Bortezomib-thalidomide-dexamethasone is superior to thalidomide-dexamethasone as consolidation therapy after autologous hematopoietic stem cell transplantation in patients with newly diagnosed multiple myeloma

被引：292

作者：

Cavo, Michele ^{[1
]}

Pantani, Lucia ^{[1
]}

Petrucci, Maria Teresa ^{[2
]}

Patriarca, Francesca ^{[3
]}

Zamagni, Elena ^{[1
]}

Donnarumma, Daniela ^{[4
]}

Crippa, Claudia ^{[5
]}

Boccadoro, Mario ^{[6
]}

Perrone, Giulia ^{[1
]}

Falcone, Antonietta ^{[7
]}

Nozzoli, Chiara ^{[8
]}

Zambello, Renato ^{[9
]}

Masini, Luciano ^{[10
]}

Furlan, Anna ^{[11
]}

Brioli, Annamaria ^{[1
]}

Derudas, Daniele ^{[12
]}

Ballanti, Stelvio ^{[13
]}

Dessanti, Maria Laura ^{[14
]}

De Stefano, Valerio ^{[15
]}

Carella, Angelo Michele ^{[16
]}

Marcatti, Magda ^{[17
]}

Nozza, Andrea ^{[18
]}

Ferrara, Felicetto ^{[19
]}

Callea, Vincenzo ^{[20
]}

Califano, Catello ^{[21
]}

Pezzi, Annalisa ^{[1
]}

Baraldi, Anna ^{[22
]}

Grasso, Mariella ^{[23
]}

Musto, Pellegrino ^{[24
]}

Palumbo, Antonio ^{[6
]}

机构：

[1] Univ Bologna, Ist Ematol Seragnoli, Policlin S Orsola Malpighi, I-40138 Bologna, Italy

[2] Univ Roma La Sapienza, Cattedra Ematol, Rome, Italy

[3] Policlin Univ, Clin Ematol, Udine, Italy

[4] Osped Ferrarotto, Cattedra Ematol, Catania, Italy

[5] Spedali Civil Brescia, Struttura Complessa Ematol & Dipartimento Oncol M, I-25125 Brescia, Italy

[6] Osped Molinette, AOU S Giovanni Battista, Unita Operat Ematol, Turin, Italy

[7] Casa Sollievo Sofferenza, Div Ematol, San Giovanni Rotondo, Italy

[8] Policlin Careggi, Cattedra Ematol, Florence, Italy

[9] Univ Padua, Dipartimento Med Clin & Sperimentale, Padua, Italy

[10] Azienda Osped ASMN, Ist Ricovero & Cura Carattere Sci, Dipartimento Oncol, Unita Ematol, Reggio Emilia, Italy

[11] Osped Ca Foncello, Treviso, Italy

[12] Osped Oncol Businco, Unita Operat Ematol, Cagliari, Italy

[13] Osped Silvestrini S Maria Misericordia, Sez Ematol & Immunol Clin, Perugia, Italy

[14] Ist Regina Elena IFO, Rome, Italy

[15] Univ Cattololica, Ist Ematol, Rome, Italy

[16] Azienda Osped Univ San Martino, Dipartimento Ematol & Oncol, Genoa, Italy

[17] Ist Sci San Raffaele, Unita Operat Ematol & Trapianto Midollo, Milan, Italy

[18] Ist Clin Humanitas, Dipartimento Oncol & Ematol, Milan, Italy

[19] Osped Cardarelli, Unita Ematol, Naples, Italy

[20] Osped Bianchi Melacrino Morelli, Unita Ematol, Reggio Di Calabria, Italy

[21] Unita Ematol, Nocera Inferiore, Italy

[22] Azienda Osped SS Antonio & Biagio & Cesare Arrigo, Alessandria, Italy

[23] Azienda Osped Santa Croce & Carle, Dipartimento Ematol & Trapianto Midollo, Cuneo, Italy

[24] Ctr Riferimento Oncol Basilicata, Ist Ricovero & Cura Carattere Sci, Rionero In Vulture, PZ, Italy

来源：

BLOOD | 2012年 / 120卷 / 01期

关键词：

HIGH-DOSE MELPHALAN; PLUS DEXAMETHASONE; MAINTENANCE THERAPY; INDUCTION TREATMENT; LENALIDOMIDE; DOXORUBICIN; CHEMOTHERAPY; SURVIVAL; PHASE-3; TRIAL;

D O I：

10.1182/blood-2012-02-408898

中图分类号：

R5 [内科学];

学科分类号：

100201 [内科学];

摘要：

In a randomized, phase 3 study, superior complete/near-complete response (CR/nCR) rates and extended progression-free survival were demonstrated with bortezomib-thalidomide-dexamethasone (VTD) versus thalidomide-dexamethasone (TD) as induction therapy before, and consolidation after, double autologous stem cell transplantation for newly diagnosed myeloma patients (intention-to-treat analysis; VTD, n = 236; TD, n = 238). This per-protocol analysis (VTD, n = 160; TD, n = 161) specifically assessed the efficacy and safety of consolidation with VTD or TD. Before starting consolidation, CR/nCR rates were not significantly different in the VTD (63.1%) and TD arms (54.7%). After consolidation, CR (60.6% vs 46.6%) and CR/nCR (73.1% vs 60.9%) rates were significantly higher for VTD-treated versus TD-treated patients. VTD consolidation significantly increased CR and CR/nCR rates, but TD did not (McNemar test). With a median follow-up of 30.4 months from start of consolidation, 3-year progression-free survival was significantly longer for the VTD group (60% vs 48% for TD). Grade 2 or 3 peripheral neuropathy (8.1% vs 2.4%) was more frequent with VTD (grade 3, 0.6%) versus TD consolidation. The superior efficacy of VTD versus TD as induction was retained despite readministration as consolidation therapy after double autologous transplantation. VTD consolidation therapy significantly contributed to improved clinical outcomes observed for patients randomly assigned to the VTD arm of the study. The study is registered at www.clinicaltrials.gov as #NCT01134484. (Blood. 2012;120(1):9-19)

引用

页码：9 / 19

页数：11

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