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Table 2 Best overall response: phase II part

From: A phase Ib/II study of xentuzumab, an IGF-neutralising antibody, combined with exemestane and everolimus in hormone receptor-positive, HER2-negative locally advanced/metastatic breast cancer

 

Xe1000+Ev10+Ex25 (n = 70)

Ev10+Ex25 (n = 70)

Best overall response

 CR

1 (1.4)

0

 PR

4 (5.7)

7 (10.0)

 Non-CR/non-PD, n (%)

10 (14.3)

8 (11.4)

  Non-CR/non-PD ≥ 24 weeks

4 (5.7)

3 (4.3)

 SD, n (%)

28 (40.0)

32 (45.7)

  SD ≥ 24 weeks

4 (5.7)

7 (10.0)

 PD, n (%)

16 (22.9)

14 (20.0)

 Not evaluable, n (%)

11 (15.7)

9 (12.9)

OR, n (%)

5 (7.1)

7 (10.0)

 Odds ratio (95% CI) [P value]

0.70 (0.20–2.32) [P = 0.5598]

 Median time to OR, months (range)

3.7 (1.8–5.3)

1.8 (1.6–7.2)

 Median duration of OR, months (95% CI)

5.6 (NC–NC)

NC (1.8–NC)

Disease control, n (%)

13 (18.6)

17 (24.3)

 Odds ratio (95% CI) [P value]

0.70 (0.31–1.59) [P = 0.4008]

 Median duration of disease control, months (95% CI)

NC (9.2–NC)

9.3 (9.0–NC)

  1. CI confidence interval, CR complete response, NC not calculable, OR objective response, PD progressive disease, PR partial response, SD stable disease
  2. Odds ratio and P value are obtained from logistic regression model adjusted for visceral involvement at screening. An odds ratio > 1 favours Xe1000+Ev10+Ex25
  3. Kaplan–Meier estimates