中华医学杂志
中華醫學雜誌
중화의학잡지
National Medical Journal of China
2015年
10期
731-735
,共5页
曾添美%何海燕%石昊天%奚昊%杜鹃%张春阳%姜华%傅卫军%周帆
曾添美%何海燕%石昊天%奚昊%杜鵑%張春暘%薑華%傅衛軍%週帆
증첨미%하해연%석호천%해호%두견%장춘양%강화%부위군%주범
多发性骨髓瘤%造血干细胞移植%预后%细胞遗传学
多髮性骨髓瘤%造血榦細胞移植%預後%細胞遺傳學
다발성골수류%조혈간세포이식%예후%세포유전학
Multiple myeloma%Stem cell transplantation%Prognosis%Cytogenetic
目的 评价PAD方案(硼替佐米+表柔吡星+地塞米松)和TAD方案(沙利度胺+表柔吡星+地塞米松)诱导治疗后多发性骨髓瘤患者的疗效及预后,并评估细胞遗传学分层及自体造血干细胞移植对PAD诱导治疗患者预后的影响.方法 前瞻性研究191例自2008年5月至2013年12月经第二军医大学长征医院血液科及上海市闸北区中心医院血液科确诊的多发性骨髓瘤患者,非随机进入PAD诱导治疗组(PAD组,132例)和TAD诱导治疗组(TAD组,59例),诱导后根据患者意愿分别按自体外周造血干细胞移植或原诱导方案巩固治疗,分析两组的诱导后疗效及生存差异,并评估细胞遗传学分层及自体造血干细胞移植对PAD诱导治疗患者的预后影响.结果 PAD与TAD组诱导后的缓解率分别为84.4％ (108/128)和69.5％(41/59),差异有统计学意义(P=0.011);获得非常好的部分缓解(VGPR)以上疗效率分别为70.3％(90/128)和32.2％ (19/59),差异有统计学意义(P＜0.001);获得接近完全缓解/完全缓解(nCR/CR)率分别为68.0％(87/128)和25.4％(15/59),差异有统计学意义(P ＜0.001).PAD组与TAD组患者的中位无进展生存(PFS)期及总生存(OS)期差异尚无统计学意义(P =0.223、0.989).接受PAD诱导治疗的132例患者的生存分析显示:荧光原位杂交(FISH)高危组患者的中位PFS和OS均短于FISH低危组(15.2比19.1个月,41.2个月比未到达),且OS差异有统计学意义(P =0.098、0.017).根据巩固方式进一步的亚组生存分析显示,在FISH高危组,诱导后接受造血干细胞移植巩固患者的中位PFS期显著长于诱导后继续原诱导方案巩固的患者(17.8比14.6个月,P=0.029),而两组之间的总生存期暂差异无统计学意义(P=0.840).在FISH低危组,诱导后接受造血干细胞移植巩固患者与接受原诱导方案巩固患者间中位PFS及OS期差异均无统计学意义(P =0.131、0.294).结论 PAD方案诱导治疗总缓解率及高质量缓解率均显著好于TAD.且在以PAD诱导后,以FISH为基础的细胞遗传学分层可以区分高危及低危多发性骨髓瘤患者的预后.对于FISH高危患者,接受自体造血干细胞移植可以延长其PFS.
目的 評價PAD方案(硼替佐米+錶柔吡星+地塞米鬆)和TAD方案(沙利度胺+錶柔吡星+地塞米鬆)誘導治療後多髮性骨髓瘤患者的療效及預後,併評估細胞遺傳學分層及自體造血榦細胞移植對PAD誘導治療患者預後的影響.方法 前瞻性研究191例自2008年5月至2013年12月經第二軍醫大學長徵醫院血液科及上海市閘北區中心醫院血液科確診的多髮性骨髓瘤患者,非隨機進入PAD誘導治療組(PAD組,132例)和TAD誘導治療組(TAD組,59例),誘導後根據患者意願分彆按自體外週造血榦細胞移植或原誘導方案鞏固治療,分析兩組的誘導後療效及生存差異,併評估細胞遺傳學分層及自體造血榦細胞移植對PAD誘導治療患者的預後影響.結果 PAD與TAD組誘導後的緩解率分彆為84.4％ (108/128)和69.5％(41/59),差異有統計學意義(P=0.011);穫得非常好的部分緩解(VGPR)以上療效率分彆為70.3％(90/128)和32.2％ (19/59),差異有統計學意義(P＜0.001);穫得接近完全緩解/完全緩解(nCR/CR)率分彆為68.0％(87/128)和25.4％(15/59),差異有統計學意義(P ＜0.001).PAD組與TAD組患者的中位無進展生存(PFS)期及總生存(OS)期差異尚無統計學意義(P =0.223、0.989).接受PAD誘導治療的132例患者的生存分析顯示:熒光原位雜交(FISH)高危組患者的中位PFS和OS均短于FISH低危組(15.2比19.1箇月,41.2箇月比未到達),且OS差異有統計學意義(P =0.098、0.017).根據鞏固方式進一步的亞組生存分析顯示,在FISH高危組,誘導後接受造血榦細胞移植鞏固患者的中位PFS期顯著長于誘導後繼續原誘導方案鞏固的患者(17.8比14.6箇月,P=0.029),而兩組之間的總生存期暫差異無統計學意義(P=0.840).在FISH低危組,誘導後接受造血榦細胞移植鞏固患者與接受原誘導方案鞏固患者間中位PFS及OS期差異均無統計學意義(P =0.131、0.294).結論 PAD方案誘導治療總緩解率及高質量緩解率均顯著好于TAD.且在以PAD誘導後,以FISH為基礎的細胞遺傳學分層可以區分高危及低危多髮性骨髓瘤患者的預後.對于FISH高危患者,接受自體造血榦細胞移植可以延長其PFS.
