Table 2 Pathological and clinical responses

From: Neoadjuvant ARX788 plus pyrotinib versus trastuzumab, pertuzumab, docetaxel and carboplatin for HER2-positive breast cancer: a randomised phase 2b trial

 

ARX788 plus pyrotinib (n = 68)

Docetaxel, carboplatin, and trastuzumab plus pertuzumab (n = 68)

Pathological response

Pathological complete responsea

48 (70.6, 58.3%–81.0%)

35 (51.5, 39.0%–63.8%)

Risk differenceb

19.1% (2.7%–34.6%)

 

OR

2.3 (1.1–4.6)

 

P value

0.023

 

Adjusted risk differenceb,c

20.0% (3.7%–36.3%)

 

Adjusted ORc

2.5 (1.1–5.3)

 

Adjusted P valuec

0.019

 

Breast pathological complete response

50 (73.5%, 61.4%–83.5%)

38 (55.9%, 43.3%–67.9%)

Residual cancer burden

 0

48 (70.6)

35 (51.5)

 I

3 (4.4)

13 (19.1)

 II

10 (14.7)

12 (17.6)

 III

7 (10.3)

8 (11.8)

Clinical response

 Complete response

14 (20.6)

9 (13.2)

 Partial response

50 (73.5)

53 (77.9)

 Stable disease

4 (5.9)

5 (7.4)

 Progressive disease

0 (0)

1 (1.5)

 Objective response

64 (94.1)

62 (91.2)

  1. Data are n (%, 95%CI) or n (%). The statistical test used was two-sided.
  2. aUsing the Clopper-Pearson method to calculate two-sided 95% CI for rates.
  3. bUsing the Miettinen-Nurminen (score) method to calculate 95% CI for rate difference.
  4. cUsing the Cochran-Mantel-Haenszel (CMH) test to correct the influence of confounding factors. Adjusted for clinical T stage, N stage and hormone receptor status at baseline.
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