Abstract
Background
The MF07-01 trial is a multicenter, phase III, randomized, controlled study comparing locoregional treatment (LRT) followed by systemic therapy (ST) with ST alone for treatment-naïve stage IV breast cancer (BC) patients.
Methods
At initial diagnosis, patients were randomized 1:1 to either the LRT or ST group. All the patients were given ST either immediately after randomization or after surgical resection of the intact primary tumor.
Results
The trial enrolled 274 patients: 138 in the LRT group and 136 in the ST group. Hazard of death was 34% lower in the LRT group than in the ST group (hazard ratio [HR], 0.66; 95% confidence interval [CI], 0.49–0.88; p = 0.005). Unplanned subgroup analyses showed that the risk of death was statistically lower in the LRT group than in the ST group with respect to estrogen receptor (ER)/progesterone receptor (PR)(+) (HR 0.64; 95% CI 0.46–0.91; p = 0.01), human epidermal growth factor 2 (HER2)/neu(–) (HR 0.64; 95% CI 0.45–0.91; p = 0.01), patients younger than 55 years (HR 0.57; 95% CI 0.38–0.86; p = 0.007), and patients with solitary bone-only metastases (HR 0.47; 95% CI 0.23–0.98; p = 0.04).
Conclusion
In the current trial, improvement in 36-month survival was not observed with upfront surgery for stage IV breast cancer patients. However, a longer follow-up study (median, 40 months) showed statistically significant improvement in median survival. When locoregional treatment in de novo stage IV BC is discussed with the patient as an option, practitioners must consider age, performance status, comorbidities, tumor type, and metastatic disease burden.
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Acknowledgments
We thank Christine Heiner, Scientific Writer, and Jeffrey Sutton, MD, for their assistance with language editing, as well as Drs. Sheryl F. Kelsey and Elizabeth D. Kennard for their statistical overview from The University of Pittsburgh and Temel Dagoglu, MD from Istanbul University for patient recruitment. In memory of Barry Lembersky, MD, of the University of Pittsburgh for his guidance and execution of the study. This study is registered on clinicaltrials.gov with identifier number NCT00557986.
Funding
Funding was provided by Turkish Federation of Breast Disease Societies (Grant Number MF07-01).
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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 25, 3141–3149 (2018). https://doi.org/10.1245/s10434-018-6494-6
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DOI: https://doi.org/10.1245/s10434-018-6494-6