| Trial |
ECOG E2108[1] | Austria[2,3] | India[4] | Turkey MF07-01[5] |
Accrual period | 2011 to 2015 | 2011 to 2015 | 2005 to 2013 | 2007 to 2012 |
Number of patients | 256 | 90 | 350 | 274 |
Inclusion | De novo stage IV breast cancer on systemic therapy for 4 to 8 months without progression | Stage IV breast cancer | De novo stage IV breast cancer with resectable hormone receptor-positive disease, or others with a partial or complete response to anthracycline-based chemotherapy | De novo stage IV breast cancer |
Prerandomization systemic therapy | Optimal systemic therapy × 4 to 8 months | None | 6 to 8 cycles of anthracycline-based chemotherapy | None |
Stratification | - Hormone receptor status
- HER2 status
- Number of metastatic sites
- Endocrine therapy
- Chemotherapy
| - Hormone receptor status
- HER2 status
- Grade
- Location of metastases
- Use of 1st-line chemotherapy
| - Hormone receptor status
- Site of metastasis
- Number of metastatic lesions
| None |
Locoregional therapy in surgery group | - 87% surgery (BCS + RT or mastectomy ± RT)
- AxD rate not reported
- 80% clear margins
| - 71% mastectomy
- 29% BCS + RT
- 93% AxD
- 76% clear margins
| - 72% mastectomy
- 23% BCS + RT
- 100% AxD
- Margin status not reported
| - 74% mastectomy
- 26% BCS + RT
- 93% AxD
- 100% clear margins
|
Median follow-up (months) | 53 | 37.5 | 23 | 40 |
OS (surgery versus no surgery) | - Median OS 54 months in both arms
- 3-year OS 68 versus 68%
- HR 1.09, 90% CI 0.80-1.49; p = 0.63
| - Median OS 35 versus 55 months
- HR 0.69, 95% CI 0.36-1.33; p = 0.27
| - Median OS 19 versus 20.5 months
- 2-year OS 42 versus 43%
- HR 1.04, 95% CI 0.81-1.34; p = 0.79
| - 5-year OS 42 versus 24%
- HR 0.66, 95% CI 0.49-0.88; p = 0.005
|
LRP (surgery versus no surgery) | LRP 10 versus 26%, p = 0.003 | LRP 9 versus 18%, p = 0.22 | LRP-free survival: Median not attained versus 18.2 months; HR 0.16, 95% CI 0.10-0.26; p <0.0001 | LRP 1 versus 11%, p = 0.001 |
Quality of life | Worse in surgery group at 18 months; no difference at 6 or 30 months | No difference | Not reported | Not reported |