Hirt Carsten, Hoster Eva, Unterhalt Michael, Hänel Mathias, Prange-Krex Gabriele, Forstpointner Roswitha, Florschütz Axel, Graeven Ullrich, Frickhofen Norbert, Wulf Gerald, Lengfelder Eva, Lerchenmüller Christian, Schlag Rudolf, Dierlamm Judith, Fischer von Weikersthal Ludwig, Ahmed Asima, Harich Hanns-Detlev, Rosenwald Andreas, Klapper Wolfram, Dreyling Martin, Hiddemann Wolfgang, Herold Michael
Klinik für Innere Medizin C, Universitätsmedizin Greifswald, Germany.
Medizinische Klinik III, Klinikum der Universität München, Germany.
Hemasphere. 2021 Jun 23;5(7):e600. doi: 10.1097/HS9.0000000000000600. eCollection 2021 Jul.
The German study groups, the German Low-Grade Lymphoma Study Group (GLSG) and Ostdeutsche Studiengruppe Hämatologie und Onkologie (OSHO), initiated in 2007 a double randomized trial to investigate efficacy and safety of rituximab maintenance versus observation in remission after randomly assigned induction treatment in the first-line follicular lymphoma. Previously untreated patients with stage II-IV follicular lymphoma in need of therapy were randomized to receive 6 cycles of R-CHOP, R-MCP, or R-FCM. Responding patients were subsequently randomized to 2 years rituximab maintenance or observation, stratified by type of immunochemotherapy, quality of remission, and Follicular Lymphoma International Prognostic Index (FLIPI). Recruitment was stopped in 2011 after the PRIMA results had been published. Median age of the 206 recruited patients was 66 years (range, 24-86), and (FLIPI) was low in 13%, intermediate in 28%, and high in 60%. High and comparable overall response rates were observed after R-CHOP (88%), R-MCP (89%), and R-FCM (91%). Rituximab maintenance substantially prolonged progression-free survival (PFS) in comparison to observation in remission (hazard ratio 0.39, = 0.0064). In the rituximab maintenance group, the 3-year PFS was 89% compared with 69% in the observation group. No differences in overall survival were observed for maintenance vs. observation (hazard ratio 1.04, 95% confidence interval 0.32-3.43, = 0.95). In this randomized trial, 2 years of rituximab maintenance was associated with significantly prolonged PFS in comparison to observation after response to first-line immunochemotherapy in follicular lymphoma. Our data represent an independent confirmation of the PRIMA trial results. (Clinical Trial EudraCT Number: 2005-005473-29, 2006-09-26).
德国的研究团队，即德国低度淋巴瘤研究组（GLSG）和东德血液学与肿瘤学研究组（OSHO），于2007年发起了一项双随机试验，旨在研究在一线滤泡性淋巴瘤中，随机分配诱导治疗后，利妥昔单抗维持治疗与观察等待相比的疗效和安全性。先前未经治疗且需要治疗的II-IV期滤泡性淋巴瘤患者被随机分配接受6个周期的R-CHOP、R-MCP或R-FCM治疗。随后，缓解的患者根据免疫化疗类型、缓解质量和滤泡性淋巴瘤国际预后指数（FLIPI）进行分层，随机接受2年的利妥昔单抗维持治疗或观察等待。在PRIMA结果公布后，招募工作于2011年停止。206名招募患者的中位年龄为66岁（范围24-86岁），FLIPI低危的占13%，中危的占28%，高危的占60%。R-CHOP（88%）、R-MCP（89%）和R-FCM（91%）治疗后的总缓解率高且相当。与缓解期观察相比，利妥昔单抗维持治疗显著延长了无进展生存期（PFS）（风险比0.39，P = 0.0064）。在利妥昔单抗维持治疗组中，3年PFS为89%，而观察组为69%。维持治疗与观察等待在总生存期方面未观察到差异（风险比1.04，95%置信区间0.32-3.43，P = 0.95）。在这项随机试验中，与滤泡性淋巴瘤一线免疫化疗缓解后观察等待相比，2年的利妥昔单抗维持治疗与显著延长的PFS相关。我们的数据是对PRIMA试验结果的独立验证。（临床试验EudraCT编号：2005-005473-29，2006-09-26）
