Low Country Cancer Care Associates, Savannah, GA, USA.
Haematologica. 2011 Apr;96(4):567-73. doi: 10.3324/haematol.2010.037390. Epub 2010 Dec 20.
Subcutaneous injections of anti-CD20 antibodies may offer benefits to both patients and the healthcare system for treatment of B-cell malignancies.
A pilot study was undertaken to evaluate the potential for subcutaneous dosing with 2(nd) generation anti-CD20 antibody veltuzumab in patients with CD20(+) indolent non-Hodgkin's lymphoma. Patients with previously untreated or relapsed disease received 4 doses of 80, 160, or 320 mg veltuzumab injected subcutaneously every two weeks. Responses were assessed by computed tomography scans, with other evaluations including adverse events, safety laboratories, B-cell blood levels, serum veltuzumab levels, and human anti-veltuzumab antibody (HAHA) titers.
Seventeen patients (14 follicular lymphoma; 13 stage III or IV disease; 5 treatment-naive) completed treatment with only occasional, mild-moderate, transient injection reactions and no other safety issues. Subcutaneous veltuzumab demonstrated a slow release pattern over several days, achieving a mean Cmax of 19, 25 and 63 μg/mL at 80, 160, and 320 mg doses for a total of 4 administrations, respectively. Depletion of circulating B cells occurred after the first injection. The objective response rate (partial responses plus complete responses plus complete responses unconfirmed) was 47% (8/17) with a complete response/complete response unconfirmed rate of 24% (4/17); 4 of 8 objective responses continued for 60 weeks or more. All serum samples evaluated for human anti-veltuzumab antibody were negative.
Subcutaneous injections of low-dose veltuzumab are convenient, well tolerated, and capable of achieving sustained serum levels, B-cell depletion, and durable objective responses in indolent non-Hodgkin's lymphoma. (Clinicaltrials.gov identifier: NCT00546793).
皮下注射抗 CD20 抗体可能会为接受 B 细胞恶性肿瘤治疗的患者和医疗保健系统带来益处。
进行了一项试点研究，以评估在 CD20(+)惰性非霍奇金淋巴瘤患者中皮下给予第二代抗 CD20 抗体veltuzumab 的潜力。既往未经治疗或复发的患者接受 4 剂 80、160 或 320mg veltuzumab 皮下注射，每两周一次。通过计算机断层扫描评估反应，其他评估包括不良事件、安全性实验室、B 细胞血液水平、血清 veltuzumab 水平和人抗 veltuzumab 抗体 (HAHA) 滴度。
17 例患者（14 例滤泡性淋巴瘤；13 例 III 或 IV 期疾病；5 例初治）完成了治疗，仅有偶尔、轻度至中度、短暂的注射反应，无其他安全问题。皮下 veltuzumab 表现出数日的缓慢释放模式，在 80、160 和 320mg 剂量下的 4 次给药后，平均 Cmax 分别为 19、25 和 63μg/ml。首次注射后循环 B 细胞耗竭。客观缓解率（部分缓解+完全缓解+不完全缓解）为 47%（17/37），完全缓解/不完全缓解率为 24%（4/17）；8 例客观缓解中有 4 例持续 60 周或更长时间。所有评估的血清样本均为阴性。
低剂量 veltuzumab 皮下注射方便、耐受性良好，能够在惰性非霍奇金淋巴瘤中实现持续的血清水平、B 细胞耗竭和持久的客观缓解。（Clinicaltrials.gov 标识符：NCT00546793）。
