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

Author

Cavo, M, Pantani, L, Petrucci, M, Patriarca, F, Zamagni, E, Donnarumma, D, Crippa, C, Boccadoro, M, Perrone, G, Falcone, A, Nozzoli, C, Zambello, R, Masini, L, Furlan, A, Brioli, A, Derudas, D, Ballanti, S, Dessanti, M, De Stefano, V, Carella, A, Marcatti, M, Nozza, A, Ferrara, F, Callea, V, Califano, C, Pezzi, A, Baraldi, A, Grasso, M, Musto, P, Palumbo, A, Tosi, P, Motta, M, 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, F, 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, M, 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, A, Levis, A, Primon, V, Tamiazzo, S, Guardigni, L, Pasini, S, Gallamini, A, Pietrantuono, G, Martorelli, M, 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, 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 F, 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, ENRICO MARIA, 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., Cavo, M, Pantani, L, Petrucci, M, Patriarca, F, Zamagni, E, Donnarumma, D, Crippa, C, Boccadoro, M, Perrone, G, Falcone, A, Nozzoli, C, Zambello, R, Masini, L, Furlan, A, Brioli, A, Derudas, D, Ballanti, S, Dessanti, M, De Stefano, V, Carella, A, Marcatti, M, Nozza, A, Ferrara, F, Callea, V, Califano, C, Pezzi, A, Baraldi, A, Grasso, M, Musto, P, Palumbo, A, Tosi, P, Motta, M, 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, F, 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, M, 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, A, Levis, A, Primon, V, Tamiazzo, S, Guardigni, L, Pasini, S, Gallamini, A, Pietrantuono, G, Martorelli, M, 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, 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 F, 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, ENRICO MARIA, 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, and Quartarone E.

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.

Published
2012

5. Systematic review of purine analog treatment for chronic lymphocytic leukemia: lessons for future trials

Author

Bauduer, M., Gribben, J., Herrmann, R., Thiel, E., Rai, K., Larson, R., Ferrara, F., Barnard, J., Pearce, H., Taylor, C., Brillant, B., Steurer, M., Weingart, O., Flinn, W., Funkhouser, A., Nallman, M., Sun, Z., Jakšić, Branimir, Suciou, S., Chevret, S., Dighiero, G., Leporrier, M., Frankel, S.R., Sirard, C., Hillmen, P., Trehu, B., Felder, M., Busch, R., Eichorst, B., Mallek, M., Stilgenbauer, S., Pangalis, G., Bezares, R., van Oers, M.H.J., van Putten, W., Gobbi, M., Spriano, M., Mabed, M., Catovsky, D., Richards, S., Wade, R., Abdelhamid, T., Dearden, C., Knauf, W., Blonski, J., Jamroziak, K., Robak, T., Mauro, F., Hiddeman, W., Johnson, S.A., Longthorne, G., Rummel, M.J., Juliusson, G., Pulluqui, P., Zinzani, P.L., Pozzato, G., Reynolds, C, Furman, R.R., Durrant, J., Elphinstone, P., Evans, V., Gettins, .L, Hicks, C., James, S., Clarke, M., MacKinnon, L., McHugh, T.M., Morris, P., Read, S., Gregory, C., Pozzato, Gabriele, Bauduer M, Gribben J, Herrmann R, Thiel E, Rai K, Larson R, Ferrara F, Barnard J, Pearce H, Taylor C, Brillant C, Steurer M, Weingart O, Flinn IW, Funkhouser A, Tallman M, Sun Z, Jaksic B, Suciu S, Chevret S, Dighiero G, Leporrier M, Frankel SR, Sirard C, Hillmen P, Trehu B, Felder M, Busch R, Eichhorst B, Hallek M, Stilgenbauer S, Pangalis G, Bezares R, van Oers MH, van Putten W, Gobbi M, Spriano M, Mabed M, Catovsky D, Richards S, Wade R, Abdelhamid T, Dearden C, Knauf W, Blonski J, Jamroziak K, Robak T, Mauro F, Hiddeman W, Johnson SA, Longthorne G, Juliusson G, Pulluqi P, Zinzani PL, Pozzato G, Oncology US, Reynolds C, Furman RR, Durrant J, Elphinstone P, Evans V, Gettins L, Hicks C, James S, Clarke M, MacKinnon L, McHugh TM, Morris P, Read S, and Gregory C. CLL Trialists’ Collaborative Group

