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Article(id=1239222198146225075, tenantId=1146029695717560320, journalId=1205117082300743687, issueId=1239222192311948159, articleNumber=null, orderNo=null, doi=10.14109/j.cnki.xyylc.2024.11.02, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1705852800000, receivedDateStr=2024-01-22, revisedDate=null, revisedDateStr=null, acceptedDate=1722787200000, acceptedDateStr=2024-08-05, onlineDate=1773383195672, onlineDateStr=2026-03-13, pubDate=1732464000000, pubDateStr=2024-11-25, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1773383195672, onlineIssueDateStr=2026-03-13, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1773383195672, creator=13701087609, updateTime=1773383195672, updator=13701087609, issue=Issue{id=1239222192311948159, tenantId=1146029695717560320, journalId=1205117082300743687, year='2024', volume='43', issue='11', pageStart='801', pageEnd='880', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=0, createTime=1773383194282, creator=13701087609, updateTime=1773384015681, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1239225637551002124, tenantId=1146029695717560320, journalId=1205117082300743687, issueId=1239222192311948159, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1239225637551002125, tenantId=1146029695717560320, journalId=1205117082300743687, issueId=1239222192311948159, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=809, endPage=813, ext={EN=ArticleExt(id=1239222198477575111, articleId=1239222198146225075, tenantId=1146029695717560320, journalId=1205117082300743687, language=EN, title=Research progress in antibody-drug conjugates in ovarian cancer, columnId=1207314219599499390, journalTitle=Chinese Journal of New Drugs and Clinical Remedies, columnName=Review, runingTitle=null, highlight=null, articleAbstract=

Antibody-drug conjugates（ADCs）consist of monoclonal antibodies, linkers, and cytotoxic drugs,representing a novel class of anti-cancer agents that combine target specificity with chemotherapeutic efficacy. ADCs have demonstrated significant efficacy not only in breast cancer, gastric cancer and lung cancer, and have also shown clinical benefits in ovarian cancer. This review discussed the structure, mechanism, and applications of ADCs in ovarian cancer,aiming to provide new insights for clinical treatment of ovarian cancer.

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抗体偶联药物（ADC）由单克隆抗体、连接子和细胞毒性药物三部分构成，是兼具靶向特异性与化疗药物杀伤性的新型抗肿瘤药物。ADC不但在乳腺癌、胃癌和肺癌等多个领域卓有成效，在卵巢癌中也有一定的临床获益。本文就ADC的结构、机制及其在卵巢癌中的应用展开综述，旨在为卵巢癌的临床治疗提供新思路。

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俞星
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荆美玲，女，硕士在读，主要从事妇科肿瘤研究，E-mail:

俞星，女，副教授，博士，主要从事妇女保健研究，E-mail:

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荆美玲，女，硕士在读，主要从事妇科肿瘤研究，E-mail:

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荆美玲，女，硕士在读，主要从事妇科肿瘤研究，E-mail:

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俞星，女，副教授，博士，主要从事妇女保健研究，E-mail:

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抗体偶联药物在卵巢癌中的研究进展
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荆美玲 1 , 俞星 2
中国新药与临床杂志 | 综述 2024,43(11): 809-813
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中国新药与临床杂志 | 综述 2024, 43(11): 809-813
抗体偶联药物在卵巢癌中的研究进展
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荆美玲1 , 俞星2
作者信息
  • 1.延边大学医学院，吉林 延吉　133002
  • 2.延边大学医学院 预防医学教研部，吉林 延吉　133002

    • 荆美玲，女，硕士在读，主要从事妇科肿瘤研究，E-mail:

    俞星，女，副教授，博士，主要从事妇女保健研究，E-mail:

通讯作者:

俞星
Research progress in antibody-drug conjugates in ovarian cancer
Mei-ling JING1 , Xing YU2
Affiliations
  • 1.Medical College, Yanbian University, Yanji JILIN 133002, China
  • 2.Department of Preventive Medicine, Medical College,Yanbian University, Yanji JILIN 133002, China
出版时间: 2024-11-25 doi: 10.14109/j.cnki.xyylc.2024.11.02
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摘要
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抗体偶联药物（ADC）由单克隆抗体、连接子和细胞毒性药物三部分构成，是兼具靶向特异性与化疗药物杀伤性的新型抗肿瘤药物。ADC不但在乳腺癌、胃癌和肺癌等多个领域卓有成效，在卵巢癌中也有一定的临床获益。本文就ADC的结构、机制及其在卵巢癌中的应用展开综述，旨在为卵巢癌的临床治疗提供新思路。

