Table 2.
Analysis of objective response rate derived from central radiology assessments (ITT population) – Week 33 analysis
| 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) | |
CI confidence interval, ITT intent-to-treat, RECIST Response Evaluation Criteria in Solid Tumours, trastuzumab-EU reference trastuzumab sourced from the European Union
aRisk ratio and associated 95% CI were based on the Miettinen and Nurminen16 method
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
cBest overall response was determined using data up to and including Week 33