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1. Impact of JAK2(V617F) mutation status on treatment response to anagrelide in essential thrombocythemia: an observational, hypothesis-generating study

Author

Cascavilla N, De Stefano V, Pane F, Pancrazzi A, Iurlo A, Gobbi M, Palandri F, Specchia G, Liberati AM, D’Adda M, Gaidano G, Fjerza R, Achenbach H, Smith J, Wilde P, and Vannucchi AM

Subjects
Therapeutics. Pharmacology, RM1-950
Abstract

Nicola Cascavilla,1 Valerio De Stefano,2 Fabrizio Pane,3 Alessandro Pancrazzi,4 Alessandra Iurlo,5 Marco Gobbi,6 Francesca Palandri,7 Giorgina Specchia,8 A Marina Liberati,9 Mariella D’Adda,10 Gianluca Gaidano,11 Rajmonda Fjerza,4 Heinrich Achenbach,12 Jonathan Smith,13 Paul Wilde,13 Alessandro M Vannucchi41Division of Hematology, Casa Sollievo della Sofferenza Hospital, IRCCS, San Giovanni Rotondo, Italy; 2Institute of Hematology, Catholic University, Rome, Italy; 3Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy; 4Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy; 5Oncohematology Unit, Fondazione IRCCS Ca’ Granda, Ospedale Maggiore Policlinico, Milan, Italy; 6IRCCS AOU San Martino, Genova, Italy; 7Department of Specialistic, Diagnostic and Experimental Medicine, St Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy; 8Unit of Hematology with Transplantation, Department of Emergency and Organ Transplantation, University of Bari, Bari, Italy; 9Ospedale Santa Maria, Terni, Italy; 10Division of Hematology, Azienda Ospedaliera Spedali Civili di Brescia, Brescia, Italy; 11Division of Hematology, Department of Translational Medicine, Amedeo Avogadro University of Eastern Piedmont, Novara, Italy; 12Research and Development, Shire GmbH, Eysins, Switzerland; 13Shire Pharmaceutical Development Ltd, Basingstoke, United KingdomAbstract: A JAK2(V617F) mutation is found in approximately 55% of patients with essential thrombocythemia (ET), and represents a key World Health Organization diagnostic criterion. This hypothesis-generating study (NCT01352585) explored the impact of JAK2(V617F) mutation status on treatment response to anagrelide in patients with ET who were intolerant/refractory to their current cytoreductive therapy. The primary objective was to compare the proportion of JAK2-positive versus JAK2-negative patients who achieved at least a partial platelet response (≤600×109/L) after anagrelide therapy. Of the 47 patients enrolled, 46 were included in the full analysis set (JAK2-positive, n=22; JAK2-negative, n=24). At 12 months, 35 patients (n=14 and n=21, respectively) had a suitable platelet sample; of these, 74.3% (n=26) achieved at least a partial response. The response rate was higher in JAK2-positive (85.7%, n=12) versus JAK2-negative patients (66.7%, n=14) (odds ratio [OR] 3.00; 95% confidence interval [CI] 0.44, 33.97). By using the last observation carried forward approach in the sensitivity analysis, which considered the imbalance in patients with suitable samples between groups, the overall response rate was 71.7% (n=33/46), with 77.3% (n=17/22) of JAK2-positive and 66.7% (n=16/24) of JAK2-negative patients achieving at least a partial response (OR 1.70; 95% CI 0.39, 8.02). There was no significant change in median allele burden over 12 months in the 12 patients who achieved a response. In conclusion, the overall platelet response rate was high in both JAK2-positive and JAK2-negative patients; however, a larger study would be required to confirm the differences observed according to JAK2(V617F) mutation status.Keywords: essential thrombocythemia, mutation, JAK2, anagrelide, treatment response, allele burden

Published
2015

2. Differences among young adults, adults and elderly chronic myeloid leukemia patients

Author

Castagnetti, F., Gugliotta, G., Baccarani, M., Breccia, M., Specchia, G., Levato, L., Abruzzese, E., Rossi, G., Iurlo, A., Martino, B., Pregno, P., Stagno, F., Cuneo, A., Bonifacio, M., Gobbi, M., Russo, D., Gozzini, A., Tiribelli, M., de Vivo, A., Alimena, G., Cavo, M., Martinelli, G., Pane, F., Saglio, G., Rosti, G., Salvi, F., Pini, M., Leoni, P., Rupoli, S., Galieni, P., Bigazzi, C., Cantore, N., Palmieri, F., Albano, F., Russo Rossi, A., Rambaldi, A., Intermesoli, T., Palandri, F., Testoni, N., Luatti, S., Soverini, S., Iacobucci, I., Bochicchio, MT., Apolinari, M., Fogli, M., Cervello, I., Capucci, A., Malagola, M., Malpignano, A., Girasoli, M., Angelucci, E., Usala, E., Storti, S., De Biasi, E., Tagariello, G., Sartori, R., Di Raimondo, F., Vigneri, P., Impera, S., Molica, S., Lanza, F., Viganò, C., Grasso, M., Rapezzi, D., Cavazzini, F., Bosi, A., Santini, V., Capalbo, SF., Spinosa, G., Pierri, I., Bergamaschi, M., Carella, AM., Bacigalupo, A., De Blasio, A., Ciccone, F., Di Renzo, N., Musolino, C., Russo, S., Cortelezzi, A., Morra, E., Pungolino, EM., Luppi, M., Marasca, R., Pogliani, EM., Gambacorti-Passerini, C., Luciano, L., Ferrara, F., Annunziata, M., Latte, G., Noli, D., Rege-Cambrin, G., Fava, C., Semenzato, G., Binotto, G., Fabbiano, F., Turri, D., Siragusa, S., Caracciolo, C., Musso, M., Porretto, F., Aversa, F., Crugnola, M., Cazzola, M., Orlandi, E., Falini, B., Falzetti, F., Visani, G., Isidori, A., Fioritoni, G., Di Lorenzo, R., Vallisa, D., Trabacchi, E., Petrini, M., Galimberti, S., Pizzuti, M., Zaccaria, A., Salvucci, M., Ronco, F., Ielo, D., Merli, F., Avanzini, P., Tosi, P., Merli, A., Musto, P., De Stefano, V., Sica, S., Latagliata, R., De Fabritiis, P., Trawiska, M., Majolino, I., Pacilli, L., Ronci, B., Cedrone, M., Petti, MC., Pisani, F., Tafuri, A., Montefusco, E., Iuliano, F., Dore, F., Pardini, S., Bocchia, M., Defina, M., Liberati, AM., Luzzi, D., Boccadoro, M., Ferrero, D., Vitolo, U., Gherlinzoni, F., Calistri, E., Fanin, R., Pizzolo, G., Meneghini, V., Rodighiero, F., and DʼEmilio, A.

