Rituximab Maintenance Versus Observation After Immunochemotherapy (R-CHOP, R-MCP, and R-FCM) in Untreated Follicular Lymphoma Patients: A Randomized Trial of the Ostdeutsche Studiengruppe Hämatologie und Onkologie and the German Low-Grade Lymphoma Study Group

被引：0

作者：

Hirt, Carsten ^{[1
]}

Hoster, Eva ^{[2
,3
]}

Unterhalt, Michael ^{[2
]}

Haenel, Mathias ^{[4
]}

Prange-Krex, Gabriele ^{[5
]}

Forstpointner, Roswitha ^{[2
]}

Florschuetz, Axel ^{[6
]}

Graeven, Ullrich ^{[7
]}

Frickhofen, Norbert ^{[8
]}

Wulf, Gerald ^{[9
]}

Lengfelder, Eva ^{[10
]}

Lerchenmueller, Christian ^{[11
]}

Schlag, Rudolf ^{[12
]}

Dierlamm, Judith ^{[13
]}

von Weikersthal, Ludwig Fischer ^{[14
]}

Ahmed, Asima ^{[15
]}

Harich, Hanns-Detlev ^{[16
]}

Rosenwald, Andreas ^{[17
]}

Klapper, Wolfram ^{[18
]}

Dreyling, Martin ^{[2
]}

Hiddemann, Wolfgang ^{[2
]}

Herold, Michael ^{[19
]}

机构：

[1] Univ Med Greifswald, Klin Innere Med C, Greifswald, Germany

[2] Klinikum Univ Munchen, Med Klin 3, Munich, Germany

[3] LMU Univ Munchen, Inst Med Informationsverarbeitung Biometrie & Epid, Lehrstuhl Epidemiol, Munich, Germany

[4] Klinikum Chemnitz, Klin Innere Med 3, Chemnitz, Germany

[5] Gemeinschaftspraxis Innere Med, Hamatol, Onkol, Dresden, Germany

[6] Stadt Klinikum Dessau, Klin Innere Med, Dessau, Germany

[7] Kliniken Maria Hilf, Klin Hamatol Onkol & Gastroenterol, Monchengladbach, Germany

[8] Dr H Schmidt Kliniken Wiesbaden, Med Klin 3, Wiesbaden, Germany

[9] Georg August Univ Gottingen, Innere Med Hamatol Onkol, Gottingen, Germany

[10] Klinikum Mannheim, Med Klin 3, Mannheim, Germany

[11] Hamato Onkol Gemeinschaftspraxis, Munster, Germany

[12] Hamatol Onkol Schwerpunktpraxis, Wurzburg, Germany

[13] Univ Klinikum Eppendorf, Med Klin 2, Hamburg, Germany

[14] Gesundheitszentrum St Marien, Hamatol Onkol, Amberg, Germany

[15] Stadt Klinikum Braunschweig, Med Klin 3, Braunschweig, Germany

[16] Onkol Schwerpunktpraxis Hof, Hof, Germany

[17] Univ Wurzburg, Inst Pathol, Wurzburg, Germany

[18] Univ Klinikum Schleswig Holstein, Inst Hamatopathol, Kiel, Germany

[19] Helios Klinikum Erfurt, Erfurt, Germany

来源：

HEMASPHERE | 2021年 / 5卷 / 07期

关键词：

PROGRESSION-FREE SURVIVAL; SIGNIFICANTLY INCREASES; PROLONGS SURVIVAL; INITIAL TREATMENT; PHASE-III; CYCLOPHOSPHAMIDE; CHEMOTHERAPY; VINCRISTINE; PREDNISONE; THERAPY;

D O I：

暂无

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

The German study groups, the German Low-Grade Lymphoma Study Group (GLSG) and Ostdeutsche Studiengruppe Hamatologie 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, P = 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, P = 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)

引用

页数：8

共 39 条

[1] Epidemiology of the non-Hodgkin's lymphomas: Distributions of the major subtypes differ by geographic locations [J].

Anderson, JR ;

Armitage, JO ;

Weisenburger, DD .

ANNALS OF ONCOLOGY, 1998, 9 (07) :717-720

[2] Sustained Progression-Free Survival Benefit of Rituximab Maintenance in Patients With Follicular Lymphoma: Long-Term Results of the PRIMA Study [J].

Bachy, Emmanuel ;

Seymour, John F. ;

Feugier, Pierre ;

Offner, Fritz ;

Lopez-Guillermo, Armando ;

Belada, David ;

Xerri, Luc ;

Catalano, John V. ;

Brice, Pauline ;

Lemonnier, Francois ;

Martin, Alejandro ;

Casasnovas, Olivier ;

Pedersen, Lars M. ;

Dorvaux, Veronique ;

Simpson, David ;

Leppa, Sirpa ;

Gabarre, Jean ;

da Silva, Maria G. ;

Glaisner, Sylvie ;

Ysebaert, Loic ;

Vekhoff, Anne ;

Intragumtornchai, Tanin ;

Le Gouill, Steven ;

Lister, Andrew ;

Estell, Jane A. ;

Milone, Gustavo ;

Sonet, Anne ;

Farhi, Jonathan ;

Zeuner, Harald ;

Tilly, Herve ;

Salles, Gilles .

