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2. Digital morphology compared to the optical microscope: A validation study on reporting bone marrow aspirates

Author

Zini, G., Chiusolo, Patrizia, Rossi, E., Di Stasio, Enrico, Bellesi, Silvia, Za, T., Viscovo, Marcello, Frioni, Filippo, Ramundo, Francesco, Pelliccioni, Nicoletta, De Stefano, Valerio, Chiusolo P. (ORCID:0000-0002-1355-1587), Di Stasio E. (ORCID:0000-0003-1047-4261), Bellesi S., Viscovo M., Frioni F., Ramundo F., Pelliccioni N., De Stefano V. (ORCID:0000-0002-5178-5827), Zini, G., Chiusolo, Patrizia, Rossi, E., Di Stasio, Enrico, Bellesi, Silvia, Za, T., Viscovo, Marcello, Frioni, Filippo, Ramundo, Francesco, Pelliccioni, Nicoletta, De Stefano, Valerio, Chiusolo P. (ORCID:0000-0002-1355-1587), Di Stasio E. (ORCID:0000-0003-1047-4261), Bellesi S., Viscovo M., Frioni F., Ramundo F., Pelliccioni N., and De Stefano V. (ORCID:0000-0002-5178-5827)

Abstract

Introduction: This study aims to evaluate the effectiveness and reliability of the utilization for clinical reporting of the evaluation of digital images of bone marrow aspirates by morphologists and their comparability with the classic microscopic morphological evaluation. Methods: We scanned 180 consecutive bone marrow needle aspirates smears using the “Metafer4 VSlide” whole slide imaging (WSI) digital scanning system. We evaluated the statistical comparability and the risk of bias of the microscopic readings with those performed on the screen on the digitized medullary images. Results: The evaluation of cellularity on the screen was equivalent, with a higher frequency of “normal” than the analysis of digital preparations. The means and medians of the percentage values obtained on the different cell populations with the microscopic and digital reading were comparable as the main categories are concerned, with an average difference equal to 0 for the neutrophilic and eosinophilic granulocytic series, at −0.2% for the total myeloid cells, at 1.2% for the erythroid series, at −0.4% for the lymphocytes and at −0.4% for the blasts. Dysplastic features were consistently identified in 69/71 cell lineages. Conclusion: Our study demonstrated that screen evaluation of digitized bone marrow needle aspirates provides quantitative and qualitative results comparable to traditional microscopic analysis of the corresponding slide smears. Digital images offer significant benefits in reducing the workload of experienced operators, reproducibility and sharing of observations, and image preservation. Even in routine diagnostic activities, their use does not alter the quality of the results obtained in evaluating bone marrow needle aspirates.

Published
2024

4. P25 EFFECT OF DARATUMUMAB ON STEM CELL YIELDS IN PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA: REPORT FROM THE MULTIPLE MYELOMA LAZIO GROUP

Author

Fazio, F., primary, Passucci, M., additional, Lisi, C., additional, Micozzi, J., additional, Fianchi, L., additional, Di Landro, F., additional, Za, T., additional, Gumenyuk, S., additional, Ferraro, S., additional, Anaclerico, B., additional, De Padua, L., additional, Annibali, O., additional, Rago, A., additional, Piciocchi, A., additional, Bongarzoni, V., additional, Cupelli, L., additional, Mengarelli, A., additional, De Stefano, V., additional, Martelli, M., additional, and Petrucci, M.T., additional

Published
2023
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5. P902: RELAPSED/REFRACTORY MULTIPLE MYELOMA PATIENTS. A MULTICENTER RETROSPECTIVE ANALYSIS OF ELIGIBILITY CRITERIA FOR CAR-T CELL THERAPY

Author

Fazio, F., primary, Di Rocco, A., additional, Giaimo, M. T., additional, Za, T., additional, Ciccone, N., additional, Sessa, M., additional, Gamberi, B., additional, Tomarchio, V., additional, De Padua, L., additional, Bongarzoni, V., additional, Mariani, S., additional, Rago, A., additional, Piciocchi, A., additional, Merli, F., additional, Cuneo, A., additional, De Stefano, V., additional, Foà, R., additional, Martelli, M., additional, and Petrucci, M. T., additional

