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

Blood - Tập 120 - Trang 9-19 - 2012
Michele Cavo1, Lucia Pantani1, Maria Teresa Petrucci2, Francesca Patriarca3, Elena Zamagni1, Daniela Donnarumma4, Claudia Crippa5, Mario Boccadoro6, Giulia Perrone1, Antonietta Falcone7, Chiara Nozzoli8, Renato Zambello9, Luciano Masini10, Anna Furlan11, Annamaria Brioli1, Daniele Derudas12, Stelvio Ballanti13, Maria Laura Dessanti14, Valerio De Stefano15, Angelo Michele Carella16
1Istituto di Ematologia Seràgnoli, Università degli Studi di Bologna, Policlinico S. Orsola-Malpighi, Bologna, Italy
2Cattedra di Ematologia, Università La Sapienza, Roma, Italy
3Clinica Ematologica, Policlinico Universitario, Udine, Italy
4Cattedra di Ematologia, Ospedale Ferrarotto, Catania, Italy
5Struttura Complessa di Ematologia e Dipartimento di Oncologia Medica, Spedali Civili, Brescia, Italy
6Unità Operativa di Ematologia, AOU S. Giovanni Battista, Ospedale Molinette, Torino, Italy
7Divisione di Ematologia, Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy
8Cattedra di Ematologia, Policlinico Careggi, Firenze, Italy
9Dipartimento di Medicina Clinica e Sperimentale, Università degli Studi di Padova, Padova, Italy
10Unità di Ematologia, Dipartimento di Oncologia, Azienda Ospedaliera ASMN, Istituto di Ricovero e Cura a Carattere Scientifico, Reggio Emilia, Italy
11Struttura Complessa di Ematologia, Ospedale Ca' Foncello, Treviso, Italy
12Unità Operativa di Ematologia, Ospedale Oncologico Businco, Cagliari, Italy
13Sezione di Ematologia ed Immunologia Clinica, Ospedale Silvestrini S. Maria della Misericordia, Perugia, Italy
14Struttura Complessa di Ematologia, Istituto Regina Elena-IFO, Roma, Italy
15Istituto di Ematologia, Università Cattolica, Roma, Italy
16Dipartimento di Ematologia e Oncologia, Azienda Ospedaliera Universitaria San Martino, Genova, Italy

Tóm tắt

Abstract 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.

Tài liệu tham khảo

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