Lancet Oncol:卡瑞利珠单抗二线治疗食管癌 III 期研究结果公布,患者死亡风险减少三成(ESCORT试验)

2020-05-14 MedSci MedSci原创

食管癌是全球死亡率最高的恶性肿瘤之一,在中国食管癌的发病率和死亡率都非常高。食管癌主要有两种病理类型:鳞癌和腺癌。鳞癌主要分布在发展中国家,尤其是中国食管鳞癌占 90% 以上。晚期食管癌一线化疗大多采

食管癌是全球死亡率最高的恶性肿瘤之一,在中国食管癌的发病率和死亡率都非常高。食管癌主要有两种病理类型:鳞癌和腺癌。鳞癌主要分布在发展中国家,尤其是中国食管鳞癌占 90% 以上。晚期食管癌一线化疗大多采用含铂方案或以氟尿嘧啶为基础的方案,有效率为 40%-60%。但一线治疗失败后患者的中位生存时间(OS)仅为 5-10 个月,二线治疗尚无标准有效的治疗方案,因此需要积极寻找有效的新药。可喜的是,卡瑞利珠单抗作为国产创新 PD-1 单抗在探索食管鳞癌的多种治疗模式上均取得了非常喜人的成绩,潜力十足。

卡瑞利珠单抗二线单药治疗食管癌的 I 期研究数据已经发表在《clinical cancer research》上,根据纳入的前 30 例食管癌的患者的数据,有 10 例患者达到部分缓解,客观缓解率(ORR)达到 33.3%,而 3 级以上的药物相关不良反应仅有 10%。值得一提的是,与已发布的同类治疗二线单药治疗食管癌的 I 期研究数据比较,卡瑞利珠单抗的疗效和安全性数据更加显著。

卡瑞利珠单抗对比研究者选择化疗方案用于二线晚期/转移性食管鳞癌患者的ESCORT试验由中国医学科学院肿瘤医院的黄镜教授和军事医学科学院附属医院(解放军307医院)徐建明教授牵头,结果刚刚公布在Lancet Oncology杂志上。

ESCORT 研究于 2017 年 5 月10日开始入组受试者,截止至 2018年7月24日,在607例筛查的患者中,有457例(75%)被随机分配到治疗。对既往接受一线化疗失败的晚期/转移性食管鳞癌患者,按 1:1 的比例随机分配进入试验组及对照组,试验组受试者接受卡瑞利珠单抗单药治疗(200 mg,每 2 周给药一次),对照组接受研究者选择的化疗方案进行治疗:多西他赛 (75 mg/m2,每 3 周给药一次) 或伊立替康 (180 mg/m2,每 2 周给药一次),其中 228 例患者接受卡瑞利珠单抗治疗,220 例患者接受了化疗。研究主要终点为总生存期(OS),次要终点包括无进展生存期(PFS)、客观缓解率(ORR)等。

457例患者中,228例接受camrelizumab治疗,220人分配至研究者选择的化疗方案组(即对照组)。截至2019年5月6日数据,卡瑞利珠单抗组的中位随访时间为8.3个月(IQR 4.1-12.8),对照化疗组中位随访时间为6.2个月(3.6-10.1)。
在在camrelizumab组中,中位总生存期为8.3个月(95% CI 6.8-9.7),而化疗组为6.2个月(5.7-6.9)(HR 0.71[95% CI 0.57-0.87];双侧P=0.0010)。3级或更严重的最常见的治疗相关不良事件是贫血(camrelizumab组 vs. 化疗组:6例[3%]vs 11例[5%])、肝功能异常(4例[2%]vs 1例[<1%])、腹泻(3例[1%]vs 9例 [4%])。在camrelizumab组的228名患者中,有37名(16%)发生严重的治疗相关不良事件,对照组有32例(15%)发生治疗相关不良事件。

发生了10例与治疗相关的死亡,camrelizumab组7例(3人死于不明原因,1人肠结肠炎,1人肝功能异常,1人 肺炎,1例心肌炎),化疗组有3例(1%)(2例不明原因死亡。1例胃肠道出血)

各个亚组分析结果与整体结果基本一致。

上述结果表明,对于既往一线化疗失败的晚期或转移性食管鳞癌患者,接受卡瑞利珠单抗单药治疗对比研究者选择的化疗,可显著提高患者生存期,将二线患者总生存期延长2个月,HR接近0.7。该研究中观察到的安全性数据与之前公布的数据基本一致,患者耐受性良好。