抗体偶联药物  /  靶向治疗  /  卵巢癌

Antibody-drug conjugates（ADCs）consist of monoclonal antibodies, linkers, and cytotoxic drugs,representing a novel class of anti-cancer agents that combine target specificity with chemotherapeutic efficacy. ADCs have demonstrated significant efficacy not only in breast cancer, gastric cancer and lung cancer, and have also shown clinical benefits in ovarian cancer. This review discussed the structure, mechanism, and applications of ADCs in ovarian cancer,aiming to provide new insights for clinical treatment of ovarian cancer.

antibody-drug conjuagte  /  targeted therapy  /  ovarian cancer
荆美玲, 俞星. 抗体偶联药物在卵巢癌中的研究进展. 中国新药与临床杂志, 2024 , 43 (11) : 809 -813 . DOI: 10.14109/j.cnki.xyylc.2024.11.02
Mei-ling JING, Xing YU. Research progress in antibody-drug conjugates in ovarian cancer[J]. Chinese Journal of New Drugs and Clinical Remedies, 2024 , 43 (11) : 809 -813 . DOI: 10.14109/j.cnki.xyylc.2024.11.02
正文
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卵巢癌（ovarian cancer）是临床上常见的女性生殖系统恶性肿瘤之一，发病早期无典型的临床症状，缺乏有效筛查手段，其死亡率位居各类妇科恶性肿瘤之首。目前卵巢癌的治疗方案以手术、药物化疗、免疫治疗和靶向治疗为主，可在一定程度上改善患者的预后，但约70%患者出现治疗后复发和耐药性，病情不断进展，5年生存率仅为40%[1,2]。抗体偶联药物（antibody-drug conjuagte，ADC）起源于1913年，由德国科学家Paul Ehrlich首次提出“魔法子弹”理论，即细胞毒性药物可由单克隆抗体（monoclonal antibody，mAb）精准输送至肿瘤细胞表面，显著提升疗效并降低全身毒性，是治疗癌症的理想选择[3]，随着生物技术的蓬勃发展，该领域日趋成熟[4]。本文梳理了不同结构及作用靶点的ADC在卵巢癌中的研究现状，以期为临床治疗提供参考。
ADC的结构与作用机制
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（1）抗体：对靶点有高亲和力，同时具有适宜的循环半衰期及良好的血液系统稳定性[5]。免疫球蛋白G（immunoglobulin G, IgG）是最常用的抗体，其中IgG1的半衰期更长、作用更强[6]。（2）连接子：是抗体和有效载荷间的纽带，分为可裂解和不可裂解两类。前者能借助内置化学键与肿瘤相关因素快速反应分离有效载荷，但稳定性差，在生理pH值下会发生一定程度的水解[7]；后者依赖溶酶体降解整个ADC后发挥作用，稳定性好但易保留带电氨基酸，影响药物作用和细胞渗透性[8]。（3）细胞毒性有效载荷：是担任细胞杀伤功能的部分，在pmol范围内即有高细胞毒性，目前应用的有效载荷主要为微管蛋白抑制剂、DNA损伤剂和免疫调节剂[9]。
ADC可特异性识别靶抗原，由内吞作用进入细胞，释放有效载荷，诱导肿瘤细胞凋亡。内吞有三种途径：网格蛋白介导的内吞作用、小窝介导的外吞作用及胞饮作用[10]。细胞毒性药物可从靶细胞扩散到邻近细胞发挥作用，即“旁观者效应”，是解决实体肿瘤靶抗原异质性表达的重要助力[11]。此外，mAb可介导抗体依赖性细胞毒作用，直接杀伤靶细胞，进一步增强ADC的药效。
不同作用靶点的ADC
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1　靶向叶酸受体α（folate receptor alpha，FRα）的ADC