JOURNAL OF CLINICAL ONCOLOGY, 2019, 37 (31) :2815-+

[3] Transformed non-Hodgkin lymphoma in the rituximab era: analysis of the NCCN outcomes database [J].

Ban-Hoefen, Makiko ;

Vanderplas, Ann ;

Crosby-Thompson, Allison L. ;

Abel, Gregory A. ;

Czuczman, Myron S. ;

Gordon, Leo I. ;

Kaminski, Mark S. ;

Kelly, Jennifer ;

Millenson, Michael ;

Nademanee, Auayporn P. ;

Rodriguez, Maria A. ;

Zelenetz, Andrew D. ;

Niland, Joyce ;

LaCasce, Ann S. ;

Friedberg, Jonathan W. .

BRITISH JOURNAL OF HAEMATOLOGY, 2013, 163 (04) :487-495

[4] Randomized Phase 3 Study in Low-Grade Lymphoma Comparing Maintenance Anti-CD20 Antibody With Observation After Induction Therapy: A Trial of the ECOG-ACRIN Cancer Research Group (E1496) [J].

Barta, Stefan K. ;

Li, Hailun ;

Hochster, Howard S. ;

Hong, Fangxin ;

Weller, Edie ;

Gascoyne, Randy D. ;

Habermann, Thomas M. ;

Gordon, Leo I. ;

Colocci, Natalia ;

Bengtson, Elizabeth M. ;

Horning, Sandra J. ;

Kahl, Brad S. .

CANCER, 2016, 122 (19) :2996-3004

[5] Comparison in low-tumor-burden follicular lymphomas between an initial no-treatment policy, prednimustine, or interferon alfa: A randomized study from the Groupe D'Etude des Lymphomes Folliculaires [J].

Brice, P ;

Bastion, Y ;

Lepage, E ;

Brousse, N ;

Haioun, C ;

Moreau, P ;

Straetmans, N ;

Tilly, H ;

Tabah, I ;

SolalCeligny, P .

JOURNAL OF CLINICAL ONCOLOGY, 1997, 15 (03) :1110-1117

[6] Early Relapse of Follicular Lymphoma After Rituximab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone Defines Patients at High Risk for Death: An Analysis From the National LymphoCare Study [J].

Casulo, Carla ;

Byrtek, Michelle ;

Dawson, Keith L. ;

Zhou, Xiaolei ;

Farber, Charles M. ;

Flowers, Christopher R. ;

Hainsworth, John D. ;

Maurer, Matthew J. ;

Cerhan, James R. ;

Link, Brian K. ;

Zelenetz, Andrew D. ;

Friedberg, Jonathan W. .

JOURNAL OF CLINICAL ONCOLOGY, 2015, 33 (23) :2516-U55

[7]

Chan WC, 1997, BLOOD, V89, P3909

[8] Report of an international workshop to standardize response criteria for non-Hodgkin's lymphomas [J].

Cheson, BD ;

Horning, SJ ;

Coiffier, B ;

Shipp, MA ;

Fisher, RI ;

Connors, JM ;

Lister, TA ;

Vose, J ;

Grillo-López, A ;

Hagenbeek, A ;

Cabanillas, F ;

Klippensten, D ;

Hiddemann, W ;

Castellino, R ;

Harris, NL ;

Armitage, JO ;

Carter, W ;

Hoppe, R ;

Canellos, GP .

JOURNAL OF CLINICAL ONCOLOGY, 1999, 17 (04) :1244-1253

[9] Newly diagnosed and relapsed follicular lymphoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up [J].

Dreyling, M. ;

Ghielmini, M. ;

Rule, S. ;

Salles, G. ;

Vitolo, U. ;

Ladetto, M. .

ANNALS OF ONCOLOGY, 2016, 27 :v83-v90

[10] R-CVP Versus R-CHOP Versus R-FM for the Initial Treatment of Patients With Advanced-Stage Follicular Lymphoma: Results of the FOLL05 Trial Conducted by the Fondazione Italiana Linfomi [J].

Federico, Massimo ;

Luminari, Stefano ;

Dondi, Alessandra ;

Tucci, Alessandra ;

Vitolo, Umberto ;

Rigacci, Luigi ;

Di Raimondo, Francesco ;

Carella, Angelo Michele ;

Pulsoni, Alessandro ;

Merli, Francesco ;

Arcaini, Luca ;

Angrilli, Francesco ;

Stelitano, Caterina ;

Gaidano, Gianluca ;

Dell'Olio, Matteo ;

Marcheselli, Luigi ;

Franco, Vito ;

Galimberti, Sara ;

Sacchi, Stefano ;

Brugiatelli, Maura .

JOURNAL OF CLINICAL ONCOLOGY, 2013, 31 (12) :1506-1513

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