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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