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Rituximab purging and maintenance therapy combined with autologous stem cell transplantation in patients with diffuse large B-cell lymphoma

机译:利妥昔单抗清洗和维持疗法联合自体干细胞移植治疗弥漫性大B细胞淋巴瘤

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摘要

The aim of this prospective, single-arm study was to test the efficacy and tolerability of autologous stem cell transplantation (auto-SCT) combined with in vivo rituximab purging and post-transplant rituximab maintenance therapy in patients with diffuse large B-cell lymphoma (DLBCL). This study included 12 DLBCL patients aged 18–65 years with an International Prognostic Index ≥2. The patients received 4–6 cycles of induction therapy consisting of rituximab plus cyclophosphamide, adriamycin, vincristine and prednisone followed by salvage therapy prior to stem cell mobilization. This regimen was followed by rituximab maintenance therapy (375 mg/m2 every three months for two years). Prior to auto-SCT, six patients (50%) achieved complete remission (CR) and six (50%) achieved unconfirmed complete remission (CRu). Three months after transplantation, 11 patients (91.7%) achieved CR and one achieved CRu. After two cycles of rituximab maintenance therapy, all 12 patients achieved CR. Long-term CR was achieved by 10 patients, while two experienced relapse at 14 and 20 months after the end of rituximab maintenance therapy. The median follow-up period was 44 months (range 35–61). Disease-free survival was noted in 10 patients, while two experienced relapse. The three-year overall survival (OS) and progression-free survival (PFS) were 100 and 83%, respectively. Prolonged hypogammaglobulinemia occurred in two patients, although no increase in major infections was observed. Hepatitis B surface antigen was continuously negative in all 12 patients. Our results demonstrated that auto-SCT combined with in vivo rituximab purging and post-transplant rituximab maintenance is safe and effective, and may extend OS and PFS in younger high-risk DLBCL patients.
机译:这项前瞻性单臂研究的目的是测试自体干细胞移植(auto-SCT)结合体内利妥昔单抗清除和移植后利妥昔单抗维持治疗在弥漫性大B细胞淋巴瘤患者中的疗效和耐受性( DLBCL)。该研究纳入了12例年龄在18-65岁且国际预后指数≥2的DLBCL患者。患者接受了4-6个周期的诱导治疗,包括利妥昔单抗加环磷酰胺,阿霉素,长春新碱和泼尼松,然后进行干细胞动员之前的抢救治疗。该方案后进行利妥昔单抗维持治疗(每3个月375 mg / m 2 两年)。在进行自动SCT之前,六名患者(50%)实现了完全缓解(CR),六名(50%)实现了未经证实的完全缓解(CRu)。移植后三个月,有11例患者(91.7%)达到了CR,其中1例达到了CRu。经过两个周期的利妥昔单抗维持治疗,所有12例患者均达到CR。 10例患者获得了长期CR,而2例在利妥昔单抗维持治疗结束后的14和20个月复发。中位随访期为44个月(范围35-61)。 10例患者无病生存,其中2例复发。三年总生存(OS)和无进展生存(PFS)分别为100%和83%。尽管未观察到主要感染的增加,但两名患者发生了长时间的低血球蛋白血症。乙肝表面抗原在所有12例患者中均持续阴性。我们的研究结果表明,自动SCT结合体内利妥昔单抗清除和移植后利妥昔单抗维持是安全有效的,并且可以延长年轻高危DLBCL患者的OS和PFS。

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