Rituximab Maintenance Therapy After Autologous Stem-Cell Transplantation in Patients With Relapsed CD20+ Diffuse Large B-Cell Lymphoma: Final Analysis of the Collaborative Trial in Relapsed Aggressive Lymphoma

被引：207

作者：

Gisselbrecht, Christian ^{[1
]}

Schmitz, Norbert ^{[6
]}

Mounier, Nicolas ^{[2
]}

Gill, Devinder Singh ^{[9
]}

Linch, David C. ^{[12
]}

Trneny, Marek ^{[14
]}

Bosly, Andre ^{[15
]}

Milpied, Noel J. ^{[3
]}

Radford, John ^{[13
]}

Ketterer, Nicolas ^{[16
]}

Shpilberg, Ofer ^{[17
]}

Duehrsen, Ulrich ^{[7
]}

Hagberg, Hans ^{[18
]}

Ma, David D. ^{[10
]}

Viardot, Andreas ^{[8
]}

Lowenthal, Ray ^{[11
]}

Briere, Josette ^{[1
]}

Salles, Gilles ^{[4
,5
]}

Moskowitz, Craig H. ^{[19
]}

Glass, Bertram ^{[6
]}

机构：

[1] Hop St Louis, F-75010 Paris, France

[2] Ctr Hosp Univ Archet, Nice, France

[3] Hop Haut Leveque, Pessac, France

[4] Hosp Civils Lyon, Lyon, France

[5] Univ Lyon, Lyon, France

[6] Asklepios Klin St Georg, Hamburg, Germany

[7] Univ Klinikum Essen, Essen, Germany

[8] Univ Klin Ulm, Ulm, Germany

[9] Princess Alexandra Hosp, Woodville, SA, Australia

[10] St Vincents Hosp Sydney, Darlinghurst, NSW, Australia

[11] Royal Hobart Hosp, Hobart, Tas, Australia

[12] UCL, Inst Canc, London, England

[13] Univ Manchester, Christie Hosp Natl Hlth Serv Trust, Manchester, Lancs, England

[14] Charles Univ Prague, Gen Hosp, Prague, Czech Republic

[15] Univ Catholique Louvain Mt Godinne, Yvoir, Belgium

[16] Clin Bois Cerf, Lausanne, Switzerland

[17] Beilinson Med Ctr, Rabin Med Ctr, Davidoff Ctr, Petah Tiqwa, Israel

[18] Uppsala Univ, Akad Sjukhuset, Uppsala, Sweden

[19] Mem Sloan Kettering Canc Ctr, New York, NY 10021 USA

来源：

JOURNAL OF CLINICAL ONCOLOGY | 2012年 / 30卷 / 36期

关键词：

NON-HODGKINS-LYMPHOMA; BONE-MARROW TRANSPLANTATION; CHEMOTHERAPY PLUS RITUXIMAB; RANDOMIZED CONTROLLED-TRIAL; ELDERLY-PATIENTS; SALVAGE THERAPY; CHOP CHEMOTHERAPY; DES-LYMPHOMES; R-CHOP; SURVIVAL;

D O I：

10.1200/JCO.2012.41.9416

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Purpose The standard treatment for relapsed diffuse large B-cell lymphoma (DLBCL) is salvage chemotherapy followed by high-dose therapy and autologous stem-cell transplantation (ASCT). The impact of maintenance rituximab after ASCT is not known. Patients and Methods In total, 477 patients with CD20(+) DLBCL who were in their first relapse or refractory to initial therapy were randomly assigned to one of two salvage regimens. After three cycles of salvage chemotherapy, the responding patients received high-dose chemotherapy followed by ASCT. Then, 242 patients were randomly assigned to either rituximab every 2 months for 1 year or observation. Results After ASCT, 122 patients received rituximab, and 120 patients were observed only. The median follow-up time was 44 months. The 4-year event-free survival (EFS) rates after ASCT were 52% and 53% for the rituximab and observation groups, respectively (P=.7). Treatment with rituximab was associated with a 15% attributable risk of serious adverse events after day 100, with more deaths (six deaths v three deaths in the observation arm). Several factors affected EFS after ASCT (P<.05), including relapsed disease within 12 months (EFS: 46% v 56% for relapsed disease after 12 months), secondary age-adjusted International Prognostic Index (saaIPI) more than 1 (EFS: 37% v 61% for saaIPI < 1), and prior treatment with rituximab (EFS: 47% v 59% for no prior rituximab). A significant difference in EFS between women (63%) and men (46%) was also observed in the rituximab group. In the Cox model for maintenance, the saaIPI was a significant prognostic factor (P<.001), as was male sex (P=.01). Conclusion In relapsed DLBCL, we observed no difference between the control group and the rituximab maintenance group and do not recommend rituximab after ASCT. J Clin Oncol 30:4462-4469. (C) 2012 by American Society of Clinical Oncology

引用

页码：4462 / 4469

页数：8

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