Milone Giuseppe, Martino Massimo, Leotta Salvatore, Spadaro Andrea, Zammit Valentina, Cupri Alessandra, Avola Giuseppe, Camuglia Maria Grazia, Di Marco Annalia, Scalzulli Potito, Morelli Mara, Olivieri Attilio, Tripepi Giovanni
a Hematology and BMT UNIT , Azienda Policlinico Vittorio Emanuele , Catania , Italy.
b Hematology and BMT UNIT , Ospedale Bianco Melacrino Morelli , Reggio Calabria , Italy.
Leuk Lymphoma. 2018 Jan;59(1):42-48. doi: 10.1080/10428194.2017.1324161. Epub 2017 Jun 2.
We here report final results of a phase II/III prospective study that evaluated in Multiple Myeloma the use of on-demand plerixafor (PLX) added to mobilizing chemotherapy for patients showing predictive signs of mobilization failure. A total of 111 patients with MM were registered, all received cyclophosphamide 4 g/m and granulocyte colony-stimulating factor (G-CSF). Overall, a successful CD34+ cell mobilization was achieved in 97.2% (108/111) of patients. Minimum harvest (≥2.0 × 10 CD34+ cells/kg) was achieved in 97.2% (108/111) and optimal harvest success (≥4.0 × 10 CD34+ cells/kg) was achieved in 84.6% (94/111). Multivariate analysis showed that patients who received on-demand PLX treatment had significantly higher likelihoods of successfully achieving both the minimal (p = .006) and optimal harvest (p = .05) in respect to a historical control group mobilized without any PLX. The incremental cost-effectiveness ratio, for each 1% increase in probability of achieving a successful minimal harvest, was €40.6 per patient.
我们在此报告一项II/III期前瞻性研究的最终结果，该研究评估了在多发性骨髓瘤患者中，对于显示动员失败预测迹象的患者，在动员化疗中添加按需使用的普乐沙福（PLX）的效果。共有111例骨髓瘤患者登记入组，所有患者均接受了4 g/m的环磷酰胺和粒细胞集落刺激因子（G-CSF）治疗。总体而言，97.2%（108/111）的患者实现了成功的CD34+细胞动员。97.2%（108/111）的患者达到了最低采集量（≥2.0×10 CD34+细胞/kg），84.6%（94/111）的患者达到了最佳采集成功量（≥4.0×10 CD34+细胞/kg）。多变量分析显示，与未使用任何PLX进行动员的历史对照组相比，接受按需PLX治疗的患者成功实现最低采集量（p = 0.006）和最佳采集量（p = 0.05）的可能性显著更高。每增加1%成功实现最低采集的概率，增量成本效益比为每位患者40.6欧元。