Published
2015
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4. Health-related quality of life in patients with newly diagnosed multiple myeloma ineligible for stem cell transplantation: results from the randomized phase III ALCYONE trial

Author

Knop, S, Mateos, MV, Dimopoulos, MA, Suzuki, K, Jakubowiak, A, Doyen, C, Lucio, P, Nagy, Z, Usenko, G, Pour, L, Cook, M, Grosicki, S, Crepaldi, A, Liberati, AM, Campbell, Philip, Shelekhova, T, Yoon, SS, Losava, G, Fujisaki, T, Garg, M, Wang, J, Wroblewski, S, Kudva, A, Gries, KS, Fastenau, J, San-Miguel, J, Cavo, M, Knop, S, Mateos, MV, Dimopoulos, MA, Suzuki, K, Jakubowiak, A, Doyen, C, Lucio, P, Nagy, Z, Usenko, G, Pour, L, Cook, M, Grosicki, S, Crepaldi, A, Liberati, AM, Campbell, Philip, Shelekhova, T, Yoon, SS, Losava, G, Fujisaki, T, Garg, M, Wang, J, Wroblewski, S, Kudva, A, Gries, KS, Fastenau, J, San-Miguel, J, and Cavo, M

Abstract

Background: In the phase III ALCYONE trial, daratumumab plus bortezomib/melphalan/prednisone (D-VMP) significantly improved overall response rate and progression-free status compared with VMP alone in transplant-ineligible patients with newly diagnosed multiple myeloma (NDMM). Here, we present patient-reported outcomes (PROs) from ALCYONE. Methods: The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) and EuroQol 5-dimensional descriptive system (EQ-5D-5L) questionnaire were administered at baseline, every 3 months (year 1) and every 6 months (until progression). Treatment effects were assessed using a repeated-measures, mixed-effects model. Results: Compliance with PRO assessments was comparable at baseline (> 90%) and throughout study (> 76%) for both treatment groups. Improvements from baseline were observed in both groups for EORTC QLQ-C30 Global Health Status (GHS), most functional scales, symptom scales and EQ-5D-5L visual analog scale (VAS). Between-group differences were significant for GHS (p = 0.0240) and VAS (p = 0.0160) at month 3. Improvements in pain were clinically meaningful in both groups at all assessment time points. Cognitive function declined in both groups, but the magnitude of the decline was not clinically meaningful. Conclusions: Patients with transplant-ineligible NDMM demonstrated early and continuous improvements in health-related quality of life, including improvements in functioning and symptoms, following treatment with D-VMP or VMP.

Published
2021

5. Daratumumab Plus Bortezomib, Melphalan, and Prednisone Versus Bortezomib, Melphalan, and Prednisone in Transplant-Ineligible Newly Diagnosed Multiple Myeloma: Frailty Subgroup Analysis of ALCYONE

Author

Mateos, MV, Dimopoulos, MA, Cavo, M, Suzuki, K, Knop, S, Doyen, C, Lucio, P, Nagy, Z, Pour, L, Grosicki, S, Crepaldi, A, Liberati, AM, Campbell, Philip, Yoon, SS, Iosava, G, Fujisaki, T, Garg, M, Iida, S, Bladé, J, Ukropec, J, Pei, H, Van Rampelbergh, R, Kudva, A, Qi, M, San-Miguel, J, Mateos, MV, Dimopoulos, MA, Cavo, M, Suzuki, K, Knop, S, Doyen, C, Lucio, P, Nagy, Z, Pour, L, Grosicki, S, Crepaldi, A, Liberati, AM, Campbell, Philip, Yoon, SS, Iosava, G, Fujisaki, T, Garg, M, Iida, S, Bladé, J, Ukropec, J, Pei, H, Van Rampelbergh, R, Kudva, A, Qi, M, and San-Miguel, J

Published
2021

6. Isatuximab plus pomalidomide and dexamethasone in relapsed/refractory multiple myeloma patients with renal impairment: ICARIA-MM subgroup analysis

Author

Dimopoulos, MA, Leleu, X, Moreau, P, Richardson, PG, Liberati, AM, Harrison, SJ, Prince, HM, Ocio, EM, Assadourian, S, Campana, F, Malinge, L, Semiond, D, van de Velde, H, Yong, K, Dimopoulos, MA, Leleu, X, Moreau, P, Richardson, PG, Liberati, AM, Harrison, SJ, Prince, HM, Ocio, EM, Assadourian, S, Campana, F, Malinge, L, Semiond, D, van de Velde, H, and Yong, K

Abstract

The randomized, phase 3 ICARIA-MM study investigated isatuximab (Isa) with pomalidomide and dexamethasone (Pd) versus Pd in patients with relapsed/refractory multiple myeloma and ≥2 prior lines. This prespecified subgroup analysis examined efficacy in patients with renal impairment (RI; estimated glomerular filtration rate <60 mL/min/1.73 m²). Isa 10 mg/kg was given intravenously once weekly in cycle 1, and every 2 weeks in subsequent 28-day cycles. Patients received standard doses of Pd. Median progression-free survival (PFS) for patients with RI was 9.5 months with Isa-Pd (n = 55) and 3.7 months with Pd (n = 49; hazard ratio [HR] 0.50; 95% confidence interval [CI], 0.30-0.85). Without RI, median PFS was 12.7 months with Isa-Pd (n = 87) and 7.9 months with Pd (n = 96; HR 0.58; 95% CI, 0.38-0.88). The overall response rate (ORR) with and without RI was higher with Isa-Pd (56 and 68%) than Pd (25 and 43%). Complete renal response rates were 71.9% (23/32) with Isa-Pd and 38.1% (8/21) with Pd; these lasted ≥60 days in 31.3% (10/32) and 19.0% (4/21) of patients, respectively. Isa pharmacokinetics were comparable between the subgroups, suggesting no need for dose adjustment in patients with RI. In summary, the addition of Isa to Pd improved PFS, ORR and renal response rates.

Published
2021

9. Bortezomib-dexamethasone as maintenance therapy or early retreatment at biochemical relapse versus observation in relapsed/refractory multiple myeloma patients: a randomized phase II study

Author

Mina, R, Belotti, A, Petrucci, MT, Zambello, R, Capra, A, Di Lullo, G, Ronconi, S, Pescosta, N, Grasso, M, Monaco, F, Cellini, C, Gobbi, M, Ballanti, S, de Fabritiis, P, Mosca-Siez, ML, Marchetti, M, Liberati, AM, Offidani, M, Giuliani, N, Ria, R, Musto, P, Romano, A, Sonneveld, Pieter, Boccadoro, M, Larocca, A, Mina, R, Belotti, A, Petrucci, MT, Zambello, R, Capra, A, Di Lullo, G, Ronconi, S, Pescosta, N, Grasso, M, Monaco, F, Cellini, C, Gobbi, M, Ballanti, S, de Fabritiis, P, Mosca-Siez, ML, Marchetti, M, Liberati, AM, Offidani, M, Giuliani, N, Ria, R, Musto, P, Romano, A, Sonneveld, Pieter, Boccadoro, M, and Larocca, A

Published
2020

10. Outcome of paraosseous extra-medullary disease in newly diagnosed multiple myeloma patients treated with new drugs

Author

Montefusco, V, Gay, F, Spada, S, De Paoli, L, Di Raimondo, F, Ribolla, R, Musolino, C, Patriarca, F, Musto, P, Galieni, P, Ballanti, S, Nozzoli, C, Cascavilla, N, Ben-Yehuda, D, Nagler, A, Hajek, R, Offidani, M, Liberati, AM, Sonneveld, Pieter, Cavo, M, Corradini, P, Boccadoro, M, Montefusco, V, Gay, F, Spada, S, De Paoli, L, Di Raimondo, F, Ribolla, R, Musolino, C, Patriarca, F, Musto, P, Galieni, P, Ballanti, S, Nozzoli, C, Cascavilla, N, Ben-Yehuda, D, Nagler, A, Hajek, R, Offidani, M, Liberati, AM, Sonneveld, Pieter, Cavo, M, Corradini, P, and Boccadoro, M

