Gastric Cancer:Trastuzumab deruxtecan (T-DXd或DS-8201)在HER2阳性胃癌患者的疗效以及安全性管理

2021-05-18 yd2015 MedSci原创

该综述阐明了T-DXd在HER2+胃癌中的疗效以及安全性,并对常见不良事件进行的管理建议,最后展望了T-DXd在HER2+胃癌的前景。

大约12–15%胃癌患者携带HER2基因阳性。HER2阳性定义为免疫组化3+或免疫组化2+加上原位杂交(FISH)阳性+(ERBB2/CEP17 ≥ 2.0)。ToGA 临床试验证实,曲妥珠单抗(Trastuzumab)联合化疗明显改善HER2+胃癌患者的预后。在乳腺癌中起作用的其他抗HER2抑制剂在HER2+胃癌中接连失败。

Trastuzumab deruxtecan(T-DXd或DS-8201)是一种靶向HER2的抗体偶联药物(ADC),利用了第一三共特有的ADC技术,将人源HER2抗体曲妥珠单抗通过四肽接头与一种新型拓扑异构酶1抑制剂(DXd)链接,靶向癌细胞,并将药物递送至细胞内部。T-DXd目前已被美国以及日本批准用于HER2+胃癌的后线治疗。欧盟也批准用于HER2+转移性乳腺癌。

近期,在Gastric Cancer上发表一篇综述,阐述了T-DXd的结构、作用机制以及临床前发现;在HER2+胃癌的临床作用;不良反应的管理还有未来的展望。

T-DXd一种靶向HER2的抗体偶联药物(ADC),将人源HER2抗体曲妥珠单抗通过四肽接头与一种新型拓扑异构酶1抑制剂(DXd)链接,靶向癌细胞,并将药物递送至细胞内部。其药物/抗体比(DAR)大约为8,是目前批准的ADC最高值,而T-DM1(批准用于HER2+转移性乳腺癌)的DAR只有3.5。临床前实验提示T-DXd在HER2高表达细胞的抗肿瘤活性类似于T-DM1,并且在HER2低表达细胞也起到作用。

                            T-DXd的作用原理

临床疗效

I期DS8201 A-J101 和II期DESTINY-Gastric01临床试验(NCT03329690)确定了T-DXd的剂量以及疗效。II期DESTINY-Gastric01临床试验中,HER2+胃癌或胃食管连接处癌接受过2线或以上治疗,包括曲妥珠单抗,达到了主要研究终点。对比研究选择的治疗,T-DXd明显提高了患者的缓解率(51% vs 14%, P<0.001)。T-DXd的中位缓解时间为11.3个月,超过了一线曲妥珠单抗联合化疗(6个月)。

安全性和耐受性

I期和II期胃癌临床试验

大部分不良事件(AEs)0为胃肠道和血液学毒性。I期和II期临床试验的大部分的AEs相似,除了所有级别的中性粒细胞减少,其中II期试验较高为63%,I期试验为27%。发生在大于等于20%患者的AEs,≥ 3 级AEs常见的是贫血(30% versus 38%), 中性粒细胞减少(20% versus 51%), 白细胞减少(16% versus 21%)。治疗相关不良事(TEAEs)导致剂量减少的比例在I期试验中为16%,II期试验中为32%。但是在II期临床试验中,T-DXd对比研究者选择的治疗,TEAEs导致的剂量减少的比例为32%和34%。在DESTINY-Gastric01临床试验中,T-DXd出现≥ 3级血液学毒性的几率较高。同时,T-DXd组出现更高的治疗中止(15% versus 6%),更高的治疗中断(62% versus 37%),提示临床医师需要注意加强对T-DXd的毒性管理。我们知道,曲妥珠单抗的常见毒性为心脏毒性,但是在DESTINY-Gastric01临床试验中,心脏毒性很低或观察不到。

                II期DESTINY-Gastric01临床试验的治疗相关不良事件

间质性肺病(ILD):乳腺癌患者发生ILD的中位时间(中位, 194天; 范围: 42–535 天)较非乳腺癌患者明显延长(胃癌: 中位, 84.5天; 范围36–638天;肺癌: 中位, 86天; 范围41–255天; 结直肠癌: 中位, 80 天;范围22–132天)。