Subjects
Oncology, medicine.medical_specialty, review, Purine analogue, chronic lymphocytic leukemia, fludarabine, clinical trial, Pharmacology, Disease-Free Survival, combination therapy, purine analog, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, Medicine, Humans, Progression-free survival, Cladribine, Antineoplastic Agents, Alkylating, Chlorambucil, business.industry, Hematology, Odds ratio, Leukemia, Lymphocytic, Chronic, B-Cell, Fludarabine, Clinical trial, Treatment Outcome, CLL, cyclophosphamide, Purines, Original Articles and Brief Reports, business, Untreated Chronic Lymphocytic Leukemia, medicine.drug
Abstract

Background. A systematic review of purine analogs revealed heterogeneity between trials in treatment effects on response and progression free survival, but not survival, perhaps partly due to variations in analysis methods. In addition, combination treatments required evaluation. Design and Methods. Individual patient data were sought for all randomized trials in untreated chronic lymphocytic leukemia which involved a purine analog, but not including antibody therapies. Results. Sixteen trials were found, addressing seven comparisons. Eight trials, with 2753 patients, showed that single agent purine analog improved progression free survival (Odds ratio = 0.71; 95% confidence interval =0.63-0.79). Heterogeneity remained substantial. Three trials, with 1403 patients, showed that progression free survival was further improved by the addition of cyclophosphamide (Odds ratio = 0.54; 0.47-0.62). Fewer data were available on the addition of other drugs to purine analog, and none showed clear benefit. Two trials, with 544 patients, suggested cladribine improved progression free survival compared to fludarabine (Odds ratio = 0.77; 0.63-0.95). No differences were seen in overall survival for any comparisons. Conclusions. Purine analogs, particularly combined with cyclophosphamide, significantly improve progression free survival but not survival. Some groups, such as the elderly, may not see the same benefits and maximising doses may be important for all treatments, including chlorambucil. Longer follow-up, consistent definitions and detailed reporting of trials should be encouraged.

Published
2012

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

Author

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., Cavo M, Pantani L, Petrucci MT, Patriarca F, Zamagni E, Donnarumma D, Crippa C, Boccadoro M, Perrone G, Falcone A, Nozzoli C, Zambello R, Masini L, Furlan A, Brioli A, Derudas D, Ballanti S, Dessanti ML, De Stefano V, Carella AM, Marcatti M, Nozza A, Ferrara F, Callea V, Califano C, Pezzi A, Baraldi A, Grasso M, Musto P, Palumbo A., 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, Cavo, M, Pantani, L, Petrucci, M, Patriarca, F, Zamagni, E, Donnarumma, D, Crippa, C, Boccadoro, M, Perrone, G, Falcone, A, Nozzoli, C, Zambello, R, Masini, L, Furlan, A, Brioli, A, Derudas, D, Ballanti, S, Dessanti, M, De Stefano, V, Carella, A, Marcatti, M, Nozza, A, Ferrara, F, Callea, V, Califano, C, Pezzi, A, Baraldi, A, Grasso, M, Musto, P, Palumbo, A, Tosi, P, Motta, M, 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, F, 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, M, 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, A, Levis, A, Primon, V, Tamiazzo, S, Guardigni, L, Pasini, S, Gallamini, A, Pietrantuono, G, Martorelli, M, 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, and Quartarone, E