Published
2020

13. Phase 1/2 study of weekly carfilzomib, cyclophosphamide, dexamethasone in newly diagnosed transplant-ineligible myeloma

Author

Bringhen, S, D'Agostino, M, De Paoli, L, Montefusco, V, Liberati, AM, Galieni, P, Grammatico, S, Muccio, VE, Esma, F, De Angelis, C, Musto, P, Ballanti, S, Offidani, M, Petrucci, MT, Gaidano, G, Corradini, P, Palumbo, A, Sonneveld, Pieter, Boccadoro, M, Bringhen, S, D'Agostino, M, De Paoli, L, Montefusco, V, Liberati, AM, Galieni, P, Grammatico, S, Muccio, VE, Esma, F, De Angelis, C, Musto, P, Ballanti, S, Offidani, M, Petrucci, MT, Gaidano, G, Corradini, P, Palumbo, A, Sonneveld, Pieter, and Boccadoro, M

Published
2018

14. FRONT-LINE THERAPY WITH FLUDARABINE, CYCLOPHOSPHAMIDE, OFATUMUMAB (FC-O2) IN YOUNG (<= 65 YRS) AND FIT CHRONIC LYMPHOCYTIC LEUKEMIA PATIENTS. RESULTS OF THE PROSPECTIVE PHASE 2 GIMEMA STUDY LLC0911

Author

Mauro, Fr, Molica, S, Zaja, F, Piciocchi, A, Ilariucci, F, Coscia, M, Carella, Am, Re, F, Liberati, Am, Tedeschi, A, Gozzetti, A, Cuneo, A, Cortelezzi, A, Baraldi, A, Del Poeta, G, Musolino, C, Battistini, R, De Propris, Ms, Della Starza, I, Raponi, S, Ilari, C, Cafforio, L, Nanni, M, Fazi, P, Vignetti, M, Russo, F, Porrazzo, M, Riemma, C, Specchia, G, Neri, A, Guarini, A, and Foa, R

Published
2017

15. Long term outcome of ph+ cml patients achieving complete cytogenetic remission with interferon based therapy moving from interferon to imatinib era

Author

Malagola M, Breccia M, Skert C, Cancelli V, Cattina F, Liberati AM, Tiribelli M, Annunziata M, Trabacchi E, De Vivo A, Fogli M, Stagno F, Pica G, Iurlo A, Pregno P, Abruzzese E, Pardini S, Bocchia M, Russo S, Pierri I, Lunghi M, Barulli S, Merante S, Mandelli F, Alimena G, Russo D., SOVERINI, SIMONA, IACOBUCCI, ILARIA, CASTAGNETTI, FAUSTO, MARTINELLI, GIOVANNI, ROSTI, GIANANTONIO, BACCARANI, MICHELE, Malagola M, Breccia M, Skert C, Cancelli V, Soverini S, Iacobucci I, Cattina F, Liberati AM, Tiribelli M, Annunziata M, Trabacchi E, De Vivo A, Castagnetti F, Martinelli G, Fogli M, Stagno F, Pica G, Iurlo A, Pregno P, Abruzzese E, Pardini S, Bocchia M, Russo S, Pierri I, Lunghi M, Barulli S, Merante S, Mandelli F, Alimena G, Rosti G, Baccarani M, and Russo D.

Subjects
Adult, Male, EUROPE, Fusion Proteins, bcr-abl, MULTICENTER, Antineoplastic Agents, Piperazines, RECOMMENDATIONS, Young Adult, CHRONIC MYELOID-LEUKEMIA, CHRONIC MYELOGENOUS LEUKEMIA, MOLECULAR RESPONSE, RESIDUAL DISEASE, T-LYMPHOCYTES, ALPHA, TRANSCRIPTS, INTERFERON THERAPY, hemic and lymphatic diseases, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Antineoplastic Combined Chemotherapy Protocols, Humans, BCR-ABL, Protein Kinase Inhibitors, Aged, Retrospective Studies, Drug Substitution, Remission Induction, Interferon-alpha, Middle Aged, Cross-Sectional Studies, Pyrimidines, Treatment Outcome, Benzamides, Imatinib Mesylate, Female, CHRONIC MYELOID LEUKEMIA (CML), Follow-Up Studies
Abstract

Interferon α (IFNα) prolongs survival of CML patients achieving CCyR and potentially synergizes with TKIs. We report on the molecular status and long term outcome of 121 patients who were treated in Italy between 1986 and 2000 with IFNα based therapy and who obtained CCyR. After a median follow up of 16.5 years, 74 (61%) patients were switched to standard imatinib: 48 (65%) lost the CCyR on IFNα, and 36 (75%) are alive and in CCyR; 26 (35%) were switched to imatinib when they were still in CCyR on IFNα, and all 26 are alive and in CCyR. Forty-seven patients (39%) were never switched to imatinib: 24 (51%) continued and 23 (49%) discontinued IFNα, respectively, and 39/47 (83%) are alive and in CCyR. At last follow-up, the BCR-ABL transcripts level was available in 96/101 living patients (95%) The BCR-ABL:ABL ratio was between 0.1 and 0.01% (MR(3.0) ) in 17%, and less than 0.01% (MR(4.0) ) in 81% of patients. No patient was completely molecular negative (MR(4.5) or MR(5.0) ). The OS at 10 and 20 years is 92 and 84%, respectively. This study confirms that CCyR achieved with IFNα and maintained with or without imatinib or any other therapy significantly correlates with long term survival in CML patients who mostly have MR(4.0) . Complete molecular response (MR(4.5) or MR(5.0) ) seems to be unnecessary for such a long survival. This study further supports development of studies testing the clinical effect of the combinations of TKIs with IFNα.

Published
2014

16. A recent update of 3 consecutive prospective trials with high-dose therapy and autograft, without or with rituximab, as primary treatment for advanced-stage follicular lymphoma shows a sizeable group of patients surviving in continuous complete remission

Author

Tarella C, Ladetto M, Benedetti F, Vitolo U, Pulsoni A, Patti C, Callea V, Rambaldi A, Piccin A, Devizzi L, Musso M, Iannitto E, Spedini P, Liberati AM, Gallamini A, Rodeghiero F, Gini G, De Crescenzo A, Di Raimondo F, Levis A, Chisesi T, Petrone T, Scalabrini DR, Rossi G, Carella AM, Parvis G, Majolino I, Passera R, Ruella M, Pileri A, Gianni AM, Corradini P., CICERI , FABIO, Tarella, C, Ladetto, M, Benedetti, F, Vitolo, U, Pulsoni, A, Patti, C, Callea, V, Rambaldi, A, Piccin, A, Devizzi, L, Musso, M, Iannitto, E, Spedini, P, Liberati, Am, Ciceri, Fabio, Gallamini, A, Rodeghiero, F, Gini, G, De Crescenzo, A, Di Raimondo, F, Levis, A, Chisesi, T, Petrone, T, Scalabrini, Dr, Rossi, G, Carella, Am, Parvis, G, Majolino, I, Passera, R, Ruella, M, Pileri, A, Gianni, Am, and Corradini, P.

