The addition of rituximab to a combination of fludarabine, cyclophosphamide, mitoxantrone (FCM) significantly increases the response rate and prolongs survival as compared with FCM alone in patients with relapsed and refractory follicular and mantle cell lymphomas:: results of a prospective randomized study of the German Low-Grade Lymphoma Study Group
The addition of rituximab to a combination of fludarabine, cyclophosphamide, mitoxantrone (FCM) significantly increases the response rate and prolongs survival as compared with FCM alone in patients with relapsed and refractory follicular and mantle cell lymphomas:: results of a prospective randomized study of the German Low-Grade Lymphoma Study Group
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DOI：
10.1182/blood-2004-04-1323
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发表时间：
2004-11-15
期刊：
影响因子：
20.3
通讯作者：
Hiddemann, W
中科院分区：
文献类型：
--
作者：
Forstpointner, R;Dreyling, M;Hiddemann, W
在滤泡性淋巴瘤（FL）和套细胞淋巴瘤（MCL）中，单克隆抗体利妥昔单抗联合化疗可改善预后。在复发性疾病患者中进行的前瞻性随机研究对此进行了研究。共有147例患者随机接受4个疗程的化疗，第1 - 3天25 mg/m2氟达拉滨，第1 - 3天200 mg/m2环磷酰胺，第1天8 mg/m2米托蒽醌（FCM），单独或联合利妥昔单抗（375 mg/m2; R-FCM）。在128例可评价患者中，62例随机接受FCM，66例接受R-FCM。RFCM显示总体缓解率为79%（33%完全缓解[CR]，45%部分缓解[PR]），而单独FCM为58%（13% CR，45% PR; P = 0.01），FL（94% vs 70%）和MCL（58% vs 46%）亚组分析结果相似。在总组中，R-FCM组在无进展生存期（PFS; P = 0.0381）和总生存期（OS; P = 0.0030）方面具有显著上级。在FL中，R-FCM组的PFS显著更长（P = 0.0139），而在MCL中观察到OS显著更长（P = 0.0042）。两个研究组的临床相关副作用无差异。因此，在FCM化疗中加入利妥昔单抗可显著改善复发性或难治性FL和MCL的结局。(C)2004年，美国血液学会。
In follicular lymphoma (FL) and mantle cell lymphoma (MCL) the monoclonal antibody rituximab may improve the prognosis when combined with chemotherapy. This was investigated in a prospective randomized study in patients with relapsed disease. A total of 147 patients were randomized to receive 4 courses of chemotherapy with 25 mg/m(2) fludarabine on days 1 to 3, 200 mg/m(2) cyclophosphamide on days 1 to 3, and 8 mg/m(2) Mitox- antrone on day 1 (FCM), alone or combined with rituximab (375 mg/m(2); R-FCM). Of 128 evaluable patients, 62 were randomized for FCM and 66 for R-FCM. RFCM revealed an overall response rate of 79% (33% complete remission [CR], 45% partial remission [PR]) as compared with 58% for FCM alone (13% CR, 45% PR; P = .01), with similar results in a subgroup analysis of FL (94% vs 70%) and MCL (58% vs 46%). In the total group, the R-FCM arm was significantly superior concerning progress ion-free survival (PFS; P = .0381) and overall survival (OS; P = .0030). In FL PFS was significantly longer in the R-FCM arm (P = .0139) whereas in MCL a significantly longer OS was observed (P = .0042). There were no differences in clinically relevant side effects in both study arms. Hence, the addition of rituximab to FCM chemotherapy significantly improves the outcome of relapsed or refractory FL and MCL. (C) 2004 by The American Society of Hematology.