                               间质性肺病(ILD)的发生率

恶心是T-DXd治疗常见的治疗相关不良事件。任何级别的恶心发生比例,在DESTINY-Gastric01 临床试验中为63%,DESTINY-Breast01临床试验为78%。而≥ 3级别的恶心发生率分别为5%和8%。这些提示恶心的管理治疗在T-DXd治疗中比较重要。

T-DXd治疗的临床管理

间质性肺病(ILD):相关的管理规范已有发表,需要常规进行监测,进行CT或胸片,血液学检查,血氧饱和度以及肺功能。同时在T-DXd治疗前,需要明确伴随疾病等情况。

                              间质性肺病(ILD)的治疗管理

恶心和呕吐:恶心呕吐的发生较常见,常用的治疗措施为预防性使用止呕药物。NCCN指南建议糖皮质激素,5-HT3抑制剂,和或阿瑞匹坦。同时也要根据迟发性或急性等来进行用药。

血液学毒性:粒细胞-集落刺激因子(G-CSF)常用于中性粒细胞降低的治疗。研究者建议治疗后第8,15天进行血液学检查。如有需要,应用G-CSF治疗。

未来前景

目前正在进行的临床试验有II期DESTINY-Gastric02试验 (NCT04014075; T-DXd; 二线), 1b/2期 DESTINY-Gastric03 试验 (NCT04379596; T-DXd单药or T-DXd + 化疗 和或 durvalumab; Part 1:二线或后线治疗; Part 2:一线), III期 DESTINY-Gastric04 试验 (NCT04704934; T-DXd or ramucirumab + 紫杉醇; 二线)。希望这些研究能促进T-DXd在HER2+胃癌的治疗。

探索性研究DES-TINY-Gastric01中,纳入HER2低表达患者 (IHC 2 + /ISH- [队列1] or IHC 1 + [队列2]) ,队列1的客观缓解率为26.3%, 中位PFS 和OS 分别为 4.4和7.8个月;队列2的客观缓解率为9.5%, 中位PFS 和OS 分别为 2.8和8.5个月。而在HER2低表达的乳腺癌中,T-DXd治疗的客观缓解率为37%, 中位PFS 和OS 分别为 11.1和29.4个月。因此,T-DXd在HER2低表达的患者也展示了一定的抗肿瘤疗效。

综上,该综述阐明了T-DXd在HER2+胃癌中的疗效以及安全性,并对常见不良事件进行的管理建议,最后展望了T-DXd在HER2+胃癌的前景。数据表明T-DXd在HER2+胃癌曲妥珠单抗失败后仍有较好的疗效并且安全性和耐受可控。

原始出处:

Shitara, K., Baba, E., Fujitani, K. et al. Discovery and development of trastuzumab deruxtecan and safety management for patients with HER2-positive gastric cancer. Gastric Cancer (2021). https://doi.org/10.1007/s10120-021-01196-3