Published
2010

17. Long-term outcome of chronic myeloid leukemia patients treated frontline with imatinib

Author

Castagnetti, F, Gugliotta, G., Breccia, M., Stagno, F., Iurlo, A., Albano, F., Abruzzese, E., Martino, B., Levato, L., Intermesoli, T., Pregno, P., Rossi, G., Gherlinzoni, F., Leoni, P., Cavazzini, F., Venturi, C., Soverini, S., Testoni, N., Alimena, G., Cavo, M., Martinelli, G., Pane, F., Saglio, G., Rosti, G., Baccarani, M., on behalf of the GIMEMA CML Working Party (Lucarelli, G., Polimeno, G., Ladetto, M., Pini, M., Rupoli, S., Scortechini, A. R., Galieni, P., Bigazzi, C., Cantore, N., Palmieri, F., Specchia, G., Russo, Rossi., Rambaldi, A., Ferrari, M. L., Palandri, F., Luatti, S., Iacobucci, I., Bochicchio, M. T., Apolinari, M., Fogli, M., Cervello, I., Capucci, A., Giuliani, G., Malpignano, A., Girasoli, M., Angelucci, E., Usala, E., De Biasi, E., Tagariello, G., Sartori, R., Di Raimondo, F., Vigneri, P., Molica, S., Lentini, M., Lanza, F., Viganò, C., Grasso, M., Rapezzi, D., Cuneo, A., Ciccone, M., Bosi, A., Gozzini, A., Gobbi, M., Pierri, I., Chianese, R., De Blasio, A., Ciccone, F., Capochiani, E., Pelosini, M., Musolino, C., Russo, S., Cortelezzi, A., Luppi, M., Marasca, R., Pogliani, E. M., Gambacorti-Passerini, C., Luciano, L., Izzo, B., Ferrara, F., Annunziata, M., Mettivier, V., Sessa, U., Latte, G., Noli, D., Rege-Cambrin, G., Fava, C., Semenzato, G., Binotto, G., Fabbiano, F., Turri, D., Siragusa, S., Caracciolo, C., Musso, M., Porretto, F., Cazzola, M., Orlandi, E., Falini, B., Falzetti, F., Visani, G., Isidor, I., Di Bartolomeo, P., Di Lorenzo, R., Vallisa, D., Trabacch, I., Pizzuti, M., Zuffa, E., Salvucci, M., Ronco, F., Lelo, D., Merli, F., Avanzini, P., Tosi, P., Merli, A., Sica, S., Sorà, F., Latagliata, R., De Fabritiis, P., Trawiska, M., Amadori, S., Cantonetti, M., Majolino, I., Pacilli, L., Ronci, B., Cedrone, M., Mengarelli, A., Romano, A., Tafuri, A., Montefusc, O., Iuliano, F., Infusino, S., Dore, F., Fozza, C., Bocchia, M., Defina, M., Liberati, Am., Luzi, D., Boccadoro, M., Ferrero, D., Vitolo, U., Nicolosi, M., Gottardi, M., Calistri, E., Fanin, R., Tiribelli, M., Pizzolo, G., Bonifacio, M., Rodeghiero, F., Di Bona, E. )., Castagnetti, F, Gugliotta, G., Breccia, M., Stagno, F., Iurlo, A., Albano, F., Abruzzese, E., Martino, B., Levato, L., Intermesoli, T., Pregno, P., Rossi, G., Gherlinzoni, F., Leoni, P., Cavazzini, F., Venturi, C., Soverini, S., Testoni, N., Alimena, G., Cavo, M., Martinelli, G., Pane, F., Saglio, G., Rosti, G., Baccarani, M., and on behalf of the GIMEMA CML Working Party [, Palandri F.], Pane, Fabrizio, Gugliotta, G, Breccia, M, Stagno, F, Iurlo, A, Albano, F, Abruzzese, E, Martino, B, Levato, L, Intermesoli, T, Pregno, P, Rossi, G, Gherlinzoni, F, Leoni, P, Cavazzini, F, Venturi, C, Soverini, S, Testoni, N, Alimena, G, Cavo, M, Martinelli, G, Pane, F, Saglio, G, Rosti, G, Baccarani, M, and GAMBACORTI PASSERINI, C

Subjects
DIAGNOSED CHRONIC-PHASE, Oncology, Male, Cancer Research, Time Factors, bcr-abl, Fusion Proteins, bcr-abl, Antineoplastic Agent, Hematology, Anesthesiology and Pain Medicine, hemic and lymphatic diseases, Antineoplastic Combined Chemotherapy Protocols, 80 and over, Cumulative incidence, Young adult, Chronic, Aged, 80 and over, Leukemia, PATIENTS RECEIVING IMATINIB, CHRONIC MYELOGENOUS LEUKEMIA, TYROSINE KINASE INHIBITORS, BCR-ABL1 TRANSCRIPT LEVELS, EARLY MOLECULAR RESPONSE, CML WORKING PARTY, 3-YEAR FOLLOW-UP, EUROPEAN LEUKEMIANET, 400 MG, Myeloid leukemia, Middle Aged, Prognosis, Treatment Outcome, Retreatment, Imatinib Mesylate, Female, Tyrosine kinase, Human, medicine.drug, Adult, medicine.medical_specialty, Time Factor, Adolescent, Prognosi, Protein Kinase Inhibitor, Socio-culturale, Antineoplastic Agents, Treatment results, Follow-Up Studie, Young Adult, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Internal medicine, medicine, Humans, Protein Kinase Inhibitors, Aged, Antineoplastic Combined Chemotherapy Protocol, business.industry, Fusion Proteins, Imatinib, Follow-Up Studies, Surgery, Imatinib mesylate, BCR-ABL Positive, business, Myelogenous
Abstract

For almost 10 years imatinib has been the therapeutic standard of chronic myeloid leukemia. The introduction of other tyrosine kinase inhibitors (TKIs) raised a debate on treatment optimization. The debate is still heated: some studies have protocol restrictions or limited follow-up; in other studies, some relevant data are missing. The aim of this report is to provide a comprehensive, long-term, intention-to-treat, analysis of 559 newly diagnosed, chronic-phase, patients treated frontline with imatinib. With a minimum follow-up of 66 months, 65% of patients were still on imatinib, 19% were on alternative treatment, 12% died and 4% were lost to follow-up. The prognostic value of BCR-ABL1 ratio at 3 months (⩽10% in 81% of patients) was confirmed. The prognostic value of complete cytogenetic response and major molecular response at 1 year was confirmed. The 6-year overall survival was 89%, but as 50% of deaths occurred in remission, the 6-year cumulative incidence of leukemia-related death was 5%. The long-term outcome of first-line imatinib was excellent, also because of second-line treatment with other TKIs, but all responses and outcomes were inferior in high-risk patients, suggesting that to optimize treatment results, a specific risk-adapted treatment is needed for such patients.

