病例:特瑞普利单抗治疗肢端型恶性黑色素瘤患者持续获益

2019-11-05 唐碧霞 肿瘤资讯

众所周知,黑色素瘤在世界范围不属于常见的恶性肿瘤,但近年来其发病率正逐步上升。不同于西方人群,我国黑色素瘤患者在发病机制、生物学行为、组织学形态、治疗方法及预后等方面均有所不同。既往针对西方人群的相关研究多针对皮肤黑色素瘤,而针对我国高发的肢端、黏膜等亚型黑色素瘤的相关研究较少。国产PD-1单抗对于我国黑色素瘤的疗效如何?这是医患皆关注的问题。本文分享1例CKIT和BRAF基因双突变的晚期肢端黑色

众所周知,黑色素瘤在世界范围不属于常见的恶性肿瘤,但近年来其发病率正逐步上升。不同于西方人群,我国黑色素瘤患者在发病机制、生物学行为、组织学形态、治疗方法及预后等方面均有所不同。既往针对西方人群的相关研究多针对皮肤黑色素瘤,而针对我国高发的肢端、黏膜等亚型黑色素瘤的相关研究较少。国产PD-1单抗对于我国黑色素瘤的疗效如何?这是医患皆关注的问题。本文分享1例CKIT和BRAF基因双突变的晚期肢端黑色素瘤患者接受国产PD-1单抗特瑞普利单抗治疗后的诊疗经过,拟探讨在免疫治疗中遇到的种种问题。

病例介绍

基本情况

患者男性,主诉:“发现左拇指甲下黑线20余年”。患者左拇指甲下黑斑,间断消失,2013年迅速增宽,2014年5月,出现破溃。患者既往1988年曾诊断乙肝,余无特殊。姐姐有肺癌病史。

手术及辅助治疗

2014年6月行左拇指远端离断术,术后病理提示:恶性黑色素瘤,厚度不详,伴有溃疡。于2014年8月使用大剂量干扰素治疗。2014年10月,患者因为发热、食欲减退,停用大剂量干扰素辅助治疗。

疾病进展

2016年7月,患者因“无意中触及左上臂皮下肿物”就诊。专科查体:左拇指术后改变,左上臂内侧可触及肿物,质地韧,大小约3 cm × 4 cm。PET-CT提示新发左上臂皮下肿物、双肺多发占位。

目前诊断:左拇指恶性黑色素瘤Ⅳ期,左上臂皮下转移,双肺转移,慢性乙肝。

晚期一线治疗

2016年8月15日,患者开始晚期一线方案治疗,予以达卡巴嗪400 mg d1~5,顺铂40 mg d2~4,恩度15 mg d1~14。2周期后疗效评价为SD,3周期后疗效评价为SD,4周期后疗效评价为PD。

基因检测结果显示:c-kit基因突变型,L576P,BRAF基因突变,V600E,PDGFRA基因野生型,NRAS基因野生型。2017年1月11日,头MRI、颈部增强CT、腹盆腔增强CT未见异常。

诊断:左拇指恶性黑色素瘤Ⅳ期,左上臂皮下转移,双肺转移,基因突变L576P BRAF V600E,慢性乙肝。

晚期二线治疗

2017年1月18日,患者入组特瑞普利单抗注册临床研究POLARIS-01/CT4,2017年1月25日开始予以特瑞普利单抗治疗,3 mg/kg,Q2W治疗。2017年3月17日,特瑞普利单抗治疗4周期后,根据irRECIST标准,疗效评价为免疫未确认疾病进展(immune unconfirmed progressive disease,iUPD)。

继续使用特瑞普利单抗,8周期后评效iUPD(左上臂皮下肿物继续增大,但肺部病灶缩小)、12周期后疗效评价为(immune stable disease,iSD),使用16周期后疗效评价为(immune partial response,iPR)。特瑞普利单抗使用20周期后综合疗效评价维持iPR。

