131I-B1（抗CD20）抗体疗法联合自体干细胞移植治疗复发B细胞淋巴瘤的II期试验
Phase II trial of 131I-B1 (anti-CD20) antibody therapy with autologous stem cell transplantation for relapsed B cell lymphomas.
作者信息
Press O W, Eary J F, Appelbaum F R, Martin P J, Nelp W B, Glenn S, Fisher D R, Porter B, Matthews D C, Gooley T
机构信息
Department of Medicine, University of Washington, Seattle 98195, USA.
出版信息
Lancet. 1995 Aug 5;346(8971):336-40. doi: 10.1016/s0140-6736(95)92225-3.
25 patients with relapsed B-cell lymphomas were evaluated with trace labelled doses (2.5 mg/kg, 185-370 MBq [5-10 mCi]) of 131I-labelled anti-CD20 (B1) antibody in a phase II trial. 22 patients achieved 131I-B1 biodistributions delivering higher doses of radiation to tumour sites than to normal organs and 21 of these were treated with therapeutic infusions of 131I-B1 (12.765-29.045 GBq) followed by autologous haemopoietic stem cell reinfusion. 18 of the 21 treated patients had objective responses, including 16 complete remissions. One patient died of progressive lymphoma and one died of sepsis. Analysis of our phase I and II trials with 131I-labelled B1 reveal a progression-free survival of 62% and an overall survival of 93% with a median follow-up of 2 years. 131I-anti-CD20 (B1) antibody therapy produces complete responses of long duration in most patients with relapsed B-cell lymphomas when given at maximally tolerated doses with autologous stem cell rescue.
在一项II期试验中，对25例复发性B细胞淋巴瘤患者使用微量标记剂量（2.5mg/kg，185 - 370MBq [5 - 10mCi]）的131I标记抗CD20（B1）抗体进行评估。22例患者的131I - B1生物分布显示，肿瘤部位接受的辐射剂量高于正常器官，其中21例接受了131I - B1（12.765 - 29.045GBq）治疗性输注，随后进行自体造血干细胞回输。21例接受治疗的患者中有18例出现客观缓解，包括16例完全缓解。1例患者死于进行性淋巴瘤，1例死于败血症。对我们使用131I标记B1的I期和II期试验分析显示，无进展生存期为62%，总生存期为93%，中位随访时间为2年。当以最大耐受剂量给予131I - 抗CD20（B1）抗体治疗并进行自体干细胞救援时，大多数复发性B细胞淋巴瘤患者会产生长期完全缓解。
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