|
| Trials | N | Eligible patient | Pathological tumor size in enrolled patients | pN (UICC) in enrolled patient | ER (+) in enrolled patients | HG in enrolled patients | Median follow-up, years | DFS HR (95% CI,
value) | OS HR (95% CI,
value) | Reference |
|
| NCCTG N9831 and NSABP B-31Joint | 3,969 | | ≤20 mm 39%
21–40 mm 45%
>40 mm 15% | pN0 53%
pN1 27%
pN3 14% | 52% | HG1, 2% HG2 28% HG3 69% | 2.9 | 0.49 (0.41–0.58, ) | 0.63 (0.49–0.81, ) | [13] |
| NCCTG N9831 (control versus sequential HER) |
2,184 | n (+) or n (−) and t > 1 cm for HR (−) and t > 2 cm for HR (+) |
NR |
NR |
NR |
NR | 5.5 | 0.67 (0.55–0.82, ) | 0.86 (0.65–1.13, ) | [41] |
| NCCTG N9831 (concurrent HER versus sequential HER) | |
5.3 | 0.75 (0.60–0.94, ) | 0.79 (0.59–1.08, ) | [41] |
|
| HERA | 5,081 | n (+) or n (−) and t > 1 cm | ≤20 mm 40%
21–50 mm 44%
>50 mm 5% | pN0 32%
pN1 29%
pN2 28% | 46% | HG1 3% HG2 32% HG3 60% | 2 | 0.76 (0.66–0.87, ) | 0.85 (0.70–1.04, ) | [43] |
|
| BCIRG 006 (control versus DXT+HER) |
3,222 | n (+) or n (−) and either t > 2 cm, HR (−), HG 2-3, or <35y.o |
≤20 mm ≈40%
21–50 mm ≈54%
>50 mm ≈6% |
pN0 ≈29%
pN1 ≈39%
pN3 ≈33% |
54% (ER and/or PgR) |
NR |
5.4 | 0.64 (0.53–0.78, ) | 0.63 (0.48–0.81, ) | [12] |
| BCIRG 006 (control versus TCH) | 0.75 (0.54–0.90, ) | 0.77 (0.60–0.99, ) | [12] |
|
| FinHER | 232 | n (+) or n (−) and t ≥ 2 cm and PgR (−) | ≤10 mm 7%
1.1–20 mm 28%
>20 mm 65% | pN0 16%
pN1 53%
pN3 31% | 47% | HG1 2% HG2 31% HG3 65% | 3 | 0.42 (0.21–0.83, ) | 0.41 (0.16–1.08, ) | [16] |
|
| PACS 04 | 528 | n (+) | ≤20 mm 44%
>20 mm 54% |
pN0 0%
pN1 58%
pN3 42% | 60% | HG1 3% HG2 31% HG3 65% | 3.9 | 0.86 (0.61–1.22, ) | 1.27 (0.68–2.38, NR) | [44] |
|
