2021BOC/BOA:殷咏梅教授解读CDK4/6抑制剂阿贝西利中国临床实践数据,以期提高可及性

2021-07-12 中国医学论坛报今日肿瘤 中国医学论坛报今日肿瘤

2021年7月2~3日,中国临床肿瘤学会(CSCO)联合北京市希思科临床肿瘤学研究基金会共同主办的“2021年中国临床肿瘤学年度进展研讨会(BOC)暨Best of ASCO® 2021 China”

2021年7月2~3日,中国临床肿瘤学会(CSCO)联合北京市希思科临床肿瘤学研究基金会共同主办的“2021年中国临床肿瘤学年度进展研讨会(BOC)暨Best of ASCO® 2021 China”(2021 BOC/BOA)在成都成功召开。

激素受体阳性(HR+)/人表皮生长因子受体2阴性(HER2-)是乳腺癌最常见的亚型,细胞周期蛋白依赖性激酶(CDK)4/6抑制剂为这部分晚期患者生存期带来了质的飞跃。会议期间,本报特别采访了江苏省人民医院殷咏梅教授,系统回顾HR+/ HER2-晚期乳腺癌治疗发展,解读CDK4/6抑制剂相关研究数据,展望未来方向。

专家简介


殷咏梅教授
主任医师,博士生导师
江苏省人民医院妇幼分院副院长
CSCO常务理事
CSCO乳腺癌专家委员会副主任委员
北京市希思科临床肿瘤学研究基金会副理事长
中国抗癌协会乳腺癌专业委员会常委
CSCO患者教育专家委员会候任主任委员

打破困局,CDK4/6抑制剂为HR+/HER2-晚期乳腺癌治疗带来跨时代飞跃

Q1:请问HR+/HER2-晚期乳腺癌总体治疗现状如何?

殷咏梅教授:根据世界卫生组织国际癌症研究机构(IARC)发布的2020年全球癌症统计数据显示,乳腺癌新发病例数达226万例,首次超过肺癌(220万例)而成为全球第一大癌症。2020年我国乳腺癌新发病例数为42万,居恶性肿瘤第4位,发病率呈逐年上升趋势。对于晚期乳腺癌,近年来随着靶向、免疫治疗等药物的应用,患者总生存期(OS)大大延长。例如HER2+晚期乳腺癌,CLEOPATRA研究8年随访数据显示这部分患者中位OS已接近5年,与过去相比是长足的进步。

HR+/HER2-是乳腺癌最常见的亚型,占比约为60%~70%。晚期HR+/HER2-乳腺癌的治疗一度进展缓慢,难有突破。一线单药内分泌治疗中,无论是他莫昔芬(TAM)还是芳香化酶抑制剂(AI),中位无进展生存期(PFS)仅约8~14个月;二线采用氟维司群治疗的中位PFS仅为3~6个月左右。既往疗效水平难以突破的主要原因就在于单药内分泌治疗的耐药问题。近年来,CDK4/6抑制剂、PI3K抑制剂及PARP抑制剂等靶向治疗的加入,为HR+/HER2-晚期乳腺癌患者带来了更好的疾病控制、更大的生存改善,尤其是CDK4/6抑制剂的探索和应用,为这部分患者的治疗带来了跨时代的飞跃。

中国数据,改变实践:MONARCH plus研究提供CDK4/6抑制剂中国循证

Q2:阿贝西利在作用机制和临床疗效上有哪些特点?在以中国患者人群为主的MONARCH plus研究中,阿贝西利显示了哪些临床优势?

