Department of Radiology, Catholic Lymphoma Study Group, The Catholic University of Korea College of Medicine, Seoul, South Korea.
Ann Hematol. 2011 Sep;90(9):1075-82. doi: 10.1007/s00277-011-1191-6. Epub 2011 Feb 19.
This phase II trial evaluated the efficacy and safety of tandem consolidation using (90)yttrium ibritumomab tiuxetan ((90)Y-IT) and high-dose therapy (HDT) with autologous peripheral blood stem cell transplantation (PBSCT) in high-risk patients with diffuse large B-cell lymphoma (DLBCL) who were in primary remission. Eleven patients with high-risk DLBCL were enrolled. All patients had achieved complete or partial response after six to eight cycles of rituximab-cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) as a frontline chemotherapy. Subsequently, the patients received one to two courses of ifosfamide-containing regimen for peripheral blood stem cell mobilization and harvesting. First consolidation with (90)Y-IT was performed, followed by second consolidation using HDT with PBSCT. All patients received (90)Y-IT therapy, but three patients did not undergo PBSCT. During the median follow-up period of 18.1 months, 9 of 11 patients exhibited disease progression, and 8 patients died. The estimated 2-year progression-free survival was 18.2%, and overall survival was 36.4%. Adverse events following (90)Y-IT consolidation were primarily transient hematologic toxicities. The present pilot study suggests that tandem consolidation therapy using (90)Y-IT followed by HDT with autologous PBSCT is not feasible for treatment of high-risk patients with DLBCL in remission after R-CHOP. In addition, this treatment failed to provide beneficial effects for the clinical outcome of subsequent PBSCT.
这项 II 期临床试验评估了在原发性缓解期的高危弥漫性大 B 细胞淋巴瘤(DLBCL)患者中,使用(90)钇替伊莫单抗替昔坦((90)Y-IT)和大剂量化疗(HDT)联合自体外周血干细胞移植(PBSCT)进行巩固治疗的疗效和安全性。入组了 11 例高危 DLBCL 患者。所有患者在接受利妥昔单抗-环磷酰胺、多柔比星、长春新碱和泼尼松(R-CHOP)作为一线化疗的 6-8 个周期后,均达到完全或部分缓解。随后,患者接受了 1-2 个疗程含异环磷酰胺的方案进行外周血干细胞动员和采集。首先进行(90)Y-IT 巩固治疗,然后进行 HDT 联合 PBSCT 的二次巩固治疗。所有患者均接受(90)Y-IT 治疗,但有 3 例患者未行 PBSCT。在中位随访 18.1 个月期间,11 例患者中有 9 例出现疾病进展,8 例患者死亡。估计 2 年无进展生存率为 18.2%,总生存率为 36.4%。(90)Y-IT 巩固治疗后的不良事件主要为短暂的血液学毒性。本初步研究表明,(90)Y-IT 联合 HDT 联合自体 PBSCT 的巩固治疗方案不适用于 R-CHOP 后缓解的高危 DLBCL 患者。此外,这种治疗方法未能为随后 PBSCT 的临床结果带来有益效果。