Subjects
Male, Boronic Acid, medicine.medical_treatment, PLUS DEXAMETHASONE, Phases of clinical research, Kaplan-Meier Estimate, Hematopoietic stem cell transplantation, Biochemistry, Antineoplastic Agent, Bortezomib-thalidomide-dexamethasone, Bortezomib, Immunosuppressive Agent, Autologous stem-cell transplantation, MULTIPLE MYELOMA, Antineoplastic Combined Chemotherapy Protocols, thalidomide-dexamethasone, Multiple myeloma, RANDOMIZED PHASE-3, LENALIDOMIDE, STEM CELL TRANSPLANTATION, Hematopoietic Stem Cell Transplantation, PHASE-III TRIAL, Hematology, Middle Aged, CHEMOTHERAPY, Prognosis, Boronic Acids, Combined Modality Therapy, Thalidomide, Transplantation, Autologou, Pyrazines, HIGH-DOSE MELPHALAN, INDUCTION TREATMENT, Female, Autologous, Immunosuppressive Agents, Pyrazine, Human, medicine.drug, MAINTENANCE THERAPY, medicine.medical_specialty, DOXORUBICIN, Antineoplastic Agents, Hormonal, Prognosi, Immunology, Urology, Antineoplastic Agents, dexamethasone, Transplantation, Autologous, Disease-Free Survival, Dexamethasone, Humans, Multiple Myeloma, Cell Biology, medicine, Autologous transplantation, METAANALYSIS, Transplantation, Antineoplastic Combined Chemotherapy Protocol, Hormonal, business.industry, medicine.disease, Surgery, business, Settore MED/15 - Malattie del Sangue
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.

Published
2012

7. Anagrelide in Essential Thrombocythemia: a retrospettive study'

Author

GUGLIOTTA L., GROSSI A., MAZZUCCONI M. G., BULGARELLI S., BEGGI C., LISO V., SPECCHIOA G., COSER P., AMATO, BRUNO, ANGELUCCI E., DI TUCCI A., SCIORIO A., GIUSTOLISI R., CACCIOLA E., CACCIOLA R., IULIANO F., GIORDANO M., BOSI A., BALESTRI F., GHIO R., BALLEARI E., SPRIANO M., SACCHI S., MARCHESELLI R., ROTOLI B., CIANCIA R., GAIDANO G., CONCONI A., RIZZOLI V., CRUGNOLA M., TRINGALI S., BALDUINI C., NORIS P., MARTELLI M., TABILIO A., LIBERATI A. M., GERMANI A., ANDRIANI A., LAURIA F., GENTILI S., CARELLA A. M., SCALZULLI P. R., BOCCADORO M., CIOCCA VASINO A., FANIN R., CANDONI A., PIZZOLO G., AMBROSETTI A., ZANOTTI R., COMUNICAZIONE ORALE, HAEMATHOLOGICA, ABSTRACT VOL SUPPL N. RO, PAG, OTTOBRE, AMATO B., MARTINELLI, VINCENZO, Gugliotta, L., Grossi, A., Mazzucconi, M. G., Bulgarelli, S., Beggi, C., Liso, V., Specchioa, G., Coser, P., Amato, Bruno, Angelucci, E., DI TUCCI, A., Sciorio, A., Giustolisi, R., Cacciola, E., Cacciola, R., Iuliano, F., Giordano, M., Bosi, A., Balestri, F., Ghio, R., Balleari, E., Spriano, M., Sacchi, S., Marcheselli, R., Rotoli, B., Martinelli, Vincenzo, Ciancia, R., Gaidano, G., Conconi, A., Rizzoli, V., Crugnola, M., Tringali, S., Balduini, C., Noris, P., Martelli, M., Tabilio, A., Liberati, A. M., Germani, A., Andriani, A., Lauria, F., Gentili, S., Carella, A. M., Scalzulli, P. R., Boccadoro, M., CIOCCA VASINO, A., Fanin, R., Candoni, A., Pizzolo, G., Ambrosetti, A., Zanotti, R., Comunicazione, Orale, Haemathologica, ABSTRACT VOL SUPPL N., Ro, Pag, Ottobre, and Amato, B.

