复旦大学附属中山医院刘天舒教授谈帕博利珠单抗获批食管癌之研究亮点与临床意义

2019-08-31 佚名 肿瘤资讯

食管癌是我国重要的疾病负担之一,新发和死亡患者占全球55%左右。目前,对于晚期食管癌治疗,缺乏有效的治疗手段,患者预后较差,免疫治疗为晚期食管癌带来新的希望。近期,帕博利珠单抗单药获FDA批准用于PD-L1阳性的(CPS≥10)复发性局部晚期或转移性食管鳞癌的二线及以上治疗,成为食管癌领域全球范围获批的第一个免疫治疗药物。【肿瘤资讯】有幸邀请到复旦大学附属中山医院的刘天舒教授,就帕博利珠单抗获批食

食管癌是我国重要的疾病负担之一,新发和死亡患者占全球55%左右。目前,对于晚期食管癌治疗,缺乏有效的治疗手段,患者预后较差,免疫治疗为晚期食管癌带来新的希望。近期,帕博利珠单抗单药获FDA批准用于PD-L1阳性的(CPS≥10)复发性局部晚期或转移性食管鳞癌的二线及以上治疗,成为食管癌领域全球范围获批的第一个免疫治疗药物。【肿瘤资讯】有幸邀请到复旦大学附属中山医院的刘天舒教授,就帕博利珠单抗获批食管癌的关键性研究及其意义做一专访。

刘天舒

主任医师、教授、博士生导师

复旦大学附属中山医院肿瘤内科主任,肿瘤教研室主任,伦理委员会委员

中国临床肿瘤学会(CSCO)理事

中国抗癌协会癌专业委员会委员

中华医学会临床流行病委员会委员

上海医学会理事

上海市医学会临床流行病学循证医学专科主任委员

上海市临床研究伦理委员会委员

中国生物医学工程学会肿瘤靶向治疗技术分会常委

中国老年学会肿瘤康复分会常委

帕博利珠单抗获批:食管癌二线治疗有据可依

刘天舒教授:东亚是全球食管癌的高发地区,中国更是食管癌的重灾区。目前食管癌在一线治疗失败后并无有效的二线治疗手段和药物,通常以紫杉类、铂类、氟尿嘧啶类及伊立替康等化疗药物进行两两组合,但证据并不充分。因此,基于KEYNOTE-181研究,帕博利珠单抗单药获批用于食管鳞癌的二线治疗,这确实对临床实践带来很大的影响,为我们提供了晚期食管癌在二线治疗上有用的证据。

KEYNOTE-181研究:帕博利珠单抗疗效与安全性均优

刘天舒教授:KEYNOTE-181为一项大型的Ⅲ期研究,入组晚期或转移性食管腺癌或鳞癌或Siewert I型食管结合部腺癌患者,所有患者均为一线治疗后或治疗中进展,体力状态良好。研究共入组628例患者,每组314例,随机给予帕博利珠单抗,或研究者选择的化疗(包括紫杉醇、多西他赛或伊立替康)。其中鳞癌401例,PD-L1阳性(CPS≥10)患者222例。该研究主要设计了3个研究终点,包括食管鳞癌(SCC)患者、PD-L1阳性(CPS≥10)患者和意向性治疗(ITT)人群的总生存(OS)。次要终点为无进展生存(PFS)、客观缓解率(ORR)和安全性。研究结果显示,OS方面,在PD-L1阳性的患者中,帕博利珠较化疗显着延长中位OS 2.6个月,死亡风险降低31%,差异达到统计学意义(9.3个月vs 6.7 个月;HR 0.69;95%CI 0.52~0.93;P=0.0074)。SCC患者中,帕博利珠单抗组的OS也有临床意义上的改善,达到8.2个月,化疗组为7.1个月(HR 0.78;95%CI 0.63~0.96;P=0.0095)。ITT人群中,18个月的OS率分别为18%和10%。基于该研究的阳性数据,帕博利珠单抗获FDA批准用于PD-L1阳性(CPS≥10)食管鳞癌的二线治疗适应证。

日本食管癌亚组数据对中国食管癌治疗意义积极

刘天舒教授:KEYNOTE-181是一项全球性的研究,入组的628例患者中,有401例是鳞癌患者。亚洲国家食管癌组织类型与欧美国家存在明显差异,亚洲国家主要以鳞癌为主。近期公布的日本食管癌亚组数据中,共入组152例日本患者,其中鳞癌150例。PD-L1阳性(CPS≥10)的患者中,帕博利珠单抗较化疗延长中位OS 4.1个月,死亡风险降低32%(12.5个月vs 8.4个月;HR 0.68;95%CI 0.42~1.08)。较总体人群数据来说,亚组中的OS获益更优,因此对于帕博利珠单抗在食管鳞癌患者中的疗效我们也更有信心。总体而言,KEYNOTE-181日本食管癌亚组数据对于中国患者的意义较大,具有非常积极的借鉴作用。

帕博利珠单抗获国内外指南一致推荐

刘天舒教授:在新版的CSCO肿瘤治疗指南中,帕博利珠单抗已被推荐用于食管癌治疗,国外NCCN指南也有推荐。之所以被指南推荐,证明其临床研究数据是被专家认可的,且同时得到国内外指南的推荐,也充分证明了其研究数据的可靠性。对于以食管鳞癌为主的中国患者,帕博利珠单抗在食管鳞癌中优异的研究数据无疑是非常利好的消息。

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    2019-09-02 zhouqu_8
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    2019-09-02 saikp