Published
2015

20. Clinical and biological features in patients with Ph-negative chronic myeloproliferative neoplasms showing different molecular pattern comparative study in 596 patients of the Registro Italiano Trombocitemie (RIT)

Author

Gugliotta, L, Iurlo, A, Gugliotta, G, Tieghi, A, Specchia, G, Gaidano, G, Candoni, A, Randi, Ml, Scalzulli, Pr, Dragani, A, Martinelli, V, Tagariello, G, Antonioli, E, Liberati, Am, Palmieri, R, Langella, M, Rago, A, Cacciola, Rossella Rosaria, Pierri, I, Ricco, A, Cattaneo, D, Santoro, U, Rupoli, S, Santoro, C, Mastrullo, L, Mazzucconi, Mg, Vianelli, N, De Stefano, V, Passamonti, F, and Vannucchi, Am

Published
2015

21. Efficacy and safety of yttrium-90 ibritumomab tiuxetan in patients with relapsed or refractory diffuse large B-cell lymphoma not appropriate for autologous stem-cell transplantation

Author

Morschhauser F, Illidge T, Huglo D, Martinelli G, Paganelli G, Rule S, Liberati AM, Milpied N, Hess G, Stein H, Kalmus J, Marcus R., ZINZANI, PIER LUIGI, Morschhauser F, Illidge T, Huglo D, Martinelli G, Paganelli G, Zinzani PL, Rule S, Liberati AM, Milpied N, Hess G, Stein H, Kalmus J, and Marcus R.

Abstract

A prospective, multicenter, nonrandomized phase 2 trial was conducted to evaluate the efficacy and safety of a single dose of yttrium-90 ((90)Y) ibritumomab tiuxetan in elderly patients in first relapsed or primary refractory diffuse large B-cell lymphoma (DLBCL) ineligible for stem-cell transplantation. Patients had been previously treated with chemotherapy (group A, n = 76) or chemotherapy plus rituximab (group B, n = 28). Patients in group A were further divided into patients in whom induction therapy had failed (stratum AI, n = 33) and patients who had relapsed after achieving complete response (CR; stratum AII, n = 43). The overall response rate (ORR) was 52% and 53% in strata AI and AII, respectively, and 19% in group B, with CR/CRu rates of 24%, 39.5%, and 12%, respectively. Median progression-free survival was 5.9 months and 3.5 months in strata AI and AII, respectively, and 1.6 months in group B. Median overall survival was 21.4, 22.4, and 4.6 months in stratum AI, stratum AII, and group B, respectively. Two patients died from thrombocytopenic cerebral bleeding following administration of therapy. Nonhematologic adverse events were mild to moderate. (90)Y-ibritumomab is active in patients with relapsed and refractory diffuse large B-cell lymphoma (DLBCL) and its further evaluation in phase 3 studies is ongoing.

Published
2007

22. Oral melphalan and prednisone chemotherapy plus thalidomide compared with melphalan and prednisone alone in elderly patients with multiple myeloma: randomised controlled trial

Author

Palumbo A, Bringhen S, Caravita T, Merla E, Capparella V, Callea V, Cangialosi C, Grasso M, Rossini F, Galli M, Catalano L, Petrucci MT, De Stefano V, Ceccarelli M, Ambrosini MT, Avonto I, Falco P, Ciccone G, Liberati AM, Musto P, Boccadoro M, Italian Multiple Myeloma Network, GIMEMA, ZAMAGNI, ELENA, Palumbo A, Bringhen S, Caravita T, Merla E, Capparella V, Callea V, Cangialosi C, Grasso M, Rossini F, Galli M, Catalano L, Zamagni E, Petrucci MT, De Stefano V, Ceccarelli M, Ambrosini MT, Avonto I, Falco P, Ciccone G, Liberati AM, Musto P, Boccadoro M, Italian Multiple Myeloma Network, and GIMEMA.

Subjects
Melphalan, Male, medicine.medical_specialty, Antineoplastic Agents, Hormonal, Hormonal Antineoplastic Combined Chemotherapy Protocols Disease-Free Survival Melphalan Multiple Myeloma/drug therapy Multiple Myeloma/mortality Prednisone Thalidomide, medicine.medical_treatment, anticoagulant agent, Gastroenterology, Disease-Free Survival, Aged Antineoplastic Agents, Prednisone, Internal medicine, thalidomide, Antineoplastic Combined Chemotherapy Protocols, Medicine, Humans, Alkylating Antineoplastic Agents, Antineoplastic Agents, Alkylating, Multiple myeloma, antineoplastic agent, Antibacterial agent, Aged, Aged, 80 and over, Chemotherapy, business.industry, Hazard ratio, enoxaparin, General Medicine, Middle Aged, medicine.disease, Surgery, melphalan, Thalidomide, prednisone, Female, business, Multiple Myeloma, Progressive disease, medicine.drug
Abstract

Summary Background Since 1960, oral melphalan and prednisone (MP) has been regarded as the standard of care in elderly multiple myeloma patients. This multicentre randomised trial compared oral MP plus thalidomide (MPT) with MP alone in patients aged 60–85 years. Methods Patients with newly diagnosed multiple myeloma were randomly assigned to receive oral MP for six 4-week cycles plus thalidomide (n=129; 100 mg per day continuously until any sign of relapse or progressive disease) or MP alone (n=126). Analysis was intention-to-treat. This study is registered at ClinicalTrial.gov, number NCT00232934. Results Patients treated with thalidomide had higher response rates and longer event-free survival (primary endpoints) than patients who were not. Combined complete or partial response rates were 76·0% for MPT and 47·6% for MP alone (absolute difference 28·3%, 95% CI 16·5–39·1), and the near-complete or complete response rates were 27·9% and 7·2%, respectively. 2-year event-free survival rates were 54% for MPT and 27% for MP (hazard ratio [HR] for MPT 0·51, 95% CI 0·35–0·75, p=0·0006). 3-year survival rates were 80% for MPT and 64% for MP (HR for MPT 0·68, 95% CI 0·38–1·22, p=0·19). Rates of grade 3 or 4 adverse events were 48% in MPT patients and 25% in MP patients (p=0·0002). Introduction of enoxaparin prophylaxis reduced rate of thromboembolism from 20% to 3% (p=0·005). Conclusion Oral MPT is an effective first-line treatment for elderly patients with multiple myeloma. Anticoagulant prophylaxis reduces frequency of thrombosis. Longer follow-up is needed to assess effect on overall survival.

Published
2006

23. BENDAMUSTINE, BORTEZOMIB AND DEXAMETHASONE (BVD) EXERT A SUBSTANTIAL ACTIVITY WITH A MANAGEABLE TOXICITY IN PATIENTS WITH RELAPSED-REFRACTORY MULTIPLE MYELOMA

Author

Offidani, M., Corvatta, L., Maracci, L., Liberati, Am, Ballanti, S., Attoli co, I., Caraffa, P., Alesiani, F., Caravita di Toritto, T., Gentili, S., Tosi, P., Brunori, M., Derudas, D., Ledda, A., Gozzetti, A., Cellini, C., Malerba, L., Mele, A., Felici, S., Galimberti, Sara, Mondello, P., Pulini, S., Coppetelli, U., Fraticelli, P., and Leoni, P.

Published
2014

24. SUBCUTANEOUS VELCADE PLUS PREDNISONE (VP) OR PLUS CYCLOPHOSFAMIDE (VCP) OR PLUS MELPHALAN (VMP) IN FRAIL, ELDERLY, NEWLY DIAGNOSED MULTIPLE MYELOMA PATIENTS: A PHASE II COMMUNITY–BASED STUDY

Author

Larocca, A, Oliva, S, Offidani, M, Levi, A, Musolino, Caterina, Falcone, Ap, Conticello, C, Caravita, T, Rossi, D, Villani, O, Nozzoli, C, Benevolo, G, Liberati, Am, Morabito F, Derudas D., Carella, Am, Caraffa, P, Astolfi, M, Palladino, C, Montefusco, V, Cavallo, F, Petrucci, Mt, Boccadoro, M, Sonneveld, P, and Palumbo, A.

