
All patients History of prior trastuzumab therapy subgroups Hormone receptor status subgroups
Prior trastuzumab therapy No prior trastuzumab therapy Estrogen receptor-positive and progesterone receptor-positive Estrogen receptor-positive and progesterone receptor-negative Estrogen receptor-negative and progesterone receptor-negative
N = 106 n = 44 n = 62 n = 45 n = 25 n = 36
Best overall response
 Patients with measurable disease at baseline 89 (84.0%) 36 (81.8%) 53 (85.5%) 39 (86.7%) 18 (72.0%) 32 (88.9%)
 Overall response rate 66 (74.2%) [63.8–82.9] 28 (77.8%) [60.8–89.9] 38 (71.7%) [57.7–83.2] 27 (69.2%) [52.4–83.0] 15 (83.3%) [58.6–96.4] 24 (75.0%) [56.6–88.5]
  Complete response 12 (13.5%) [7.2–22.4] 6 (16.7%) [6.4–32.8] 6 (11.3%) [4.3–23.0] 6 (15.4%) [5.9–30.5] 1 (5.6%) [0.1–27.3] 5 (15.6%) [5.3–32.8]
  Partial response 54 (60.7%) [49.7–70.9] 22 (61.1%) [43.5–76.9] 32 (60.4%) [46.0–73.5] 21 (53.8%) [37.2–69.9] 14 (77.8%) [52.4–93.6] 19 (59.4%) [40.6–76.3]
 Stable disease 16 (18.0%) [10.6–27.5] 6 (16.7%) [6.4–32.8] 10 (18.9%) [9.4–32.0] 9 (23.1%) [11.1–39.3] 3 (16.7%) [3.6–41.4] 4 (12.5%) [3.5–29.0]
 Progressive disease 5 (5.6%) [1.8–12.6] 2 (5.6%) [0.7–18.7] 3 (5.7%) [1.2–15.7] 2 (5.1%) [0.6–17.3] 0 [0.0–18.5] 3 (9.4%) [2.0–25.0]
 Not evaluable 2 (2.2%) [0.3–7.9] 0 [0.0–9.7] 2 (3.8%) [0.5–13.0] 1 (2.6%) [0.1–13.5] 0 [0.0–18.5] 1 (3.1%) [0.1–16.2]
Progression-free survival
 Median 14.3 months
[11.2–17.5]
11.8 months
[8.3–14.9]
16.8 months
[11.0–20.5]
13.6 months
[8.3–20.3]
14.3 months
[10.5–17.5]
15.5 months
[10.4–23.8]
 Number of patients with events 74 (69.8%) 36 (81.8%) 38 (61.3%) 32 (71.1%) 18 (72.0%) 24 (66.7%)
 Number of patients censored 32 (30.2%) 8 (18.2%) 24 (38.7%) 13 (28.9%) 7 (28.0%) 12 (33.3%)
  1. Data are reported number (%) [95% CI] for best overall response and median number of months [95% CI] or number (%) for progression-free survival. Best overall response was assessed only in patients of the intent-to-treat population with measurable disease at baseline. Progression-free survival was assessed in the intent-to-treat population. One patient had a missing progesterone receptor score and was considered as having a negative score