Lymphoma department, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China.
Med Oncol. 2012 Dec;29(4):2409-16. doi: 10.1007/s12032-012-0211-2. Epub 2012 Apr 3.
This study was conducted to evaluate the efficacy and safety of Rituximab, Gemcitabine, Cisplatin, and Dexamethasone (R-GDP) in relapsed or refractory aggressive B-Cell Non-Hodgkin's Lymphoma (NHL). Treatments consisted of rituximab 375 mg/m2, i.v. on day 1; gemcitabine 1,000 mg/m2, i.v. on days 1 and 8, dexamethasone 40 mg i.v. on days 1-4, and cisplatin 25 mg/m2 i.v. on days 1-3, every 21 days. The primary end-points were the overall survival (OS) and progression-free survival (PFS). Secondary endpoints included response rate (ORR; CR) and toxicities. Eligible patients could then proceed to high-dose chemotherapy (HDC) and autologous stem cell transplantation (ASCT) or receive up to six treatment cycles. From January 2005 to December 2010, 50 successive patients at Tianjin cancer hospital lymphoma department were enrolled in this study. All patients were recurrent or refractory aggressive B-cell NHL, including diffuse large B-cell lymphoma (n=30) and follicular lymphoma grade 3b (n=20). The median follow-up time was 42 months (range, 12-70). After two cycles, the overall response rate was 72.0%, with a CR/CRu rate of 56%. The 2-year OS and PFS of all patients were 70.0 and 48.0%, respectively. Grade III-IV neutropenia and thrombocytopenia occurred in 34 and 40% of patients, respectively. Twenty-one patients (42%) proceeded to ASCT. Higher International Prognostic Index and refractory disease were independently associated with worse survival and progression-free survival. R-GDP chemotherapy in patients with refractory or relapsed aggressive B-Cell NHL was effective as a salvage therapy and helpful for HDC/ASCT.
这项研究旨在评估利妥昔单抗、吉西他滨、顺铂和地塞米松（R-GDP）在复发或难治性侵袭性 B 细胞非霍奇金淋巴瘤（NHL）中的疗效和安全性。治疗方案包括利妥昔单抗 375mg/m2，静脉注射，第 1 天；吉西他滨 1000mg/m2，静脉注射，第 1 天和第 8 天；地塞米松 40mg，静脉注射，第 1-4 天；顺铂 25mg/m2，静脉注射，第 1-3 天，每 21 天 1 个周期。主要终点是总生存期（OS）和无进展生存期（PFS）。次要终点包括缓解率（ORR；CR）和毒性。符合条件的患者随后可以进行高剂量化疗（HDC）和自体干细胞移植（ASCT），或接受最多 6 个周期的治疗。2005 年 1 月至 2010 年 12 月，天津肿瘤医院淋巴瘤科连续入组 50 例患者。所有患者均为复发或难治性侵袭性 B 细胞 NHL，包括弥漫性大 B 细胞淋巴瘤（n=30）和滤泡性淋巴瘤 3b 级（n=20）。中位随访时间为 42 个月（范围 12-70）。完成两个周期后，总缓解率为 72.0%，完全缓解/部分缓解率为 56%。所有患者的 2 年 OS 和 PFS 分别为 70.0%和 48.0%。III-IV 级中性粒细胞减少和血小板减少的发生率分别为 34%和 40%。21 例（42%）患者进行了 ASCT。较高的国际预后指数和难治性疾病与较差的生存和无进展生存独立相关。R-GDP 化疗作为挽救性治疗，对复发或难治性侵袭性 B 细胞 NHL 患者有效，有助于 HDC/ASCT。
