Abstract
PURPOSE Distant metastases are present in 6% or more of patients with newly diagnosed breast cancer. In this context, locoregional therapy for the intact primary tumor has been hypothesized to improve overall survival (OS), but clinical trials have reported conflicting results. METHODS Women presenting with metastatic breast cancer and an intact primary tumor received systemic therapy for 4-8 months; if no disease progression occurred, they were randomly assigned to locoregional therapy for the primary site (surgery and radiotherapy per standards for nonmetastatic disease) or continuing sysmetic therapy. The primary end point was OS; locoregional control and quality of life were secondary end points. The trial design provided 85% power to detect a 19.3% absolute difference in the 3-year OS rate in randomly assigned patients. The stratified log-rank test and Cox proportional hazards model were used to compare OS between arms. Cumulative incidence of locoregional progression was compared using Gray's test. Quality-of-life assessment used standard instruments. RESULTS Of 390 participants enrolled, 256 were randomly assigned: 131 to continued systemic therapy and 125 to early locoregional therapy. The 3-year OS was 67.9% without and 68.4% with early locoregional therapy (hazard ratio 5 1.11; 90% CI, 0.82 to 1.52; P 5 .57). The median OS was 53.1 months (95% CI, 47.9 to not estimable) in the systemic therapy arm and 54.9 months (95% CI, 46.7 to not estimable) in the locoregional therapy arm. Locoregional progression was less frequent in those randomly assigned to locoregional therapy (3-year rate: 16.3% v 39.8%; P , .001). Quality-of-life measures were largely similar between arms. CONCLUSION Early locoregional therapy for the primary site did not improve survival in patients presenting with metastatic breast cancer. Although it was associated with improved locoregional control, this had no overall impact on quality of life.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 978-987 |
| Number of pages | 10 |
| Journal | Journal of Clinical Oncology |
| Volume | 40 |
| Issue number | 9 |
| DOIs | |
| State | Published - Mar 20 2022 |
Funding
This study was conducted by the ECOG-ACRIN Cancer Research Group (Peter J. O’Dwyer, MD, and Mitchell D. Schnall, MD, PhD, group cochairs) and supported by the National Cancer Institute of the National Institutes of Health under the following award numbers: U10CA180821, U10CA180863, Canadian Cancer Society #704970, U10CA180820, U10CA180868, U10CA180822, U10CA180888, U10CA180794, UG1CA189830, UG1CA189859, UG1CA189953, UG1CA232760, UG1CA233180, UG1CA233193, UG1CA233234, UG1CA233277, UG1CA233320, UG1CA233329, and UG1CA233341. The trial (E2108) was coordinated by the ECOG-ACRIN Cancer Research Group and sponsored by the National Cancer Institute. Adults with pathologically confirmed locoregional breast cancer and distant metastases were eligible for registration, if systemic therapy had been initiated within 8 weeks after diagnosis. Written informed consent, approved by the local institutional review board, was required. This confirmed willingness to be randomly assigned to either early locoregional therapy after initial systemic therapy or continuation of systemic therapy. Biopsy confirmation of a suspected solitary metastatic lesion was required for eligibility. Patients who had already initiated systemic therapy were eligible for registration if the duration of systemic therapy was # 30 weeks. Patients with a history of invasive malignancy $ 5 years previously were included (if recurrence-free), but not those with synchronous contralateral breast cancer. The full Protocol (online only) is available at the JCO website.
ASJC Scopus subject areas
- Oncology
- Cancer Research
