Bortezomib-thalidomide-dexamethasone is superior to thalidomide- dexamethasone as consolidation therapy after autologous hematopoietic stem cell transplantation in patients with newly diagnosed multiple myeloma
Articolo
Data di Pubblicazione:
2012
Citazione:
Bortezomib-thalidomide-dexamethasone is superior to thalidomide- dexamethasone as consolidation therapy after autologous hematopoietic stem cell transplantation in patients with newly diagnosed multiple myeloma / Cavo, Michele; Pantani, Lucia; Petrucci, Maria Teresa; Patriarca, Francesca; Zamagni, Elena; Donnarumma, Daniela; Crippa, Claudia; Boccadoro, Mario; Perrone, Giulia; Falcone, Antonietta; Nozzoli, Chiara; Zambello, Renato; Masini, Luciano; Furlan, Anna; Brioli, Annamaria; Derudas, Daniele; Ballanti, Stelvio; Dessanti, Maria Laura; De Stefano, Valerio; Carella, Angelo Michele; Marcatti, Magda; Nozza, Andrea; Ferrara, Felicetto; Callea, Vincenzo; Califano, Catello; Pezzi, Annalisa; Baraldi, Anna; Grasso, Mariella; Musto, Pellegrino; Palumbo, ; Antonio Collaboratori: Tosi, P; Motta, Mr; Rizzi, S; Fanin, R; Buttignol, S; Foà, R; Levi, A; Calabrese, E; Rambaldi, A; Galli, M; Rossi, G; Ferrari, S; Bringhen, S; Leoni, P; Offidani, M; Polloni, C; Corradini, P; Montefusco, V; Torelli, G; Narni, Franco; Fioritoni, G; Spadano, A; Cortelazzo, S; Pescosta, N; Billio, A; Lambertenghi Deliliers, G; Baldini, L; Onida, F; Annaloro, C; La Nasa, G; Ledda, A; Zaccaria, A; Cellini, C; De Fabritiis, P; Caravita, T; Siniscalchi, A; Cascavilla, N; Bosi, A; Semenzato, G; Gugliotta, L; Merli, F; Gherlinzoni, F; Angelucci, E; Martelli, M; Petti, Mc; Pisani, F; Leone, G; Rossi, E; Za, T; Fianchi, L; Catania, G; Spriano, M; Ciceri, F; Peccatori, J; Girlanda, S; Santoro, A; Castagna, L; Palmieri, S; Nobile, F; D'Arco, Am; Levis, A; Primon, V; Tamiazzo, S; Guardigni, L; Pasini, S; Gallamini, A; Pietrantuono, G; Martorelli, Mc; Fattori, P; Pasquini, E; Galieni, P; Ruggieri, M; Morandi, S; Tajana, M; Amadori, D; Ronconi, S; Cangini, D; Ceccolini, M; Gobbi, M; Ballerini, F; Pane, F; Catalano, L; Cangialosi, C; Vallisa, D; Lazzaro, A; Paladini, G; De Sabbata, G; Mozzana, R; Ciambelli, F; Pinotti, G; Rodeghiero, F; Elice, F; Cantore, N; Volpe, S; Pavone, V; Mele, A; Pogliani, E; Rossini, F; Liberati, A; Majolino, I; De Rosa, L; Amadori, S; Rizzo, M; Lauria, F; Gozzetti, A; Aglietta, M; Capaldi, A; Quarta, G; Mele, G; Storti, S; Fraticelli, V; Morabito, F; Gentile, C; Capalbo, S; Gianni, A; Magni, M; Mettivier, V; Nunziata, G; Rizzoli, V; Giuliani, N; Crugnola, M; Bernasconi, C; Fregoni, V; Visani, G; Olivieri, A; Pizzuti, M; La Verde, G; Moscetti, A; Avvisati, G; Tirindelli, M; Longinotti, M; Podda, L; Gallo, E; Pregno, P; Dammacco, F; Perosa, F; Russo, D; Roccaro, A; Bacigalupo, A; Dominietto, A; Musolino, C; Quartarone, E.. - In: BLOOD. - ISSN 0006-4971. - 120:1(2012), pp. 9-19. [10.1182/blood-2012-02-408898]
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. © 2012 by The American Society of Hematology.
