The latest data from the NATALEE trial showed the absolute 3-year invasive disease-free survival benefit was 4.9%between the experimental and control groups.That is to say,in the intermediate-risk hormone receptor pos...The latest data from the NATALEE trial showed the absolute 3-year invasive disease-free survival benefit was 4.9%between the experimental and control groups.That is to say,in the intermediate-risk hormone receptor positive/human epidermal growth factor receptor-2 negative subgroup,there are also some patients with primary resistance to ribociclib.These patients benefit less from ribociclib,and they are unable to gain significant benefit even with the intensive adjuvant therapy of ribociclib.Considering the drug toxicity and health economic benefits,a 3-year course of ribociclib may not be appropriate for all intermediate-risk populations.Therefore,how to screen out the prime population for intensive adjuvant therapy of ribociclib needs to worth explored.In this paper,we discussed that the adaptive neoadjuvant endocrine therapy can screen out the prime population for intensive adjuvant therapy of ribociclib.展开更多
目的:从中国卫生体系视角出发,评估瑞波西利联合内分泌治疗与单独内分泌治疗相比对于绝经前妇女HR+/HER2-晚期或转移性乳腺癌的经济性,为医疗卫生决策提供参考。方法:基于Ⅲ期随机对照临床试验MONALEESA-7的临床疗效数据建立分区生存模...目的:从中国卫生体系视角出发,评估瑞波西利联合内分泌治疗与单独内分泌治疗相比对于绝经前妇女HR+/HER2-晚期或转移性乳腺癌的经济性,为医疗卫生决策提供参考。方法:基于Ⅲ期随机对照临床试验MONALEESA-7的临床疗效数据建立分区生存模型,该模型的循环周期为4周,模拟时限为20年。通过比较总成本、生命年、质量调整生命年(quality-adjusted life years,QALYs)和增量成本效果比(incremental cost-effectiveness ratio,ICER),评估瑞波西利联合内分泌治疗与单独内分泌治疗在长期疗效与经济效益方面的差异。此外,采用单因素敏感性分析、概率敏感性分析和情景分析检验模型的稳健性。结果:基础分析结果表明,与单独内分泌治疗相比,瑞波西利联合内分泌治疗在临床疗效上更优异,能够额外增加0.86 QALYs,但相应成本增加234623.99元,ICER值为272632.70元·QALY^(-1)。单因素敏感性分析结果显示,对ICER影响最大的3个因素分别为无进展生存期的效用值、折现率和瑞波西利的成本。概率敏感性分析结果显示,当意愿支付阈值(willingness to pay,WTP)为2023年3倍中国人均GDP(268074元·QALY^(-1))时,瑞波西利联合内分泌治疗方案具有经济性的概率为45%。情景分析结果显示,随着模拟时限的延长,瑞波西利联合内分泌治疗方案的ICER逐渐降低,且下降幅度逐渐减小。结论:当WTP为268074元·QALY^(-1)时,对于绝经前妇女HR+/HER2-晚期或转移性乳腺癌的一线治疗,瑞波西利联合内分泌治疗相比单独内分泌治疗方案不具有经济性。展开更多
1文献来源Lu Y-S, Mahidin EIBM, Azim H, et al.Abstract GS1-10:Primary results from the randomized phaseⅡRIGHT Choice trial of premenopausal patients with aggressive HR+/HER2-advanced breast cancer treated with ribocic...1文献来源Lu Y-S, Mahidin EIBM, Azim H, et al.Abstract GS1-10:Primary results from the randomized phaseⅡRIGHT Choice trial of premenopausal patients with aggressive HR+/HER2-advanced breast cancer treated with ribociclib+endocrine therapy vs physician’s choice combination chemotherapy[J].Cancer Res,2023,83(5S):GS1-10.展开更多
Endocrine therapy(ET)is the therapy backbone of hormone receptor(HR)-positive and human epidermal growth factor receptor 2(HER2)-negati ve advanced breast cancer.However,there are about 20%HR positive patients with no...Endocrine therapy(ET)is the therapy backbone of hormone receptor(HR)-positive and human epidermal growth factor receptor 2(HER2)-negati ve advanced breast cancer.However,there are about 20%HR positive patients with no response to ET due to primary or acquired ET resistance.In this background,many agents have been studied to overcome ET resistance and of which the important agents are cyclin-dependent kinase 4/6(CDK4/6)inhibitors.The prognosis of advanced breast cancer has been improved by combing ET with CDK4/6 inhibitors.In this review,we mainly focused on the CDK4/6 inhibitors in the treatment of HR-positive,HER2-negative advanced breast cancer and discussed the action mechanisms of CDK4/6 inhibitors alone or combined with ET.We also summarized several molecular features that would predict response or resistance to CDK4/6 inhibitors.In addition,we put forward possible strategies to overcome CDK4/6 inhibitor resistance according to the latest research.展开更多
基金supported by China Postdoctoral Science Foundation(No.2022M721987)Natural Science Foundation of Shandong Province(No.ZR2024QH058).
