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. Author manuscript; available in PMC: 2018 Jan 1.
Published in final edited form as: Lancet Oncol. 2016 Dec 7;18(1):52–62. doi: 10.1016/S1470-2045(16)30631-3

Table 3.

Univariate and multivariate analyses of progression-free survival and overall survival

Number of patients PFS events OS events Univariate analysis Multivariate analysis
Progression-free survival Overall survival Progression-free survival Overall survival
HR (95% CI) p value HR (95% CI) p value HR (95% CI) p value HR p value
Stromal TILs (per 10% increment) 678 519 358 0·97 (0·93–1·11) 0·15 0·93 (0·89–0·98) 0·011 0·95 (0·90–1·00) 0·063 0·89 (0·83–0·96) 0·0014
Age (<65 vs ≥65 years) ·· ·· ·· 1·06 (0·83–1·36) 0·63 1·02 (0·76–1·37) 0·89 1·01 (0·74–1·38) 0·95 1·03 (0·70–1·53) 0·86
 <65 years 573 445 306 ·· ·· ·· ·· ·· ·· ·· ··
 ≥65 years 105 74 52 ·· ·· ·· ·· ·· ·· ·· ··
Ethnicity (white vs Asian) ·· ·· ·· 1·22 (1·01–1·47) 0·042 1·12 (0·90–1·41) 0·32 1·29 (1·03–1·62) 0·028 1·08 (0·82–1·42) 0·60
 White 391 311 211 ·· ·· ·· ·· ·· ·· ·· ·· ··
 Asian 230 169 118 ·· ·· ·· ·· ·· ·· ·· ··
Oestrogen receptor status (positive vs negative) ·· ·· ·· 1·01 (0·85–1·21) 0·89 0·79 (0·64–0·97) 0·026 1·07 (0·86–1·33) 0·57 0·79 (0·60–1·04) 0·091
 Positive 325 255 160 ·· ·· ·· ·· ·· ·· ·· ··
 Negative 344 257 193 ·· ·· ·· ·· ·· ·· ·· ··
PIK3CA genotype (mutant vs wild type) ·· ·· ·· 1·64 (1·31–2·04) <0·0001 1·54 (1·18–2·01) 0·0016 1·81 (1·43–2·29) <0·0001 1·65 (1·24–2·19) 0·00054
 Mutant 147 122 84 ·· ·· ·· ·· ·· ·· ·· ··
 Wild type 318 229 148 ·· ·· ·· ·· ·· ·· ·· ··
Previous treatment (treatment naive vs previous [neo] adjuvant therapy) ·· ·· ·· 0·99 (0·84–1·18) 0·94 0·90 (0·73–1·11) 0·34 1·04 (0·83–1·30) 0·73 0·87 (0·66–1·15) 0·33
 No previous (neo) adjuvant therapy 366 278 184 ·· ·· ·· ·· ·· ·· ·· ··
 Previous (neo)adjuvant therapy 312 241 174 ·· ·· ·· ·· ·· ·· ·· ··
Visceral disease at screening (yes vs no) 1·26 (1·02–1·57) 0·034 1·84 (1·37–2·46) <0·0001 1·30 (1·00–1·70) 0·059 1·86 (1·27–2·71) 0·0013
 Yes 538 417 305 ·· ·· ·· ·· ·· ·· ·· ··
 No 140 102 53 ·· ·· ·· ·· ·· ·· ·· ··
Treatment group (pertuzumab vs placebo) ·· ·· ·· 0·65 (0·55–0·77) <0·0001 0·64 (0·52–0·79) <0·0001 0·69 (0·55–0·86) 0·00083 0·66 (0·51–0·87) 0·0029
 Pertuzumab 336 241 151 ·· ·· ·· ·· ·· ·· ·· ··
 Placebo 342 278 207 ·· ·· ·· ·· ·· ·· ·· ··

All variables included in the univariate and multivariate Cox proportional analyses are shown. HR=hazard ratio. TILs=tumour-infiltrating lymphocytes. PFS=progression-free survival. OS=overall survival.