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خرید پکیج
تعداد آیتم قابل مشاهده باقیمانده : 3 مورد
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Randomized trials of surgery of the primary tumor in patients with de novo stage IV breast cancer

Randomized trials of surgery of the primary tumor in patients with de novo stage IV breast cancer
  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
ECOG: Eastern Cooperative Oncology Group; HER2: human epidermal growth factor receptor 2; BCS: breast-conserving surgery; RT: radiation therapy; AxD: axillary dissection; OS: overall survival; HR: hazard ratio; CI: confidence interval; LRP: locoregional progression.
References:
  1. Khan SA, Zhao F, Solin LJ, et al. A randomized phase III trial of systemic therapy plus early local therapy versus systemic therapy alone in women with de novo stage IV breast cancer: A trial of the ECOG-ACRIN Research Group (E2108). J Clin Oncol 2020; 38S: ASCO #LBA2.
  2. Fitzal F, Bjelic-Radisic V, Knauer M, et al. Impact of breast surgery in primary metastasized breast cancer: Outcomes of the prospective randomized phase III ABCSG-28 POSYTIVE trial. Ann Surg 2019; 269:1163.
  3. Bjelic-Radisic V, Fitzal F, Knauer M, et al. Primary surgery versus no surgery in synchronous metastatic breast cancer: Patient-reported quality-of-life outcomes of the prospective randomized multicenter ABCSG-28 Posytive Trial. BMC Cancer 2020; 20:392.
  4. Badwe R, Hawaldar R, Nair N, et al. Locoregional treatment versus no treatment of the primary tumour in metastatic breast cancer: An open-label randomised controlled trial. Lancet Oncol 2015; 16:1380.
  5. Soran A, Ozmen V, Ozbas S, et al. Randomized trial comparing resection of primary tumor with no surgery in stage IV breast cancer at presentation: Protocol MF07-01. Ann Surg Oncol 2018; 25:3141.
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