Rituximab added to first-line mitoxantrone, chlorambucil, and prednisolone chemotherapy followed by interferon maintenance prolongs survival in patients with advanced follicular lymphoma:: An East German Study Group hematology and oncology study
Rituximab added to first-line mitoxantrone, chlorambucil, and prednisolone chemotherapy followed by interferon maintenance prolongs survival in patients with advanced follicular lymphoma:: An East German Study Group hematology and oncology study
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DOI：
10.1200/jco.2006.06.4618
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发表时间：
2007-05-20
影响因子：
45.3
通讯作者：
von Gruenhagen, Ullrich
中科院分区：
文献类型：
--
作者：
Herold, Michael;Haas, Antje;von Gruenhagen, Ullrich
目的利妥昔单抗单药治疗和联合化疗治疗滤泡性淋巴瘤（FL）均有效。我们进行了一项随机试验比较米托蒽醌，苯丁酸氮芥，和泼尼松龙（MCP）化疗加利妥昔单抗与MCP单独。患者和MethodsPreviously未经治疗的患者与III期或IV期CD 20（+）惰性或套细胞淋巴瘤被随机分配到任何8个28天的周期的MCP加利妥昔单抗（R-MCP; n = 181）或8个周期的MCP单独（n = 177）。所有达到完全或部分缓解的患者均接受干扰素维持治疗，直至复发。在此，我们报告了FL患者的主要分析人群的结果，这些患者构成了试验招募的大多数患者（56%）（n = 201; R-MCP，n = 105;结果R-MCP组的总缓解率和完全缓解率明显高于MCP组（总体缓解率分别为92%和75%，- P = 0.0009;完全缓解率分别为50%和25%; P = 0.004）。中位随访时间为47个月，与MCP相比，R-MCP的中位无事件生存期（EFS）和无进展生存期（PFS）时间显著延长（EFS，分别为26个月和26个月; P
PurposeRituximab has been shown to be active in follicular lymphoma (FL), both as monotherapy and in combination with chemotherapy. We conducted a randomized trial comparing mitoxantrone, chlorambucil, and prednisolone (MCP) chemotherapy plus rituximab with MCP alone.Patients and MethodsPreviously untreated patients with stage III or IV CD20(+) indolent or mantle cell lymphoma were randomly assigned to either eight 28-day cycles of MCP plus rituximab (R-MCP; n = 181) or eight cycles of MCP alone (n = 177). All patients who achieved a complete or partial remission were treated with interferon maintenance until relapse. Herein, we report the results from the primary analysis population of patients with FL, who constituted the majority of patients (56%) recruited to the trial (n = 201; R-MCP, n = 105; MCP, n = 96).ResultsRates of overall and complete response were significantly higher in the R-MCP arm than the MCP arm (overall response, 92% v 75%, respectively,- P =.0009; complete response, 50% v 25%, respectively; P =.004). With a median follow-up time of 47 months, median event-free survival (EFS) and progression-free survival (PFS) times were significantly prolonged with R-MCP compared with MCP (EFS, not reached v 26 months, respectively; P