年轻MM患者的最佳治疗
年轻MM患者的一线治疗
自体移植的长期生存优于单纯化疗 序贯移植可进一步提高疗效;联合移植(一次自体移植+减低预处理剂量的异基因移植)的疗效与序贯移植相似 新药的应用显著提高了移植的短期和长期疗效
“移植+新药”是年轻MM患者的最佳选择
从TT1到TT3:疗效不断提高
治疗方案:VAD诱导,序贯移植,干扰素维持治疗 1990~1995年,231名MM初治患者入组 5年EFS为40%。随访12年时出现EFS平台,14%EFS,20%CCR,30%OS
*
试验背景
对于不适合HDT-ASCT的MM患者,MP曾经是标准方案。 MP的CR率: <4%1–4 MP的中位OS : 29–37 months1–3 万珂: 单药化疗对于复发/难治性MM有显著疗效5,6 体外研究发现万珂联用细胞毒性药物如马法兰可有协同作用7。 我们进行的I/II期 PETHEMA/GEM 研究显示:万珂联合MP(VMP)可以使机体产生迅速而持久的缓解8,9 89% ≥PR ,其中32% CR 中位 TTP 为27.2 月8 OS为85% (vs 历史研究中MP为38%) (38 月时)9,10 患者可以很好的耐受VMP; 患者接受该方案的中位时间为9个月8
0.000002
PFS
0.609
0.486–0.763
0.00001
OS
0.607
0.419–0.880
0.00782
TNT
0.522
0.390–0.699
0.000009
CR
11.2*
6.1–20.6
<0.000001
Jesús F. San Miguel,1 Rudolf Schlag,2 Nuriet K. Khuageva,3 Meletios A. Dimopoulos,4 Ofer Shpilberg,5 Martin Kropff,6 Ivan Spicka,7 Maria T. Petrucci,8 Antonio Palumbo,9 Olga S. Samoilova,10 Anna Dmoszynska,11 Kudrat M. Abdulkadyrov,12 Rik Schots,13 Bin Jiang,14 Maria-Victoria Mateos,1 Kenneth C. Anderson,15 Dixie L. Esseltine,16 Kevin Liu,17 Andrew Cakana,18 Helgi van de Velde,18 Paul G. Richardson15 11Hospital Universitario Salamanca, CIC, IBMCC (USAL-CSIC), Spain; 2Praxisklinik Dr. Schlag, Würzburg, Germany; 3SP Botkin Moscow City Clinical Hospital, Russian Federation; 4University of Athens School of Medicine, Greece; 5Rabin Medical Center, Petah-Tiqva, Israel; 6University of Münster, Germany; 7University Hospital, Prague, Czech Republic; 8University La Sapienza, Rome, Italy; 9Universita di Torino, Italy; 10Nizhnii Novgorod Region Clinical Hospital, Russian Federation; 11Medical University of Lublin, Poland; 12St Petersburg Clinical Research Institute of Hematology & Transfusiology, Russian Federation; 13Myeloma Study Group Belgian Hematological Society, Belgium; 14People’s Hospital, Peking University, China; 15Dana-Farber Cancer Institute, Boston, USA; 16Millennium Pharmaceuticals, Inc, Cambridge, USA; 17Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Raritan, USA; 18Johnson & Johnson Pharmaceutical Research & Development, Beerse, Belgium