Abstract

COMUNICAZIONE ORALE HAEMATHOLOGICA, (ABSTRACT) VOL 88 (SUPPL) N.RO 15

Published
2003

9. A PROSPECTIVE RANDOMIZED TRIAL OF BORTEZOMIB-MELPHALANPREDNISONE-THALIDOMIDE FOLLOWED BY CONTINUOUS BORTEZOMIB-THALIDOMIDE FOR INITIAL THERAPY OF MULTIPLE MYELOMA:EFFECT OF AGE AND CO-MORBIDITIES

Author

Palumbo, Antonio, Bringhen, S., Rossi, D., Cavalli, M., Ria, R., Offidani, M., Nozzoli, C., Baldini, L., De Rosa, L., De Sabbata, G., Liberati, Am, Crippa, C., Ciambelli, F., Callea, V., Spriano, M., Ferrara, F., Elice, F., Galli, M., Peccatori, J., Catalano, L., Rizzo, M., Marasca, R., Pisani, F., Cavo, M., Petrucci, M., Musto, P., Omedè, P., Larocca, Alessandra, Gaidano, G., and Boccadoro, Mario

Published
2010

10. A Prospective Randomized Trial of Bortezomib-melphalan-prednisone-thalidomide Followed By Continuous Bortezomib-thalidomide For Initial Therapy of Multiple Myeloma: Effect of Age and Co-morbidities

Author

Palumbo, A., Bringhen, S., Rossi, D., Cavalli, M., Ria, R., Offidani, M., Nozzoli, C., Baldini, L., Rosa, L. D., Sabbata, G. D., Liberati, Anna Marina, Crippa, C., Ciambelli, F., Callea, V., Spriano, M., Ferrara, F., Elice, F., Galli, M., Peccatori, J., Catalano, L., Rizzo, M., Marasca, R., Pisani, F., Cavo, M., Petrucci, M., Musto, P., Omede, P., Larocca, A., Gaidano, G., and Boccadoro, M.

Published
2010

11. BISPHOSPHONATES (BP) RELATED OSTEONECROSIS OF THE JAW (ONJ): A LONG TERM FOLLOW UP (FU) OF A SERIES OF 35 CASES OBSERVED BY GISL

Author

Samantha Pozzi, Marcheselli, R., Sacchi, S., Baldini, L., Angrilli, F., Falorio, S., Ouarta, G., Stelitano, C., Caparotti, G., Luminari, S., Falcone, A., Natale, D., Broglia, Ch, Cuoghi, A., Dini, D., Ditonno, P., Leonardi, G., Pianezze, G., Pitini, V., Polimeno, G., Ponchio, L., Masini, L., Maurizio, M., Spriano, M., and Musto, P.

Subjects
BISPHOSPHONATES
Published
2008

15. Anagrelide in essential thrombocythemia: a retrospective analysis of 220 patients

Author

Gugliotta, L., Grossi, A., Mazzucconi, M. G., Bulgarelli, S., Gamberi, B., Imovilli, A., Ba, F., Lestri, Liso, V., Specchia, G., Scalzulli, P. R., Liberati, A. M., Bassetti, A., Angelucci, E., A, Tucci, Di, Iuliano, F., Gaidano, G., Conconi, A. R., Cacciola, E., Cacciola, Rossella Rosaria, Spriano, M., Prugnola, M., Tabilio, A., Balduini, C., Noris, P., Amato, B., Candoni, A., Balleari, E., Sacchi, S, Ambrosetti, A., Canotti, R., Giordano, M., Andriani, A., Sciorino, A., Ciocca, A., Vasino, Martinelli, V., Ciancia, R., Tringali, S., and Lauria, F.