Published
2022
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8. Treatment of primary plasma cell leukemia with high doses of cyclophosphamide, bortezomib, and dexamethasone followed by double autologous HSCT

Author

Pagano, Livio, Maraglino, Alessio Maria Edoardo, Fianchi, Luana, Criscuolo, Marianna, Rossi, Elena, Za, Tommaso, Chiusolo, Patrizia, Bonanni, Matteo, Dragonetti, Giulia, Bacigalupo, Andrea, Sica, Simona, De Stefano, Valerio, Pagano L. (ORCID:0000-0001-8287-928X), Maraglino A. M. E., Fianchi L., Criscuolo M., Rossi E. (ORCID:0000-0002-7572-9379), Za T., Chiusolo P. (ORCID:0000-0002-1355-1587), Bonanni M., Dragonetti G., Bacigalupo A. (ORCID:0000-0002-9119-567X), Sica S. (ORCID:0000-0003-2426-3465), De Stefano V. (ORCID:0000-0002-5178-5827), Pagano, Livio, Maraglino, Alessio Maria Edoardo, Fianchi, Luana, Criscuolo, Marianna, Rossi, Elena, Za, Tommaso, Chiusolo, Patrizia, Bonanni, Matteo, Dragonetti, Giulia, Bacigalupo, Andrea, Sica, Simona, De Stefano, Valerio, Pagano L. (ORCID:0000-0001-8287-928X), Maraglino A. M. E., Fianchi L., Criscuolo M., Rossi E. (ORCID:0000-0002-7572-9379), Za T., Chiusolo P. (ORCID:0000-0002-1355-1587), Bonanni M., Dragonetti G., Bacigalupo A. (ORCID:0000-0002-9119-567X), Sica S. (ORCID:0000-0003-2426-3465), and De Stefano V. (ORCID:0000-0002-5178-5827)

Abstract

nd

Published
2020

15. Multiple Myeloma Treatment in Real-world Clinical Practice: Results of a Prospective, Multinational, Noninterventional Study

