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依托泊苷联合粒细胞集落刺激因子(G-CSF)与单纯G-CSF用于新诊断多发性骨髓瘤患者外周血干细胞动员的前瞻性比较研究,随后采用风险适应性普乐沙福:天主教多发性骨髓瘤研究网络(CAREMM-2001)研究

Prospective Comparative Study of Etoposide plus G-CSF versus G-CSF Alone, Followed by Risk-Adapted Plerixafor for Peripheral Blood Stem Cell Mobilization in Patients with Newly Diagnosed Multiple Myeloma: CAtholic REsearch Network for Multiple Myeloma Study (CAREMM-2001).

作者信息

Park Sung-Soo, Shin Seung-Hwan, Lee Jung-Yeon, Jeon Young-Woo, Yhang Seung-Ah, Min Chang-Ki

机构信息

Hematology Hospital, Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul 02706, Republic of Korea.

Myeoma Center, Hematology Institute, Eunpyeong St. Mary's Hospital, The Catholic University of Korea, Seoul 03312, Republic of Korea.

出版信息

Cancers (Basel). 2023 Sep 28;15(19):4783. doi: 10.3390/cancers15194783.

Abstract

To explore the optimal mobilization for multiple myeloma (MM) patients, we conducted a prospective trial comparing single-dose etoposide (375 mg/m for one day) plus G-CSF versus G-CSF alone, followed by risk-adapted plerixafor. After randomization, 27 patients in the etoposide group and 29 patients in the G-CSF alone group received mobilizations. Six (22.2%) patients in the etoposide group and 15 (51.7%) patients in the G-CSF alone group received plerixafor based on a peripheral blood CD34+ cell count of < 15/mm ( = 0.045). The median count of CD34+ cells collected was significantly higher in the etoposide group (9.5 × 10/kg vs. 7.9 × 10/kg; = 0.018), but the optimal collection rate (CD34+ cells ≥ 6 × 10/kg) was not significantly different between the two groups (96.3% vs. 82.8%; = 0.195). The rate of CD34+ cells collected of ≥ 8.0 × 10/kg was significantly higher in the etoposide group (77.8% vs. 44.8%; = 0.025). Although the rates of grade II-IV thrombocytopenia (63.0% vs. 31.0%; = 0.031) and grade I-IV nausea (14.8% vs. 0%; = 0.048) were significantly higher in the etoposide group, the rates of adverse events were low in both groups, with no neutropenic fever or septic shock. Thus, both single-dose etoposide plus G-CSF and G-CSF alone with risk-adapted plerixafor were effective and safe, but the former may be the better option for patients who are expected to receive two or more transplantations.

摘要

为探索多发性骨髓瘤(MM)患者的最佳动员方案,我们开展了一项前瞻性试验,比较单剂量依托泊苷(375mg/m²,持续1天)加粒细胞集落刺激因子(G-CSF)与单纯G-CSF,随后进行风险适应性普乐沙福动员的效果。随机分组后,依托泊苷组27例患者和单纯G-CSF组29例患者接受了动员。依托泊苷组6例(22.2%)患者和单纯G-CSF组15例(51.7%)患者基于外周血CD34⁺细胞计数<15/μL接受了普乐沙福治疗(P = 0.045)。依托泊苷组采集的CD34⁺细胞中位数显著更高(9.5×10⁶/kg vs. 7.9×10⁶/kg;P = 0.018),但两组的最佳采集率(CD34⁺细胞≥6×10⁶/kg)无显著差异(96.3% vs. 82.8%;P = 0.195)。依托泊苷组采集的CD34⁺细胞≥8.0×10⁶/kg的比例显著更高(77.8% vs. 44.8%;P = 0.025)。尽管依托泊苷组II-IV级血小板减少症发生率(63.0% vs. 31.0%;P = 0.031)和I-IV级恶心发生率(14.8% vs. 0%;P = 0.048)显著更高,但两组不良事件发生率均较低,均未发生中性粒细胞减少性发热或感染性休克。因此,单剂量依托泊苷加G-CSF以及单纯G-CSF联合风险适应性普乐沙福均有效且安全,但对于预计接受两次或更多次移植的患者,前者可能是更好的选择。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/be23/10572075/9ed478851931/cancers-15-04783-g001.jpg

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