KEY TAKEAWAYS
- The EA2108 randomized controlled trial examines the impact of early locoregional therapy on overall survival in metastatic breast cancer patients.
- Metastatic breast cancer patients will be tested to see if locoregional therapy for the primary site improves survival.
- After 4-8 months of systemic therapy, patients were randomly assigned to locoregional therapy for the primary location or continued systemic therapy.
- Those randomly assigned locoregional therapies had less locoregional progression.
- Although quality-of-life assessments were equivalent between arms, early locoregional therapy for the primary site did not affect the quality of life.
About 6% or more of individuals with a new breast cancer diagnosis had distant metastases. Overall survival (OS) is thought to be improved by locoregional therapy for the entire original tumor. However, clinical trials have revealed inconsistent findings. After 4-8 months of systemic therapy, women with metastatic breast cancer and an entire main tumor were randomly randomized to either locoregional therapy for the primary site (surgery and radiotherapy according to criteria for nonmetastatic illness) or continued systemic therapy.
OS was the key metric, with locoregional control and quality of life as supplementary aims. Thanks to the trial’s design, a 19.3% absolute difference in the 3-year OS rate between randomly assigned individuals was detectable with 85% power. For comparing OS between groups, researchers employed the stratified log-rank test and the Cox proportional hazards model. Researchers used Gray’s test to compare the rates of locoregional development across time. Finally, the quality of life was measured with the usual suspects.
Among the 390 signed up, 256 were randomly randomized to early locoregional or continuing systemic therapy. With early locoregional therapy, the 3-year OS was 68.4% compared to 67.9% without it (hazard ratio = 1.11; 90% CI, 0.82 to 1.52; P =.57). Median overall survival (OS) for patients who had systemic therapy was 53.1 months (95% CI, 47.9 to not estimable), while those who received locoregional therapy had a median OS of 54.9 months (95% CI, 46.7 to not estimable). Those randomly assigned to locoregional therapy had a lower risk of locoregional advancement during three years (16.3% vs 39.8%, P < .001). Regarding the quality of life, there was little to no difference between the groups. Survival rates of patients with metastatic breast cancer did not improve with the introduction of locoregional therapy for the main location at an earlier stage. This factor had no bearing on life satisfaction despite its correlation with enhanced locoregional control.
Source:https://pubmed.ncbi.nlm.nih.gov/34995128/
Clinical Trial:https://clinicaltrials.gov/ct2/show/NCT01242800
Khan SA, Zhao F, Goldstein LJ, Cella D, Basik M, Golshan M, Julian TB, Pockaj BA, Lee CA, Razaq W, Sparano JA, Babiera GV, Dy IA, Jain S, Silverman P, Fisher CS, Tevaarwerk AJ, Wagner LI, Sledge GW. Early Local Therapy for the Primary Site in De Novo Stage IV Breast Cancer: Results of a Randomized Clinical Trial (EA2108). J Clin Oncol. 2022 Mar 20;40(9):978-987. doi: 10.1200/JCO.21.02006. Epub 2022 Jan 7. Erratum in: J Clin Oncol. 2022 Apr 20;40(12):1392. PMID: 34995128; PMCID: PMC8937009.
