Lancet oncol:S-1 complementary therapy combined endocrine therapy is used for the efficacy and safety of ER-Her2-primary invasive breast cancer

Oral fluorouracil, such as S-1, has been shown to play a controlling role in the progression of metastasis breast cancer.
study aims to assess the efficacy and safety of complementary treatments for estrogen-positive (ER)-positive and Her2-negative primary breast cancer using S-1.
study was a multi-center, open-label, randomized phase 3 trial that recruited histologically diagnosed patients with stage I-IIIB invasive breast cancer aged 20-75.
patients received 5 years of standard assisted endocrine therapy (selective estrogen recipient regulators ±ovarian inhibitors and aromatase inhibitors) and or no S-1 assisted therapy for 1 year.
end of the disease is survival without invasive disease.
February 1, 2012 - February 1, 2016, a total of 1,930 patients were recruited, of whom 957 (50%) received endocrine therapy and 1,973 (50%) received endocrine therapy only.
followed for 52.2 months.
155 patients (16%) in the single endocrine therapy group and 101 (11%) in the joint group received non-invasive disease survival events (risk ratio of 0.63,95% CI 0.49-0.81, p=0.0003).
given that the main endpoint was reached during the interim analysis, the trial ended early.
the most common level 3 and above adverse events were a decrease in nexus granulocyte count (joint group vs single endocrine therapy group: 8% vs 1%), diarrhea (2% vs 0%) and white blood cell reduction (2% vs. slt;1%) and fatigue (lt;1% vs 0).
(1%) reported severe adverse reactions in 970 patients in the single endocrine therapy group, while 25 out of 954 patients in the combined group (3%).
group had one treatment-related adverse death and died of pulmonary embolism.
, the study suggests that S-1 combined endocrine therapy could be a potential treatment option for patients with high-risk ER-positive, HER2-negative primary breast cancer.
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