Published
2003

16. Anagrelide in assential thronbocythemia: a retrospective study

Author

Gugliotta, L, Grossi, A, Mazzucconi, Mg, Bulgarelli, S, Beggi, C, Liso, V, Specchia, G, Coser, P, Amato, B, Angelucci, E, Di Tucci, A, Sciorino, A, Giustolisi, R, Cacciola, Emma, Cacciola, Rossella Rosaria, Iuliano, F, Giordano, M, Bosi, A, Balestri, F, Ghio, R, Balleari, E, Spriano, M, Sacchi, S, Marcheselli, R, Rotoli, B, Martinelli, V, Ciancia, R, Gaidano, G, Conconi, A, Rizzoli, V, Prugnola, M, Trincali, S, Balduini, C, Noris, P, Martelli, M, Tabilio, A, Liberati, Am, Germani, A, Andriani, A, Lauria, F, Gentili, S, Carella, Am, Scalzulli, Pr, Boccadoro, M, Ciocca Vasino, A, Fanin, R, Candoni, A, Pizzolo, G, Ambrosetti, A, and Canotti, R.

Published
2003

17. Anagrelide treatment in 167 patients with essential thrombocythaemia : a retrospective study of the Italian Group GIMMC

Author

Gugliotta, L., Grossi, A., Mazzucconi, M. G., Beggi, C, Bulgarelli, S, Redi, R, Balestri, F, Scalzulli, P. R, Noris, P, Liberati, A. M., Spriano, M, Tabilio, A, Amato, B, DI TUCCI, A, Candoni, A, Iuliano, F, Balleari, E, Sacchi, S, Gaidano, G, Giordano, M, Sciorino, A, Specchia, G, Andriani, A, Cacciola, Emma, Cacciola, Rossella Rosaria, Martinelli, V, Tringali, S, Lauria, F, CIOCCA VASINO, A, and Prugnola, M.

Published
2003

19. Anagrelide treatment in 167 patients with assential thrombocythaemia: a retrospective study of the Italian Group GIMMC

Author

Gugliotta, L., Grossi, A., Mazzucconi, M. G., Beggi, C., Bulgarelli, S., Redi, R., Balestri, F., Scalzulli, P. R., Noris, P., Liberati, A. M., Spriano, M., Tabilio, A., Amato, B., DI TUCCI, A., Candoni, A., Iuliano, F., Balleari, E., Sacchi, S., Gaidano, G., Giordano, M., Sciorino, A., Specchia, G, Andriani, A., Cacciola, E., Cacciola, Rossella Rosaria, Martinelli, V., Trincali, S., Lauria, F., A, Ciocca, Vasino, and Prugnola, M.

Published
2003

23. Bortezomib with HIG-dose dexamethasone as first line therapy in patients with multiple myeloma candidates to high-dose therapy

Author

Corso, A, Barbarano, L, Mangiacavalli, S, Montalbetti, L, Brasca, P, Zappasodi, P, Carella, A, Spriano, M, Alessandrino, E, Cairoli, R, Petro, D, Varettoni, M, Bernasconi, P, Lazzarino, M, Morra, E, Alessandrino, EP, Corso, A, Barbarano, L, Mangiacavalli, S, Montalbetti, L, Brasca, P, Zappasodi, P, Carella, A, Spriano, M, Alessandrino, E, Cairoli, R, Petro, D, Varettoni, M, Bernasconi, P, Lazzarino, M, Morra, E, and Alessandrino, EP

