Thorac Cancer:多中心回顾性研究比较pembrolizumab单药或联合化疗治疗非小细胞肺癌的疗效

2021-12-06 yd2015 MedSci原创

研究表明,虽然PFS、OS和RR在pembrolizumab单药和pembrolizumab联合化疗的患者之间没有显著差异,但伴有特定转移部位的NSCLC患者可能更能从单药治疗中获益。

Pembrolizumab单药或联合化疗是PD-L1高表达的非小细胞肺癌(NSCLC)患者的标准治疗方法。然而,没有研究比较这两种方案的疗效。因此,来自日本的学者开展了多中心回顾性研究,目的是比较pembrolizumab单药或联合化疗对PD-L1高表达NSCLC患者的疗效。相关结果发表在Thoracic Cancer杂志上。

研究是一项多中心回顾性研究,纳入不可切除或复发性非小细胞肺癌的患者,这些患者一线接受了pembrolizumab单药或联合化疗。患者分为单药治疗组和联合治疗组。比较各组间无进展生存期(PFS)、总生存期(OS)和缓解率(RR)。分析患者的临床特征,以评估其与治疗结果的可能关系。

研究纳入96例患者,其中47例患者单药治疗,49例患者联合治疗。单药治疗组中位年龄为71(范围36-87),联合治疗组为68(范围52-81)(p = 0.0113)单药组中非鳞癌22例,鳞癌18例。联合治疗组中非鳞癌35例,鳞癌12例。

单药治疗组中位随访时间为379天(范围58-1169),联合治疗组中位随访时间为271天(范围44-552);这种差异具有统计学意义(p = 0.0018)。单药治疗组的中位PFS为343天,联合治疗组为328天(log- rank p = 0.99, HR=1.003, 95%可信区间[CI] 0.54-1.85)。在PD-L1高表达(TPS ≥50%)的患者中,单药治疗组的中位PFS为343天(n = 46),联合治疗组的中位PFS为20天(log-rank p = 0.74, HR=1.14, 95% CI 0.51-2.58)。两组的中位OS均未达到(p = 0.99, HR 0.99, 95% CI 0.36–2.69),即使是PD-L1高表达患者(TPS ≥ 50%)。

           单药和联合治疗的预后对比

同样,单药治疗组分别有24例、10例、1例患者出现PR, SD 和PD;联合治疗组分别有30例、10例、7例患者出现PR, SD 和PD。单药治疗组的客观缓解率(ORR)为55.3%,联合治疗组客观缓解率(ORR)为65.3%,但差异无统计学意义(p = 0.3172)。

          单药和联合治疗的疗效对比

对于伴有脑,肝,肺,胸膜,肾上腺,骨,胸外淋巴结转移患者,两组的PFS没有统计学差异。但是对于肝、肺、肾上腺、骨或淋巴结转移患者,单药治疗组的PFS较联合治疗组趋于延长。对于伴有上诉5个转移部位任意一个部位的患者,单药治疗组的中位PFS较联合治疗组延长(p = 0.048, HR 0.41, 95% CI 0.16–1.02)。相反,对于没有任何转移的患者,联合治疗组的PFS较单药治疗组长(p = 0.034, HR 2.68, 95% CI 1.04-6.95)。在接受pembrolizuma单药治疗的患者中,出现转移患者较没有出现转移患者的PFS显著延长(p = 0.036, HR 0.43, 95% CI 0.194-0.968)。

           伴有或无转移的预后比较

在单药治疗组,转转移患者的客观缓解率明显高于非转移性转移患者(82% vs 29%, p = 0.0002)。

      单药治疗有或无转移的疗效对比

单药治疗组治疗持续时间为6.8个月(0.7–40.0),联合治疗组治疗持续时间为5.0个月(0.7–18.1)。治疗相关不良事件在联合治疗组(95.9%)比单药治疗组(63.8%)更高。

综上,研究表明,虽然PFS、OS和RR在pembrolizumab单药和pembrolizumab联合化疗的患者之间没有显著差异,但伴有特定转移部位的NSCLC患者可能更能从单药治疗中获益。

原始出处:

Hiromi Matsumoto, Nobuaki Kobayashi, Kohei Somekawa, et al. Pembrolizumab monotherapy versus pembrolizumab plus chemotherapy in patients with non-small-cell lung cancer: A multicenter retrospective trial. 2021. Thorac Cancer. DOI: 10.1111/1759-7714.14252

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    2022-04-19 snf701207
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    2022-11-02 yyj062
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    2021-12-23 chendoc242
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time=2021-12-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1077650, encodeId=e75310e765025, content=上海市女医师协会从2021年9月启动, beContent=null, objectType=article, channel=null, level=null, likeNumber=46, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTIrrxxDxnLic8t6EAs38Qfwo6H2h6JMleIgb9OSYf6LMnVDkQEqUXWoSDWboibjhOBI9SJDTXweqQIA/132, createdBy=50aa5321359, createdName=查查佳佳, createdTime=Tue Dec 07 08:53:00 CST 2021, time=2021-12-07, status=1, ipAttribution=)]
  8. 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    2021-12-07 查查佳佳

    上海市女医师协会从2021年9月启动

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