Early Local Therapy for the Primary Site in De Novo Stage IV Breast Cancer: Results of a Randomized Clinical Trial (EA2108)

Author(s): Seema A. Khan, MD, MPH¹; Fengmin Zhao, MS, MHS, PhD²; Lori J. Goldstein, MD³; David Cella, PhD⁴; Mark Basik, MD⁵; Mehra Golshan, MD, MBA⁶;

Source: DOI: 10.1200/JCO.21.02006 Journal of Clinical Oncology Published online January 07, 2022. PMID: 34995128

Dr. Lucio Gordan's Thoughts

Benefit of locoregional control seems limited probably to situations in which surgery could clearly help recurrent breast inflammatory/infectious issues. This study is helpful to quote to patients who are anxious about not having breast surgery accomplished in this setting.

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 = 1.11; 90% CI, 0.82 to 1.52; P = .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.

Author Affiliations

¹Northwestern University, Chicago, IL;; ²Dana Farber Cancer Institute—ECOG-ACRIN Biostatistics Center, Boston, MA; ³Albert Einstein Medical Center, Philadelphia, PA; ⁴Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL; ⁵Jewish General Hospital Lady Davis Institute, McGill University, Montréal, QC, Canada; ⁶Yale School of Medicine, Yale Cancer Center, New Haven, CT; ⁷The Allegheny Health Network Cancer Institute, Pittsburgh, PA; ⁸Mayo Clinic, Phoenix, AZ; ⁹Swedish Medical Center, Seattle, WA; ¹⁰University of Oklahoma Health Sciences Center, Oklahoma City, OK; ¹¹Montefiore Medical Center, Bronx, NY; ¹²University of Texas MD Anderson Cancer Center, Houston, TX; ¹³Eisenhower Medical Center, Rancho Mirage, CA; ¹⁴Case Western Reserve University, Cleveland, OH; ¹⁵Indiana University School of Medicine, Indianapolis, IN; ¹⁶University of Wisconsin Carbone Cancer Center, Madison, WI; ¹⁷Wake Forest University Health Sciences, Winston Salem, NC; ¹⁸Stanford University School of Medicine, Stanford, CA

1 thought on “Early Local Therapy for the Primary Site in De Novo Stage IV Breast Cancer: Results of a Randomized Clinical Trial (EA2108)”

Luis Carrascosa
March 11, 2022 at 7:16 am

This should be interpreted with caution. It definitely makes sense for uncomplicated breast tumors, however, if there is evidence of local progression before, during or after systemic therapy such as tumor eroding through skin, bleeding, pain, infections, etc, local therapy with either surgery or radiation should be seriously considered as it significantly improves quality of life. By avoiding locoregional complications the patient will be able to continue systemic therapy without interruptions.

Reply

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