文摘The latest data from the NATALEE trial showed the absolute 3-year invasive disease-free survival benefit was 4.9%between the experimental and control groups.That is to say,in the intermediate-risk hormone receptor positive/human epidermal growth factor receptor-2 negative subgroup,there are also some patients with primary resistance to ribociclib.These patients benefit less from ribociclib,and they are unable to gain significant benefit even with the intensive adjuvant therapy of ribociclib.Considering the drug toxicity and health economic benefits,a 3-year course of ribociclib may not be appropriate for all intermediate-risk populations.Therefore,how to screen out the prime population for intensive adjuvant therapy of ribociclib needs to worth explored.In this paper,we discussed that the adaptive neoadjuvant endocrine therapy can screen out the prime population for intensive adjuvant therapy of ribociclib.
文摘目的:从中国卫生体系视角出发,评估瑞波西利联合内分泌治疗与单独内分泌治疗相比对于绝经前妇女HR+/HER2-晚期或转移性乳腺癌的经济性,为医疗卫生决策提供参考。方法:基于Ⅲ期随机对照临床试验MONALEESA-7的临床疗效数据建立分区生存模型,该模型的循环周期为4周,模拟时限为20年。通过比较总成本、生命年、质量调整生命年(quality-adjusted life years,QALYs)和增量成本效果比(incremental cost-effectiveness ratio,ICER),评估瑞波西利联合内分泌治疗与单独内分泌治疗在长期疗效与经济效益方面的差异。此外,采用单因素敏感性分析、概率敏感性分析和情景分析检验模型的稳健性。结果:基础分析结果表明,与单独内分泌治疗相比,瑞波西利联合内分泌治疗在临床疗效上更优异,能够额外增加0.86 QALYs,但相应成本增加234623.99元,ICER值为272632.70元·QALY^(-1)。单因素敏感性分析结果显示,对ICER影响最大的3个因素分别为无进展生存期的效用值、折现率和瑞波西利的成本。概率敏感性分析结果显示,当意愿支付阈值(willingness to pay,WTP)为2023年3倍中国人均GDP(268074元·QALY^(-1))时,瑞波西利联合内分泌治疗方案具有经济性的概率为45%。情景分析结果显示,随着模拟时限的延长,瑞波西利联合内分泌治疗方案的ICER逐渐降低,且下降幅度逐渐减小。结论:当WTP为268074元·QALY^(-1)时,对于绝经前妇女HR+/HER2-晚期或转移性乳腺癌的一线治疗,瑞波西利联合内分泌治疗相比单独内分泌治疗方案不具有经济性。
文摘1文献来源Lu Y-S, Mahidin EIBM, Azim H, et al.Abstract GS1-10:Primary results from the randomized phaseⅡRIGHT Choice trial of premenopausal patients with aggressive HR+/HER2-advanced breast cancer treated with ribociclib+endocrine therapy vs physician’s choice combination chemotherapy[J].Cancer Res,2023,83(5S):GS1-10.
文摘Endocrine therapy(ET)is the therapy backbone of hormone receptor(HR)-positive and human epidermal growth factor receptor 2(HER2)-negati ve advanced breast cancer.However,there are about 20%HR positive patients with no response to ET due to primary or acquired ET resistance.In this background,many agents have been studied to overcome ET resistance and of which the important agents are cyclin-dependent kinase 4/6(CDK4/6)inhibitors.The prognosis of advanced breast cancer has been improved by combing ET with CDK4/6 inhibitors.In this review,we mainly focused on the CDK4/6 inhibitors in the treatment of HR-positive,HER2-negative advanced breast cancer and discussed the action mechanisms of CDK4/6 inhibitors alone or combined with ET.We also summarized several molecular features that would predict response or resistance to CDK4/6 inhibitors.In addition,we put forward possible strategies to overcome CDK4/6 inhibitor resistance according to the latest research.