Author

Mohty, M. Terpos, E. Mateos, M.-V. Cavo, M. Lejniece, S. Beksac, M. Bekadja, M.A. Legiec, W. Dimopoulos, M. Stankovic, S. Durán, M.S. De Stefano, V. Corso, A. Kochkareva, Y. Laane, E. Berthou, C. Salwender, H. Masliak, Z. Pečeliūnas, V. Willenbacher, W. Silva, J. Louw, V. Nemet, D. Borbényi, Z. Abadi, U. Pedersen, R.S. Černelč, P. Potamianou, A. Couturier, C. Feys, C. Thoret-Bauchet, F. Boccadoro, M. Bekadja, M. Hamladji, R.-M. Ali, H.A. Hamdi, S. Touhami, H. Mansour, N.S. Linkesch, W. Abildgaard, N. Hein, M. Eveillard, J.R. Yamani, A.E. Moreau, P. Sanhes, L. Lepeu, G. Laribi, K. Jourdan, E. Fitoussi, O. Allangba, O. Fleury, J. Escoffre, M. Benramdane, R. Cartron, G. Dine, G. Legouffe, E. Harich, H.-D. Illmer, T. Dörfel, S. Hannig, C.V. Koenigsmann, M. Prange-Krex, G. Tamm, I. Zeller, W. Maasberg, M. Schlag, R. Klausmann, M. Uhlig, J. Alkemper, B. Schütz, S. Tessen, H.-W. Mohr, B. Schmidt, P. Heinrich, B. Hebart, H. Seipelt, G. Zoeller, T. Heits, F. Müller-Naendrup, C. Hansen, R. Repp, R. Von Weikersthal, L.F. Schmits, R. Heßling, J. Krammer-Steiner, B. Janzen, V. Schauer, M. Grüner, M.W. Kisro, J. Denzlinger, C. Freier, W. Junghanss, C. Görner, M. Laichinger, K. Ostermann, H. Dürk, H. Hess, G. Reich, G. Matsouka, P. Pouli, A. Anagnostopoulos, A. Masszi, T. Ivanyi, J. Szomor, A. Nagler, A. Magen, H. Avivi, I. Quitt, M. Palumbo, A. Za, T. Vallisa, D. Foa, R. Bosi, A. Vacca, A. Lanza, F. Palazzo, G. Avvisati, G. Ferrara, F. Consoli, U. Cantonetti, M. Angelucci, E. Califano, C. Di Raimondo, F. Guarini, A. Musso, M. Pizzuti, M. Giuliani, N. Ardizzoia, A. Di Renzo, N. Gaidano, G. Gozzetti, A. Pitini, V. Farina, G. Centurioni, R. De Fabritiis, P. Iuliano, F. La Nasa, G. La Verde, G. Pane, F. Recine, U. La Targia, M. Mineo, G. Cangialosi, C. Fagnani, D. Federici, A. Romano, A. Specchia, G. Storti, S. Bongarzoni, V. Bacigalupo, A. Gobbi, M. Latte, G. Mannina, D. Capalbo, S. Jurgutis, M. Woszczyk, D. Hołojda, J. Gornik, S. Pluta, A. Morawiec-Szymonik, E. Kyrcz-Krzemien, S. Homenda, W. Grosicki, S. Sulek, K. Lange, A. Kloczko, J. Starzak-Gwozdz, J. Hellmann, A. Komarnicki, M. Kuliczkowski, K. Viveiros, C. Gonçalves, C. Esefyeva, N. Kaplanov, K. Volodicheva, E. Laricheva, E. Dergacheva, V. Chukavina, M. Volchenko, N. Nazarova, I. Anchukova, L. Ovanesova, E. Salogub, G. Magomedova, L. Kuznetsova, I. Osyunikhina, S. Serdyuk, O. Karyagina, E. Ivanova, V. Černelč, S.P. Coetzee, C. Gunther, K. Moodley, D. Duran, S. Gutiérrez, A.E. De Oteyza, J.P. Capote, F.J. Casanova, M. Sanchez, J.M. Rios-Herranz, E. Ibañez-Garcia, J. Herranz, M.J. Hernandez, B. Sanchez, S.S. Escalante, F. Carnicero, F. Lleonart, J.B. Gironella, M. Martínez, R. De La Guia, A.L. Palomera, L. Iglesias, R. Ramos, F.S. De La Serna, J. Sanchez, P.G. Vidal, J.B. Morfa, M.D. Beksac, T.-M. Vural, F. Aydin, Y. Unal, A. Goker, H. Bilgir, O. Guvenc, B. Turgut, M. Ozet, G.G. Ali, R. Kyselyova, M. Glushko, N. Vybyrana, R. Skrypnyk, I. Tretyak, N. Kharchevska, T. Dyagil, I. Popovs'ka, T. Shimanskiy, V. Lysa, T. Oliynyk, H. Vilchevskaya, K. Kryachok, I. Popovych, Y. Romanyuk, N. Yushchenko, N. Kaplan, P. Rekhtman, G. Pylypenko, H. Kozlov, V. Drach, J. Harousseau, J.-L. Einsele, H. Goldschmidt, H. Facon, T. Michalet, M. Savchenko, V.G. De la Rubia, J. Cook, G. Mellqvist, U.-H. Ludwig, H. EMMOS Investigators