专家点评

纵观该例患者出现转移后的治疗过程,有多处需要抉择的关键点,准确的判断和医患的信任,为这位患者带来了良好的疗效。需要补充的病史有两点:

1、该例患者在2016年转移以后LDH始终在正常高限,患者没有明显的相关临床症状;

2、2017年5月初,使用PD-1单抗4个月的时候,腹盆增强CT发现旁新发一个14 mm × 10 mm的淋巴结,临床不完全除外转移。

实际上,这例患者几乎包含了当下所有晚期黑色素瘤患者在免疫治疗中的难点、疑点和热点,比如:

一线化疗进展后选用什么治疗?

BRAF突变患者选靶向还是免疫?

BRAF + c-kit双突变的患者选靶向还是免疫?

二线PD-1单抗免疫治疗中出现肿瘤增大,如何判断真性进展还是假性进展?

如果PD-1耐药后续如何选择治疗?

在黑色素瘤学界,在肺癌领域中被高度肯定的PD-L1检测并没有得到公认,大部分靠临床指标来判断是否免疫治疗的优势人群,比如LDH正常,ECOG评分0分,无肝转移,转移病灶小于3个,BRAF突变患者中缓慢进展(且符合前面临床指标)的可能都是免疫治疗的获益者,接受一线或者二线免疫治疗都可能获益,该例患者就具备这些临床特点。c-kit突变患者对于免疫治疗是否敏感,目前尚无循证医学证据,该例患者是非常好的案例。

如何判断假性进展和真性进展,是使用PD-1单抗的一大难点。据我科前期的临床研究数据,真正的假性进展比例非常少(1% ~ 2%),多数患者会呈现病灶增大(未达PD)然后缩小的情况,在淋巴结转移的患者中更为常见。该例患者在使用PD-1单抗后第一次评效靶病灶增大30%(并未翻倍,主要表现为皮下转移增大,肺部病灶稳定),但该例患者LDH仍在正常范围,没有明显症状,体能状况良好,因此我们依然让患者继续使用PD-1单抗;第二次评效时皮下转移灶继续增大,新发旁淋巴结,但肺部病灶已开始缩小,患者临床症状及临床指标都正常,这时候建议让患者继续使用PD-1单抗是有风险的,所幸的是患者的信任和决心也起到了关键性作用,终于在第三次评效也就是患者使用半年PD-1单抗后出现了全部肿瘤的缩小,这例患者共使用PD-1单抗2年,于2019年1月停药,到最近的2019年7月的随访,患者保持了几乎CR的状态。

如果这例患者再次出现病情进展,再次PD-1单抗的尝试无疑是首选;其次还可以考虑一些新的临床研究,针对PD-1耐药的研究;再次穿刺对基因状态进行检测,后续靶向药物都可以考虑选择。

总之,每个病例都是一本活的教科书,仔细研读,深入思考,会让我们总结经验教训,精进专业,让患者获益。

斯璐, 主任医师、硕士生导师、副教授,北京大学肿瘤医院,《CSCO黑色素瘤诊治指南》执笔人,《CSCO免疫检查点抑制剂相关毒性管理指南》执笔人,CSCO黑色素瘤专家委员会副主任委员,CSCO神经系统肿瘤专委会副主任委员,CSCO罕见肿瘤专委会常委,CSCO青年专家委员会常委,CSCO患者教育专家委员会常委,CSCO免疫治疗专委会委员,《肿瘤学杂志》青年编委副主编,Clinical Cancer Research审稿专家。

迟志宏 教授,医学博士 主任医师,曾在美国Memorial Sloan-Kettering Cancer Center学习,现任北京大学肿瘤医院肾癌黑色素瘤内科主任医师,CSCO黑色素瘤专业委员会委员,《肿瘤防治研究》等杂志审稿专家,主要从事黑色素瘤、晚期泌尿生殖系统肿瘤的内科治疗。

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