Background:CDK4/6 inhibitors(CDK4/6i)have shown promising results in the treatment of hormone receptor‐positive(HR+)metastatic breast cancer(MBC)when combined with endocrine therapy(ET).It is crucial to evaluate the ...Background:CDK4/6 inhibitors(CDK4/6i)have shown promising results in the treatment of hormone receptor‐positive(HR+)metastatic breast cancer(MBC)when combined with endocrine therapy(ET).It is crucial to evaluate the actual effectiveness and safety of CDK4/6i in clinical practice,as well as to analyze the factors that can predict their outcomes.Methods:Patients with HR+MBC who received CDK4/6i‐based therapy between May 2016 and May 2023 at Hunan Cancer Hospital were evaluated for progression‐free survival(PFS).Adverse reactions were assessed based on the National Cancer Institute Common Toxicity Criteria(version 5.0).Results:This study included 344 patients,with a median PFS(mPFS)of 12.8 months(range:10.4–15.2 months).After adjustment,Cox multivariate regression analysis revealed that visceral metastasis(specifically liver and brain metastases),Eastern Cooperative Oncology Group Performance Status(ECOG PS)≥1,estrogen receptor≤80%,progesterone receptor≤10%,Ki‐67>30%,and treatment in later stages were significant factors associated with reduced PFS.Based on this,we created a prognostic nomogram and validated its performance,obtaining a C‐index of 0.714(95%confidence interval:0.640–0.787)as well as reliable calibration and clinical impact.The mPFS of CDK4/6i rechallenge was 7.7 months;for patients who initially discontinued CDK4/6i for reasons other than disease progression,CDK4/6i rechallenge still provided a mPFS of 11.4 months.The tolerability and safety of combining CDK4/6is with ET were manageable.Adverse events led to treatment discontinuation in 3.8%of patients.Neutropenia(29.1%),leukopenia(13.7%),and anemia(4.1%)were the primary grade 3/4 adverse reactions.Conclusions:This real‐world study highlights the ample efficacy and reasonable safety of combined CDK4/6i and ET in patients with HR+MBC.Individualized treatment decisions and ongoing safety monitoring are important to optimize the therapeutic benefit of CDK4/6i treatment.展开更多
基金Hunan Provincial Natural Science Foundation of China,Grant/Award Numbers:2023JJ60334,2023JJ60464,2024JJ6289Beijing Science and Technology Innovation Medical Development Foundation,Grant/Award Number:KC2023‐JX‐0082‐05The Climb Plan of Hunan Cancer Hospital,Grant/Award Numbers:QH2023006,ZX2021005。
文摘Background:CDK4/6 inhibitors(CDK4/6i)have shown promising results in the treatment of hormone receptor‐positive(HR+)metastatic breast cancer(MBC)when combined with endocrine therapy(ET).It is crucial to evaluate the actual effectiveness and safety of CDK4/6i in clinical practice,as well as to analyze the factors that can predict their outcomes.Methods:Patients with HR+MBC who received CDK4/6i‐based therapy between May 2016 and May 2023 at Hunan Cancer Hospital were evaluated for progression‐free survival(PFS).Adverse reactions were assessed based on the National Cancer Institute Common Toxicity Criteria(version 5.0).Results:This study included 344 patients,with a median PFS(mPFS)of 12.8 months(range:10.4–15.2 months).After adjustment,Cox multivariate regression analysis revealed that visceral metastasis(specifically liver and brain metastases),Eastern Cooperative Oncology Group Performance Status(ECOG PS)≥1,estrogen receptor≤80%,progesterone receptor≤10%,Ki‐67>30%,and treatment in later stages were significant factors associated with reduced PFS.Based on this,we created a prognostic nomogram and validated its performance,obtaining a C‐index of 0.714(95%confidence interval:0.640–0.787)as well as reliable calibration and clinical impact.The mPFS of CDK4/6i rechallenge was 7.7 months;for patients who initially discontinued CDK4/6i for reasons other than disease progression,CDK4/6i rechallenge still provided a mPFS of 11.4 months.The tolerability and safety of combining CDK4/6is with ET were manageable.Adverse events led to treatment discontinuation in 3.8%of patients.Neutropenia(29.1%),leukopenia(13.7%),and anemia(4.1%)were the primary grade 3/4 adverse reactions.Conclusions:This real‐world study highlights the ample efficacy and reasonable safety of combined CDK4/6i and ET in patients with HR+MBC.Individualized treatment decisions and ongoing safety monitoring are important to optimize the therapeutic benefit of CDK4/6i treatment.