卡瑞利珠单抗在食管鳞癌的探索没有结束,才刚刚开始

事实上,另一项研究卡瑞利珠单抗联合阿帕替尼和化疗(紫杉醇脂质体+奈达铂)一线治疗晚期食管鳞癌的Ⅱ期临床研究。该研究对于入组的 30 例不能切除的局部晚期或转移性晚期食管鳞癌患者,给予卡瑞利珠单抗 200 mg、脂质体紫杉醇 150 mg/m2(day 1)、奈达铂 50 mg/m2(day 1)和阿帕替尼 250 mg(day1-14)治疗,每 14 天重复给药治疗,最多 6-9 个周期。随后用卡瑞利珠单抗、阿帕替尼或两者同时进行维持治疗。

就目前的结果而言(在ASCO会议上公布),入组的 30 例患者中,总有效率高达 80%(其中还有 10% 的患者达到临床完全缓解)、 疾病控制率(DCR)高达 96.7%,结果令人十分期待。提示未来在筛选合适人群的前提下,食管鳞癌的一线治疗中或许可以选择「强强联合」(卡瑞利珠单抗+抗血管生成靶向药物阿帕替尼+化疗)的治疗手段,实现精准治疗,让更多的患者获益。

原始出处:

Huang J, Xu J, Chen Y,et al. Camrelizumab versus investigator’s choice of chemotherapy as second-line therapy for advanced or metastatic oesophageal squamous cell carcinoma (ESCORT): a multicentre, randomised, open-label, phase 3 study. Lancet Oncol 2020 Published Online May 13, 2020 https://doi.org/10.1016/ S1470-2045(20)30110-8

黄镜教授

  • 医学博士,教授, 博士生导师,中国医学科学院肿瘤医院内科副主任
  • 中国老年学和老年医学会肿瘤康复分会副主任委员
  • 北京医师协会结直肠肿瘤专业委员会副主任委员
  • 中国临床肿瘤学协会(CSCO)理事
  • CSCO 食管癌专家委员会副主任委员兼秘书长
  • 中国抗癌协会食管癌专业委员会常委
  • 中国医师协会结直肠肿瘤专业委员会常委
  • 中国医师协会结直肠肿瘤专业委员会内科治疗委员会副主任委员
  • 海峡两岸医药卫生交流协会肿瘤防治专家委员会胃癌学组副组长
  • 北京市希思科临床肿瘤学研究基金会理事
  • 北京市朝阳区青联委员
  • 《中华结直肠疾病电子杂志》编委
  • 《癌症进展杂志》编委、《中国生化药物杂志》副主编

徐建明教授

  • 主任医师,博士,教授,军事医学科学院附属医院(解放军307医院)消化道肿瘤科主任。
  • 中国人民解放军总医院第五医学中心消化肿瘤科主任,教授,博士生导师
  • 中国临床肿瘤学会 胃肠胰腺神经内分泌癌专业委员会 主任委员
  • 中国生物医学工程协会 肿瘤分子靶向药物治疗专业委员会 副主任委员
  • 中国研究型医院 肿瘤学专业委员会 副主任委员
  • 主要从事胃癌、结直肠癌、食管癌、肝癌、胰腺癌以及神经内分泌肿瘤等消化系统肿瘤的内科治疗和研究。尤其是对新近出现的肿瘤靶向治疗药物进行了系统的研究,提出了靶向药物临床应用的新思路。承担多项国家自然科学基金和全军攻关课题,进行胃肠道肿瘤分子靶向治疗的临床和基础研究。获军队医疗成果一等奖、二等奖各1项,参与国家863课题1项。在国内核心期刊上发表论文80余篇,在国际肿瘤专业的权威杂志《European J Cancer》、《Biochemical Pharmacology》、《International J Cancer》上发表论文20篇,参与编写肿瘤治疗学等专著3部。

