Division of Hematology and Stem Cell Transplantation Unit, Cardarelli Hospital, Naples, Italy.
Hematol Oncol. 2011 Sep;29(3):139-43. doi: 10.1002/hon.978. Epub 2010 Nov 30.
Different authors have explored the feasibility of autografting patients with multiple myeloma (MM) on an outpatient basis. Peg-filgrastim (PEG), a long-acting recombinant G-CSF, has similar efficacy when compared to conventional G-CSF for chemotherapy-induced neutropenia, but little is known about its use in the autologous stem-cell transplantation (ASCT) setting, namely in patients programmed to be autografted on outpatient basis. In this study, we compared therapeutic results in terms of hematopoietic recovery, non-hematologic toxicity, duration of hospitalization and percentage of hospital readmission between patients receiving either conventional G-CSF or PEG. Thirty-eight MM patients (48 autografts) received PEG, given at a single dose of 6 mg at day +5 from stem cell infusion, while 81 (113 autografts) received G-CSF from day + 2 up to stable neutrophil recovery. The conditioning regimen was high dose melphalan in all patients. The median age and the median number of CD34 + cell infused were comparable between the two groups. Overall, a second hospital admission was required in 36 procedures out of 161 (32%). Febrile neutropenia (FN) and severe mucositis were the most frequent causes of hospitalization. There was no statistically significant difference as percentage of hospital readmission is concerned: in the PEG group readmission was needed in 6 out of 48 autografts (12%) as opposed to 30 out of 113 (26%) in the G-CSF subgroup, p: 0.06. The median time of hospital stay for readmitted patients was identical for the two subgroups (9 days vs. 9 days, p: 0.94). Finally, one case of transplant related mortality occurred in the whole patient series (0.6%). In conclusion, ASCT on an outpatient basis is feasible and safe in patients with MM, the majority of whom are manageable at home. The administration of single dose PEG results in no different outcome in terms of safety and efficacy as compared to 8 days of G-CSF.
不同的作者已经探索了多发性骨髓瘤（MM）患者门诊自体移植的可行性。培非格司亭（PEG）是一种长效重组 G-CSF，其在化疗诱导的中性粒细胞减少症方面的疗效与常规 G-CSF 相似，但对于其在自体干细胞移植（ASCT）中的应用知之甚少，即在计划门诊自体移植的患者中。在这项研究中，我们比较了接受常规 G-CSF 或 PEG 的患者在造血恢复、非血液学毒性、住院时间和住院再入院率方面的治疗结果。38 例 MM 患者（48 例自体移植）于干细胞输注后第 5 天给予单剂量 6mg 的 PEG，而 81 例（113 例自体移植）则于第 2 天至中性粒细胞稳定恢复期间给予 G-CSF。所有患者的预处理方案均为大剂量美法仑。两组患者的中位年龄和中位 CD34+细胞输注数量相当。总体而言，在 161 例中有 36 例（32%）需要再次住院。发热性中性粒细胞减少症（FN）和严重粘膜炎是最常见的住院原因。从再入院率来看，PEG 组的 48 例自体移植中有 6 例（12%）需要再入院，而 G-CSF 组的 113 例中有 30 例（26%）需要再入院，p：0.06。两组再入院患者的中位住院时间相同（9 天 vs. 9 天，p：0.94）。最后，整个患者系列中发生 1 例移植相关死亡（0.6%）。总之，MM 患者门诊 ASCT 是可行且安全的，大多数患者可以在家中得到管理。单次 PEG 给药与 8 天 G-CSF 相比，在安全性和疗效方面没有差异。