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04:01:41 CST 2021, time=2021-10-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1952128, encodeId=73bf1952128f4, content=<a href='/topic/show?id=e56658621e' target=_blank style='color:#2F92EE;'>#deruxtecan#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=5862, encryptionId=e56658621e, topicName=deruxtecan)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1ce4238, createdName=dangious, createdTime=Sat Mar 05 07:01:41 CST 2022, time=2022-03-05, status=1, ipAttribution=)]
    2021-12-10 skhzy
  4. [GetPortalCommentsPageByObjectIdResponse(id=1652482, encodeId=34ec165248284, content=<a href='/topic/show?id=13d01e24509' target=_blank style='color:#2F92EE;'>#TEC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=45, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17245, encryptionId=13d01e24509, topicName=TEC)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=852f24292001, createdName=shock_melon, createdTime=Fri Apr 01 17:01:41 CST 2022, time=2022-04-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1769702, encodeId=bdee1e6970246, content=<a href='/topic/show?id=900b8323461' target=_blank style='color:#2F92EE;'>#胃癌患者#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=83234, encryptionId=900b8323461, topicName=胃癌患者)], attachment=null, authenticateStatus=null, createdAvatar=null, 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04:01:41 CST 2021, time=2021-10-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1952128, encodeId=73bf1952128f4, content=<a href='/topic/show?id=e56658621e' target=_blank style='color:#2F92EE;'>#deruxtecan#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=5862, encryptionId=e56658621e, topicName=deruxtecan)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1ce4238, createdName=dangious, createdTime=Sat Mar 05 07:01:41 CST 2022, time=2022-03-05, status=1, ipAttribution=)]
    2021-10-23 snf701207
  5. [GetPortalCommentsPageByObjectIdResponse(id=1652482, encodeId=34ec165248284, content=<a href='/topic/show?id=13d01e24509' target=_blank style='color:#2F92EE;'>#TEC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=45, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17245, encryptionId=13d01e24509, topicName=TEC)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=852f24292001, createdName=shock_melon, createdTime=Fri Apr 01 17:01:41 CST 2022, time=2022-04-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1769702, encodeId=bdee1e6970246, content=<a href='/topic/show?id=900b8323461' target=_blank style='color:#2F92EE;'>#胃癌患者#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=83234, encryptionId=900b8323461, topicName=胃癌患者)], attachment=null, authenticateStatus=null, createdAvatar=null, 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04:01:41 CST 2021, time=2021-10-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1952128, encodeId=73bf1952128f4, content=<a href='/topic/show?id=e56658621e' target=_blank style='color:#2F92EE;'>#deruxtecan#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=5862, encryptionId=e56658621e, topicName=deruxtecan)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1ce4238, createdName=dangious, createdTime=Sat Mar 05 07:01:41 CST 2022, time=2022-03-05, status=1, ipAttribution=)]
    2022-01-05 许安
  6. 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04:01:41 CST 2021, time=2021-10-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1952128, encodeId=73bf1952128f4, content=<a href='/topic/show?id=e56658621e' target=_blank style='color:#2F92EE;'>#deruxtecan#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=5862, encryptionId=e56658621e, topicName=deruxtecan)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1ce4238, createdName=dangious, createdTime=Sat Mar 05 07:01:41 CST 2022, time=2022-03-05, status=1, ipAttribution=)]
  7. [GetPortalCommentsPageByObjectIdResponse(id=1652482, encodeId=34ec165248284, content=<a href='/topic/show?id=13d01e24509' target=_blank style='color:#2F92EE;'>#TEC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=45, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17245, encryptionId=13d01e24509, topicName=TEC)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=852f24292001, createdName=shock_melon, createdTime=Fri Apr 01 17:01:41 CST 2022, time=2022-04-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1769702, encodeId=bdee1e6970246, content=<a href='/topic/show?id=900b8323461' target=_blank style='color:#2F92EE;'>#胃癌患者#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=83234, encryptionId=900b8323461, topicName=胃癌患者)], attachment=null, authenticateStatus=null, createdAvatar=null, 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objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2896, encryptionId=9a1c289680, topicName=AST)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8b9831894722, createdName=ms24272190615788285182, createdTime=Wed Jan 12 16:01:41 CST 2022, time=2022-01-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1657464, encodeId=db4f165e46409, content=<a href='/topic/show?id=3ca31e71903' target=_blank style='color:#2F92EE;'>#TRA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17719, encryptionId=3ca31e71903, topicName=TRA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=757b24868428, createdName=bsmagic9140, createdTime=Sun Mar 20 08:01:41 CST 2022, time=2022-03-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1768971, 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04:01:41 CST 2021, time=2021-10-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1952128, encodeId=73bf1952128f4, content=<a href='/topic/show?id=e56658621e' target=_blank style='color:#2F92EE;'>#deruxtecan#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=5862, encryptionId=e56658621e, topicName=deruxtecan)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1ce4238, createdName=dangious, createdTime=Sat Mar 05 07:01:41 CST 2022, time=2022-03-05, status=1, ipAttribution=)]
    2022-03-20 bsmagic9140
  8. 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  9. 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