Table 2 Analysis of objective response rate derived from central radiology assessments (ITT population) – Week 33 analysis

From: PF-05280014 (a trastuzumab biosimilar) plus paclitaxel compared with reference trastuzumab plus paclitaxel for HER2-positive metastatic breast cancer: a randomised, double-blind study

 

PF-05280014 plus paclitaxel (n = 352)

Trastuzumab-EU plus paclitaxel (n = 355)

Risk ratio estimate (95% CI)a

Objective response rateb

 n (%)

220 (62.5)

236 (66.5)

0.940

  (95% CI)

(57.2–67.6)

(61.3–71.4)

(0.842–1.049)

Best overall response category,c n (%)

  Complete response

10 (2.8)

13 (3.7)

 

  Partial response

210 (59.7)

223 (62.8)

 

  Stable disease

76 (21.6)

74 (20.8)

 

  Progressive disease

18 (5.1)

11 (3.1)

 

  Indeterminate

38 (10.8)

34 (9.6)

 
  1. CI confidence interval, ITT intent-to-treat, RECIST Response Evaluation Criteria in Solid Tumours, trastuzumab-EU reference trastuzumab sourced from the European Union
  2. aRisk ratio and associated 95% CI were based on the Miettinen and Nurminen16 method
  3. bDefined as the percentage of patients within each treatment group who achieved complete response or partial response by Week 25 that was subsequently confirmed by Week 33 (or early discontinuation), in accordance with RECIST 1.1
  4. cBest overall response was determined using data up to and including Week 33
Back to article page