一项前瞻性 II 期研究，对惰性 B 细胞淋巴瘤患者采用 RICE 再诱导治疗，然后使用高剂量氟达拉滨和白消安，继以自体或同种异体造血干细胞移植。
A prospective phase II study of RICE re-induction, then high-dose fludarabine and busulfan, followed by autologous or allogeneic blood stem cell transplantation for indolent b-cell lymphoma.
机构信息
Department of Oncology and Medicine, University of Calgary, and Tom Baker Cancer, Centre, Canada.
出版信息
Clin Lymphoma Myeloma Leuk. 2011 Dec;11(6):475-82. doi: 10.1016/j.clml.2011.06.012. Epub 2011 Aug 10.
BACKGROUND
Optimal high dose conditioning and relative roles of autologous stem cell transplantation (autoSCT) or allogeneic (alloSCT) for indolent lymphoma are uncertain.
METHODS
A prospective phase II study evaluated autoSCT and alloSCT depending on availability of sibling donor after uniform rituximab, ifosfamide, carboplatin, etoposide (RICE) re-induction and novel myeloablative fludarabine, busulfan (FluBu) conditioning for patients with mantle cell lymphoma in first remission or first relapse, or indolent lymphoma in first or second relapse.
RESULTS
The 68 patients (autoSCT, 36; syngeneic [syn], 1; alloSCT, 31) who were accrued had a 10-month median progression-free survival (PFS) after their last chemotherapy treatment. After RICE, the overall response rate was 69%, and 24 of 39 patients (62%) cleared marrow of lymphoma. Treatment-related mortality at 100 days and 1 year after FluBu were both 0% post-auto/synSCT, but were 6% and 26% post-alloSCT, respectively. At a median follow-up of 60 months, the respective 5-year overall survival and PFS rates were 71% and 46% for auto/synSCT, and were 58% and 47% for alloSCT. Quality of life assessment 1-year post-SCT favoured auto/synSCT.
CONCLUSIONS
The protocol was feasible, FluBu was well-tolerated, and both auto/synSCT and alloSCT conferred similar 5-year PFS following the RICE-FluBu protocol.
背景
惰性淋巴瘤的最佳高剂量预处理方案和自体干细胞移植(autoSCT)或异体干细胞移植(alloSCT)的相对作用尚不确定。
方法
一项前瞻性 II 期研究评估了自体干细胞移植和异体干细胞移植，根据是否有同胞供者决定，方案为利妥昔单抗、异环磷酰胺、卡铂、依托泊苷（RICE）再诱导后，应用新型大剂量氟达拉滨、白消安（FluBu）预处理，用于初治或复发 1 次的套细胞淋巴瘤或复发 1 次或 2 次的惰性淋巴瘤患者。
结果
共入组 68 例患者（自体干细胞移植 36 例、同基因移植 1 例、异体干细胞移植 31 例），末次化疗后中位无进展生存期（PFS）为 10 个月。RICE 后，总缓解率为 69%，39 例患者中有 24 例（62%）骨髓中淋巴瘤完全清除。自体/同基因干细胞移植后 100 天和 1 年的治疗相关死亡率均为 0%，而异体干细胞移植后分别为 6%和 26%。在中位随访 60 个月时，自体/同基因干细胞移植的 5 年总生存率和 PFS 率分别为 71%和 46%，而异体干细胞移植的 5 年总生存率和 PFS 率分别为 58%和 47%。SCT 后 1 年的生活质量评估显示，自体/同基因干细胞移植更有优势。
结论
该方案是可行的，FluBu 耐受性良好，RICE-FluBu 方案后，自体/同基因干细胞移植和异体干细胞移植的 5 年 PFS 相似。
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