Rituximab (anti-CD20 monoclonal antibody) as single first-line therapy for patients with follicular lymphoma with a low tumor burden:: clinical and molecular evaluation

Rituximab (anti-CD20 monoclonal antibody) as single first-line therapy for patients with follicular lymphoma with a low tumor burden:: clinical and molecular evaluation
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DOI:
10.1182/blood.v97.1.101
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发表时间:
2001-01-01
期刊:
影响因子:
20.3
通讯作者:
Solal-Céligny, P
Solal-Céligny, P
中科院分区:
医学1区
文献类型:
--
作者:
Colombat, P;Salles, G;Solal-Céligny, P

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利妥昔单抗(一种与 CD20 抗原结合的嵌合单克隆抗体)的临床活性作为滤泡性非霍奇金淋巴瘤 (NHL) 患者的单一一线疗法进行了评估。对 50 名滤泡性 CD20(+) NHL 和低肿瘤负荷患者的临床和分子反应进行了分析。他们每周接受 4 次利妥昔单抗输注,剂量为 375 mg/m(2)。治疗一个月后(第50天)的缓解率为49例中的36例(73%),其中10名患者完全缓解,3名患者完全缓解/未确诊,23名患者部分缓解。 10 名患者疾病稳定,3 名患者疾病进展,13 名患者中的 1 名(8%)完全缓解,23 名患者中的 9 名(39%)部分缓解,10 名疾病稳定的患者中有 5 名(50%)在第一年出现疾病进展。在研究人群中,32 名患者最初获得了有关 bcl-2-J(H) 重排的聚合酶链反应 (PCR) 数据。第50天,30名患者中的17名(57%)外周血bcl-2-J(H)重排呈阴性,29名患者中的9名(31%)骨髓中bcl-2-J(H)重排呈阴性;在分子反应和临床反应之间观察到显着相关性 (P < .0001)。第 12 个月时,26 名患者中有 16 名 (62%) 外周血 PCR 呈阴性。这些结果表明早期分子反应可以持续长达 12 个月,并且这种反应与无进展生存期高度相关。利妥昔单抗具有高临床活性和低毒性,可在滤泡性淋巴瘤患者中诱导高完全分子缓解率和低肿瘤负荷。 (C) 2001 年,美国血液学会。
The clinical activity of rituximab, a chimeric monoclonal antibody which binds to the CD20 antigen, was evaluated as a single first-line therapy for patients with follicular non-Hodgkin lymphoma (NHL). Fifty patients with follicular CD20(+) NHL and a low tumor burden were analyzed for clinical and molecular responses, They received 4 weekly infusions of rituximab at a dose of 375 mg/m(2). The response rate a month after treatment (day 50) was 36 of 49 (73%), with 10 patients in complete remission, 3 patients in complete remission/unconfirmed, and 23 patients in partial remission. Ten patients had stable disease, and the disease progressed in 3 patients, One of 13 (8%) patients in complete remission, 9 of 23 (39%) patients in partial remission, and 5 of 10 (50%) patients with stable disease exhibited disease progression during the first year. Within the study population, 32 patients were initially informative for polymerase chain reaction (PCR) data on bcl-2-J(H) rearrangement. On day 50, 17 of 30 patients (57%) were negative for bcl-2-J(H) rearrangement in peripheral blood, and 9 of 29 (31%) were negative in bone marrow; a significant association was observed between molecular and clinical responses (P < .0001), At month 12, 16 of 26 patients (62%) were PCR negative in peripheral blood. These results indicate that early molecular responses can be sustained for up to 12 months and that this response is highly correlated with progression-free survival. Rituximab has a high clinical activity and a low toxicity and induces a high complete molecular response rate in patients with follicular lymphoma and a low tumor burden. (C) 2001 by The American Society of Hematology.