CDK4/6抑制剂联合方案给HR+/HER2-乳腺癌患者带来的新希望

2019-05-31 徐菲 王树森 肿瘤资讯

徐菲副主任医师、硕士导师,中山大学附属肿瘤医院内科,中国临床肿瘤学会(CSCO)青委会委员,广东省胸部肿瘤防治委员会乳腺癌专业委员会委员兼秘书长,中国南方肿瘤临床研究协会(SWOG)青委会常委,广东省中西医结合学会乳腺病专业委员会委员 ,广东省药学会乳腺科用药专家委员会委员

徐菲副主任医师、硕士导师,中山大学附属肿瘤医院内科,中国临床肿瘤学会(CSCO)青委会委员,广东省胸部肿瘤防治委员会乳腺癌专业委员会委员兼秘书长,中国南方肿瘤临床研究协会(SWOG)青委会常委,广东省中西医结合学会乳腺病专业委员会委员 ,广东省药学会乳腺科用药专家委员会委员

基本病史

患者女性,55岁,已绝经。2018年2月主因“发现右侧乳腺肿物近3年”就诊。

病检及化疗史

患者因体表局部病灶肿痛伴溃烂于2018年3月就诊于当地医院,行超声引导下右乳肿块穿刺活检术,病理示:(右乳)浸润性小叶癌。免疫组化结果:ER(+,80%)、PR(+,50%)、HER2(2+)(FISH检测提示HER2未见扩增)、Ki-67(约40%+) 。结合相关实验室和影像学检查结果,诊断为:右乳浸润性小叶癌伴右锁骨上、右侧腋窝淋巴结转移(cT4N3M0,Ⅲ期,luminal B, HER2阴性型)。

患者在当地医院于2018年3月起行表柔比星联合紫杉类化疗药化疗,共8周期,最佳疗效为SD(stable disease)。后因病情进展(progressive disease,PD),于8月更换化疗方案为长春瑞滨联合顺铂(NP)方案化疗2周期,疗效评估为SD(增大)。

CDK4/6抑制剂联合内分泌治疗

2018年10月患者就诊于我院。患者局部病灶明显(图1),右乳病灶病理会诊示:(右乳)浸润性小叶癌。免疫组化结果:ER(+,90%)、PR(+,50%)、HER2(1+)、Ki-67(约40%+)。胸腹部增强CT示:1、右乳腺肿物,符合乳腺癌累及皮肤及右胸壁,BI-RADS 6类;2、双侧颈部Ⅱ、Ⅳ区见数个淋巴结,性质待定;3、右侧锁骨上区、纵膈、双侧腋窝见数个淋巴结,结合病史考虑转移瘤;4、左肾盂内细小点状钙化致密影,左肾盂小结石。

患者于2018年10月起予以哌柏西利 125mg 每日一次口服,d1-d21,休1周,联合来曲唑2.5mg 每日一次口服。用药后第一周,患者局部病灶即开始受到控制(图2),疗效PR(partial response)。目前患者的PFS时间已经超过7个月。用药期间患者的不良反应主要有Ⅱ度白细胞下降,Ⅱ度中性粒细胞下降,Ⅰ度贫血。不良反应可控,患者未调整服药剂量,也未进行GCSF的处理。

王树森主任医师、教授、博士生导师,中山大学肿瘤医院乳腺癌单病种首席专家,内科乳腺病区主任,中国研究型医院协会乳腺癌专业委员会副主任委员,中国抗癌协会乳腺癌专业委员会常务委员,中国临床肿瘤协会乳腺癌专业委员会常务委员,中国抗癌协会肿瘤临床化疗专业委员会青委会副主任委员

广东省胸部肿瘤防治研究会乳腺癌专业委员会主任委员,广东省抗癌协会乳腺癌专业委员会副主任委员,广东省医师协会乳腺专科工作委员会副主任委员,广东省抗癌协会化疗专业委员会副主任委员

