利妥昔单抗治疗Ⅲ期和Ⅳ期滤泡性淋巴瘤：塞尔维亚淋巴瘤研究组REFLECT 1研究结果

Rituximab in the therapy of stage III and IV follicular lymphoma: Results of the REFLECT 1 study of the Serbian Lymphoma Group.

作者信息

Popovic Stevan, Jovanovic Darjana, Mihaljevic Biljana, Andjelkovic Nebojsa, Marjanovic Goran, Marisavljevic Dragomir, Vlaisavljevic Nada, Popovic Lazar, Salma Svetlana, Agic Danijela, Milosevic Rajko, Smiljanic Mihajlo, Sretenović Snezana, Djurdjević Predrag, Markovic Olivera, Hajder Jelena, Govedarovic Nenad

机构信息

Haematology Clinic, Clinical Centre of Vojvodina Novi Sad, Serbia.

出版信息

J BUON. 2017 Mar-Apr;22(2):487-494.

PMID:28534374

Abstract

PURPOSE

Follicular lymphoma (FL) is an indolent lymphoma that responds well to rituximab+chemotherapy. We evaluated the prognosis and efficacy of immunochemotherapy in patients with previously untreated, advanced FL.

METHODS

REFLECT 1 is a multicentre, prospective study of 99 patients with previously untreated FL stage III-IV. All patients were treated with rituximab+chemotherapy x 6 cycles, plus 2 cycles of rituximab monotherapy. Clinical assessment was performed at baseline, after completion of the first 6 cycles of therapy and every 3 months from the end of immunochemotherapy to the end of the study period.

RESULTS

Eighty-nine out of 99 patients with complete documentation were included. Complete remission (CR) was achieved in 61.6%, partial remission (PR) in 11.6% and progressive disease (PD) in 24.4% of the patients. Time to progression (TTP) and overall survival (OS) after the 1st, 2nd and 3rd year were 89.9, 72.7, 57.8%, and 94.2, 92,6 and 92.6%, respectively. The probability of achieving CR was significantly lower in the high risk group according to Follicular Lymphoma Prognostic Index (FLIPI) score. Expression of CD43 antigen had a significant impact on the probability of 2-year TTP and OS, and ECOG performance status had a significant impact on OS.

CONCLUSIONS

Treatment with rituximab plus chemotherapy is effective in advanced stages of FL. Significant prognostic factors are FLIPI score for induction therapy outcome, CD43 antigen expression for OS and TTP and ECOG performance status for OS.

摘要

目的

滤泡性淋巴瘤（FL）是一种惰性淋巴瘤，对利妥昔单抗联合化疗反应良好。我们评估了免疫化疗在先前未经治疗的晚期FL患者中的预后和疗效。

方法

REFLECT 1是一项针对99例先前未经治疗的III-IV期FL患者的多中心前瞻性研究。所有患者接受利妥昔单抗联合化疗6个周期，加2个周期的利妥昔单抗单药治疗。在基线、完成前6个周期治疗后以及从免疫化疗结束到研究期结束每3个月进行一次临床评估。

结果

99例有完整记录的患者中，89例被纳入。61.6%的患者达到完全缓解（CR），11.6%的患者达到部分缓解（PR），24.4%的患者疾病进展（PD）。第1年、第2年和第3年的无进展生存期（TTP）和总生存期（OS）分别为89.9%、72.7%、57.8%和94.2%、92.6%、92.6%。根据滤泡性淋巴瘤预后指数（FLIPI）评分，高危组达到CR的概率显著较低。CD43抗原的表达对2年TTP和OS的概率有显著影响，东部肿瘤协作组（ECOG）体能状态对OS有显著影响。