Montefiore-Einstein Cancer Center, Montefiore Medical Center, Bronx, NY 10461, USA.
Blood. 2010 Apr 15;115(15):3008-16. doi: 10.1182/blood-2009-08-231613. Epub 2009 Dec 18.
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/microL 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.
利妥昔单抗联合静脉推注化疗是治疗 B 细胞非霍奇金淋巴瘤(NHL)的免疫功能正常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 的毒性过高有关,而输注化疗可能更有效。我们进行了一项随机 2 期试验,比较了利妥昔单抗(375mg/m²)在 HIV 相关 NHL 患者中,分别在每个依托泊苷、长春新碱、多柔比星、环磷酰胺和泼尼松(EPOCH)化疗周期前同时给予,或在所有化疗完成后序贯(每周 6 周)给予,与 EPOCH 化疗的疗效。EPOCH 方案包括依托泊苷、多柔比星和长春新碱 96 小时静脉输注,加用口服泼尼松,随后每 21 天静脉推注环磷酰胺 4 至 6 个周期。在同期臂中,48 例可评估患者中有 35 例(73%;95%置信区间,58%-85%)达到完全缓解。在序贯臂中,53 例可评估患者中有 29 例(55%;95%置信区间,41%-68%)达到完全缓解。仅同期臂达到了主要疗效终点。2 个臂的毒性相当,尽管基线 CD4 计数<50/µL 的患者在同期臂中感染死亡率较高。我们的结论是,同期利妥昔单抗联合输注 EPOCH 是治疗 HIV 相关淋巴瘤的有效方案。