叶酸是一种水溶性维生素，在DNA、RNA、蛋白质的合成与甲基化及细胞增殖、生长过程中发挥着重要作用。FRα对叶酸具有高亲和力，可通过内吞作用转运叶酸至细胞内。FRα在卵巢癌、子宫内膜癌、乳腺癌、非小细胞肺癌等恶性肿瘤中高度表达，并与预后不良有关[12]。mirvetuximab soravtansine（MS）是首个获得美国食品和药物管理局（FDA）批准的用于铂耐药性卵巢癌（platinum resistant ovarian cancer，PROC）的ADC，由靶向FRα的IgG（M9346A）通过可裂解的连接子与微管蛋白抑制剂DM4偶联而成。
PARKER等[12]在2018年开展的Ⅰ期临床试验结果显示，对于FRα阳性的PROC患者，MS可提高客观缓解率（objective response rate，ORR）和无进展生存期（progression free survival，PFS）。治疗相关的不良事件（treatment-related adverse events，TRAEs）主要为角膜病变、视力模糊、疲劳、腹泻等，毒性微弱且可控。眼毒性可能与药物脱靶效应有关，预防性使用皮质类固醇滴眼液可改善症状。分析发现，FRα表达情况与MS抗肿瘤活性呈正相关，且该治疗方案在既往接受不超过三线治疗的患者中获益明显。后续进行的Ⅲ期临床试验将PROC患者随机分配到MS组和标准化疗组［聚乙二醇化脂质体多柔比星（PLD）、托泊替康或紫杉醇］，MS组ORR明显提高且安全性良好。但在FRα阳性患者中未观察到PFS获益，考虑评估FRα表达的方法不甚严谨，结果有待进一步研究验证[13]。
一项Ⅰb期临床试验评估了MS和贝伐珠单抗联合治疗PROC患者的疗效与安全性，研究纳入66例FRα阳性患者，ORR和PFS分别为39%和6.9个月，TRAEs主要为眼部病变和周围神经病变，该方案在初次使用贝伐珠单抗治疗的患者中疗效更佳[14]。基于联合用药方案的获益，MS联合聚腺苷酸二磷酸核糖聚合酶（PARP）抑制剂或吉西他滨的临床试验正在进行中（NCT03552471、NCT02996825）。联合用药方案在铂敏感复发性卵巢癌患者中也有获益，MS联合卡铂和贝伐珠单抗方案试验结果显示，ORR和PFS分别为81%和12个月，TRAEs与既往研究相似，部分临床试验也招募了铂敏感复发性卵巢癌患者入组研究[15]。
2　靶向NaPi2b的ADC
NaPi2b是溶质载体SLC34家族中的钠依赖性磷酸盐转运蛋白，在维持磷酸盐稳态中发挥关键作用。研究发现，NaPi2b在正常组织中表达有限，而在高级别浆液性上皮性卵巢癌、输卵管癌、原发性腹膜癌以及甲状腺癌中高度表达[16]。lifastuzumab vedotin（LIFA）是由靶向NaPi2b的IgG通过可裂解连接子偶联微管蛋白抑制剂MMAE而成的ADC。GERBER等[17]在2017年开展的Ⅰa期临床试验证明，LIFA在非小细胞肺癌和PROC患者中具有初步抗肿瘤活性和可控的安全性，且在NaPi2b高表达患者中疗效最佳。NaPi2b的表达不会随着时间推移和标准化疗模式改变，有望成为预测LIFA临床获益的标志物。一项Ⅱ期临床试验纳入95例PROC患者，随机接受LIFA治疗或标准化疗。LIFA组ORR（34%vs. 16%）显著提高，PFS（5.1个月vs. 3.4个月）无显著差异，TRAEs包括疲劳、胃肠道反应和周围神经病变，总体程度较轻[18]。该项研究提示，仅凭ORR无法全面评价ADC的疗效，谨慎选择靶点、评估反应率和反应持续时间是未来研究的重点。
upifitamab rilsodotin（UpRi）是首个应用新型连接子的ADC，由靶向NaPi2b的IgG与细胞毒性药物AF-HPA偶联而成，仅需低剂量或低频率给药即可大幅提高肿瘤表面的药物浓度，同时有效载荷具有可控的旁观者效应且扩散能力有限，减少了对周围健康细胞的杀伤作用[19]。一项针对UpRi的Ⅰ期临床试验评估了其疗效和安全性，研究纳入97例高级别浆液性卵巢癌患者，既往接受过一至三线化疗、贝伐珠单抗治疗或PARP抑制剂治疗。结果显示，总体ORR为23%，NaPi2b高表达人群ORR为34%。常见TRAEs是转氨酶升高、疲劳、贫血和血小板减少，未观察到中性粒细胞减少症、周围神经病变或眼毒性。UpRi展现出显著的单药抗肿瘤活性，且在标准治疗失败的患者中具有良好的耐受性[20]。目前评估UpRi单药、联合治疗用于PROC患者的两项Ⅱ期临床试验（NCT03319628、NCT04907968）及针对铂敏感复发性卵巢癌患者的Ⅲ期随机对照临床试验（NCT05329545）正在进行中。
3　靶向MUC16的ADC