Abstract

Introduction: A phase II multi-center study was performed to investigate the efficacy of Bortezomib with high-dose dexamethasone (Vel-Dex) as induction therapy in multiple myeloma (MM) patients (pts) candidates to high-dose therapy. Methods: Patients were planned to receive 4 courses of Vel-Dex (Bortezomib 1.3 mg/m2 i.v. on days 1, 4, 8, 11; oral Dexamethasone 40 mg on days 1–4 and 8–11 every 3 weeks), followed by 2 courses of DCEP 4 weeks apart with stem cell collection, and a single autologous transplant with melphalan 200 mg/m2. Patients were untreated, aged ≤65 years, with Durie-Salmon stage III, II, or I in progression. Criteria of response were: CR: negative serum/urine immunofixation with <5% bone marrow plasmacytosis (BMPC); nCR: positive serum/urine immunofixation with <5% BMPC; VGPR/PR: reduction of at least 90%/50% of serum/urine monoclonal component (MC), and of BMPC. Adverse events (AE) were graded by the NCI-CTC version 3.0. Mann-Whitney U test was used to correlate response and main prognostic parameters. Results: From March 2006 to June 2007, 52 out of the 54 planned pts entered the protocol. Patient characteristics at enrolment were: male/female 33/19; median age 57 years (37–65); IgG/IgA/light-chain 33/9/10 pts; stage III/II/I in progression 44/5/3 pts; ISS I/II/III 21/14/17 pts; cytogenetic analysis showed del 13 in 54%, t (4;14) in 15%. Thirty-nine of 52 enrolled pts are evaluable for efficacy and toxicity after 4 Vel-Dex courses. Six pts were withdrawn (3 for progression, 2 for toxicity, 1 patient withdrew informed consent). Overall response rate (ORR) was 85%, with 67% major responses (CR 33%, nCR 26%, VGPR 8%), PR 18%, stable disease 7%, progression 8%. No statistically significant correlation was found between response and either age, stage, ISS, or unfavorable cytogenetics. Friedman ANOVA (p=0.00001) and Wilcoxon Matched Pairs (p<.05) tests showed a statistically significant progressive decrease of serum MC after each Vel-Dex cycle.

Published
2007

30. First line Fludarabine treatment of symptomatic chronic lymphoproliferative diseases: clinical results and molecular analysis of minimal residual disease

Author

Clavio, M., primary, Miglino, M., additional, Spriano, M., additional, Pietrasanta, D., additional, Vallebella, E., additional, Celesti, L., additional, Canepa, L., additional, Pierri, I., additional, Cavaliere, M., additional, Ballerini, F., additional, Beltrami, G., additional, Rossi, E., additional, Vimercati, R., additional, Bruni, R., additional, Congiu, M., additional, Nati, S., additional, Damasio, E., additional, Santini, G., additional, and Gobbi, M., additional

Published
2009
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40. VACOP-B versus VACOP-B plus autologous bone marrow transplantation for advanced diffuse non-Hodgkin's lymphoma: results of a prospective randomized trial by the non-Hodgkin's Lymphoma Cooperative Study Group.

Author

Santini, G, primary, Salvagno, L, additional, Leoni, P, additional, Chisesi, T, additional, De Souza, C, additional, Sertoli, M R, additional, Rubagotti, A, additional, Congiu, A M, additional, Centurioni, R, additional, Olivieri, A, additional, Tedeschi, L, additional, Vespignani, M, additional, Nati, S, additional, Soracco, M, additional, Porcellini, A, additional, Contu, A, additional, Guarnaccia, C, additional, Pescosta, N, additional, Majolino, I, additional, Spriano, M, additional, Vimercati, R, additional, Rossi, E, additional, Zambaldi, G, additional, Mangoni, L, additional, and Rizzoli, V, additional

Published
1998
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41. Mobilizatiod/Transplantation of Peripheral Blood Progenitor Cells for Aggressive Non-Hodgkin's Lymphoma with Marrow Involvement

Author

Santini, G., primary, Congiu, A. M., additional, Nati, S., additional, Canepa, L., additional, Spriano, M., additional, Chisesi, T., additional, Rossi, E., additional, Vimercati, R., additional, Sertoli, MR, additional, Figari, O., additional, Gobbi, M., additional, Piaggio, G., additional, Vassallo, F., additional, Benvenuto, F., additional, Soracco, M., additional, Miglino, M., additional, Ravetti, J. L., additional, and Truini, M., additional

Published
1997
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43. Anaplastic Large Cell Lymphoma: A Clinicopathologic Study of 53 Patients

Author

Clavio, M., primary, Rossi, E., additional, Truinp, M., additional, Carrara, P., additional, Ravettf, J. L., additional, Spriano, M., additional, Vimercati, A. R., additional, Santini, G., additional, Canepa, L., additional, Pierri, I., additional, Celesti, L., additional, Miglino, M., additional, Castellaneta, A., additional, Damasio, E., additional, and Gobbi, M., additional

