Boué François, Gabarre Jean, Gisselbrecht Christian, Reynes Jacques, Cheret Antoine, Bonnet Fabrice, Billaud Eric, Raphael Martine, Lancar Remi, Costagliola Dominique
Agence Nationale Recherche sur le Sida et les Hépatites, Paris, France.
J Clin Oncol. 2006 Sep 1;24(25):4123-8. doi: 10.1200/JCO.2005.05.4684. Epub 2006 Aug 8.
To evaluate the safety and efficacy of rituximab adjunction to the cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) regimen in patients with newly diagnosed AIDS-related non-Hodgkin's lymphoma.
HIV-seropositive patients with high-grade lymphoma of B-cell origin were eligible if they had no more than one of the following characteristics: CD4 cell count less than 100/microL, prior AIDS, or performance status less than 2. This multicenter phase II trial evaluated the response rate and disease-free survival after six courses of rituximab plus CHOP. Results Sixty-one patients were enrolled. All the patients were assessable for safety and 52 were assessable for the tumor response after treatment completion. Characteristics of patients were median age, 41 years; median CD4 cells, 172/microL; histology, diffuse large B-cell lymphoma (n = 42), immunoblastic (n = 2), Burkitt lymphoma (n = 16), and plasmablastic (n = 1); 42 patients with stage III to IV; International Prognostic Index 0 to 1 (n=31), and 2 to 3 (n = 27). Grade 3 or 4 toxicity consisted of febrile neutropenia in nine patients, anemia in 16 patients, and thrombocytopenia in five patients. Complete remission (CR) or unconfirmed CR was achieved in 40 of the 52 assessable patients, partial remission was achieved in five patients, and seven patients experienced progression. Forty-three patients were alive after a median follow-up of 33 months. The estimated 2-year overall survival rate was 75% (95% CI, 64% to 86%). Eighteen patients died: 16 as a result of lymphoma, one as a result of infection, and one as a result of encephalitis.
Rituximab adjunction to CHOP produced a CR rate of 77% and a 2-year survival rate of 75% in patients with AIDS-related non-Hodgkin's lymphoma, without increasing the risk of life-threatening infections.
评估利妥昔单抗联合环磷酰胺、阿霉素、长春新碱和泼尼松（CHOP）方案治疗新诊断的艾滋病相关非霍奇金淋巴瘤患者的安全性和疗效。
B细胞起源的高级别淋巴瘤HIV血清学阳性患者，若具有以下特征不超过一项则符合条件：CD4细胞计数低于100/μL、既往有艾滋病或体能状态低于2。这项多中心II期试验评估了利妥昔单抗联合CHOP六个疗程后的缓解率和无病生存期。结果61例患者入组。所有患者均进行了安全性评估，52例患者在治疗结束后进行了肿瘤反应评估。患者特征为：中位年龄41岁；中位CD4细胞数172/μL；组织学类型：弥漫性大B细胞淋巴瘤（n = 42）、免疫母细胞型（n = 2）、伯基特淋巴瘤（n = 16）和浆母细胞型（n = 1）；42例患者为III至IV期；国际预后指数0至1（n = 31），2至3（n = 27）。3或4级毒性包括9例患者出现发热性中性粒细胞减少、16例患者出现贫血、5例患者出现血小板减少。52例可评估患者中，40例达到完全缓解（CR）或未确认的CR，5例达到部分缓解，7例病情进展。中位随访33个月后，43例患者存活。估计2年总生存率为75%（95%CI，64%至86%）。18例患者死亡：16例死于淋巴瘤，1例死于感染，1例死于脑炎。
利妥昔单抗联合CHOP治疗艾滋病相关非霍奇金淋巴瘤患者的CR率为77%，2年生存率为75%，且未增加危及生命感染的风险。