根据NCCN2019 V1乳腺癌指南和《中国临床肿瘤学会(CSCO)乳腺癌诊疗指南》2019版,对于晚期luminal型HER2阴性乳腺癌,现有国内外共识一致推荐内分泌治疗可以作为HR+/HER2–的标准治疗[1],尤其是符合以下特点的患者:①肿瘤进展相对缓慢;②无内脏危象的患者;③既往未曾接受内分泌治疗或内分泌有一定敏感性。

在Ⅱ期PALOMA-1研究中,来曲唑联合CDK4/6抑制剂哌柏西利组的中位PFS是20.2个月,对照组是 10.2个月,联合治疗组延长了10个月的无进展生存期。根据Ⅱ期研究获得的良好临床疗效,2015年2月美国FDA批准了CDK4/6抑制剂哌柏西利联合来曲唑一线治疗ER+/HER2-绝经后晚期乳腺癌患者的适应证[2]。随后进行的PALOMA-2研究是一项全球性、随机双盲安慰剂对照III期临床研究[3],该研究纳入666例绝经后既往未接受针对复发或转移性肿瘤进行系统性治疗的晚期乳腺癌患者,按2:1随机分配至哌柏西利联合来曲唑组、安慰剂联合来曲唑组。Ⅲ期研究中,中位PFS为27.6个月(95% CI, 22.1~NE),而与之相比来曲唑+安慰剂组治疗方案的患者仅为14.5个月(95%CI,12.9~17.1), (HR=0.58;95% CI;0.46~0.72;P<0.001),降低疾病进展的风险达到42%。这是第一个证实CDK4/6抑制剂能够延长患者生存期的Ⅲ期临床研究,也是第一个把HR阳性晚期乳腺癌患者的中位PFS延长到超过2年的Ⅲ期临床研究。

PALOMA-2的Ⅲ期研究显示哌柏西利+来曲唑方案相比安慰剂+来曲唑方案,最常见3/4级不良反应为中性粒细胞减少(66.4% vs 1.4%)、白细胞减少(24.5% vs 0)、 感染(6.5% vs 3.2%)以及贫血(5.4% vs 1.8%)。既往研究显示,哌柏西利的主要不良反应是骨髓抑制,但哌柏西利主要是诱导骨髓细胞静滞而非骨髓细胞衰老。诱导的中性粒细胞减少症可逆,而化疗则不可逆。特别是在停药后,中性粒细胞前体能够恢复,但对乳腺癌细胞的生长抑制仍持续一段时间。未见其他不良反应有特殊报告。

患者为已绝经的中年女性,诊断为右乳浸润性小叶癌伴右锁骨上、双侧腋窝淋巴结转移(cT4N3M0,Ⅲ期,luminal B,HER2阴性型)。根据患者初次就诊时当地医生给予一线蒽环联合紫杉的联合抗肿瘤方案,以及二线的含铂治疗方案,但治疗效果欠佳。依据现有临床研究结果,CDK4/6抑制剂联合AI是重要的内分泌治疗策略,在CSCO乳腺癌诊疗指南中激素受体阳性的晚期乳腺癌内分泌治疗部分,无论是既往未经接受内分泌治疗还是既往TAM治疗失败,AI联合CDK4/6抑制剂均获得了指南的推荐,证据级别1A。目前,哌柏西利已经在中国上市。结合患者半年的复查结果,CDK4/6抑制剂联合AI治疗是合适的。而且在PALOMA-2研究亚组分析中,既往早期接受过化疗的亚组分析中,两组患者分别为213例(48%)和109例(49.1%),结果显示对于既往早期接受过化疗(新辅助和辅助)的亚组与总体人群结果一致,哌柏西利联合来曲唑组与安慰剂联合来曲唑组的中位PFS分别为22.4个月和13.7个月(HR=0.53,95%CI 0.40~0.72)。说明既往早期是否进行过化疗,并不影响CDK4/6抑制剂的疗效。患者在用药后很快就取得病灶的缓解而且耐受可,并未出现调整用药剂量的情况,患者的生活质量得到很好保证。