Published
1996
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44. Mobilization of Cytogenetically ‘Normal’ Blood Progenitors Cells by Intensive Conventional Chemotherapy for Chronic Myeloid and Acute Lymphoblastic Leukemia

Author

Carella, A. M., primary, Pollicardo, N., additional, Pungolino, E., additional, Raffo, M. R., additional, Podesta, M., additional, Ferrero, R., additional, Pierluigi, D., additional, Nati, S., additional, Naibo, K., additional, Congiu, A., additional, Spriano, M., additional, Vimercati, R., additional, Figari, O., additional, Rosso, C., additional, Saglio, G., additional, Sessarego, M., additional, Lercari, G., additional, Valbonesi, M., additional, Carlier, P., additional, Vitale, V., additional, Corvo, P., additional, and Parodi, M., additional

Published
1993
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50. Dose-intensive melphalan with stem cell support (CM regimen) is effective and well tolerated in elderly myeloma patients

Author

Palumbo, A., Triolo, S., Baldini, L., Callea, V., Capaldi, A., Stefano, V., Grasso, M., Liberati, M., Lotesoriere, C., Marcenò, R., Marmont, F., Pellegrino Musto, Petrucci, M. T., Spriano, M., Pileri, A., and Boccadoro, M.

Subjects
INTRAVENOUS MELPHALAN, STANDARD TREATMENT, Antigens, CD34, TERM FOLLOW-UP, Transplantation, Autologous, REFRACTORY MULTIPLE-MYELOMA, Author Keywords:myeloma, TIMED SEQUENTIAL CHEMOTHERAPY, WHOLE-BLOOD, Humans, dose-intensive chemotherapy, melphalan, transplantation KeyWords Plus:BONE-MARROW TRANSPLANTATION, COLONY-STIMULATING FACTOR, AUTOLOGOUS TRANSPLANTATION, HEMATOPOIETIC PROGENITORS, Antineoplastic Agents, Alkylating, Cyclophosphamide, Aged, Graft Survival, Hematopoietic Stem Cell Transplantation, Middle Aged, Drug Evaluation, Multiple Myeloma, Immunosuppressive Agents
Abstract

Multiple myeloma (MM) typically afflicts elderly patients. High-dose therapy has recently been shown to lead to a better outcome than standard treatment, mainly in younger patients. The extent to which older subjects can benefit from intensified approaches without excessive toxicity is examined in this study.Between December 1994 and May 1997, 12 Italian Multiple Myeloma Study Group institutions entered 68 patients at diagnosis (median age 65) into an intensified chemotherapy regimen: cyclophosphamide (CY) 3 g/m(2) plus melphalan 60 mg/m(2) followed by peripheral blood progenitor cells (PBPC) and G-CSF (CM regimen). CY (day 0) and G-CSF were used to mobilize PBPC harvested by a single leukapheresis on day 10. Melphalan was infused on day 11. PBPC were kept unprocessed at 4 degrees C for 48 hours and reinfused on day 12. Three CM regimens were delivered at 6-month intervals.Sufficient PBPC to support the first CM cycle were available (median CD34(+) harvest: 4.9x10(6)/kg), but dropped significantly after the second (median CD34(+) harvest: 2x10(6)/kg) and the third (median CD34(+) harvest: 0.9x10(6)/kg). The median durations of severe neutropenia (absolute neutrophil count500 microL) were 3, 4, and 3 days, and those of severe thrombocytopenia (platelets25,000/microL) were 2.5, 2, and 1 days, after the first, second and third courses, respectively. The frequency of extramedullary toxicities was low. Treatment-related mortality (TRM) was 3% after the first CM, only. Complete remission (CR) was 14% after the first, 16% after the second and 27% after the third CM. After a median follow-up of 34 months (range 19-49 months), median event-free survival was 35.6 months.These results indicate that dose-intensity of melphalan can be increased by reinfusing PBPC with acceptable low toxicity. The combination of CY and melphalan followed by PBPC is an effective chemotherapy for elderly myeloma patients. Repeated melphalan infusion hampered subsequent CD34(+) harvests.

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