Subjects
subcutaneous bortezomib, Multiple Myeloma, subcutaneous bortezomib, Multiple Myeloma
Published
2013

25. Lenalidomide plus cyclophosphamide, doxorubicin, vincristine, prednisone and rituximab is safe and effective in untreated, elderly patients with diffuse large B-cell lymphoma: a phase I study by the Fondazione Italiana Linfomi

Author

Chiappella, A1, Tucci, A, Castellino, A, Pavone, V, Baldi, I, Carella, Am, Orsucci, L, Zanni, M, Salvi, F, Liberati, Am, Gaidano, G, Bottelli, C, Rossini, B, Perticone, S, De Masi, P, Ladetto, Marco, Ciccone, G, Palumbo, Antonio, Rossi, G, Vitolo, U, and Fondazione Italiana Linfomi

Published
2013

26. Efficacy and safety of 3 lenalidomide–based combinations in elderly newly diagnosed multiple myeloma patients: results from the phase 3 community based EMN01 trial

Author

Gay, F, Bringhen, S, Offidani, M, Liberati, Am, Cellini, C, Magarotto, V, Benevolo, G, Aitoro, G, Patriarca, F, Omede, P, Conticello, C, Montefusco, V, Rossi, D, Palladino, C, Pour, L, Allegra, Alessandro, Pietrantuono, G, Falcone, Ap, Rocci, A, Zambello, R, Ledda, A, Gentili, S, Musto, P, Boccadoro, M, Hajek, R, and Palumbo, A.

Subjects
Multiple myeloma, Lenalidomide, EMN01, EMN01, Multiple myeloma, Lenalidomide
Published
2013

28. FOLLOW UP A LUNGO TERMINE DEI PAZIENTI CON LMC-PH+ IN RISPOSTA CITOGENETICA COMPLETA CON TERAPIA INCLUDENTE INTERFERONE NELL’ERA IMATINIB - PROTOCOLLO GIMEMA CML0509

Author

Russo, D, Alimena, G, Colombi, C, Breccia, M, Soverini, S, Iacobucci, I, Cattina, F, Martinelli, G, Testoni, N, Liberati, Am, Appolloni, V, Tiribelli, M, Fanin, R, Ferrara, F, Annunziata, M, Trabacchi, E, Vallisa, D, De Vivo, A, Castagnetti, F, Fogli, M, Durante, S, Di Raimondo, F, Stagno, F, Carella, Am, Pica, G, Cortelezzi, A, Iurlo, A, Pregno, P, Vitolo, U, Abruzzese, E, De Fabritiis, P, Longinotti, M, Pardini, S, Musolino, C, Russo, S, Gobbi, M, Pierri, I, Gaidano, G, Lunghi, M, Visani, G, Barulli, S, Cazzola, M, Merante, S, Skert, C, Malagola, M, Rosti, G, Mandelli, F, and Baccarani, M

Published
2012

29. A SINGLE-ARM MULTI-CENTER TRIAL OF BENDAMUSTINE GIVEN WITH OFATUMUMAB (BENDOFA) IN PATIENTS WITH REFRACTORY OR RELAPSED CHRONIC LYMPHOCYTIC LEUKEMIA. GIMEMA CLL0809 PROTOCOL

Author

Cortelezzi, A., Liberati, Am, Sciume, M., Cuneo, A., Reda, G., Gritti, G., Laurenti, L., Zaja, F., Marasca, R., Chiarenza, A., Orsucci, L., Storti, S., Murru, R., Cascavilla, N., Gobbi, M., Mauro, Francesca Romana, Gregorini, A., Morabito, F., Fabris, S., Maura, F., Piciocchi, A., Vignetti, M., Neri, A., Rossi, D., Gaidano, G., Marinelli, M., Guarini, Anna, and Foa, Roberto

Published
2012

30. Impact of JAK2(V617F) mutation status on treatment response to anagrelide in essential thrombocythemia: an observational, hypothesis-generating study

Author

Cascavilla, N, DE STEFANO, VALERIO, Pane, F, Pancrazzi, A, Iurlo, A, Gobbi, M, Palandri, F, Specchia, G, Liberati, AM, D'Adda, M, Gaidano, G, Fjerza, R, Achenbach, H, Smith, J, Wilde, P, Vannucchi, AM, Cascavilla, N, DE STEFANO, VALERIO, Pane, F, Pancrazzi, A, Iurlo, A, Gobbi, M, Palandri, F, Specchia, G, Liberati, AM, D'Adda, M, Gaidano, G, Fjerza, R, Achenbach, H, Smith, J, Wilde, P, and Vannucchi, AM

Published
2015

33. Hydroxyurea treatment in 1075 patients with essential thrombocythemia and occirrence of extra- hematological adverse events: a preliminary report of the Registro Italiano Trrombocitemia (RIT)

Author

Gugliotta, L, Papayannidis, C, Piccin, A, Pieghi, A, Vinelli, M, Scalzulli, Pr, Candoni, A, Dragani, A, Patriarca, A, Lunghi, M, Ciancia, R, Martionelli, V, Liberati, Am, Specchia, G, Imovilli, A, Vannucchi, Am, Maschio, A, Iurlo, A, Randi, Ml, Passamonti, F, Calmieri, Mazzucconi, Mg, LA TAGLIATA, R, Mastrullo, R, Cimino, G, Pierri, I, Cacciola, Emma, Lucchesi, A, Luraschi, A, Cozzani, E, Parodi, A, Martinelli, G, and Baccarani, M.

Published
2010

34. 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

35. ACHIEVEMENT OF COMPLETE REMISSION IS A STRONG PROGNOSTIC FACTOR IN 895 ELDERLY MYELOMA PATIENTS TREATED WITH MELPHALAN-PREDNISONE BASED-REGIMENS: RESULTS OF 3 MULTICENTER ITALIAN TRIALS

Author

Gay, F., Larocca, A., Petrucci, Mt, Musto, P., Liberati, Am, Callea, V., Ria, R., Caravita, T., Cangialosi, C., Grasso, M., Offidani, M., Pregno, P., Patriarca, F., Galli, M., Cavo, M., Catalano, L., Nozzoli, C., Guglielmelli, T., Zambello, R., Pisani, F., Montefusco, V., Rossini, F., DE STEFANO, V., Lupo, B., DI RAIMONDO, Francesco, Gaidano, G., Boccadoro, M., and Palumbo, A.

