IJRO(Red):EPO不能提高贫血HNSCC患者放化疗的局控率

2015-04-07 Zhang JL译 MedSci原创

肿瘤放射治疗项目(RTOG)9903的长期分析结果表明,加用促红细胞生成素(EPO)并没有改善接受放疗或放化疗的贫血的头颈部鳞状细胞癌(HNSCCa)患者的肿瘤局部控制率。该项研究结果发表在最新一期美国放射肿瘤学协会(ASTRO)的官方科学杂志——International Journal of Radiation Oncology * Biology * Physics 杂志上。R

肿瘤放射治疗项目(RTOG)9903的长期分析结果表明,加用促红细胞生成素(EPO)并没有改善接受放疗或放化疗的贫血的头颈部鳞状细胞癌(HNSCCa)患者的肿瘤局部控制率。该项研究结果发表在最新一期美国放射肿瘤学协会(ASTRO)的官方科学杂志——International Journal of Radiation Oncology * Biology * Physics 杂志上。

RTOG 9903是一个非盲的Ⅲ期随机临床试验,目的是检测加用EPO(促红细胞生成素)能否刺激人体骨髓增加红细胞生产以预防和治疗贫血,以及会改善HNSCCa贫血患者接受放射治疗的局部控制率。这项研究募集了从2000年6月至2003年11月19日接受治疗的148名患者,共有54个癌症中心参加。合格的入组病人为口腔、口咽、喉咽、喉HNSCCa患者;Zubrod状态评分为0-2分(Zubrod分数表明病人的健康状况从0到4,0表示病人“完全活跃,能够无限制地进行所有疾病预防活动”,4表示病人“完全残疾,不能进行任何自我保健,完全局限于床上或椅子上”)和血红蛋白水平(男性13.5 g/dL或12.5 g/dL)。入组这项研究中后,4例患者被认为是不合格的,和三个病人退出了试验。

在这项研究入组的141例患者中,69人被随机分配接受放疗或化疗加放疗,而72人被随机分配接受放疗或放化疗加促红细胞生成素。患者随机在放疗开始前10天接受促红细胞生成素首剂治疗,然后在每周接受40000单位治疗剂量,除非血红蛋白水平男性超过16 g/dL或女性超过14 g/dL。如果病人在接受4次EPO治疗后的血红蛋白水平没有增加至1 g/dL,则接受剂量增加到60000单位的治疗。

在治疗期间,患者每周对毒性作用和全血细胞计数进行评估。在疗程结束的两到四个星期后开始随访,然后是治疗后第一个两年内的每三个月随访一次,接下来的三年内每六个月随访一次,此后每年随访一次。对于这个长期分析,幸存者的中位随访时间为7.95年(范围从1.66-10.08年),所有患者的中位随访时间为3.33年(范围0.03-10.08年)。

经过5年的随访发现,接受放疗或放化疗没有加用EPO的患者局控失败率为39.4%,而加用EPO的患者局控失败率则为46.2% (单变量分析危害比(HR)为1.27,多变量分析HR 为1.40)。没有加用EPO的患者5年局部无进展生存率为37.6%,而接受了EPO的患者5年局部无进展生存率为31.5% (单变量分析HR为1.28,多变量分析HR为1.39)。没有加用EPO的患者5年总体生存率为38.2%,而加用EPO的患者则为36.9% (单变量分析HR为1.13,多变量分析HR为1.23)。没有加用EPO的患者5年远处转移率为14.5%,而加用EPO的患者则为15.6% (单变量分析HR为1.03,多变量分析HR为1.07)。尽管所有这些差异均没有显著的统计学意义,然而长期随访中的HR提示没有接受EPO治疗的患者预后更好。

“众所周知,贫血(低血红蛋白)的癌症患者治愈率低于正常血红蛋白水平的患者。RTOG 9903项目旨在通过恢复他们的血红蛋白水平以改善贫血的头颈部鳞状细胞癌患者的预后,”这项研究的主要作者、蒙特利尔McGill大学健康中心的肿瘤学和耳鼻咽喉科副教授George Shenouda说,“然而该研究的初步分析结果是不理想的,导致了研究的早期关闭,因为EPO可能产生的负面效应。虽然EPO提高血红蛋白水平,但局控率并没有预想的改善。这个长期分析结果表明EPO对于贫血HNSCCa患者来说并不是合适的治疗选择。更需要注意的是,EPO是一种生长因子,可能会刺激癌细胞的生长,从而降低肿瘤的控制率。需要设计更精心的试验以解决如何治疗癌症患者贫血的问题。”

原始出处:


