Yun Hou, Zhang Hui Lai, Wang Hua-Qing
Lymphoma Department of Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Tianjin, China.
Med Oncol. 2015 Jan;32(1):353. doi: 10.1007/s12032-014-0353-5. Epub 2014 Dec 16.
This study was conducted to evaluate the efficacy and safety of rituximab and Bortezomib in relapsed or refractory indolent B cell non-Hodgkin's lymphoma (NHL). Treatments consisted of rituximab 375 mg/m(2), i.v. on days 1, 8, 15, and 22 of cycle 1 and on day one of cycles 2-5, bortezomib 1.6 mg/m(2), given by intravenous injection (3-s to 5-s bolus) on days 1, 8, 15, and 22 of a maximum of five cycles. The primary end points were the overall survival (OS) and progression-free survival (PFS). Secondary endpoints included response rate (ORR; CR) and toxicities. From January 2008 to December 2010, 60 successive patients at Tianjin cancer hospital lymphoma department were enrolled in this study. All patients were recurrent or refractory indolent B cell NHL, including follicular lymphoma grades 1-2 (n = 35), small lymphocytic lymphoma/chronic lymphocytic leukemia (LL/CLL; n = 16) and marginal zone lymphoma (n = 9). The median follow-up time was 30 months (range 12-48). The overall response rate was 70.0 %, with a CR/CRu rate of 31.7 %. The 2-year OS and PFS of all patients were 75.0 and 41.0 %, respectively. Grade 3-4 neutropenia and thrombocytopenia occurred in 10 and 3.3 % of patients, respectively. Higher IPI and refractory disease were independently associated with worse survival and PFS. RB chemotherapy in patients with refractory or relapsed indolent B cell NHL was effective with low toxicity.
本研究旨在评估利妥昔单抗和硼替佐米治疗复发或难治性惰性B细胞非霍奇金淋巴瘤（NHL）的疗效和安全性。治疗方案为：第1周期的第1、8、15和22天静脉注射利妥昔单抗375mg/m²，第2至5周期的第1天静脉注射；硼替佐米1.6mg/m²，在最多5个周期的第1、8、15和22天静脉注射（3至5秒推注）。主要终点为总生存期（OS）和无进展生存期（PFS）。次要终点包括缓解率（ORR；CR）和毒性。2008年1月至2010年12月，天津医科大学肿瘤医院淋巴瘤科连续纳入60例患者。所有患者均为复发或难治性惰性B细胞NHL，包括1-2级滤泡性淋巴瘤（n = 35）、小淋巴细胞淋巴瘤/慢性淋巴细胞白血病（LL/CLL；n = 16）和边缘区淋巴瘤（n = 9）。中位随访时间为30个月（范围12至48个月）。总缓解率为70.0%，CR/CRu率为31.7%。所有患者的2年OS和PFS分别为75.0%和41.0%。3-4级中性粒细胞减少和血小板减少分别发生在10%和3.3%的患者中。较高的国际预后指数（IPI）和难治性疾病与较差的生存期和PFS独立相关。利妥昔单抗联合硼替佐米治疗复发或难治性惰性B细胞NHL疗效显著且毒性低。