Tipologia CRIS:
Articolo su rivista
Keywords:
Antineoplastic Agents; Antineoplastic Agents, Hormonal; Antineoplastic Combined Chemotherapy Protocols; Boronic Acids; Bortezomib; Combined Modality Therapy; Dexamethasone; Disease-Free Survival; Female; Hematopoietic Stem Cell Transplantation; Humans; Immunosuppressive Agents; Kaplan-Meier Estimate; Male; Middle Aged; Multiple Myeloma; Prognosis; Pyrazines; Thalidomide; Transplantation, Autologous; Immunology; Biochemistry; Hematology; Cell Biology
Elenco autori:
Cavo, Michele; Pantani, Lucia; Petrucci, Maria Teresa; Patriarca, Francesca; Zamagni, Elena; Donnarumma, Daniela; Crippa, Claudia; Boccadoro, Mario; Perrone, Giulia; Falcone, Antonietta; Nozzoli, Chiara; Zambello, Renato; Masini, Luciano; Furlan, Anna; Brioli, Annamaria; Derudas, Daniele; Ballanti, Stelvio; Dessanti, Maria Laura; De Stefano, Valerio; Carella, Angelo Michele; Marcatti, Magda; Nozza, Andrea; Ferrara, Felicetto; Callea, Vincenzo; Califano, Catello; Pezzi, Annalisa; Baraldi, Anna; Grasso, Mariella; Musto, Pellegrino; Palumbo, ; Antonio Collaboratori: Tosi, P; Motta, Mr; Rizzi, S; Fanin, R; Buttignol, S; Foà, R; Levi, A; Calabrese, E; Rambaldi, A; Galli, M; Rossi, G; Ferrari, S; Bringhen, S; Leoni, P; Offidani, M; Polloni, C; Corradini, P; Montefusco, V; Torelli, G; Narni, Franco; Fioritoni, G; Spadano, A; Cortelazzo, S; Pescosta, N; Billio, A; Lambertenghi Deliliers, G; Baldini, L; Onida, F; Annaloro, C; La Nasa, G; Ledda, A; Zaccaria, A; Cellini, C; De Fabritiis, P; Caravita, T; Siniscalchi, A; Cascavilla, N; Bosi, A; Semenzato, G; Gugliotta, L; Merli, F; Gherlinzoni, F; Angelucci, E; Martelli, M; Petti, Mc; Pisani, F; Leone, G; Rossi, E; Za, T; Fianchi, L; Catania, G; Spriano, M; Ciceri, F; Peccatori, J; Girlanda, S; Santoro, A; Castagna, L; Palmieri, S; Nobile, F; D'Arco, Am; Levis, A; Primon, V; Tamiazzo, S; Guardigni, L; Pasini, S; Gallamini, A; Pietrantuono, G; Martorelli, Mc; Fattori, P; Pasquini, E; Galieni, P; Ruggieri, M; Morandi, S; Tajana, M; Amadori, D; Ronconi, S; Cangini, D; Ceccolini, M; Gobbi, M; Ballerini, F; Pane, F; Catalano, L; Cangialosi, C; Vallisa, D; Lazzaro, A; Paladini, G; De Sabbata, G; Mozzana, R; Ciambelli, F; Pinotti, G; Rodeghiero, F; Elice, F; Cantore, N; Volpe, S; Pavone, V; Mele, A; Pogliani, E; Rossini, F; Liberati, A; Majolino, I; De Rosa, L; Amadori, S; Rizzo, M; Lauria, F; Gozzetti, A; Aglietta, M; Capaldi, A; Quarta, G; Mele, G; Storti, S; Fraticelli, V; Morabito, F; Gentile, C; Capalbo, S; Gianni, A; Magni, M; Mettivier, V; Nunziata, G; Rizzoli, V; Giuliani, N; Crugnola, M; Bernasconi, C; Fregoni, V; Visani, G; Olivieri, A; Pizzuti, M; La Verde, G; Moscetti, A; Avvisati, G; Tirindelli, M; Longinotti, M; Podda, L; Gallo, E; Pregno, P; Dammacco, F; Perosa, F; Russo, D; Roccaro, A; Bacigalupo, A; Dominietto, A; Musolino, C; Quartarone, E.
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