Stewart A K, Vescio R, Schiller G, Ballester O, Noga S, Rugo H, Freytes C, Stadtmauer E, Tarantolo S, Sahebi F, Stiff P, Meharchard J, Schlossman R, Brown R, Tully H, Benyunes M, Jacobs C, Berenson R, White M, DiPersio J, Anderson K C, Berenson J
Princess Margaret Hospital, Toronto, Ontario, Canada.
J Clin Oncol. 2001 Sep 1;19(17):3771-9. doi: 10.1200/JCO.2001.19.17.3771.
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.
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.
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.
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.
尽管自体外周血祖细胞（PBPC）移植支持的大剂量化疗可提高多发性骨髓瘤患者的缓解率和生存率，但所有患者在移植后最终都会发展为疾病进展。据推测，从自体移植物中清除恶性浆细胞可能通过减少导致复发的输入细胞来改善预后。
一项随机III期研究使用CEPRATE SC系统（Cellpro公司，华盛顿州博塞尔）富集CD34(+)自体移植物细胞并被动清除恶性浆细胞，该研究纳入了190例骨髓瘤患者，随机接受CD34选择或未选择的PBPC自体移植。
CD34选择后，肿瘤负荷降低了1.6至6.0对数（中位数为3.1），54%的CD34富集产物未检测到肿瘤。两个移植组之间的中性粒细胞恢复中位时间、输血次数、移植相关死亡率和住院天数相当。中位随访37个月时，选择组33例患者（36%）和未选择组34例患者（35%）死亡（P = 0.784）。选择组的中位总生存期为50个月，未选择组目前尚未达到（P = 0.78）。无病生存期的中位数分别为100周和104周（P = 0.82），选择组67%的患者和未选择组66%的患者复发。
这项III期试验表明，尽管CD34选择可显著降低PBPC采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。