George Shenouda, Qiang Zhang, K. Kian Ang, Mitchell Machtay, Matthew B. Parliament, Diane Hershock, Mohan Suntharalingam, Alexander Lin, Marvin Rotman, Abdenour Nabid, Susan Hong, Sarwat Shehata, Anthony J. Cmelak, Khalil Sultanem, Quynh-Thu Le. Long-Term Results of Radiation Therapy Oncology Group 9903: A Randomized Phase 3 Trial to Assess the Effect of Erythropoietin on Local-Regional Control in Anemic Patients Treated With Radiation Therapy for Squamous Cell Carcinoma of the Head and Neck . International Journal of Radiation Oncology*Biology*Physics, 2015; 91 (5): 907 DOI:10.1016/j.ijrobp.2014.12.018

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    2015-09-24 zutt
  2. [GetPortalCommentsPageByObjectIdResponse(id=1987639, encodeId=8dfb198e639db, content=<a href='/topic/show?id=67dd1596982' target=_blank style='color:#2F92EE;'>#SCC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=15969, encryptionId=67dd1596982, topicName=SCC)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=742793, createdName=zutt, createdTime=Thu Sep 24 01:27:00 CST 2015, time=2015-09-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=24732, encodeId=e7dc24e3279, content=不错,学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=125, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=/v1.0.0/img/user_icon.png, createdBy=ac181616815, createdName=ljjj1053, createdTime=Sun May 24 12:52:00 CST 2015, time=2015-05-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=20160, encodeId=6dbd2016047, content=对症处理吧, beContent=null, objectType=article, channel=null, level=null, likeNumber=126, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=28c01618629, createdName=twostops, createdTime=Sat Apr 11 11:52:00 CST 2015, time=2015-04-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1287872, encodeId=c13c128e87224, content=<a href='/topic/show?id=4d185e31825' target=_blank style='color:#2F92EE;'>#放化疗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=57318, encryptionId=4d185e31825, topicName=放化疗)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=310e209, createdName=yzh399, createdTime=Thu Apr 09 06:27:00 CST 2015, time=2015-04-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1629132, encodeId=fa8a1629132ff, content=<a href='/topic/show?id=f28e900536' target=_blank style='color:#2F92EE;'>#HNSCC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9005, encryptionId=f28e900536, topicName=HNSCC)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=27ec21318163, createdName=huirong, createdTime=Thu Apr 09 06:27:00 CST 2015, time=2015-04-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=19874, encodeId=a437198e4dd, content=加药要慎重, beContent=null, objectType=article, channel=null, level=null, likeNumber=95, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8b26101142, createdName=leaderbilly, createdTime=Tue Apr 07 16:12:00 CST 2015, time=2015-04-07, status=1, ipAttribution=)]
    2015-05-24 ljjj1053

    不错,学习了

    0

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    2015-04-11 twostops

    对症处理吧

    0

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    2015-04-09 yzh399
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    2015-04-09 huirong
  6. [GetPortalCommentsPageByObjectIdResponse(id=1987639, encodeId=8dfb198e639db, content=<a href='/topic/show?id=67dd1596982' target=_blank style='color:#2F92EE;'>#SCC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=15969, encryptionId=67dd1596982, topicName=SCC)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=742793, createdName=zutt, createdTime=Thu Sep 24 01:27:00 CST 2015, time=2015-09-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=24732, encodeId=e7dc24e3279, content=不错,学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=125, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=/v1.0.0/img/user_icon.png, createdBy=ac181616815, createdName=ljjj1053, createdTime=Sun May 24 12:52:00 CST 2015, time=2015-05-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=20160, encodeId=6dbd2016047, content=对症处理吧, beContent=null, objectType=article, channel=null, level=null, likeNumber=126, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=28c01618629, createdName=twostops, createdTime=Sat Apr 11 11:52:00 CST 2015, time=2015-04-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1287872, encodeId=c13c128e87224, content=<a href='/topic/show?id=4d185e31825' target=_blank style='color:#2F92EE;'>#放化疗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=57318, encryptionId=4d185e31825, topicName=放化疗)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=310e209, createdName=yzh399, createdTime=Thu Apr 09 06:27:00 CST 2015, time=2015-04-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1629132, encodeId=fa8a1629132ff, content=<a href='/topic/show?id=f28e900536' target=_blank style='color:#2F92EE;'>#HNSCC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9005, encryptionId=f28e900536, topicName=HNSCC)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=27ec21318163, createdName=huirong, createdTime=Thu Apr 09 06:27:00 CST 2015, time=2015-04-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=19874, encodeId=a437198e4dd, content=加药要慎重, beContent=null, objectType=article, channel=null, level=null, likeNumber=95, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8b26101142, createdName=leaderbilly, createdTime=Tue Apr 07 16:12:00 CST 2015, time=2015-04-07, status=1, ipAttribution=)]
    2015-04-07 leaderbilly

    加药要慎重

    0

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