利妥昔单抗在滤泡性和套细胞淋巴瘤大剂量化疗及自体造血干细胞移植后的巩固治疗：一项前瞻性、多中心II期研究。
Rituximab consolidation after high-dose chemotherapy and autologous blood stem cell transplantation in follicular and mantle cell lymphoma: a prospective, multicenter phase II study.
作者信息
Brugger W, Hirsch J, Grünebach F, Repp R, Brossart P, Vogel W, Kopp H-G, Manz M G, Bitzer M, Schlimok G, Kaufmann M, Ganser A, Fehnle K, Gramatzki M, Kanz L
机构信息
Department of Hematology, University of Tübingen, Tübingen, Germany.
出版信息
Ann Oncol. 2004 Nov;15(11):1691-8. doi: 10.1093/annonc/mdh425.
BACKGROUND
Patients with follicular (FL) or mantle cell lymphoma (MCL) are incurable with conventional therapy. We investigated the safety and efficacy of rituximab consolidation after autologous stem cell transplantation (ASCT) in order to prevent relapse by clearance of minimal residual disease (MRD).
METHODS
Rituximab was given approximately 8 weeks after CD34+ cell enriched ASCT at 375 mg/m2, weekly for 4 weeks. Monitoring of MRD was performed by repetitive PCR analyses.
RESULTS
Thirty-one patients were included; one died early after ASCT before rituximab administration. Thirty patients (20 FL, 10 MCL) were evaluable after rituximab consolidation, and 27 of these were assessable for MRD detection. Rituximab consolidation post-ASCT was safe, the most common toxicity being infection. At a median follow-up of 42 months (range 13-96) after ASCT, 25 patients were censored with an actuarial event-free survival (EFS) of 81% at 4 and 5 years. Four patients (two FL, two MCL) relapsed, and one additional MCL patient died unexpectedly in complete remission. PCR-negativity was observed in 22% of the patients before ASCT, 53% post-ASCT (P=0.0547), 72% after rituximab (P=0.0018) and 100% at 6 months post-transplant (P < 0.001).
CONCLUSIONS
One single course of rituximab consolidation given after ASCT is safe, may help to eliminate MRD and may translate into improved EFS in both FL and MCL patients.
背景
滤泡性淋巴瘤（FL）或套细胞淋巴瘤（MCL）患者无法通过传统疗法治愈。我们研究了自体干细胞移植（ASCT）后利妥昔单抗巩固治疗的安全性和疗效，以通过清除微小残留病（MRD）来预防复发。
方法
在富集CD34 +细胞的ASCT后约8周给予利妥昔单抗，剂量为375mg/m²，每周一次，共4周。通过重复PCR分析监测MRD。
结果
纳入31例患者；1例在ASCT后早期、利妥昔单抗给药前死亡。30例患者（20例FL，10例MCL）在利妥昔单抗巩固治疗后可评估，其中27例可进行MRD检测。ASCT后利妥昔单抗巩固治疗是安全的，最常见的毒性是感染。在ASCT后的中位随访42个月（范围13 - 96个月）时，25例患者被 censored，4年和5年的无事件生存率（EFS）为81%。4例患者（2例FL，2例MCL）复发，另外1例MCL患者在完全缓解期意外死亡。ASCT前22%的患者观察到PCR阴性，ASCT后为53%（P = 0.0547），利妥昔单抗治疗后为72%（P = 0.0018），移植后6个月为100%（P < 0.001）。
结论
ASCT后给予一个疗程的利妥昔单抗巩固治疗是安全的，可能有助于消除MRD，并可能改善FL和MCL患者的EFS。
Zotero 插件