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createdAvatar=https://wx.qlogo.cn/mmopen/aLGWoFXAyMbIu3qymFOyheQLjPSX3OUs5GmkyBlcCOwTPIeq3why9NGibxxUqYo6hcx8qZLHZFgNPnBK1yzWeOFpyg2OnWOt0/0, createdBy=fa4716, createdName=zhouqu_8, createdTime=Fri May 15 23:35:02 CST 2020, time=2020-05-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1502863, encodeId=fac1150286309, content=<a href='/topic/show?id=d56636526e4' target=_blank style='color:#2F92EE;'>#卡瑞利珠#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=36526, encryptionId=d56636526e4, topicName=卡瑞利珠)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8d779566916, createdName=by2012, createdTime=Fri May 15 23:35:02 CST 2020, time=2020-05-15, status=1, ipAttribution=)]
    2020-07-10 minlingfeng
  3. 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target=_blank style='color:#2F92EE;'>#患者死亡#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=53048, encryptionId=628553048e3, topicName=患者死亡)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=12de429, createdName=sunylz, createdTime=Tue Jan 12 13:35:02 CST 2021, time=2021-01-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2004416, encodeId=3656200441665, content=<a href='/topic/show?id=54ebe8621cf' target=_blank style='color:#2F92EE;'>#结果公布#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=78621, encryptionId=54ebe8621cf, topicName=结果公布)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=279b407, createdName=shanyongle, createdTime=Fri Aug 28 11:35:02 CST 2020, time=2020-08-28, status=1, ipAttribution=), 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createdAvatar=https://wx.qlogo.cn/mmopen/aLGWoFXAyMbIu3qymFOyheQLjPSX3OUs5GmkyBlcCOwTPIeq3why9NGibxxUqYo6hcx8qZLHZFgNPnBK1yzWeOFpyg2OnWOt0/0, createdBy=fa4716, createdName=zhouqu_8, createdTime=Fri May 15 23:35:02 CST 2020, time=2020-05-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1502863, encodeId=fac1150286309, content=<a href='/topic/show?id=d56636526e4' target=_blank style='color:#2F92EE;'>#卡瑞利珠#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=36526, encryptionId=d56636526e4, topicName=卡瑞利珠)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8d779566916, createdName=by2012, createdTime=Fri May 15 23:35:02 CST 2020, time=2020-05-15, status=1, ipAttribution=)]
    2020-12-07 howi
  4. 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target=_blank style='color:#2F92EE;'>#患者死亡#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=53048, encryptionId=628553048e3, topicName=患者死亡)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=12de429, createdName=sunylz, createdTime=Tue Jan 12 13:35:02 CST 2021, time=2021-01-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2004416, encodeId=3656200441665, content=<a href='/topic/show?id=54ebe8621cf' target=_blank style='color:#2F92EE;'>#结果公布#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=78621, encryptionId=54ebe8621cf, topicName=结果公布)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=279b407, createdName=shanyongle, createdTime=Fri Aug 28 11:35:02 CST 2020, time=2020-08-28, status=1, ipAttribution=), 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  5. [GetPortalCommentsPageByObjectIdResponse(id=1739545, encodeId=f83e1e39545d0, content=<a href='/topic/show?id=8041e343504' target=_blank style='color:#2F92EE;'>#研究结果#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=73435, encryptionId=8041e343504, topicName=研究结果)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=55683, createdName=仁医06, createdTime=Tue Jul 07 11:35:02 CST 2020, time=2020-07-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1865834, encodeId=e99418658349b, content=<a href='/topic/show?id=16ce133504e' target=_blank style='color:#2F92EE;'>#Oncol#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13350, encryptionId=16ce133504e, topicName=Oncol)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b63894, 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target=_blank style='color:#2F92EE;'>#患者死亡#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=53048, encryptionId=628553048e3, topicName=患者死亡)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=12de429, createdName=sunylz, createdTime=Tue Jan 12 13:35:02 CST 2021, time=2021-01-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2004416, encodeId=3656200441665, content=<a href='/topic/show?id=54ebe8621cf' target=_blank style='color:#2F92EE;'>#结果公布#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=78621, encryptionId=54ebe8621cf, topicName=结果公布)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=279b407, createdName=shanyongle, createdTime=Fri Aug 28 11:35:02 CST 2020, time=2020-08-28, status=1, ipAttribution=), 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createdAvatar=https://wx.qlogo.cn/mmopen/aLGWoFXAyMbIu3qymFOyheQLjPSX3OUs5GmkyBlcCOwTPIeq3why9NGibxxUqYo6hcx8qZLHZFgNPnBK1yzWeOFpyg2OnWOt0/0, createdBy=fa4716, createdName=zhouqu_8, createdTime=Fri May 15 23:35:02 CST 2020, time=2020-05-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1502863, encodeId=fac1150286309, content=<a href='/topic/show?id=d56636526e4' target=_blank style='color:#2F92EE;'>#卡瑞利珠#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=36526, encryptionId=d56636526e4, topicName=卡瑞利珠)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8d779566916, createdName=by2012, createdTime=Fri May 15 23:35:02 CST 2020, time=2020-05-15, status=1, ipAttribution=)]
    2020-10-07 juliusluan78
  6. 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