VTD is superior to VCD prior to intensive therapy in multiple myeloma: results of the prospective IFM2013-04 trial

被引：222

作者：

Moreau, Philippe ^{[1
]}

Hulin, Cyrille ^{[2
]}

Macro, Margaret ^{[3
]}

Caillot, Denis ^{[4
]}

Chaleteix, Carine ^{[5
]}

Roussel, Murielle ^{[6
]}

Garderet, Laurent ^{[7
]}

Royer, Bruno ^{[8
]}

Brechignac, Sabine ^{[9
]}

Tiab, Mourad ^{[10
]}

Puyade, Mathieu ^{[11
]}

Escoffre, Martine ^{[12
]}

Stoppa, Anne-Marie ^{[13
]}

Facon, Thierry ^{[14
]}

Pegourie, Brigitte ^{[15
]}

Chaoui, Driss ^{[16
]}

Jaccard, Arnaud ^{[17
]}

Slama, Borhane ^{[18
]}

Marit, Gerald ^{[2
]}

Laribi, Karim ^{[19
]}

Godmer, Pascal ^{[20
]}

Luycx, Odile ^{[21
]}

Eisenmann, Jean-Claude ^{[22
]}

Allangba, Olivier ^{[23
]}

Dib, Mamoun ^{[24
]}

Araujo, Carla ^{[25
]}

Fontan, Jean ^{[26
]}

Belhadj, Karim ^{[27
]}

Wetterwald, Marc ^{[28
]}

Dorvaux, Veronique ^{[29
]}

Fermand, Jean-Paul ^{[30
]}

Rodon, Philippe ^{[31
]}

Kolb, Brigitte ^{[32
]}

Glaisner, Sylvie ^{[33
]}

Malfuson, Jean-Valere ^{[34
]}

Lenain, Pascal ^{[35
]}

Biron, Laetitia ^{[1
]}

Planche, Lucie ^{[1
]}

Caillon, Helene ^{[1
]}

Avet-Loiseau, Herve ^{[6
]}

Dejoie, Thomas ^{[1
]}

Attal, Michel ^{[6
]}

机构：

[1] Univ Hosp, Pl Alexis Ricordeau, F-44093 Nantes, France

[2] Univ Hosp, Bordeaux, France

[3] Univ Hosp, Caen, France

[4] Univ Hosp, Dijon, France

[5] Univ Hosp, Clermont Ferrand, France

[6] Inst Univ Canc Toulouse Oncopole, Toulouse, France

[7] Univ Hosp St Antoine, Paris, France

[8] Univ Hosp, Amiens, France

[9] Univ Hosp Avicenne, Bobigny, France

[10] Ctr Hosp Dept, La Roche Sur Yon, France

[11] Univ Hosp, Poitiers, France

[12] Univ Hosp, Rennes, France

[13] Inst J Paoli I Calmettes, F-13009 Marseille, France

[14] Univ Hosp, Lille, France

[15] Univ Hosp, Grenoble, France

[16] Ctr Hosp Dept, Argenteuil, France

[17] Univ Hosp, Limoges, France

[18] Ctr Hosp Dept, Avignon, France

[19] Ctr Hosp Dept, Le Mans, France

[20] Ctr Hosp Dept, Vannes, France

[21] Ctr Hosp Dept, Lorient, France

[22] Ctr Hosp Dept, Mulhouse, France

[23] Ctr Hosp Dept, St Brieuc, France

[24] Univ Hosp, Angers, France

[25] Ctr Hosp Dept, Bayonne, France

[26] Univ Hosp, Besancon, France

[27] Univ Hosp, Creteil, France

[28] Ctr Hosp Dept, Dunkerque, France

[29] Univ Hosp, Metz, France

[30] St Louis Univ Hosp, Paris, France

[31] Ctr Hosp Dept, Perigueux, France

[32] Univ Hosp, Reims, France

[33] Inst Curie, Paris, France

[34] Hop Armees, Clamart, France

[35] Ctr Henri Becquerel, F-76038 Rouen, France

来源：

BLOOD | 2016年 / 127卷 / 21期

关键词：

STEM-CELL TRANSPLANTATION; THALIDOMIDE PLUS DEXAMETHASONE; INDUCTION TREATMENT; PHASE-II; BORTEZOMIB; CYCLOPHOSPHAMIDE; LENALIDOMIDE; COMBINATION;