殷咏梅教授:阿贝西利是一种新型的口服、高选择性CDK4/6抑制剂,作用机制为抑制肿瘤细胞有丝分裂周期由G1期进入S期。CDK4主要参与肿瘤细胞增殖,CDK6主要促进造血干细胞增殖。既往研究显示阿贝西利对CDK4的抑制效力是CDK6的14倍,从而能够更强地抑制乳腺癌细胞增殖,相对血液学毒性更小。

无论是在国外开展的全球多中心MONARCH 2、MONARCH 3研究还是在以中国患者为主(超过80%)的国际多中心MONARCH plus研究中,无论对于既往内分泌治疗耐药还是一线内分泌治疗的HR+/HER2-晚期乳腺癌患者,阿贝西利联合内分泌治疗相较内分泌治疗单药都显示了显著PFS获益,提升了客观缓解率(ORR),在MONARCH 2研究中,阿贝西利联合氟维司群显著延长了既往内分泌治疗耐药患者OS。

基于MONARCH plus研究中国亚组数据,阿贝西利也已于去年年底获得国家药品监督管理局(NMPA)批准用于HR+/HER2-局部晚期或转移性乳腺癌治疗适应证。今年更新发布的《2021 CSCO乳腺癌诊疗指南》中,阿贝西利以1A类证据作为Ⅰ级推荐联合氟维司群用于非甾体类AI和甾体类AI治疗失败的HR+晚期乳腺癌治疗的CDK4/6抑制剂。由此可见MONARCH plus研究数据进一步改变了中国HR+晚期乳腺癌治疗的临床实践。

患之所急,业之所需:期待阿贝西利尽快纳入医保,惠及更多乳腺癌患者

Q3:您对阿贝西利纳入国家医保目录有何期待?

殷咏梅教授:我国乳腺癌患者基数大,且HR+/HER2-乳腺癌患者占比高达60%~70%,是一个数量庞大的患者群体。对于HR+/HER2-晚期乳腺癌,多年来无论AI还是氟维司群,对生存期都很难有大的提升。阿贝西利首次以高级别研究数据确证了CDK4/6抑制剂在中国HR+/HER2-晚期乳腺癌患者中的疗效和安全性,显著延长了PFS、提升了ORR,实现了内分泌治疗史上的重大突破。

对于晚期乳腺癌患者,我们强调的是不仅要让患者活得更长,同时还要活得更好。CDK4/6抑制剂不仅大大延长了患者生存时间,也提升了患者生活质量。相较于传统化疗,CDK4/6抑制剂联合内分泌治疗的毒副作用如肝功能损伤、白细胞减少引发的感染等并发症明显减少,且住院时间缩短,进而能够降低医保费用支出。

基于以上,我们认为对于HR+/HER2-晚期乳腺癌治疗,阿贝西利尽快被纳入国家医保目录非常重要,可以更好地惠及国内广大患者。

精准时代,“精”无止境:重视规范检测、排兵布阵、安全性管理,使患者更大获益

Q4:您认为乳腺癌的精准治疗还有哪些提升的方向?

殷咏梅教授:在肿瘤学精准诊疗的大背景下,于乳腺癌,无论是HR+/HER2-、HER2+还是三阴性乳腺癌,我们都强调遵循精准理念去开展临床实践。以HR+/HER2-晚期乳腺癌的新型靶向治疗药物为例,药物种类日益丰富,除了CDK4/6抑制剂,还包括HDAC抑制剂、PI3K抑制剂及针对BRCA突变PARP抑制剂等,因此临床应用中如何对合适的患者选择合适的药物,就需要精准检测、规范评估。其二,随着药物和方案的丰富,临床医生的选择也越来越多,如何科学地排兵布阵从而使乳腺癌患者治疗全程中每种方案的价值能够最大化,也是值得我们不断思考的问题。其三,患者的安全性、药物的毒副反应管理,仍然是需要始终予以关注和重视的方面。如此才能将这些新型的靶向药物用得更好、用得其所,更大程度地提升乳腺癌患者的生存期和生存质量。

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    2021-07-27 jklm09
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    2022-03-13 soongzhihua
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    2021-05-13 zhouqu_8
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    2021-05-13 zhangj7111
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    2021-05-12 weizhaoyang

    加强公益活动!为健康保驾护航

    0

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