Rituximab plus concurrent infusional EPOCH chemotherapy is highly effective in HIV-associated B-cell non-Hodgkin lymphoma

Rituximab plus concurrent infusional EPOCH chemotherapy is highly effective in HIV-associated B-cell non-Hodgkin lymphoma
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DOI:
10.1182/blood-2009-08-231613
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发表时间:
2010-04-15
期刊:
影响因子:
20.3
通讯作者:
Mitsuyasu, Ronald
Mitsuyasu, Ronald
中科院分区:
医学1区
文献类型:
--
作者:
Sparano, Joseph A.;Lee, Jeannette Y.;Mitsuyasu, Ronald

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利妥昔单抗联合静脉推注化疗是免疫功能正常的 B 细胞非霍奇金淋巴瘤 (NHL) 患者的标准治疗方法。一些研究表明,利妥昔单抗与 HIV 相关 NHL 的过度毒性有关,输注化疗可能更有效。我们进行了一项随机 2 期试验,在 HIV 相关 NHL 患者中,在每个输注依托泊苷、长春新碱、阿霉素、环磷酰胺和泼尼松 (EPOCH) 化疗周期之前同时给予利妥昔单抗 (375 mg/m(2)),或者在完成所有化疗后依次给予(每周一次,持续 6 周)。 EPOCH 包括 96 小时静脉输注依托泊苷、阿霉素和长春新碱加口服泼尼松,然后每 21 天静脉推注环磷酰胺,持续 4 至 6 个周期。在同期组中,48 名可评估患者中有 35 名(73%;95% 置信区间,58%-85%)获得完全缓解。在序贯组中,53 名可评估患者中有 29 名(55%;95% 置信区间,41%-68%)获得完全缓解。仅同步组达到了主要疗效终点。尽管基线 CD4 计数低于 50/μL 的患者在同时治疗组中的感染死亡率较高,但两组的毒性相当。我们的结论是,同时利妥昔单抗加输注 EPOCH 是治疗 HIV 相关淋巴瘤的有效方案。该研究在 http://clinicaltrials.gov 上注册为 NCT00049036。 (血。2010;115(15):3008-3016)
Rituximab plus intravenous bolus chemotherapy is a standard treatment for immunocompetent patients with B-cell non-Hodgkin lymphoma (NHL). Some studies have suggested that rituximab is associated with excessive toxicity in HIV-associated NHL, and that infusional chemotherapy may be more effective. We performed a randomized phase 2 trial of rituximab (375 mg/m(2)) given either concurrently before each infusional etoposide, vincristine, doxorubicin, cyclophosphamide, and prednisone (EPOCH) chemotherapy cycle or sequentially (weekly for 6 weeks) after completion of all chemotherapy in HIV-associated NHL. EPOCH consisted of a 96-hour intravenous infusion of etoposide, doxorubicin, and vincristine plus oral prednisone followed by intravenous bolus cyclophosphamide given every 21 days for 4 to 6 cycles. In the concurrent arm, 35 of 48 evaluable patients (73%; 95% confidence interval, 58%-85%) had a complete response. In the sequential arm, 29 of 53 evaluable patients (55%; 95% confidence interval, 41%-68%) had a complete response. The primary efficacy endpoint was met for the concurrent arm only. Toxicity was comparable in the 2 arms, although patients with a baseline CD4 count less than 50/mu L had a high infectious death rate in the concurrent arm. We conclude that concurrent rituximab plus infusional EPOCH is an effective regimen for HIV-associated lymphoma. This study is registered at http://clinicaltrials.gov as NCT00049036. (Blood. 2010;115(15):3008-3016)