Tositumomab and iodine I 131 tositumomab for recurrent indolent and transformed B-cell non-Hodgkin's lymphoma
Tositumomab and iodine I 131 tositumomab for recurrent indolent and transformed B-cell non-Hodgkin's lymphoma
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DOI：
10.1200/jco.2004.06.055
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发表时间：
2004-04-15
影响因子：
45.3
通讯作者：
Radford, JA
中科院分区：
文献类型：
--
作者：
Davies, AJ;Rohatiner, AZS;Radford, JA
目的 在两个中心进行了一项开放标签 II 期研究，以确定托西莫单抗和碘 I 131 托西莫单抗在惰性或转化性惰性 B 细胞淋巴瘤第一次或第二次复发时的有效性和安全性。 患者和方法 在单次剂量测定后 7 至 14 天，根据患者具体情况进行放射性治疗，以提供 0.75 Gy 的全身剂量（患者减少至 0.65 Gy）血小板计数为 100 至 149 x 10(9)/L)。 41 名患者中的 40 名接受了两种输注。 结果 41 名患者中的 31 名 (76%) 有反应，其中 20 名患者 (49%) 实现完全缓解 (CR) 或未经证实的完全缓解 [CR(u)]，11 名患者 (27%) 实现部分缓解。惰性疾病 (76%) 和转化性疾病 (71%) 的缓解率相似。总体中位缓解时间为 1.3 年。对于达到 CR 或 CR(u) 的患者，尚未达到中位缓解持续时间。 11 名患者在治疗后 2.6 年以上至 5.2 年以上期间继续处于 CR 或 CR(u) 状态。治疗耐受性良好；血液学毒性是主要的不良事件。分别有 5%、45% 和 32% 的患者出现 3 级或 4 级贫血、中性粒细胞减少和血小板减少。一名患者出现继发性骨髓增生异常。四名患者在治疗后产生了人类抗小鼠抗体。 38 名可评估患者中有 5 名出现促甲状腺激素升高；一名患者已开始甲状腺素治疗。 结论 在该患者组中单剂量托西莫单抗和碘 I 131 托西莫单抗后观察到较高的总体率和 CR 率。毒性较低且易于控制。
Purpose An open-label phase II study was conducted at two centers to establish the efficacy and safety of tositumomab and iodine I 131 tositumomab at first or second recurrence of indolent or transformed indolent B-cell lymphoma.Patients and Methods A single dosimetric dose was followed at 7 to 14 days by the patient-specific administered radioactivity required to deliver a total body dose of 0.75 Gy (reduced to 0.65 Gy for patients with platelets counts of 100 to 149 x 10(9)/L). Forty of 41 patients received both infusions.Results Thirty-one of 41 patients (76%) responded, with 20 patients (49%) achieving either a complete (CR) or unconfirmed complete remission [CR(u)] and 11 patients (27%) achieving a partial remission. Response rates were similar in both indolent (76%) and transformed disease (71%). The overall median duration of remission was 1.3 years. The median duration of remission has not yet been reached for those patients who achieved a CR or CR(u). Eleven patients continue in CR or CR(u) between 2.6+ and 5.2+ years after therapy. Therapy was well tolerated; hematologic toxicity was the principal adverse event. Grade 3 or 4 anemia, neutropenia, and thrombocytopenia were observed in 5%, 45%, and 32% of patients, respectively. Secondary myelodysplasia has occurred in one patient. Four patients developed human antimouse antibodies after therapy. Five of 38 assessable patients have developed an elevated thyroid-stimulating hormone; treatment with thyroxine has been initiated in one patient.Conclusion High overall and CR rates were observed after a single dose of tositumomab and iodine I 131 tositumomab in this patient group. Toxicity was modest and easily managed.