含美罗华方案治疗B细胞性惰性淋巴瘤34例报告

Efficacy of Rituximab-containing Regimens on Indolent B-cell Lymphoma-a Report of 34 Cases

背景与目的:国外临床研究证实利妥昔单抗(rituximab,商品名美罗华)无论是单药还是与化疗药物联用治疗初治或复发惰性淋巴瘤均取得较好疗效。本研究目的是观察含美罗华方案治疗我国惰性淋巴瘤的疗效和安全性。方法:从1999年3月到2005年1月,共34例经病理确诊的惰性淋巴瘤患者接受含美罗华的方案化疗,中位疗程数5个(3～8个),单药治疗2例,联合化疗32例。化疗方案包括CHOP16例、FMD5例、CHOPE4例、EPOCH2例、DICE2例、DAHP2例和FN1例。结果:34例患者中30例可评价疗效,总有效(OR)率为93.3%,完全缓解(CR)率为60.0%;22例初治患者可评价疗效,OR率95.4%,CR率66.7%;18例滤泡淋巴瘤患者可评价疗效,OR率为88.9%,CR率为66.7%。中位随访期17个月(4～68个月),1年无疾病进展生存(progression-freelysurvival,PFS)率为85.3%。主要不良反应为骨髓抑制,19例患者出现白细胞下降,5例患者血小板下降,其中Ⅲ+Ⅳ度白细胞和血小板下降4例,2例出现中性粒细胞减少性发热;其它不良反应包括Ⅰ～Ⅱ度恶心呕吐、轻度脱发和肝功能受损等。美罗华输注相关不良反应有Ⅰ～Ⅱ度寒战和发热(发生率20.5%)、皮疹、轻度血压下降和无症状性室性早搏等。结论:美罗华单药或联合化疗治疗惰性淋巴瘤具有良好的临床疗效和安全性。

BACKGROUND ＆ OBJECTIVE： The efficacy of rituximab given alone or in combination with chemotherapy on naive or relapsed indolent lymphoma is good. This study was to investigate the efficacy and safety of rituximab-containing regimens for patients with indolent B-cell lymphoma in China. METHODS： From Mar. 1999 to Jan. 2005, 34 patients with indolent B- cell lymphoma received rituximab-containing regimens with a median of 5 cycles （ranged from 3 to 8 cycles）. Of the 34 patients, 2 received rituximab alone, and 32 received rituximab-based regimens, which including.CHOP （16 cases）, FMD （5 cases）, CHOPE （4 cases）, EPOCH （2 cases）, DICE （2 cases）, DAHP （2 cases）, and FN （1 case）. RESULTS： Of the 34 patients, 30 were evaluable for objective response. The overall response （OR） rate was 93.3%, and the complete response （CR） rate was 60.0%; the OR rate and CR rate of 22 evaluable naive patients were 95.4% and 66.7%, those of 18 evaluable follicular lymphoma patients were 88.9% and 66.7%. With a median follow-up of 17 months （4-68 months）, the 1-year progression-freely survival rate was 85.3%. Myelosuppression was the major adverse event： 19 patients suffered from leukopenia with 4 cases of grade Ⅲ-Ⅳ event, 5 suffered from thrombocytopenia with 4 cases of grade Ⅲ-Ⅳ event, and 2 suffered from febrile neutropenia. Other adverse events included grade Ⅰ-Ⅱ nausea/vomiting, mild alopecia, and transient liver function abnormality. The infusional reaction of rituximab consisted of grade Ⅰ-Ⅱ rigor/febrile, skin rash, mild hypotension, and asymptomatic ventricular premature beat. CONCLUSION： Rituximab-containing chemotherapeutic regimens are effective for indolent B-cell lymphoma with mild toxicity.