Purging of autologous peripheral-blood stem cells using CD34 selection does not improve overall or progression-free survival after high-dose chemotherapy for multiple myeloma: Results of a multicenter randomized controlled trial
Purging of autologous peripheral-blood stem cells using CD34 selection does not improve overall or progression-free survival after high-dose chemotherapy for multiple myeloma: Results of a multicenter randomized controlled trial
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DOI：
10.1200/jco.2001.19.17.3771
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发表时间：
2001-09-01
影响因子：
45.3
通讯作者：
Berenson, J
中科院分区：
文献类型：
--
作者：
Stewart, AK;Vescio, R;Berenson, J
目的：虽然自体外周血祖细胞（PBPC）移植支持的高剂量化疗可提高多发性骨髓瘤患者的缓解率和生存率，但所有患者最终都会在移植后出现进展性疾病。据推测，自体移植物中恶性浆细胞的消耗可能会通过减少导致复发的输注细胞来改善预后。患者和方法：一项随机 III 期研究使用 CEPRATE SC 系统（Cellpro，Bothell，WA）来富集 CD34（+）自体移植细胞并被动清除恶性浆细胞，该研究在 190 名骨髓瘤患者中完成，该患者随机接受 CD34 选择或未选择的自体移植物PBPC。结果：经过 CD34 选择后，肿瘤负荷减少了 1.6 至 6.0 个对数（中位数为 3.1），其中 54% 的富含 CD34 的产品没有检测到肿瘤。两个移植组之间的中位恢复时间、输血次数、移植相关死亡率和住院天数相当。中位随访时间为 37 个月，选定组中有 33 名患者 (36%) 死亡，未选定组有 34 名患者 (35%) 死亡 (P = .784)。选定组的中位总生存期在 50 个月时达到，而未选定组此时尚未达到中位总生存期 (P = .78)。中位无病生存期为 100 周与 104 周 (P = 0.82)，所选组中 67% 的患者和未选择组中 66% 的患者出现复发。结论：这项 III 期试验表明，尽管 CD34 选择显着减少了 PBPC 收集中的骨髓瘤细胞污染，但无病生存期或总生存期并未得到改善。
Purpose: Although high-dose chemotherapy supported by autologous peripheral-blood progenitor-cell (PBPC) transplantation improves response rates and survival for patients with multiple myeloma, all patients eventually develop progressive disease after transplantation. It has been hypothesized that depletion of malignant plasma cells from autografts may improve outcome by reducing infused cells contributing to relapse.Patients and Methods: A randomized phase III study using the CEPRATE SC System (Cellpro, Bothell, WA) to enrich CD34(+) autograft cells and passively purge malignant plasma cells was completed in 190 myeloma patients randomized to receive an autograft of CD34-selected or unselected PBPCs.Results: After CD34 selection, tumor burden was reduced by 1.6 to 6.0 logs (median, 3.1), with 54% of CD34-enriched products having no detectable tumor. Median time to count recovery, number of transfusions, transplantation-related mortality, and days in hospital were equivalent between the two transplantation arms. With a median follow-up of 37 months, 33 patients (36%) in the selected and 34 patients (35%) in the unselected arm had died (P = .784). Median overall survival in the selected arm was reached at 50 months and is not reached at this time in the unselected arm (P = .78). Median disease-free survival was 100 versus 104 weeks (P = .82), with 67% of patients in the selected arm and 66% of patients in the unselected arm relapsing.Conclusion: This phase III trial demonstrates that although CD34 selection significantly reduces myeloma cell contamination in PBPC collections, no improvement in disease-free or overall survival was achieved.