D O I：

10.1182/blood-2016-01-693580

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

The Intergroupe Francophone du Myelome conducted a randomized trial to compare bortezomib-thalidomide-dexamethasone (VTD) with bortezomib-cyclophosphamide-dexamethasone (VCD) as induction before high-dose therapy and autologous stem cell transplantation (ASCT) in patients with newly diagnosed multiple myeloma. Overall, a total of 340 patients were centrally randomly assigned to receive VTD or VCD. After 4 cycles, on an intent-to-treat basis, 66.3% of the patients in the VTD arm achieved at least a very good partial response (primary end point) vs 56.2% in the VCD arm (P = .05). In addition, the overall response rate was significantly higher in the VTD arm (92.3% vs 83.4% in the VCD arm; P = .01). Hematologic toxicity was higher in the VCD arm, with significantly increased rates of grade 3 and 4 anemia, thrombocytopenia, and neutropenia. On the other hand, the rate of peripheral neuropathy (PN) was significantly higher in the VTD arm. With the exception of hematologic adverse events and PN, other grade 3 or 4 toxicities were rare, with no significant differences between the VTD and VCD arms. Our data support the preferential use of VTD rather than VCD in preparation for ASCT. This trial was registered at www.clinicaltrials.gov as #NCT01564537 and at EudraCT as #2013-003174-27.

引用

页码：2569 / 2574

页数：6

共 21 条

[1] Multiple Myeloma, Version 2.2016 [J].

Anderson, Kenneth C. ;

Alsina, Melissa ;

Atanackovic, Djordje ;

Biermann, J. Sybil ;

Chandler, Jason C. ;

Costello, Caitlin ;

Djulbegovic, Benjamin ;

Fung, Henry C. ;

Gasparetto, Cristina ;

Godby, Kelly ;

Hofmeister, Craig ;

Holmberg, Leona ;

Holstein, Sarah ;

Huff, Carol Ann ;

Kassim, Adetola ;

Krishnan, Amrita Y. ;

Kumar, Shaji K. ;

Liedtke, Michaela ;

Lunning, Matthew ;

Raje, Noopur ;

Singhal, Seema ;

Smith, Clayton ;

Somlo, George ;

Stockerl-Goldstein, Keith ;

Treon, Steven P. ;

Weber, Donna ;

Yahalom, Joachim ;

Shead, Dorothy A. ;

Kumar, Rashmi .

JOURNAL OF THE NATIONAL COMPREHENSIVE CANCER NETWORK, 2015, 13 (11) :1398-1435

[2]

Attal M, 2015, BLOOD, V126

[3] Predictors of early response to initial therapy in patients with newly diagnosed symptomatic multiple myeloma [J].

Binder, Moritz ;

Rajkumar, S. Vincent ;

Gertz, Morie A. ;

Lacy, Martha Q. ;

Dispenzieri, Angela ;

Buadi, Francis K. ;

Dingli, David ;

Hayman, Suzanne R. ;

Lust, John A. ;

Kapoor, Prashant ;

Lin, Yi ;

Go, Ronald S. ;

Hwa, Yi L. ;

Kyle, Robert A. ;

Kumar, Shaji K. .

AMERICAN JOURNAL OF HEMATOLOGY, 2015, 90 (10) :888-891

[4] Bortezomib-thalidomide-dexamethasone (VTD) is superior to bortezomib-cyclophosphamide-dexamethasone (VCD) as induction therapy prior to autologous stem cell transplantation in multiple myeloma [J].

Cavo, M. ;

Pantani, L. ;

Pezzi, A. ;

Petrucci, M. T. ;

Patriarca, F. ;

Di Raimondo, F. ;

Marzocchi, G. ;

Galli, M. ;

Montefusco, V. ;

Zamagni, E. ;

Gamberi, B. ;

Tacchetti, P. ;

Brioli, A. ;

Palumbo, A. ;

Sonneveld, P. .

LEUKEMIA, 2015, 29 (12) :2429-2431

[5] International Myeloma Working Group consensus approach to the treatment of multiple myeloma patients who are candidates for autologous stem cell transplantation [J].

