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目的:评价注射用盐酸苯达莫司汀单药治疗利妥昔单抗治疗失败的B细胞惰性淋巴瘤的有效性和安全性。方法:2010年4月至2013年4月,全国8个研究中心入组100例利妥昔单抗治疗失败的B细胞惰性淋巴瘤患者,接受苯达莫司汀单药治疗(120 mg/m2,d1、2,每21天1个周期,最多8个周期)。主要终点指标为总反应率(ORR),次要终点指标包括疾病控制率(DCR)、无进展生存(PFS)、总生存(OS)及安全性评估。结果:全组100例患者,中位年龄为56(28~74)岁,共计化疗447个周期,中位4(1~8)个周期。93例患者完成至少2个周期治疗,可评价疗效。15例(16.1%)获得完全缓解(CR),52例(55.9%)获得部分缓解(PR),22例(23.7%)稳定(SD),4例(4.3%)进展(PD),ORR为72%,DCR为95.7%。中位随访时间26.6(2~48.4)个月,59例(63.4%)出现疾病进展,中位PFS为8.53个月(95%CI:6.518~10.542),1年PFS率(40.6±5.3)%。48例(48%)出现3/4级不良事件,3/4级白细胞减少、中性粒细胞减少、血小板减少发生率分别为26%、24%和11%。结论:苯达莫司汀治疗利妥昔单抗耐药的B细胞惰性淋巴瘤客观缓解率较高,骨髓抑制为最常见不良反应,系二线治疗惰性B细胞淋巴瘤的新选择。
OBJECTIVE: To evaluate the efficacy and safety of bendamustine monotherapy for the treatment of indolent B-cell lymphoma with rituximab injections. METHODS: From April 2010 to April 2013, 100 patients with B-cell lymphoma who failed to receive rituximab were enrolled in eight research centers across the country and received bendamustine monotherapy (120 mg / m2 , d1,2, 1 cycle every 21 days, up to 8 cycles). The primary endpoint was overall response rate (ORR). Secondary endpoints included disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety assessment. Results: The median age of all 100 patients was 56 (28-74) years old, with a total of 447 cycles of chemotherapy and a median of 4 (1 ~ 8) cycles. 93 patients completed at least 2 cycles of treatment, can evaluate the efficacy. Complete remission (CR) was achieved in 15 cases (16.1%), partial remission (PR) in 52 cases (SD), stable in 23 cases (SD) in 22 cases, and progression in 4 cases (4.3% 72%, DCR 95.7%. Median PFS was 8.53 months (95% CI: 6.518-10.542), and 1-year PFS was (40.6 ± 5.3)% with a median follow-up time of 26.6 (2-48.4) months and 59 (63.4% . Forty-eight (48%) patients had grade 3/4 adverse events, grade 3/4 leucopenia, neutropenia, and thrombocytopenia rates of 26%, 24%, and 11%, respectively. CONCLUSION: Bendamustine has a higher objective response rate to rituximab-resistant B-cell lymphoma and myelosuppression is the most common adverse reaction, which is a new choice for second-line treatment of I-B lymphoblastic lymphoma.