Segeren Christine M, Sonneveld Pieter, van der Holt Bronno, Vellenga Edo, Croockewit Alexandra J, Verhoef Gregor E G, Cornelissen Jan J, Schaafsma Martijn R, van Oers Marinus H J, Wijermans Pierre W, Fibbe Wim E, Wittebol Shulamit, Schouten Harry C, van Marwijk Kooy Marinus, Biesma Douwe H, Baars Joke W, Slater Rosalyn, Steijaert Monique M C, Buijt Ivon, Lokhorst Henk M
Erasmus Medical Center Rotterdam, The Netherlands.
Blood. 2003 Mar 15;101(6):2144-51. doi: 10.1182/blood-2002-03-0889. Epub 2002 Nov 27.
We compared the efficacy of intensified chemotherapy followed by myeloablative therapy and autologous stem cell rescue with intensified chemotherapy alone in patients newly diagnosed with multiple myeloma. There were 261 eligible patients younger than 66 years with stage II/III multiple myeloma who were randomized after remission induction therapy with vincristine, adriamycin, dexamethasone (VAD) to receive intensified chemotherapy, that is, melphalan 140 mg/m(2) administered intravenously in 2 doses of 70 mg/m(2) (intermediate-dose melphalan [IDM]) without stem cell rescue (n = 129) or the same regimen followed by myeloablative therapy consisting of cyclophosphamide, total body irradiation, and autologous stem cell reinfusion (n = 132). Interferon-alpha-2a was given as maintenance. Of the eligible patients, 79% received both cycles of IDM and 79% of allocated patients actually received myeloablative treatment. The response rate (complete remission [CR] plus partial remission [PR]) was 88% in the intensified chemotherapy group versus 95% in the myeloablative treatment group. CR was significantly higher after myeloablative therapy (13% versus 29%; P =.002). With a median follow-up of 33 months (range, 8-65 months), the event-free survival (EFS) was not different between the treatments (median 21 months versus 22 months; P =.28). Time to progression (TTP) was significantly longer after myeloablative treatment (25 months versus 31 months; P =.04). The overall survival (OS) was not different (50 months versus 47 months; P =.41). Intensified chemotherapy followed by myeloablative therapy as first-line treatment for multiple myeloma resulted in a higher CR and a longer TTP when compared with intensified chemotherapy alone. However, it did not result in a better EFS and OS.
我们比较了强化化疗后进行清髓性治疗及自体干细胞挽救与单纯强化化疗对新诊断的多发性骨髓瘤患者的疗效。共有261例年龄小于66岁、处于II/III期多发性骨髓瘤的符合条件患者，在接受长春新碱、阿霉素、地塞米松（VAD）诱导缓解治疗后随机分组，分别接受强化化疗，即静脉注射美法仑140mg/m²，分2次给药，每次70mg/m²（中间剂量美法仑[IDM]）且不进行干细胞挽救（n = 129），或相同方案后接着进行由环磷酰胺、全身照射及自体干细胞回输组成的清髓性治疗（n = 132）。给予α-干扰素-2a进行维持治疗。在符合条件的患者中，79%接受了两个周期的IDM，79%被分配的患者实际接受了清髓性治疗。强化化疗组的缓解率（完全缓解[CR]加部分缓解[PR]）为88%，而清髓性治疗组为95%。清髓性治疗后的CR显著更高（13%对29%；P = 0.002）。中位随访33个月（范围8 - 65个月），两种治疗的无事件生存期（EFS）无差异（中位21个月对22个月；P = 0.28）。清髓性治疗后的疾病进展时间（TTP）显著更长（25个月对31个月；P = 0.04）。总生存期（OS）无差异（50个月对47个月；P = 0.41）。与单纯强化化疗相比，强化化疗后接着进行清髓性治疗作为多发性骨髓瘤的一线治疗可导致更高的CR和更长的TTP。然而，它并未带来更好的EFS和OS。
