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Breast cancer consists of three main molecular subtypes, Her2 over-expression, hormone-positive (HR-plus) and triple negative breast cancer (TNBC).
metastatic breast cancer (mBCs) expressed in HR plus and Her2 are currently available for conversion therapy (endocrine therapy, CDK4/6 inhibitors, and Her2 inhibitors).
anti-PD-L1 antibody inhibits PD1-mediated immunosuppressive signal transduction.
phase II clinical trials have shown that some mBC patients can benefit from these immunotherapy treatments.
Phase III trial of chemotherapy in combination with anti-PD-L1 antibodies showed moderate efficacy for progression-free survival (PFS) in metastasis TNBC patients.
, however, it is not clear how effective anti-PD-L1 monodrative antibodies are as maintenance therapy in patients with metastasis breast cancer.
the study presented the results of a Phase II randomized trial, SAFIR02-BREAST IMMUNO, and biomarker analysis, which compared the effects of anti-PD-L1 antibodies (durvalumab, deveryu monoantigen) with maintenance chemotherapy in patients with Her2-negative mBC.
Kaplan-Meier analyzed the processless survival and overall survival rates of patients who were recruited for Her2-negative metastasis breast cancer patients who had not progressed after six to eight chemotherapy cycles.
199 patients were randomly divided into the durvalumab group and the maintenance chemotherapy group.
study showed that durvalumab did not improve patients' progress-free survival and overall survival rate (OS).
in an exploratory subgroup analysis, durvalumab improved OS in patients with triple-negative breast cancer.
exploratory analysis showed that the death risk ratio (HR) for PD-L1-TNBC patients was 0.37, while for PD-L1-TNBC patients (n-29) it was 0.49.
exploratory analysis of patients with CD274 gene gain/amplification showed that the durvalumab efficacy (OS)HR in patients with CD274 gene gain/amplification (n s 23) was 0.18.
patients with normal/lost CD274 genes (n s 32) had an HR of 1.12.
Kaplan-Meier analyzed the effect of PD-L1 expression on the overall survival rate of TNBC patients lymphocytes (CD8, FoxP3, and CD103 expressions) in leaching and hoyngen recombinant tumors and not predicting sensitivity to durvalumab through exploratory analysis.
the findings should be interpreted with caution because only one patient has a lineage BRCA mutation.
, the findings provide the basis for evaluating the single-drug treatment of durvalumab in TNBC patient maintenance therapy.
of the CD274 gene was determined to be a potentially sensitive biomarker.
in patients who were positive for hormones and Her2-negative, maintaining chemotherapy was more effective than durvalumab.