Abstract

Multiple myeloma (MM) remains an incurable disease, with little information available on its management in real-world clinical practice. The results of the present prospective, noninterventional observational study revealed great diversity in the treatment regimens used to treat MM. Our results also provide data to inform health economic, pharmacoepidemiologic, and outcomes research, providing a framework for the design of protocols to improve the outcomes of patients with MM. Background: The present prospective, multinational, noninterventional study aimed to document and describe real-world treatment regimens and disease progression in multiple myeloma (MM) patients. Patients and Methods: Adult patients initiating any new MM therapy from October 2010 to October 2012 were eligible. A multistage patient/site recruitment model was applied to minimize the selection bias; enrollment was stratified by country, region, and practice type. The patient medical and disease features, treatment history, and remission status were recorded at baseline, and prospective data on treatment, efficacy, and safety were collected electronically every 3 months. Results: A total of 2358 patients were enrolled. Of these patients, 775 and 1583 did and did not undergo stem cell transplantation (SCT) at any time during treatment, respectively. Of the patients in the SCT and non-SCT groups, 49%, 21%, 14%, and 15% and 57%, 20%, 12% and 10% were enrolled at treatment line 1, 2, 3, and ≥ 4, respectively. In the SCT and non-SCT groups, 45% and 54% of the patients had received bortezomib-based therapy without thalidomide/lenalidomide, 12% and 18% had received thalidomide/lenalidomide-based therapy without bortezomib, and 30% and 4% had received bortezomib plus thalidomide/lenalidomide-based therapy as frontline treatment, respectively. The corresponding proportions of SCT and non-SCT patients in lines 2, 3, and ≥ 4 were 45% and 37%, 30% and 37%, and 12% and 3%, 33% and 27%, 35% and 32%, and 8% and 2%, and 27% and 27%, 27% and 23%, and 6% and 4%, respectively. In the SCT and non-SCT patients, the overall response rate was 86% to 97% and 64% to 85% in line 1, 74% to 78% and 59% to 68% in line 2, 55% to 83% and 48% to 60% in line 3, and 49% to 65% and 36% and 45% in line 4, respectively, for regimens that included bortezomib and/or thalidomide/lenalidomide. Conclusion: The results of our prospective study have revealed great diversity in the treatment regimens used to manage MM in real-life practice. This diversity was linked to factors such as novel agent accessibility and evolving treatment recommendations. Our results provide insight into associated clinical benefits. © 2018 The Authors

Published
2018

16. PB2161 TREATMENT OF PRIMARY PLASMA CELL LEUKEMIA WITH HIGH DOSES OF CYCLOPHOPHAMIDE, BORTEZOMIB AND DEXAMETHASONE FOLLOWED BY DOUBLE AUTOLOGOUS HSCT

Author

Pagano, L., primary, Maraglino, A. E. M., additional, Criscuolo, M., additional, Fianchi, L., additional, Rossi, E., additional, Za, T., additional, Chiusolo, P., additional, Bonanni, M., additional, Dragonetti, G., additional, Bacigalupo, A., additional, Sica, S., additional, and De Stefano, V., additional

Published
2019
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17. Multiple Myeloma Treatment in Real-world Clinical Practice: Results of a Prospective, Multinational, Noninterventional Study

