Micallef Ivana N M, Kahl Brad S, Maurer Matthew J, Dogan Ahmet, Ansell Stephen M, Colgan Joseph P, Geyer Susan, Inwards David J, White William L, Habermann Thomas M
Division of Hematology, Department of Internal Medicine, Mayo Clinic College of Medicine, Rochester, Minnesota 55905, USA.
Cancer. 2006 Dec 15;107(12):2826-32. doi: 10.1002/cncr.22342.
In this pilot study, the authors assessed the feasibility of combination epratuzumab and rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (ER-CHOP) in patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL).
Patients received chemotherapy on the following schedule: epratuzumab 360 mg/m2, rituximab 375 mg/m2, and standard-dose CHOP every 3 weeks for 6 to 8 cycles. The primary endpoint was the incidence of grade 4 neutropenia and grade 3 or 4 antibody infusional toxicity. Secondary endpoints were the complete response (CR) rate, the overall response rate (ORR), and progression-free survival (PFS). Weekly blood counts were obtained to monitor hematologic toxicity. Fifteen patients were enrolled and treated. Baseline patient characteristics included a median age of 63 years (range, 42-78 years), 60% of patients had stage III or IV disease, 7 patients had a low-risk International Prognostic Index (IPI) score (0 or 1), 7 patients had an intermediate-risk IPI score (2 or 3), and 1 patient was high risk.
Grade 3 or 4 neutropenia was observed in 14 patients (93%) or in 28 of 92 treatment cycles (30%). Three patients developed grade > or =3 infection or fever. Eleven patients (73%) required dose reductions. No grade 3 antibody infusion-related toxicity was reported. Thirteen of 15 patients responded (ORR, 87%,), including 10 CRs (67%), 3 partial responses (20%), 1 patient with stable disease, and 1 patient with disease progression. At a median follow-up of 30 months, 13 of 15 patients remained alive. The 1-year PFS and OS rates were 93% and 100%, respectively; and the 2-year PFS and OS rates were 86% and 86%, respectively.
ER-CHOP every 21 days was feasible as treatment for newly diagnosed patients with DLBCL. A Phase II multicenter study is underway.
在这项初步研究中，作者评估了联合使用依帕珠单抗和利妥昔单抗加环磷酰胺、多柔比星、长春新碱和泼尼松（ER-CHOP）方案治疗新诊断的弥漫性大B细胞淋巴瘤（DLBCL）患者的可行性。
患者按照以下方案接受化疗：依帕珠单抗360mg/m²、利妥昔单抗375mg/m²，标准剂量CHOP方案，每3周一次，共6至8个周期。主要终点是4级中性粒细胞减少症和3级或4级抗体输注毒性的发生率。次要终点是完全缓解（CR）率、总缓解率（ORR）和无进展生存期（PFS）。每周进行血常规检查以监测血液学毒性。共纳入15例患者并进行治疗。患者基线特征包括中位年龄63岁（范围42 - 78岁），60%的患者为Ⅲ期或Ⅳ期疾病，7例患者国际预后指数（IPI）评分为低危（0或1），7例患者为中危（2或3），1例患者为高危。
14例患者（93%）或92个治疗周期中的28个周期（30%）出现3级或4级中性粒细胞减少症。3例患者发生≥3级感染或发热。11例患者（73%）需要减量。未报告3级抗体输注相关毒性。15例患者中有13例有反应（ORR为87%），包括10例CR（67%）、3例部分缓解（20%）、1例疾病稳定患者和1例疾病进展患者。中位随访30个月时，15例患者中有13例存活。1年PFS率和OS率分别为93%和100%；2年PFS率和OS率分别为86%和86%。
每21天一次的ER-CHOP方案治疗新诊断的DLBCL患者是可行的。一项Ⅱ期多中心研究正在进行中。