Published
2010

38. Prospective, multicenter randomized GITMO/IIL trial comparing intensive (R-HDS) versus conventional (CHOP-R) chemoimmunotherapy in high-risk follicular lymphoma at diagnosis: the superior disease control of R-HDS does not translate into an overall survival advantage

Author

Ladetto, M, DE MARCO, F, Benedetti, F, Vitolo, U, Patti, C, Rambaldi, A, Pulsoni, Alessandro, Musso, M, Liberati, Am, Olivieri, A, Gallamini, A, Pogliani, E, Scalabrini, Dr, Callea, V, DI RAIMONDO, F, Pavone, V, Tucci, A, Cortelazzo, S, Levis, A, Boccadoro, M, Majolino, I, Pileri, A, Gianni, Am, Passera, R, Corradini, P, Tarella, C, GRUPPO ITALIANO TRAPIANTO DI MIDOLLO OSSEO GITMO, INTERGRUPPO ITALIANO LINFOMI IIL, Foa, Roberto, Ladetto, M, De Marco, F, Benedetti, F, Vitolo, U, Patti, C, Rambaldi, A, Pulsoni, A, Musso, M, Liberati, A, Olivieri, A, Gallamini, A, Pogliani, E, Scalabrini, D, Callea, V, Di Raimondo, F, Pavone, V, Tucci, A, Cortelazzo, S, Levis, A, Boccadoro, M, Majolino, I, Pileri, A, Gianni, A, Passera, R, Corradini, P, and Tarella, C

Subjects
Male, Lymphoma, Follicular lymphoma, Salvage therapy, PREDICTIVE MODEL, Kaplan-Meier Estimate, INDOLENT LYMPHOMA, CHOP, Biochemistry, Gastroenterology, Antibodies, Monoclonal, Murine-Derived, Risk Factors, MED/15 - MALATTIE DEL SANGUE, hemic and lymphatic diseases, BONE-MARROW-TRANSPLANTATION, TERM-FOLLOW-UP, DOSE SEQUENTIAL CHEMOTHERAPY, STEM-CELL TRANSPLANTATION, NON-HODGKINS-LYMPHOMA, PROGRESSION-FREE SURVIVAL, MINIMAL RESIDUAL DISEASE, UNTREATED PATIENTS, Antineoplastic Combined Chemotherapy Protocols, Clinical endpoint, Medicine, Prospective Studies, Treatment Failure, Lymphoma, Follicular, Antibodies, Monoclonal, Hematology, Middle Aged, Rituximab, prognosis, Transplantation, Autologou, Treatment Outcome, Female, Survival Analysi, Immunotherapy, medicine.drug, Human, Adult, medicine.medical_specialty, Adolescent, Immunology, Transplantation, Autologous, Chemoimmunotherapy, Internal medicine, Humans, Proportional Hazards Models, Salvage Therapy, Antineoplastic Combined Chemotherapy Protocol, business.industry, Risk Factor, Cell Biology, Phosphamide, medicine.disease, Survival Analysis, Surgery, Transplantation, Feasibility Studie, Prospective Studie, Proportional Hazards Model, Feasibility Studies, business
Abstract

In this randomized multicenter study of 136 patients, 6 courses of CHOP (cyclo-phosphamide/doxorubicin/vincristine/prednisone) followed by rituximab (CHOP-R) were compared with rituximab-supplemented high-dose sequential chemotherapy with autografting (R-HDS) to assess the value of intensified chemo-therapy as a first-line treatment for high-risk follicular lymphoma (FL) after the introduction of monoclonal antibodies. The analysis was intention to treat with event-free survival (EFS) as the primary endpoint. Complete remission (CR) was 62% with CHOP-R and 85% with R-HDS (P < .001). At a median follow-up (MFU) of 51 months, the 4-year EFS was 28% and 61%, respectively (P < .001), with no difference in overall survival (OS). Molecular remission (MR) was achieved in 44% of CHOP-R and 80% of R-HDS patients (P < .001), and was the strongest independent outcome predictor. Patients relapsing after CHOP-R underwent salvage R-HDS in 71% of cases. Salvage R-HDS had an 85% CR rate and a 68% 3-year EFS (MFU, 30 months). We conclude that (1) achieving MR is critical for effective disease control, regardless of which treatment is used; (2) R-HDS ensures superior disease control and molecular outcome than CHOP-R, but no OS improvement; and (3) CHOP-R failures have a good outcome after salvage R-HDS, suggesting that relapsed/refractory FL could be the most appropriate setting for R-HDS–like treatments. This trial was registered at www.clinicaltrials.gov as no. NCT00435955.

Published
2008

41. Bendamustine in combination with Ofatumumab in relapsed or refractory chronic lymphocytic leukemia: a GIMEMA Multicenter Phase II Trial

Author

Cortelezzi, A, Sciumè, M, Liberati, Am, Vincenti, D, Cuneo, A, Reda, G, Laurenti, Luca, Zaja, F, Marasca, R, Chiarenza, A, Gritti, G, Orsucci, L, Storti, S, Angelucci, E, Cascavilla, N, Gobbi, M, Mauro, Fr, Morabito, F, Fabris, S, Piciocchi, A, Vignetti, M, Neri, A, Rossi, D, Giannarelli, D, Guarini, A, Foà, R., Laurenti, Luca (ORCID:0000-0002-8327-1396), Cortelezzi, A, Sciumè, M, Liberati, Am, Vincenti, D, Cuneo, A, Reda, G, Laurenti, Luca, Zaja, F, Marasca, R, Chiarenza, A, Gritti, G, Orsucci, L, Storti, S, Angelucci, E, Cascavilla, N, Gobbi, M, Mauro, Fr, Morabito, F, Fabris, S, Piciocchi, A, Vignetti, M, Neri, A, Rossi, D, Giannarelli, D, Guarini, A, Foà, R., and Laurenti, Luca (ORCID:0000-0002-8327-1396)

Abstract

We conducted a phase II, noncomparative, open-label, multicenter GIMEMA (Gruppo Italiano Malattie EMatologiche dell'Adulto) study (CLL0809) to assess the efficacy and safety of bendamustine in combination with ofatumumab (BendOfa) in relapsed/refractory chronic lymphocytic leukemia (CLL). Forty-seven patients from 14 centers were evaluated. Therapy consisted of bendamustine (70 mg/m(2)) for 2 consecutive days every 28 days, and ofatumumab 300 mg on day 1 and 1000 mg on day 8 during the first cycle, and 1000 mg on day 1 subsequently. Treatment was administered up to six cycles. The overall response rate (ORR), as per intention-to-treat analysis, was 72.3% (95% confidence of interval (CI), 57-84%), with 17% complete responses. After a median follow-up of 24.2 months, the overall survival was 83.6% (95% CI, 73.0-95.7%) and the progression-free survival (PFS) was 49.6% (95% CI, 35.9-68.6%). The median PFS was 23.6 months. Univariate and multivariate analyses were used to identify clinical and biological characteristics associated with ORR and PFS. Myelosuppression was the most common toxicity; grade 3 neutropenia was observed in 61.7% of patients; however, grade 3 infections occurred in 6% of patients. BendOfa is feasible and effective in relapsed/refractory CLL patients, including patients with high-risk clinical and biological features.Leukemia advance online publication, 3 December 2013; doi:10.1038/leu.2013.334.

Published
2014

42. 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

43. Quality of life in elderly patients with essential thrombocythaemia. An Italian multicentre study

Author

Oliva, E, Piccin, A, Mazzucconi, M, Morra, E, Recine, U, Pogliani, E, Pane, F, Gobbi, M, Gugliotta, L, Krampera, M, Cascavilla, N, Cacciola, R, Cacciola, E, Fioritoni, G, Fanin, R, Liberati, A, Angelucci, E, Tura, S, Oliva, EN, Mazzucconi, MG, POGLIANI, ENRICO MARIA, Liberati, AM, Tura, S., Oliva, E, Piccin, A, Mazzucconi, M, Morra, E, Recine, U, Pogliani, E, Pane, F, Gobbi, M, Gugliotta, L, Krampera, M, Cascavilla, N, Cacciola, R, Cacciola, E, Fioritoni, G, Fanin, R, Liberati, A, Angelucci, E, Tura, S, Oliva, EN, Mazzucconi, MG, POGLIANI, ENRICO MARIA, Liberati, AM, and Tura, S.