Cavo, Michele ;

Rajkumar, S. Vincent ;

Palumbo, Antonio ;

Moreau, Philippe ;

Orlowski, Robert ;

Blade, Joan ;

Sezer, Orhan ;

Ludwig, Heinz ;

Dimopoulos, Meletios A. ;

Attal, Michel ;

Sonneveld, Pieter ;

Boccadoro, Mario ;

Anderson, Kenneth C. ;

Richardson, Paul G. ;

Bensinger, William ;

Johnsen, Hans E. ;

Kroeger, Nicolaus ;

Gahrton, Gosta ;

Bergsagel, P. Leif ;

Vesole, David H. ;

Einsele, Hermann ;

Jagannath, Sundar ;

Niesvizky, Ruben ;

Durie, Brian G. M. ;

San Miguel, Jesus ;

Lonial, Sagar .

BLOOD, 2011, 117 (23) :6063-6073

[6] Bortezomib with thalidomide plus dexamethasone compared with thalidomide plus dexamethasone as induction therapy before, and consolidation therapy after, double autologous stem-cell transplantation in newly diagnosed multiple myeloma: a randomised phase 3 study [J].

Cavo, Michele ;

Tacchetti, Paola ;

Patriarca, Francesca ;

Petrucci, Maria Teresa ;

Pantani, Lucia ;

Galli, Monica ;

Di Raimondo, Francesco ;

Crippa, Claudia ;

Zamagni, Elena ;

Palumbo, Antonio ;

Offidani, Massimo ;

Corradini, Paolo ;

Narni, Franco ;

Spadano, Antonio ;

Pescosta, Norbert ;

Deliliers, Giorgio Lambertenghi ;

Ledda, Antonio ;

Cellini, Claudia ;

Caravita, Tommaso ;

Tosi, Patrizia ;

Baccarani, Michele .

LANCET, 2010, 376 (9758) :2075-2085

[7] How we manage autologous stem cell transplantation for patients with multiple myeloma [J].

Gertz, Morie A. ;

Dingli, David .

BLOOD, 2014, 124 (06) :882-890

[8] A comparison of lenalidomide/dexamethasone versus cyclophosphamide/lenalidomide/dexamethasone versus cyclophosphamide/bortezomib/dexamethasone in newly diagnosed multiple myeloma [J].

Khan, Meaghan L. ;

Reeder, Craig B. ;

Kumar, Shaji K. ;

Lacy, Marthy Q. ;

Reece, Donna E. ;

Dispenzieri, Angela ;

Gertz, Morie A. ;

Greipp, Phillip ;

Hayman, Suzanne ;

Zeldenhurst, Steven ;

Dingli, David ;

Lust, John ;

Russell, Stephen ;

Laumann, Kristina M. ;

Mikhael, Joseph R. ;

Bergsagel, P. Leif ;

Fonseca, Rafael ;

Rajkumar, S. Vincent ;

Stewart, A. Keith .

BRITISH JOURNAL OF HAEMATOLOGY, 2012, 156 (03) :326-333

[9] Randomized, multicenter, phase 2 study (EVOLUTION) of combinations of bortezomib, dexamethasone, cyclophosphamide, and lenalidomide in previously untreated multiple myeloma [J].

Kumar, Shaji ;

Flinn, Ian ;

Richardson, Paul G. ;

Hari, Parameswaran ;

Callander, Natalie ;

Noga, Stephen J. ;

Stewart, A. Keith ;

Turturro, Francesco ;

Rifkin, Robert ;

Wolf, Jeffrey ;

Estevam, Jose ;

Mulligan, George ;

Shi, Hongliang ;

Webb, Iain J. ;

Rajkumar, S. Vincent .

BLOOD, 2012, 119 (19) :4375-4382

[10] Phase III trial of bortezomib, cyclophosphamide and dexamethasone (VCD) versus bortezomib, doxorubicin and dexamethasone (PAd) in newly diagnosed myeloma [J].

Mai, E. K. ;

Bertsch, U. ;

Duerig, J. ;

Kunz, C. ;

Haenel, M. ;

Blau, I. W. ;

Munder, M. ;

Jauch, A. ;

Schurich, B. ;

Hielscher, T. ;

Merz, M. ;

Huegle-Doerr, B. ;

Seckinger, A. ;

Hose, D. ;

Hillengass, J. ;

Raab, M. S. ;

Neben, K. ;

Lindemann, H-W ;

Zeis, M. ;

Gerecke, C. ;

Schmidt-Wolf, I. G. H. ;

Weisel, K. ;

Scheid, C. ;

Salwender, H. ;

Goldschmidt, H. .

LEUKEMIA, 2015, 29 (08) :1721-1729

← 1 2 3 →