艾滋病恶性肿瘤联盟试验的汇总分析，评估利妥昔单抗联合 CHOP 或 EPOCH 输注化疗治疗 HIV 相关非霍奇金淋巴瘤。
Pooled analysis of AIDS malignancy consortium trials evaluating rituximab plus CHOP or infusional EPOCH chemotherapy in HIV-associated non-Hodgkin lymphoma.
机构信息
Albert Einstein College of Medicine, Department of Oncology, Montefiore Medical Center, Bronx, New York, USA.
出版信息
Cancer. 2012 Aug 15;118(16):3977-83. doi: 10.1002/cncr.26723. Epub 2011 Dec 16.
BACKGROUND
Improved outcomes have recently been reported for rituximab (R) plus rituximab plus infusional etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin (R-EPOCH) chemotherapy in patients with human immunodeficiency virus (HIV)-associated, aggressive B-cell, non-Hodgkin lymphoma (NHL). The objective of the current analysis was to assess whether patient selection or other factors contributed to this improvement and to identify patients who are at the greatest risk for lethal toxicity.
METHODS
The authors performed a pooled analysis of 2 consecutive trials that included 150 patients with HIV-associated NHL who received either R-CHOP (n = 99; Acquired Immunodeficiency Syndrome [AIDS] Malignancy Consortium Trial 010 [AMC010]) or R-EPOCH (n = 51; AMC034). Age-adjusted International Prognostic Index (aaIPI), CD4 count at lymphoma diagnosis (<100/μL vs ≥100/μL), and treatment (R-CHOP vs R-EPOCH) were included as variables in a multivariate logistic regression model for complete response (CR) and in a Cox proportional hazards regression models for event-free survival (EFS) and overall survival (OS).
RESULTS
Features that were associated significantly with an improved CR rate and improved EFS and OS included a low aaIPI score and a baseline CD4 count ≥100/μL. When the analysis was adjusted for aaIPI and CD4 count, patients who received concurrent R-EPOCH had improved EFS (hazard ratio [HR] 0.40; 95% confidence intervals [CI], 0.23, 0.69; P < .001) and OS (HR, 0.38; 95% CI, 0.21, 0.69; P < .01). Treatment-associated death occurred significantly more often in patients with CD4 counts <50/μL (37% vs 6%; P < .01).
CONCLUSIONS
The current analysis provided additional level 2 evidence supporting the use of concurrent R-EPOCH in patients with HIV-associated lymphoma and a CD4 count >50/μL, and the results support the design of an ongoing phase 3 trial comparing concurrent R-EPOCH with R-CHOP in immunocompetent patients with diffuse large B-cell lymphoma (National Clinical Trial no. NCT00118209).
背景
最近有报道称，对于人免疫缺陷病毒（HIV）相关侵袭性 B 细胞非霍奇金淋巴瘤（NHL）患者，利妥昔单抗（R）联合利妥昔单抗联合依托泊苷、泼尼松、长春新碱、环磷酰胺和多柔比星（R-EPOCH）化疗可改善预后。本分析旨在评估患者选择或其他因素是否有助于改善预后，并确定存在致命毒性风险最大的患者。
方法
作者对连续两项临床试验进行了汇总分析，共纳入 150 例 HIV 相关 NHL 患者，分别接受 R-CHOP（n = 99；获得性免疫缺陷综合征（AIDS）恶性肿瘤联盟试验 010 [AMC010]）或 R-EPOCH（n = 51；AMC034）治疗。年龄调整的国际预后指数（aaIPI）、淋巴瘤诊断时的 CD4 计数（＜100/μL 与≥100/μL）和治疗方案（R-CHOP 与 R-EPOCH）作为变量，纳入多变量逻辑回归模型以评估完全缓解（CR），并纳入 Cox 比例风险回归模型以评估无事件生存（EFS）和总生存（OS）。
结果
与改善 CR 率以及 EFS 和 OS 相关的特征包括低 aaIPI 评分和基线 CD4 计数≥100/μL。当分析调整 aaIPI 和 CD4 计数后，接受同期 R-EPOCH 治疗的患者 EFS 改善（风险比[HR] 0.40；95%置信区间[CI]，0.23，0.69；P＜0.001）和 OS 改善（HR，0.38；95%CI，0.21，0.69；P＜0.01）。CD4 计数＜50/μL 的患者治疗相关死亡发生率显著更高（37% vs 6%；P＜0.01）。
结论
本分析提供了额外的 2 级证据，支持对 CD4 计数＞50/μL 的 HIV 相关 NHL 患者使用同期 R-EPOCH，结果支持设计一项比较 CD4 计数正常的弥漫性大 B 细胞淋巴瘤患者同期接受 R-EPOCH 与 R-CHOP 治疗的 3 期临床试验（国家临床试验编号 NCT00118209）。
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