利妥昔单抗联合高剂量治疗和自体外周血干细胞移植治疗侵袭性B细胞淋巴瘤的多中心前瞻性研究

A prospective multicenter study of rituximab combined with high-dose chemotherapy and autologous peripheral blood stem cell transplantation for aggressive B-cell lymphoma

目的探讨在高剂量治疗联合自体外周血干细胞移植的基础上，加用利妥昔单抗治疗侵袭性B细胞淋巴瘤的可行性和疗效。方法12个癌症研究中心共入组28例侵袭性B细胞淋巴瘤患者，其中22例为新诊断患者，6例为复发患者。每例患者共接受4次利妥昔单抗静脉输注，即在外周血干细胞动员化疗的前1天、动员化疗的第7天、干细胞回输的前1天和回输后的第8天各给予1次，每次375mg／m^2，共1500mg／m^2。结果高剂量治疗后，所有患者均达到完全缓解。中位随访37个月时，全组患者的4年总生存率和无进展生存率分别为75．0％和70．3％，新诊断患者的4年总生存率和无进展生存率均为72．7％。全组患者对利妥昔单抗治疗的耐受性较好，不良反应多为1、2度。结论在高剂量治疗联合自体造血干细胞移植的基础上加入利妥昔单抗治疗侵袭性B细胞淋巴瘤是可行的，并且可能使患者的生存获益。

Objective To investigate the feasibility and efficacy of rituximab combined with highdose chemotherapy supported by autologous peripheral blood stem cell transplantation （ASCT） in patients with aggressive B-cell non-Hodgkin lymphoma （NHL）. Methods Twenty-eight patients with aggressive B-cell NHL （22 newly diagnosed, 6 relapsed） were enrolled in this study. The high-dose chemotherapy included CHOP regimen （ CTX ＋ ADM ＋ VCR ＋ PDN） for the newly diagnosed patients and DICE （ DEX ＋ IFO ＋ DDP ＋ VP-16） or EPOCH （ VP-16 ＋ PDN ＋ VCR ＋ CTX ＋ ADM） for the relapsed patients. Each patient received infusion of rituximab at a dose of 375 mg/m2 for four times, on D1 before and on D7 of peripheral blood stem cell mobilization, and on D1 before and D8 after stem cell reinfusion. Results Complete remission was achieved in all patients after high dose chemotherapy and ASCT. At a median follow-up of 37 months, the estimated overall 4-year survival and progression-free survival rate for all patients were 75.0% and 70.3% , respectively, while both were 72.7% for the previously untreated patients. The therapy was generally well tolerated with few side-effects attributable to rituximab. Conclusion These results suggest that adding rituximab to high-dose chemotherapy with peripheral blood stem cell transplantation is feasible and may be beneficial for patients with aggressive B-cell non-Hodgkin lymphoma.