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We prospectively evaluated the utility of  ESR1  and  PIK3CA  mutation analysis with cell-free DNA (cfDNA) using droplet digital PCR (ddPCR) for the efficacy of endocrine therapy (ET) in hormone receptive positive (HR+) metastatic breast cancer (MBC) patients. CfDNA was analyzed just before the start of ET for MBC.  E380Q, Y537N, Y537S,  and  D538G  were assessed for  ESR1  mutations and  H1047R, E545K , and  E542K  were assessed for  PIK3CA  mutations. A total of 75 patients were enrolled. Of those, 31 (41.3%) received letrozole with palbociclib, and 28 (37.3%) received exemestane and everolimus (EverX).  ESR1  mutations were found in 36 (48.0%) patients, of which 16 (21.3%) had more than one variant. Seventeen (23.6%) patients had one  PIK3CA  mutation and 8 (11.1%) had two. In the total population, time to progression of the first ET after enrollment (TTP1) decreased significantly as the number of  ESR1  mutations increased ( p  < 0.001).  PIK3CA  mutations were also significantly associated with shorter TTP1 (median TTP1: 16.2 months vs. 10.9 months,  p  = 0.03). In contrast,  PIK3CA  mutations were significantly associated with longer TTP in patients receiving EverX treatment (median TTP of EverX: 15.9 months vs. 5.2 months,  p  = 0.01) and remained a significant factor in multivariable analysis for TTP of EverX in this subgroup (hazard ratio = 0.2, 95% CI = 0.1– 0.8,  p  = 0.03).  ESR1  and  PIK3CA  mutations in cfDNA were associated with clinical efficacies of ET in HR+ MBC patients.

Mutation analysis using cell-free DNA for endocrine therapy in patients with HR+ metastatic breast cancer