The title of the article is Primary Surgery with Systemic Therapy in Patients with de Novo Stage IV Breast Cancer: 10-year Follow-up; Protocol MF07-01 Randomized Clinical Trial. The article was published in the Journal of the American College of Surgeons in 2021. The first author is Dr. Atilla Soran. The objective of this randomized clinical trial was to evaluate whether resection of primary tumor results in better overall survival in patients with de novo stage 4 breast cancer. 265 patients participated in this study. They were randomly assigned into one of the two treatment groups. 134 patients received locoregional treatment (resection of primary tumor) with subsequent systemic therapy and 131 patients received systemic therapy only. And the researchers followed these patients for 10 years to evaluate the outcomes of each treatment approach.
In general, at 10-year f/u, they found that the overall survival was statistically higher in the surgery group than in the systemic therapy group. 19% of pt survived in the surgery group, and 5% survived in ST group. This was different compared to the results at 3rd-year f/u. In 3rd year, the overall survival was similar between the 2 groups. The improvement in overall survival becomes more significant as the f/u period increases.
They also found that In patients with ER/PR +, HER 2+ type of cancer, pt with solitary bone metastasis, and patients who are less than 55yo, primary tumor resection followed by systemic therapy has significant improvement in overall survival compared to systemic therapy alone.
Another new finding at this 10-year f/u is that HER 2 – pt has a median 8-month survival benefit in the surgery group.
In triple-negative and ER/PR- pt, the overall survival is similar between the 2 groups. In patients with lung/liver metastasis, surgery showed no survival benefit compared to systemic therapy.
The secondary outcome that they evaluate was quality of life. They wanted to see there is a decline in quality of life in post-surgical pt with increased overall survival. They found that in pts who lived longer than 3 years after treatment, primary tumor resection has no detrimental effect on the overall quality of life compared to systemic therapy alone.
One limitation of the study is that there is a higher percentage of hormone receptor + pt and lower triple-negative pt in the surgery group, which might contribute to the overall difference in treatment outcome.
The clinical bottom line with this article is that primary tumor resection showed an overall survival benefit in a certain patient population. It should be presented as a treatment option in patients with de novo stage 4 breast cancer.
