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利妥昔单抗联合环磷酰胺、阿霉素和依托泊苷静脉滴注治疗HIV相关非霍奇金淋巴瘤:3项2期试验的汇总结果

Rituximab plus infusional cyclophosphamide, doxorubicin, and etoposide in HIV-associated non-Hodgkin lymphoma: pooled results from 3 phase 2 trials.

作者信息

Spina Michele, Jaeger Ulrich, Sparano Joseph A, Talamini Renato, Simonelli Cecilia, Michieli Mariagrazia, Rossi Giuseppe, Nigra Ezio, Berretta Massimiliano, Cattaneo Chiara, Rieger Armin C, Vaccher Emanuela, Tirelli Umberto

机构信息

Division of Medical Oncology A, National Cancer Institute, Via Pedemontana Occidentale 12, 33081, Aviano (PN) Italy.

出版信息

Blood. 2005 Mar 1;105(5):1891-7. doi: 10.1182/blood-2004-08-3300. Epub 2004 Nov 18.

DOI:10.1182/blood-2004-08-3300
PMID:15550484
Abstract

Evidence suggests that infusional therapy is a more effective means for administering cytotoxic therapy than intravenous bolus therapy for lymphoma and offers greater potential for therapeutic synergy with rituximab, which has a long half-life. We pooled the results of 3 prospective phase 2 trials evaluating rituximab in combination with 96-hour infusion of cyclophosphamide (187.5-200 mg/m2 per day), doxorubicin (12.5 mg/m2 per day), and etoposide (60 mg/m2 per day) (R-CDE) plus granulocyte-colony-stimulating factor (G-CSF) in 74 patients with HIV-associated, B-cell non-Hodgkin lymphoma, of whom 56 (76%) patients received concurrent highly active antiretroviral therapy (HAART). The complete remission (CR) rate was 70% (95% confidence interval [CI], 59%-81%), and the estimated 2-year failure-free survival and overall survival rates were 59% (95% CI, 47%-71%) and 64% (95% CI, 52%-76%), respectively. Ten (14%) patients had opportunistic infections during or within 3 months of the end of R-CDE, and 17 (23%) patients developed nonopportunistic infections after that time. Six (8%) patients died because of infection; 2 (3%) of those infections were bacterial sepsis during R-CDE, and 4 (5%) were opportunistic infections that occurred between 2 and 8 months after the completion of R-CDE. R-CDE produced a 70% CR rate and a 59% 2-year failure-free survival rate in patients with HIV-associated lymphoma. Consistent with other reports, adding rituximab to cytotoxic therapy in this population may increase the risk for life-threatening infection. Further studies evaluating rituximab in combination with infusional chemotherapy are warranted, but caution is advised.

摘要

有证据表明,对于淋巴瘤患者,与静脉推注疗法相比,输注疗法是一种更有效的细胞毒性疗法给药方式,并且与具有较长半衰期的利妥昔单抗联合使用时具有更大的治疗协同潜力。我们汇总了3项前瞻性2期试验的结果,这些试验评估了利妥昔单抗联合96小时输注环磷酰胺(每天187.5 - 200mg/m²)、多柔比星(每天12.5mg/m²)和依托泊苷(每天60mg/m²)(R - CDE)加粒细胞集落刺激因子(G - CSF)用于74例HIV相关B细胞非霍奇金淋巴瘤患者,其中56例(76%)患者同时接受了高效抗逆转录病毒治疗(HAART)。完全缓解(CR)率为70%(95%置信区间[CI],59% - 81%),估计的2年无失败生存率和总生存率分别为59%(95% CI,47% - 71%)和64%(95% CI,52% - 76%)。10例(14%)患者在R - CDE期间或结束后3个月内发生机会性感染,17例(23%)患者在此之后发生非机会性感染。6例(8%)患者因感染死亡;其中2例(3%)感染是R - CDE期间的细菌性败血症,4例(5%)是R - CDE完成后2至8个月发生的机会性感染。R - CDE在HIV相关淋巴瘤患者中产生了70%的CR率和59%的2年无失败生存率。与其他报告一致,在该人群中将利妥昔单抗添加到细胞毒性疗法中可能会增加危及生命感染的风险。有必要进一步研究评估利妥昔单抗与输注化疗联合使用,但建议谨慎行事。

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