Phase I/II study of galiximab, an Anti-CD80 antibody, for relapsed or refractory follicular lymphoma
Phase I/II study of galiximab, an Anti-CD80 antibody, for relapsed or refractory follicular lymphoma
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DOI：
10.1200/jco.2005.09.018
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发表时间：
2005-07-01
影响因子：
45.3
通讯作者：
Leigh, BR
中科院分区：
文献类型：
--
作者：
Czuczman, MS;Thall, A;Leigh, BR
目的：本多中心、剂量递增研究评价加利昔单抗的安全性、药代动力学和疗效（抗CD80单克隆抗体）在复发性或难治性滤泡性淋巴瘤患者中的应用。患者和方法患者患有滤泡性淋巴瘤，其复发或对初级治疗无效;大多数（90%）表现为III期或IV期疾病。以125、250、375、250、2结果37例患者接受了加利昔单抗治疗，并进行了安全性评价; 35例患者可评价反应，抗体输注安全，耐受性良好，无近限性毒性，22例（60%）患者发生了与加利昔单抗相关的不良事件。除1起事件外，所有事件均为1级或2级;最常见的是疲乏、恶心和头痛。血细胞减少症罕见;仅1例患者发生贫血和发热性中性粒细胞减少症，与加利昔单抗无关，治疗后消退。无患者发生抗加利昔单抗抗体形成。平均血清半衰期范围为13至24天。总缓解率为11%（2例完全缓解和2例部分缓解）。至最佳缓解时间延迟（第3、6、9和12个月）。12例患者（34%）病情稳定。所有患者中近一半（49%）的指示病灶减少。两名应答者仍在研究中无进展（22和24.4个月）。结论加利昔单抗的有利安全性特征以及单药生物活性和剂量依赖性药代动力学证据支持进一步评估加利昔单抗作为滤泡性淋巴瘤治疗，可能与其他淋巴瘤治疗联合。(c)2005年，美国临床肿瘤学会。
Purpose This multicenter, dose-escalation study evaluates the safety, pharmacokinetics, and efficacy of galiximab (anti-CD80 monoclonal antibody) in patients with relapsed or refractory follicular lymphoma.Patients and Methods Patients had follicular lymphoma that had relapsed or failed to respond to primary therapy; the majority (90%) presented with stage III or IV disease, Four weekly intravenous infusions of galiximab were administered at doses of 125, 250, 375, or 500 mg/m(2).Results Thirty-seven patients received galiximab treatment and were evaluated for safety; 35 were assessable for response, Antibody infusions were safe and well tolerated with no close-limiting toxicities, A total of 22 (60%) of 37 patients experienced adverse events related to galiximab. All but one of the events were grade 1 or 2; the most common were fatigue, nausea, and headache. Cytopenias were rare; only one patient experienced anemia and febrile neutropenia, which were unrelated to galiximab and resolved after treatment. No patient developed antigaliximab antibody formation. The mean serum half-life ranged from 13 to 24 days. The overall response rate was 11% (two complete responses and two partial responses). Time to best response was delayed (months 3, 6, 9, and 12). Twelve patients (34%) maintained stable disease. Nearly half of all patients (49%) had a decrease in indicator lesions. Two responders remain on study without progression (22 and 24.4 months),Conclusion The favorable safety profile of galiximab and evidence of single-agent biologic activity and dose-dependent pharmacokinetics support further evaluation of galiximab as a treatment for follicular lymphoma, possibly in combination with other lymphoma therapies. (c) 2005 by American Society of Clinical Oncology.