Abstract

Essential thrombocythaemia (ET) is a myeloproliferative neoplasm characterized by elevated platelet counts and increased incidence of thrombosis and haemorrhage. Median age at diagnosis is 65-70 years. Life expectancy is similar to that of the healthy population. Symptoms and complications may affect quality of life (QoL); in particular, in elderly patients ET may represent an additional burden. We performed a survey in 494 elderly ET patients to evaluate patient-reported outcomes (PROs). Comorbidities were present in 305 (62%) patients. Factorial analysis based on survey items representing psychological aspects of daily life identified an "attitude domain" with four clusters of patients: (A) very pessimistic (n=99), (B) pessimistic (n=101), (C) optimistic (n=90), and (D) very optimistic (n=107). Patients in cluster A had more comorbidities (p=0.003) while patients in cluster D required fewer medical visits and were less disturbed by medications (p<0.0001). Independent factors predicting Short-Form Health Survey, version 2 physical QoL were grade of optimism (p<0.0001), gender (p=0.007), and Charlson comorbidity index (p<0.0001)). Grade of optimism and disturbances related to medication predicted mental QOL (p<0.0001). In conclusion, physicians should take into consideration PROs, as "attitude" is associated with physical and mental QoL. Treatment should be tailored to patients' needs according to comorbidities, lifestyle, and psychological conditions. © Springer-Verlag 2011.

Published
2012

44. Bendamustine with or without rituximab for the treatment of heavily pretreated non-Hodgkin's lymphoma patients : A multicenter retrospective study on behalf of the Italian Lymphoma Foundation (FIL).

Author

Rigacci, L, Puccini, B, Cortelazzo, S, Gaidano, G, Piccin, A, D'Arco, A, Freilone, R, Storti, Sergio, Orciuolo, E, Zinzani, Pl, Zaja, F, Bongarzoni, V, Balzarotti, M, Rota Scalabrini, D, Patti, C, Gobbi, M, Carpaneto, A, Liberati, Am, Bosi, Alessandro, Iannitto, E., Storti, Sergio (ORCID:0000-0002-4374-3985), Rigacci, L, Puccini, B, Cortelazzo, S, Gaidano, G, Piccin, A, D'Arco, A, Freilone, R, Storti, Sergio, Orciuolo, E, Zinzani, Pl, Zaja, F, Bongarzoni, V, Balzarotti, M, Rota Scalabrini, D, Patti, C, Gobbi, M, Carpaneto, A, Liberati, Am, Bosi, Alessandro, Iannitto, E., and Storti, Sergio (ORCID:0000-0002-4374-3985)

Abstract

Bendamustine is an alkylating agent with a nitrogen mustard group and a purine-like benzimidazole group. The aim of this study was to collect all the Italian experiences with this drug in order to evaluate the results in term of response to therapy and toxicities. We analyzed lymphoma patients treated in 24 Italian haematological centres with bendamustine alone or in combination with anti-CD20 antibody. One hundred seventy-five relapsed or refractory lymphoma patients were enrolled. The median age was 69 years (range 26-87). Seventy-nine patients were relapsed, 35 were refractory and 61 presented a progressive disease after partial response. The diagnoses were 60 indolent non-follicular lymphomas, 34 diffuse large B-cell lymphomas, 48 follicular lymphomas, 30 mantle cell lymphomas and three peripheral T-cell lymphomas. All patients were evaluable for response: 52 (29%) with complete remission, 72 (43%) with partial response with an overall response rate of 71%, and 51 non-responders. With a median observation period of 10 months (1-43), 70% of patients are alive. In summary, this retrospective study shows that treatment with bendamustine alone or in combination with rituximab is a safe and effective regimen in a subset of multi-resistant patients.

Published
2012

45. ABVD versus BEACOPP for Hodgkin's lymphoma when high-dose salvage is planned

Author

Viviani, S, Zinzani, P, Rambaldi, A, Brusamolino, E, Levis, A, Bonfante, V, Vitolo, U, Pulsoni, A, Liberati, A, Specchia, G, Valagussa, P, Rossi, A, Zaja, F, Pogliani, E, Pregno, P, Gotti, M, Gallamini, A, Rota Scalabrini, D, Bonadonna, G, Gianni, A, Zinzani, PL, Liberati, AM, Gianni, AM, POGLIANI, ENRICO MARIA, Viviani, S, Zinzani, P, Rambaldi, A, Brusamolino, E, Levis, A, Bonfante, V, Vitolo, U, Pulsoni, A, Liberati, A, Specchia, G, Valagussa, P, Rossi, A, Zaja, F, Pogliani, E, Pregno, P, Gotti, M, Gallamini, A, Rota Scalabrini, D, Bonadonna, G, Gianni, A, Zinzani, PL, Liberati, AM, Gianni, AM, and POGLIANI, ENRICO MARIA

Abstract

BEACOPP, an intensified regimen consisting of bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone, has been advocated as the new standard of treatment for advanced Hodgkin's lymphoma, in place of the combination of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD).

Published
2011

46. Dose-dense and high-dose chemotherapy plus rituximab with autologous stem cell transplantation for primary treatment of diffuse large B-cell lymphoma with a poor prognosis: A phase II multicenter study

Author

Vitolo, U, Chiappella, A, Angelucci, E, Rossi, G, Liberati, A, Cabras, M, Botto, B, Ciccone, G, Gaidano, G, Falchi, L, Freilone, R, Novero, D, Orsucci, L, Pavone, V, Pogliani, E, Rota Scalabrini, D, Salvi, F, Tonso, A, Tucci, A, Levis, A, Liberati, AM, Cabras, MG, Levis, A., POGLIANI, ENRICO MARIA, Vitolo, U, Chiappella, A, Angelucci, E, Rossi, G, Liberati, A, Cabras, M, Botto, B, Ciccone, G, Gaidano, G, Falchi, L, Freilone, R, Novero, D, Orsucci, L, Pavone, V, Pogliani, E, Rota Scalabrini, D, Salvi, F, Tonso, A, Tucci, A, Levis, A, Liberati, AM, Cabras, MG, Levis, A., and POGLIANI, ENRICO MARIA

Abstract

We investigated the addition of rituximab to dose-dense and high-dose chemotherapy with autologous stem cell transplantation in patients with untreated poor-prognosis diffuse large B-cell lymphoma.

Published
2009

49. Factors that influence achievment of complete remission and its duration after polychemotherapy in follicular non Hodgikin's lymphoma

Author

Liberati, Am, Di Clemente, F, Biscottini, B, Cinieri, S, De Angelis, V, De Renzo, A, Rotoli, B, Abate, G, Russo, F, Milani, S, Mustacchi, G, Ambrosi, L, Leoni, P, Mastria, A, Lorusso, V, Vecchi, A, Sacchi, Stefano, Palmieri, F, Volpe, E, Minischetti, Gadaleta, Dammacco, F, Di Costanzo, F, Brugiatelli, M, and Grignani, F.

Subjects
Polychemotherpy, Follicular NHL
Published
1996

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