JAMA Oncol:DDGP方案 vs SMILE方案治疗新诊断的局部晚期结外自然杀伤/T细胞淋巴瘤

2022-06-23 MedSci原创 MedSci原创

对于新诊断的局部晚期ENKL患者,DDGP方案显示出了良好的初步疗效

结外自然杀伤/T细胞淋巴瘤 (ENKL) 是成熟T细胞和NK细胞淋巴瘤的一种亚型,以EB病毒感染为特征。临床上,ENKL病变常侵犯鼻腔、鼻咽、鼻窦等中线结构。部分ENKL甚至可能发展为噬血细胞综合征,导致预后不良。

基于左旋天冬酰胺酶的SMILE(地塞米松、甲氨蝶呤、异环磷酰胺、左旋天冬酰胺酶和依托泊苷)化疗方案在ENKL患者中展现出了比含蒽环类药物方案更高的有效率和生存率。但是,该方案的安全性尚差强人意。目前还缺乏一种耐受性良好、疗效佳的治疗方案。

该研究是一项在我国开展的开放标签、多中心的随机临床试验,旨在评估DDGP(地塞米松、顺铂、吉西他滨和培门冬酶)方案与SMILE方案在新确诊的晚期(III/IV期)ENKL患者中的疗效和安全性。

14-70岁的ECOG表现状态0-2分的新确诊的III/IV期ENKL患者被随机分至DDGP组或SMIE组,各组患者都接受了6个疗程的治疗(21天/疗程)。主要终点是无进展生存期(PFS),次要终点包括总缓解率和总生存率(OS)。


两组的无进展生存率和总生存率

87位患者被随机分组,其中80位接受了研究治疗(两组各40位);中位年龄43岁,51位(64%)男性。两组患者的基线特征相近。中位随访了41.5个月后,DDGP组和SMILE组的中位PFS分别是未达到和6.8个月(HR 0.42, p=0.004),中位OS分别是未达到和75.2个月(HR 0.41, p=0.02)。DDGP组的3年PFS率和5年OS率均明显高于SMILE组(3年PFS率:56.6% vs 41.8%;5年OS率:74.3% vs 51.7%)。DDGP组的总缓解率明显高于SMILE组(90.0% vs 60.0%,p=0.002)。


两组的治疗反应

3/4级血液毒性反应更常见于SMILE组(SMILE组 vs DDGP组:白细胞减少症,85.0% vs 62.5%,中性粒细胞减少症,85.0% vs 65.0%)。

综上,该研究结果显示,对于新诊断的局部晚期ENKL患者,DDGP方案显示出了良好的初步疗效

 

原始出处:

Wang X, Zhang L, Liu X, et al. Efficacy and Safety of a Pegasparaginase-Based Chemotherapy Regimen vs an L-asparaginase–Based Chemotherapy Regimen for Newly Diagnosed Advanced Extranodal Natural Killer/T-Cell Lymphoma: A Randomized Clinical Trial. JAMA Oncol. Published online June 16, 2022. doi:10.1001/jamaoncol.2022.1968.

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    2023-04-06 rgjl
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    2023-01-16 minlingfeng
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    2022-06-24 docwu2019
  7. [GetPortalCommentsPageByObjectIdResponse(id=1915330, encodeId=538c191533062, content=<a href='/topic/show?id=e381586e94d' target=_blank style='color:#2F92EE;'>#新诊断#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=58679, encryptionId=e381586e94d, topicName=新诊断)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8b48400, createdName=rgjl, createdTime=Thu Apr 06 17:07:31 CST 2023, time=2023-04-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1650859, encodeId=62b41650859db, content=<a href='/topic/show?id=ffae4e614b6' target=_blank style='color:#2F92EE;'>#局部晚期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=47614, encryptionId=ffae4e614b6, topicName=局部晚期)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=901d24099859, createdName=yhy100208, createdTime=Mon Oct 31 00:07:31 CST 2022, time=2022-10-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1866646, encodeId=ec381866646fb, content=<a href='/topic/show?id=16ce133504e' target=_blank style='color:#2F92EE;'>#Oncol#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13350, encryptionId=16ce133504e, topicName=Oncol)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b63894, createdName=minlingfeng, createdTime=Mon Jan 16 20:07:31 CST 2023, time=2023-01-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1702719, encodeId=42791e0271945, content=<a href='/topic/show?id=ddc9e795159' target=_blank style='color:#2F92EE;'>#细胞淋巴瘤#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=77951, encryptionId=ddc9e795159, topicName=细胞淋巴瘤)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=201630414353, createdName=marlenexl, createdTime=Sun Jan 22 08:07:31 CST 2023, time=2023-01-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1372698, encodeId=16bf13e269876, content=<a href='/topic/show?id=7d2d1802820' target=_blank style='color:#2F92EE;'>#T细胞淋巴瘤#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=53, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=18028, encryptionId=7d2d1802820, topicName=T细胞淋巴瘤)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=bfa6343, createdName=aliceclz, createdTime=Fri Jun 24 13:07:31 CST 2022, time=2022-06-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1406193, encodeId=d82b140619332, content=<a href='/topic/show?id=a5404e589d7' target=_blank style='color:#2F92EE;'>#局部#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=47589, encryptionId=a5404e589d7, topicName=局部)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=docwu2019, createdTime=Fri Jun 24 13:07:31 CST 2022, time=2022-06-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1243573, encodeId=2fdd12435e358, content=JAMA上文章都是顶级的,谢谢梅斯及时上新, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=肿瘤克星, createdTime=Thu Jun 23 01:07:31 CST 2022, time=2022-06-23, status=1, ipAttribution=)]
    2022-06-23 肿瘤克星

    JAMA上文章都是顶级的,谢谢梅斯及时上新

    0

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