该病例遵循各项指南与规范结合临床实践合理诊疗给患者带来了切实的临床获益,对制定晚期激素受体阳性HER2阴性乳癌的治疗策略很值得借鉴和学习。特别是在转移的乳腺癌患者解救治疗中,化疗与内分泌治疗都是不可或缺的重要手段,如何为患者带来更好的临床获益以及生活质量,是我们需要讨论的永恒的话题。

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    2020-05-09 jklm09
  3. 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GetPortalCommentsPageByObjectIdResponse(id=1490693, encodeId=5ab61490693af, content=<a href='/topic/show?id=2765440372' target=_blank style='color:#2F92EE;'>#CDK4/6#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=18, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4403, encryptionId=2765440372, topicName=CDK4/6)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c7068807080, createdName=zhangj7111, createdTime=Sun Jun 02 05:23:00 CST 2019, time=2019-06-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1571158, encodeId=2f2a15e115884, content=<a href='/topic/show?id=f42823e48d7' target=_blank style='color:#2F92EE;'>#乳腺癌患者#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=23748, encryptionId=f42823e48d7, topicName=乳腺癌患者)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=37bc15724202, createdName=hanhaisha2013, createdTime=Sun Jun 02 05:23:00 CST 2019, time=2019-06-02, status=1, ipAttribution=)]
    2019-10-05 珙桐
  4. [GetPortalCommentsPageByObjectIdResponse(id=1971894, encodeId=d0e319e18949c, content=<a href='/topic/show?id=f9c480e0860' target=_blank style='color:#2F92EE;'>#联合方案#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=80708, encryptionId=f9c480e0860, topicName=联合方案)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=f13d475, createdName=mashirong, createdTime=Thu Mar 19 18:23:00 CST 2020, time=2020-03-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1852010, encodeId=244e18520109d, content=<a href='/topic/show?id=f0a254918f0' target=_blank style='color:#2F92EE;'>#抑制剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=54918, encryptionId=f0a254918f0, topicName=抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=44a360, 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attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210106/c7d141c5b9f640b4bf5309f7f30ccd66/87d054c3c6134208853926bc58921565.jpg, createdBy=18085080581, createdName=145b0f37m47暂无昵称, createdTime=Mon Jun 10 12:32:31 CST 2019, time=2019-06-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1435520, encodeId=477a14355207a, content=<a href='/topic/show?id=09dc439915' target=_blank style='color:#2F92EE;'>#CDK#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=18, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4399, encryptionId=09dc439915, topicName=CDK)], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/aLGWoFXAyMbIu3qymFOyheQLjPSX3OUs5GmkyBlcCOwTPIeq3why9NGibxxUqYo6hcx8qZLHZFgNPnBK1yzWeOFpyg2OnWOt0/0, createdBy=fa4716, createdName=zhouqu_8, createdTime=Sun Jun 02 05:23:00 CST 2019, time=2019-06-02, status=1, ipAttribution=), 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createdBy=37bc15724202, createdName=hanhaisha2013, createdTime=Sun Jun 02 05:23:00 CST 2019, time=2019-06-02, status=1, ipAttribution=)]
    2019-12-27 soongzhihua
  5. 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createdBy=37bc15724202, createdName=hanhaisha2013, createdTime=Sun Jun 02 05:23:00 CST 2019, time=2019-06-02, status=1, ipAttribution=)]
    2019-08-28 luwei00
  6. 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createdBy=37bc15724202, createdName=hanhaisha2013, createdTime=Sun Jun 02 05:23:00 CST 2019, time=2019-06-02, status=1, ipAttribution=)]
    2019-06-10 145b0f37m47暂无昵称

    学习

    0

  7. 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    2019-06-02 zhouqu_8
  8. 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