RADIOIMMUNOTHERAPY OF B-CELL LYMPHOMA WITH [I-131] ANTI-B1 (ANTI-CD20) ANTIBODY
RADIOIMMUNOTHERAPY OF B-CELL LYMPHOMA WITH [I-131] ANTI-B1 (ANTI-CD20) ANTIBODY
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DOI：
10.1056/nejm199308123290703
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发表时间：
1993-08-12
影响因子：
158.5
通讯作者：
WAHL, RL
中科院分区：
文献类型：
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作者：
KAMINSKI, MS;ZASADNY, KR;WAHL, RL
背景许多非霍奇金淋巴瘤患者不能通过现有疗法治愈，需要新的治疗方法。作为一项正在进行的1期研究的一部分，我们研究了放射免疫治疗与I-131标记的B细胞特异性抗CD 20单克隆抗体在10例CD 20阳性B细胞淋巴瘤患者中的主要化疗失败的效果。以大约1周的间隔静脉给予I-131示踪标记的抗B1（抗CD 20）小鼠单克隆抗体（15 mg，含5 mCi）：首先，所有10例患者未接受未标记抗B1抗体预处理;然后，8例患者接受135 mg未标记抗体预处理;然后，2例患者接受685 mg预处理。在每次示踪剂给药后，获得系列定量伽马相机图像和全身放射性测量。所有大于2 cm的已知病变部位均可成像。预处理剂量的未标记抗B1抗体对放射性标记抗体靶向肿瘤的影响是可变的，在示踪剂研究中产生肿瘤剂量与全身剂量的最高比率的未标记抗体的预处理剂量然后用于在9名患者中提供更高剂量的放射性用于放射免疫治疗。三名患者接受了设计为全身递送25 cGy的剂量（两名患者治疗两次，间隔6至8周），四名患者接受了35 cGy（一名患者治疗两次），两名患者接受了45 cGy（一名患者治疗两次）;每个剂量含有34至66 mCi的活性。9名接受治疗的患者中有6名有肿瘤反应，包括患有巨大或化疗耐药疾病的患者：4名患者完全缓解，2名患者部分缓解。3例患者在接受放射免疫剂量前对示踪剂输注有客观反应。在4例完全缓解的患者中，1例持续缓解8个月，另外3例继续无疾病进展（11、9和8个月）。有轻度或无骨髓抑制。[I-131]抗B1抗体的放射免疫治疗是一种很有前途的淋巴瘤治疗新方法。
Background. Many patients with non-Hodgkin's lymphomas are not cured by current therapies, and new approaches to treatment are needed. As part of an ongoing phase 1 study, we examined the effect of radioimmunotherapy with I-131-labeled B-cell-specific anti-CD20 monoclonal antibody in 10 patients with CD20-positive B-cell lymphomas in whom primary chemotherapy had failed.Methods and Results. Anti-B1 (anti-CD20) mouse monoclonal antibody trace-labeled with I-131 (15 mg containing 5 mCi) was given intravenously at approximately one-week intervals: first, without pretreatment with unlabeled anti-B1 antibody, to all 10 patients; then, with pretreatment with 135 mg of unlabeled antibody, to 8 patients; and then, with pretreatment with 685 mg, to 2 patients. Serial quantitative gamma-camera images and measures of whole-body radioactivity were obtained after each tracer dose. All known disease sites larger than 2 cm could be imaged. The effect of a pretreatment dose of unlabeled anti-B1 antibody on targeting of the tumor with the radiolabeled antibody was variable.The pretreatment dose of unlabeled antibody that produced the highest ratio of the tumor dose to the whole-body dose in tracer studies was then used to deliver higher doses of radioactivity for radioimmunotherapy in nine patients. Three patients received doses designed to deliver 25 cGy to the whole body (two patients treated twice, six to eight weeks apart), four patients received 35 cGy (one patient treated twice), and two patients received 45 cGy (one patient treated twice); each dose contained 34 to 66 mCi of activity. Six of the nine treated patients had tumor responses, including patients with bulky or chemotherapy-resistant disease: four patients had complete remissions, and two had partial responses. Three patients had objective responses to tracer infusions before they received radioimmunotherapeutic doses. Of the four patients with complete remissions, one remained in remission for eight months and the other three continue to have no disease progression (for 11, 9, and 8 months). There was mild or no myelosuppression.Conclusions. Radioimmunotherapy with [I-131]anti-B1 antibody is a promising new treatment for lymphoma.