ASCO 2015:膀胱尿路上皮癌抗PD-1及PD-L1抗体免疫治疗进展

2015-06-07 盛锡楠 郭军 医学论坛报

北京大学肿瘤医院肾癌黑色素瘤内科 盛锡楠 郭军近十余年来晚期尿路上皮癌的治疗尚无重大突破,特别是二线治疗仍处于探索阶段,虽然不断尝试新型化疗药物以及靶向药物等,但仍无标准二线治疗。近一年来肿瘤免疫治疗的突破性进展给晚期尿路上皮癌的治疗带来了一些曙光。2014年ASCO大会晚期尿路上皮癌的进展情况基本代表了目前现状,以拉帕替尼、Apatorsen为代表的靶向治疗Ⅱ期临床研究均告失败,而以PD-1以及

北京大学肿瘤医院肾癌黑色素瘤内科 盛锡楠 郭军


近十余年来晚期尿路上皮癌的治疗尚无重大突破,特别是二线治疗仍处于探索阶段,虽然不断尝试新型化疗药物以及靶向药物等,但仍无标准二线治疗。近一年来肿瘤免疫治疗的突破性进展给晚期尿路上皮癌的治疗带来了一些曙光。2014年ASCO大会晚期尿路上皮癌的进展情况基本代表了目前现状,以拉帕替尼、Apatorsen为代表的靶向治疗Ⅱ期临床研究均告失败,而以PD-1以及PD-L1的肿瘤免疫治疗值得期待。因此就今年尿路上皮癌的免疫治疗进展进行点评。

本次会议报告了两项抗PD-1及PD-L1抗体治疗晚期尿路上皮癌的最新临床研究数据。 治疗既往化疗失败的膀胱尿路上皮癌ⅠA期临床研究,总共92例至少一线治疗失败后的晚期尿路上皮癌患者,其中大部分患者(72%)接受过2线及其以上治疗,在可评价的87例患者中,55%的患者出现肿瘤缩小的情况,总体客观有效率为34%。根据PD-L1免疫组化表达情况分为低表达组(1+或0)与高表达组(2+及3+),两组的客观有效率分别为17%与50%,中位PFS时间分别为1个月与6个月,1年生存率分别为38%与57%,中位总生存方面,低表达组为7.6个月,而高表达组未达到中位值。总体来说PD-L1高表达的疗效更佳。

另外一项PD-1单抗Pembrolizumab治疗进展性恶性肿瘤的ⅠB研究,入组尿路上皮癌患者33例,60%患者既往接受过辅助或新辅助化疗,疾病进展后76%(25/33)的患者接受了全身治疗,结果显示治疗相关的3/4级不良反应发生率为15%,总体客观有效率为27.6%,其中完全缓解为10.3%,将近64%的患者肿瘤靶病灶出现过缩小,中位PFS时间为2个月,中位总生存为12.7个月。

KEYNOTE-012研究还探索性分析了PD-L1表达的预测价值,分析了单独肿瘤细胞PD-L1检测以及联合免疫细胞两种情况下的疗效分析,可评价28例,结果显示肿瘤细胞PD-L1阴性表达患者客观有效率为9%,阳性表达为33%。而联合肿瘤浸润性免疫细胞PD-L1表达阴性患者的客观有效率为0,这说明应将肿瘤细胞及其浸润性免疫细胞联合检测作为预测疗效的指标,从而降低假阴性率。

应该来说,这两项免疫治疗的疗效数据,无论是从客观有效率、无进展生存及其总生存数据方面,都要优于目前晚期尿路上皮癌既有二线治疗,无论是化疗还是TKI制剂,而且免疫治疗主要的3/4级不良反应发生率低(8%与15%),耐受性也要优于既往治疗,因此较以往治疗提高了疗效,为晚期尿路上皮癌的二线治疗提供了新的选择,当然这还需要更多的临床研究,尤其是需要扩大样本量。另外对于PD-1及PD-L1免疫治疗,PD-L1的表达很可能是疗效预测指标。因此免疫治疗前应常规进行PD-L1的表达,而PD-L1的检测可能需要进一步标准化,不仅仅单纯检测肿瘤细胞,也应包含肿瘤浸润性免疫细胞检测,目前我们医院已经与北大医院泌尿外科合作开展这方面的检测与研究工作,相信会为中国的晚期尿路上皮癌患者提供福音。

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    2015-07-01 quxin068
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    2015-08-07 hlycom3356

    期待有更多研究

    0

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    2015-06-09 huaxipanxing

    看看

    0

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    2015-06-09 smartjoy
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