Yokohama City University Hospital, Kanagawa, Japan.
J Clin Oncol. 2013 Jun 10;31(17):2103-9. doi: 10.1200/JCO.2012.46.5203. Epub 2013 May 6.
Effective and less aggressive therapies are required for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for or have undergone autologous stem-cell transplantation (ASCT). The present phase II study assessed the efficacy and safety of bendamustine plus rituximab (BR) in this population.
Patients with relapsed or refractory DLBCL treated with one to three prior chemotherapy regimens received rituximab 375 mg/m(2) intravenous (IV) infusion on day 1 and bendamustine 120 mg/m(2) by IV infusion on days 2 and 3 of each 21-day cycle for up to six cycles. The primary end point was overall response rate (ORR), and the secondary end points were complete response (CR) rate, progression-free survival (PFS), and safety.
Sixty-three patients were enrolled, and 59 received BR. The median age was 67 years (range, 36 to 75 years), and 62.7% of patients were 65 years of age or older. Fifty-seven patients (96.6%) were previously treated with rituximab-containing chemotherapy. The ORR was 62.7% (95% CI, 49.1% to 75.0%), with a CR rate of 37.3% (95% CI, 25.0% to 50.9%). The ORRs were comparable between patients ≥ 65 years of age and less than 65 years (62.2% and 63.6%, respectively). The median PFS was 6.7 months (95% CI, 3.6 to 13.7 months). The most frequently observed grade 3 or 4 adverse events were hematologic: lymphopenia (78.0%), neutropenia (76.3%), leukopenia (72.9%), CD4 lymphopenia (66.1%), and thrombocytopenia (22.0%).
BR is a promising salvage regimen for patients with relapsed or refractory DLBCL after rituximab-containing chemotherapy, warranting further investigation.
对于不符合自体干细胞移植（ASCT）条件或已接受 ASCT 的复发或难治性弥漫性大 B 细胞淋巴瘤（DLBCL）患者，需要采用更有效且侵袭性更小的治疗方法。本 II 期研究评估了利妥昔单抗联合苯达莫司汀（BR）在该人群中的疗效和安全性。
接受过 1 至 3 种先前化疗方案治疗的复发或难治性 DLBCL 患者，在每个 21 天周期的第 1 天接受利妥昔单抗 375mg/m²静脉输注，第 2 天和第 3 天接受苯达莫司汀 120mg/m²静脉输注，最多 6 个周期。主要终点为总缓解率（ORR），次要终点为完全缓解（CR）率、无进展生存期（PFS）和安全性。
共有 63 例患者入组，其中 59 例接受 BR 治疗。中位年龄为 67 岁（范围：36 至 75 岁），62.7%的患者年龄≥65 岁。57 例（96.6%）患者曾接受过含利妥昔单抗的化疗。ORR 为 62.7%（95%CI：49.1%至 75.0%），CR 率为 37.3%（95%CI：25.0%至 50.9%）。≥65 岁与<65 岁患者的 ORR 相似（分别为 62.2%和 63.6%）。中位 PFS 为 6.7 个月（95%CI：3.6 至 13.7 个月）。最常见的 3 级或 4 级血液学不良事件为淋巴细胞减少（78.0%）、中性粒细胞减少（76.3%）、白细胞减少（72.9%）、CD4 淋巴细胞减少（66.1%）和血小板减少（22.0%）。
BR 是利妥昔单抗联合化疗后复发或难治性 DLBCL 患者有前景的挽救治疗方案，值得进一步研究。
