Table 2.
TIL values and clinicopathological characteristics
| Number of samples with evaluable TILs (n=678) | Stromal TIL value | p value | |
|---|---|---|---|
| Age at randomisation (years) | |||
| <65 | 573 (85%) | 10·00% (5·00–30·00) | 0·47* |
| ≥65 | 105 (15%) | 10·00% (5·00–25·00) | ·· |
|
| |||
| Ethnicity | ·· | ·· | 0·00074† |
| White | 391 (58%) | 10·00% (5·00–25·00) | ·· |
| Asian | 230 (34%) | 15·00% (5·00–35·00) | ·· |
| Black or African American | 24 (4%) | 5·00% (4·00–16·25) | ·· |
| Other | 33 (5%) | ·· | ·· |
|
| |||
| HER2 FISH status | ·· | ·· | 0·65† |
| FISH positive | 650 (96%) | 10·00% (5·00–30·00) | ·· |
| FISH negative | 5 (1%) | 15·00% (10·00–20·00) | ·· |
| FISH unknown | 23 (3%) | ·· | ·· |
|
| |||
| HER2 IHC status | ·· | ·· | 0·38† |
| IHC 0 | 1 (<1%) | 15·00% (15·00–15·00) | ·· |
| IHC 1+ | 2 (<1%) | 12·50% (8·75–16·25) | ·· |
| IHC 2+ | 69 (10%) | 10·00% (5·00–20·00) | ·· |
| IHC 3+ | 604 (89%) | 10·00% (5·00–30·00) | ·· |
| IHC unknown | 2 (<1%) | ·· | ·· |
|
| |||
| Histological grade | ·· | ·· | 0·14† |
| Poorly differentiated | 213 (31%) | 15·00% (5·00–30·00) | ·· |
| Moderately differentiated | 228 (34%) | 10·00% (5·00–30·00) | ·· |
| Well differentiated | 23 (3%) | 10·00% (5·00–22·50) | ·· |
| Unknown or other | 214 (32%) | ·· | ·· |
|
| |||
| Oestrogen receptor status | ·· | ·· | <0·0001* |
| Positive | 325 (48%) | 10·00% (5·00–20·00) | ·· |
| Negative | 344 (51%) | 15·00% (5·00–35·00) | ·· |
| Unknown | 9 (1%) | ·· | ·· |
|
| |||
| PIK3CA genotype | ·· | ·· | 0·035* |
| Mutant | 147 (22%) | 15·00% (5·00–35·00) | ·· |
| Wild type | 318 (47%) | 10·00% (5·00–30·00) | ·· |
| Unknown | 213 (31%) | ·· | ·· |
|
| |||
| Metastatic disease at screening | |||
| Visceral disease | 538 (79%) | 10·00% (5·00–30·00) | 0·16* |
| Non-visceral disease | 140 (21%) | 10·00% (5·00–31·25) | ·· |
|
| |||
| Tissue biopsy type | |||
| Freshly obtained | 155 (23%) | 10·00% (5·00–20·00) | 0·00036* |
| Archival | 519 (77%) | 15·00% (5·00–35·00) | ·· |
| Unknown | 4 (<1%) | ·· | ·· |
|
|
|||
| Unpaired tissue biopsy | |||
| Primary tissue | 631 (93%) | 10·00% (5·00–30·00) | 0·10* |
| Metastatic tissue | 47 (7%) | 10·00% (5·00–20·00) | ·· |
|
| |||
| Paired tissue biopsy (n=20) | |||
| Primary tissue | 20 | 10·00% (5·00–40·00) | 0·068* |
| Metastatic tissue | 20 | 7·50% (5·00–15·00) | ·· |
|
| |||
| Site of metastatic tissue biopsy (n=58) | |||
| Bone | 9 (15%) | 5·00% (1·00–5·00) | 0·0070*‡ |
| Liver | 20 (34%) | 5·00% (1·00–10·00) | ·· |
| Skin | 23 (40%) | 5·00% (4·00–10·00) | ·· |
| Lung | 6 (10%) | 30·00% (11·25–78·75) | ·· |
Data are n (%) or median (IQR) unless stated otherwise. Freshly obtained tissue samples were samples obtained 45 days or fewer before randomisation from patients who had not received any previous endocrine therapy. TIL=tumour-infiltrating lymphocyte. FISH=fluorescence in-situ hybridisation. IHC=immunohistochemistry.
*
Wilcoxon-Mann-Whitney test p value.
†
Kruskal-Wallis test p value.
‡
Lung metastases vs non-lung metastases.