Tarella Corrado, Zanni Manuela, Magni Michele, Benedetti Fabio, Patti Caterina, Barbui Tiziano, Pileri Alessandro, Boccadoro Mario, Ciceri Fabio, Gallamini Andrea, Cortelazzo Sergio, Majolino Ignazio, Mirto Salvo, Corradini Paolo, Passera Roberto, Pizzolo Giovanni, Gianni Alessandro M, Rambaldi Alessandro
Dipartimento Medicina-Oncologia Sperimentale, Divisione Universitaria di Ematologia, Az. Osp. S. Giovanni Battista, Via Genova 3, 10126 Torino, Italy.
J Clin Oncol. 2008 Jul 1;26(19):3166-75. doi: 10.1200/JCO.2007.14.4204. Epub 2008 May 19.
To investigate the impact of adding rituximab to intensive chemotherapy with peripheral-blood progenitor cell (PBPC) autograft for high-risk diffuse large B-cell lymphoma (DLB-CL) and follicular lymphoma (FL).
Data were collected from 10 centers associated with Gruppo Italiano Terapie Innnovative nei Linfomi for 522 patients with DLB-CL and 223 patients with FL (median age, 47 years) who received the original or a modified high-dose sequential (HDS) chemotherapy regimen. HDS was delivered to 396 patients without (R-) and to 349 patients with (R+) rituximab; 154 (39%) and 178 patients (51%) in the R- and R+ subsets, respectively, underwent HDS for relapsed/refractory disease.
A total of 355 R- (90%) and 309 R+ patients (88%) completed the final PBPC autograft. Early treatment-related mortality was 3.3% for R- and 2.8% for R+ (P = not significant). Two parameters significantly influenced the outcome: disease status at HDS, with 5-year overall survival (OS) projections of 69% versus 57% for diagnosis versus refractory/relapsed status, respectively, and rituximab addition, with 5-year OS of 69% versus 60% in the R+ versus R- groups, respectively. In the multivariate analysis, these two variables maintained an independent prognostic value. The marked benefit of rituximab was evident in patients receiving HDS as salvage treatment: the 5-year OS projections for R+ versus R- were, respectively, 64% versus 38%, for patients with refractory disease or early relapse and 71% versus 57%, for patients with late relapse, partial response, or second/third relapse.
The results of this large series indicate that rituximab should be included in the current practice of PBPC autograft for DLB-CL and FL.
探讨在高危弥漫性大B细胞淋巴瘤(DLBCL)和滤泡性淋巴瘤(FL)患者接受外周血祖细胞(PBPC)自体移植的强化化疗中加入利妥昔单抗的影响。
收集来自意大利淋巴瘤创新治疗组相关的10个中心的522例DLBCL患者和223例FL患者(中位年龄47岁)的数据,这些患者接受了原始或改良的大剂量序贯(HDS)化疗方案。396例患者未接受利妥昔单抗(R-),349例患者接受利妥昔单抗(R+)进行HDS治疗;R-和R+亚组中分别有154例(39%)和178例(51%)患者因复发/难治性疾病接受HDS治疗。
共有355例R-患者(90%)和309例R+患者(88%)完成了最终的PBPC自体移植。R-组早期治疗相关死亡率为3.3%,R+组为2.8%(P值无统计学意义)。有两个参数对结果有显著影响:HDS时的疾病状态,诊断时5年总生存率(OS)预测为69%,难治/复发状态时为57%;以及是否加入利妥昔单抗,R+组和R-组的5年OS分别为69%和60%。在多变量分析中,这两个变量保持独立的预后价值。利妥昔单抗的显著益处在接受HDS作为挽救治疗的患者中很明显:对于难治性疾病或早期复发的患者,R+组和R-组的5年OS预测分别为64%和38%;对于晚期复发、部分缓解或第二次/第三次复发的患者,分别为71%和57%。
这个大型系列研究的结果表明,在目前DLBCL和FL患者PBPC自体移植的治疗实践中应加入利妥昔单抗。