MUC16是一种跨膜糖蛋白，在细胞外裂解时可释放CA125，是卵巢癌的常用血清标志物。MUC16在80%的卵巢癌和胰腺癌中过表达，参与肿瘤细胞的免疫逃逸、侵袭和转移[21]。DMUC5754A由MUC16靶向抗体与MMAE偶联而成。一项Ⅰ期临床试验评估了DMUC5754A用于治疗复发性PROC患者的疗效与安全性，结果显示仅有MUC16过表达的患者出现客观反应，可将CA125降低≥70%和人附睾蛋白4（HE4）降低≥40%作为疗效评估指标，TRAEs主要为疲劳、周围神经病变等。周围神经病变被认为是抗微管蛋白治疗的副作用及使用MMAE作为有效载荷的潜在毒性，其程度轻微、可控且随着剂量减少，症状可逆[22]。DMUC4064A是采用位点定向偶联技术连接IgG和MMAE的新型ADC，实现了药物与抗体的严格配比，具有更均匀的有效载荷。评估DMUC4064A疗效的Ⅰ期临床试验纳入65例PROC患者，总体ORR为42%，在54例MUC16高表达患者中临床获益率为46%，中位PFS为3.9个月，TRAEs主要为眼毒性、周围神经病变等[23]。以上数据证实了MUC16作为PROC患者治疗靶点的可行性，期待后续进一步研究。
4　靶向间皮素的ADC
间皮素是通过糖基磷脂酰肌醇锚定在细胞表面的蛋白,参与肿瘤发生、侵袭和转移。间皮素在胸膜、心包和腹膜的间皮细胞中正常表达，在恶性间皮瘤、胰腺癌、卵巢癌、肺腺癌中高度表达，且与癌症的不良预后相关[24]。anetumab ravtansine（AR）由靶向间皮素的IgG与微管抑制剂DM4通过可裂解的连接子偶联而成。HASSAN等[25]在2019年开展的Ⅰ期临床试验招募晚期、难治性卵巢癌患者接受AR单药治疗，在不同剂量下均观察到了客观反应，间皮素表达情况与抗肿瘤活性之间存在初步的相关性趋势。常见的TRAEs是疲劳、眼毒性、恶心等，通过中断治疗或减少剂量进行控制。一项Ⅱ期临床试验评估了AR与PLD的联合疗法，该试验招募了65例间皮素表达阳性的PROC患者，结果显示ORR和中位PFS分别为27.7%和5.0个月，其中19例间皮素高度表达患者既往接受≤3种系统治疗，ORR和PFS分别为42.1%和8.5个月。TRAEs为中性粒细胞和血小板计数下降[26]。AR联合PLD显示出良好的临床获益和安全性，可为PROC患者的治疗提供新选择。目前，评估贝伐珠单抗联合AR或紫杉醇在PROC中的疗效的Ⅱ期临床试验正在进行中（NCT03587311）。
5　靶向人滋养层细胞表面抗原2（Trop-2）的ADC
Trop-2是一种跨膜糖蛋白，参与细胞内钙信号转导，促进肿瘤细胞增殖、侵袭和转移。Trop-2在宫颈癌、子宫内膜样腺癌和卵巢癌中高度表达，是一种独立的不良预后标志物[27]。sacituzumab govitecan（SG）由人源化RS7抗体与伊立替康的活性代谢产物SN-38偶联而成。PERRONE等[28]在2020年进行的临床前研究发现，Trop-2过表达的卵巢癌细胞对SG具有更高的敏感性，同时SG具有显著的旁观者效应，有助于治疗具有抗原异质性表达的肿瘤，该项研究为后续临床试验的开展提供了数据支持。
综上所述，ADC在卵巢癌的治疗中展现出了良好的疗效，但药物的研发和应用仍面临着许多问题与挑战。（1）耐药：ADC的耐药机制复杂多样，靶抗原表达下调、溶酶体功能缺失、无效内化或凋亡通路失调等都是潜在原因。选择联合治疗模式、更换不同靶点和优化设计等是克服耐药的重要策略[29]。（2）提高疗效：mAb是特异性识别的关键部分，双靶点抗体可增强特异性和加速抗体内化，是新的研究方向[30]。创新有效载荷也有望成为提升疗效的新模式，如联合使用两种协同作用的细胞毒性药物或更换为新型的靶向药物和免疫抑制剂等。（3）安全性问题：ADC虽然降低了全身毒性，但由于作用机制、制备技术等问题，在实际应用中仍存在多种不良反应。脱靶毒性、正常细胞低表达靶抗原及旁观者效应对肿瘤周围正常细胞的杀伤性是发生不良反应的重要因素。药物抗体偶联比（drug-to-antibody ratio，DAR）与疗效呈正相关，但数值过高会导致药物聚集、半衰期缩短、毒副作用增加[31]。在未来的研究中需要探索稳定性更好、靶抗原表达更精准、DAR更佳的ADC，并建立相应的安全性评价及处理标准[32]，同时，探寻反映预后的有效生物标志物和优化联合用药方案也是重要的研究方向，期待开发出更加精准、高效、低毒的ADC使更多卵巢癌患者获益。
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doi: 10.14109/j.cnki.xyylc.2024.11.02
  • 接收时间：2024-01-22
  • 首发时间：2026-03-13
  • 出版时间：2024-11-25
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  • 收稿日期：2024-01-22
  • 录用日期：2024-08-05
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吉林省卫生健康科技能力提升项目(2021JC064)
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    1.延边大学医学院，吉林 延吉　133002
    2.延边大学医学院 预防医学教研部，吉林 延吉　133002

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