목적 평개PAD방안(붕체좌미+표유필성+지새미송)화TAD방안(사리도알+표유필성+지새미송)유도치료후다발성골수류환자적료효급예후,병평고세포유전학분층급자체조혈간세포이식대PAD유도치료환자예후적영향.방법 전첨성연구191례자2008년5월지2013년12월경제이군의대학장정의원혈액과급상해시갑북구중심의원혈액과학진적다발성골수류환자,비수궤진입PAD유도치료조(PAD조,132례)화TAD유도치료조(TAD조,59례),유도후근거환자의원분별안자체외주조혈간세포이식혹원유도방안공고치료,분석량조적유도후료효급생존차이,병평고세포유전학분층급자체조혈간세포이식대PAD유도치료환자적예후영향.결과 PAD여TAD조유도후적완해솔분별위84.4％ (108/128)화69.5％(41/59),차이유통계학의의(P=0.011);획득비상호적부분완해(VGPR)이상료효솔분별위70.3％(90/128)화32.2％ (19/59),차이유통계학의의(P＜0.001);획득접근완전완해/완전완해(nCR/CR)솔분별위68.0％(87/128)화25.4％(15/59),차이유통계학의의(P ＜0.001).PAD조여TAD조환자적중위무진전생존(PFS)기급총생존(OS)기차이상무통계학의의(P =0.223、0.989).접수PAD유도치료적132례환자적생존분석현시:형광원위잡교(FISH)고위조환자적중위PFS화OS균단우FISH저위조(15.2비19.1개월,41.2개월비미도체),차OS차이유통계학의의(P =0.098、0.017).근거공고방식진일보적아조생존분석현시,재FISH고위조,유도후접수조혈간세포이식공고환자적중위PFS기현저장우유도후계속원유도방안공고적환자(17.8비14.6개월,P=0.029),이량조지간적총생존기잠차이무통계학의의(P=0.840).재FISH저위조,유도후접수조혈간세포이식공고환자여접수원유도방안공고환자간중위PFS급OS기차이균무통계학의의(P =0.131、0.294).결론 PAD방안유도치료총완해솔급고질량완해솔균현저호우TAD.차재이PAD유도후,이FISH위기출적세포유전학분층가이구분고위급저위다발성골수류환자적예후.대우FISH고위환자,접수자체조혈간세포이식가이연장기PFS.
Objective To evaluate the impact of cytogenetic grouping and autologous stem cell transplantation on the prognosis of patients with multiple myeloma (MM) induced by PAD (velcade + epirubicin + dexamethasone) and TAD (thalidomide + epirubicin + dexamethasone).Methods A total of 191 patients with a definite diagnosis of MM were enrolled from May 2008 to December 2013 into this prospective study.They were non-randomly induced by PAD (n =132) or TAD (n =59) plus autologous stem cell transplantation or chemotherapy.Response and survival rates were also analyzed between two groups.Results The overall response rates of PAD and TAD groups were 84.4％ (108/128) and 69.5％ (41/59) (P =0.011) respectively.The very good partial remission(VGPR) rates were 70.3％ (90/128) and 32.2％ (19/59) (P ＜ 0.001) and near complete remission/complete remission (nCR/CR) rates 68.0％ (87/128) and 25.4％ (15/59) respectively (P ＜ 0.001).Both progression-free survival (PFS) and overall survival (OS) showed no significant inter-group difference (P =0.223,0.989).The survival analysis of PAD group showed that FISH high-risk group had shorter PFS and OS than FISH low-risk group (15.2 vs 19.1 months for PFS,P-0.098; 41.2 months vs non-attaining for OS,P =0.017).In FISH high-risk group,patients consolidated with autologous stem cell transplantation showed longer PFS than those with chemotherapy (17.8 vs 14.6 months,P =0.029) while the OS showed no difference(P--0.840).In FISH low-risk group,no difference were observed in PFS and OS between patients with consolidation therapies alone (P =0.131,0.294).Conclusions The response rates are higher in patients induced by PAD than by TAD.After PAD induction,cytogenetic grouping may further distinguish the prognosis of MM patients.For FISH high-risk patients,their PFS is prolonged by autologous stem cell transplantation.