Author

Mohty, M., Terpos, E., Mateos, M. -V., Cavo, M., Lejniece, S., Beksac, M., Bekadja, M. A., Legiec, W., Dimopoulos, M., Stankovic, S., Duran, M. S., De Stefano, Valerio, Corso, A., Kochkareva, Y., Laane, E., Berthou, C., Salwender, H., Masliak, Z., Peceliunas, V., Willenbacher, W., Silva, J., Louw, V., Nemet, D., Borbenyi, Z., Abadi, U., Pedersen, R. S., Cernelc, P., Potamianou, A., Couturier, C., Feys, C., Thoret-Bauchet, F., Boccadoro, M., Bekadja, M., Hamladji, R. -M., Ali, H. A., Hamdi, S., Touhami, H., Mansour, N. S., Linkesch, W., Abildgaard, N., Hein, M., Eveillard, J. R., Yamani, A. E., Moreau, P., Sanhes, L., Lepeu, G., Laribi, K., Jourdan, E., Fitoussi, O., Allangba, O., Fleury, J., Escoffre, M., Benramdane, R., Cartron, G., Dine, G., Legouffe, E., Harich, H. -D., Illmer, T., Dorfel, S., Hannig, C. V., Koenigsmann, M., Prange-Krex, G., Tamm, I., Zeller, W., Maasberg, M., Schlag, R., Klausmann, M., Uhlig, J., Alkemper, B., Schutz, S., Tessen, H. -W., Mohr, B., Schmidt, P., Heinrich, B., Hebart, H., Seipelt, G., Zoeller, T., Heits, F., Muller-Naendrup, C., Hansen, R., Repp, R., Von Weikersthal, L. F., Schmits, R., Hessling, J., Krammer-Steiner, B., Janzen, V., Schauer, M., Gruner, M. W., Kisro, J., Denzlinger, C., Freier, W., Junghanss, C., Gorner, M., Laichinger, K., Ostermann, H., Durk, H., Hess, G., Reich, G., Matsouka, P., Pouli, A., Anagnostopoulos, A., Masszi, T., Ivanyi, J., Szomor, A., Nagler, A., Magen, H., Avivi, I., Quitt, M., Palumbo, A., Za, Tommaso, Vallisa, D., Foa, R., Bosi, A., Vacca, A., Lanza, F., Palazzo, G., Avvisati, G., Ferrara, F., Consoli, U., Cantonetti, M., Angelucci, E., Califano, C., Di Raimondo, F., Guarini, A., Musso, M., Pizzuti, M., Giuliani, N., Ardizzoia, A., Di Renzo, N., Gaidano, G., Gozzetti, A., Pitini, V., Farina, G., Centurioni, R., De Fabritiis, P., Iuliano, F., La Nasa, G., La Verde, G., Pane, F., Recine, U., La Targia, M., Mineo, G., Cangialosi, C., Fagnani, D., Federici, A., Romano, A., Specchia, G., Storti, Sergio, Bongarzoni, V., Bacigalupo, Andrea, Gobbi, M., Latte, G., Mannina, D., Capalbo, S., Jurgutis, M., Woszczyk, D., Holojda, J., Gornik, S., Pluta, A., Morawiec-Szymonik, E., Kyrcz-Krzemien, S., Homenda, W., Grosicki, S., Sulek, K., Lange, A., Kloczko, J., Starzak-Gwozdz, J., Hellmann, A., Komarnicki, M., Kuliczkowski, K., Viveiros, C., Goncalves, C., Esefyeva, N., Kaplanov, K., Volodicheva, E., Laricheva, E., Dergacheva, V., Chukavina, M., Volchenko, N., Nazarova, I., Anchukova, L., Ovanesova, E., Salogub, G., Magomedova, L., Kuznetsova, I., Osyunikhina, S., Serdyuk, O., Karyagina, E., Ivanova, V., Cernelc, S. P., Coetzee, C., Gunther, K., Moodley, D., Duran, S., Gutierrez, A. E., De Oteyza, J. P., Capote, F. J., Casanova, M., Sanchez, J. M., Rios-Herranz, E., Ibanez-Garcia, J., Herranz, M. J., Hernandez, B., Sanchez, S. S., Escalante, F., Carnicero, F., Lleonart, J. B., Gironella, M., Martinez, R., De La Guia, A. L., Palomera, L., Iglesias, R., Ramos, F. S., De La Serna, J., Sanchez, P. G., Vidal, J. B., Morfa, M. D., Beksac, T. -M., Vural, F., Aydin, Y., Unal, A., Goker, H., Bilgir, O., Guvenc, B., Turgut, M., Ozet, G. G., Ali, R., Kyselyova, M., Glushko, N., Vybyrana, R., Skrypnyk, I., Tretyak, N., Kharchevska, T., Dyagil, I., Popovs'Ka, T., Shimanskiy, V., Lysa, T., Oliynyk, H., Vilchevskaya, K., Kryachok, I., Popovych, Y., Romanyuk, N., Yushchenko, N., Kaplan, P., Rekhtman, G., Pylypenko, H., Kozlov, V., Drach, J., Harousseau, J. -L., Einsele, H., Goldschmidt, H., Facon, T., Michalet, M., Savchenko, V. G., De la Rubia, J., Cook, G., Mellqvist, U. -H., Ludwig, H., De Stefano V. (ORCID:0000-0002-5178-5827), Za T., Storti S. (ORCID:0000-0002-4374-3985), Bacigalupo A. (ORCID:0000-0002-9119-567X), Mohty, M., Terpos, E., Mateos, M. -V., Cavo, M., Lejniece, S., Beksac, M., Bekadja, M. A., Legiec, W., Dimopoulos, M., Stankovic, S., Duran, M. S., De Stefano, Valerio, Corso, A., Kochkareva, Y., Laane, E., Berthou, C., Salwender, H., Masliak, Z., Peceliunas, V., Willenbacher, W., Silva, J., Louw, V., Nemet, D., Borbenyi, Z., Abadi, U., Pedersen, R. S., Cernelc, P., Potamianou, A., Couturier, C., Feys, C., Thoret-Bauchet, F., Boccadoro, M., Bekadja, M., Hamladji, R. -M., Ali, H. A., Hamdi, S., Touhami, H., Mansour, N. S., Linkesch, W., Abildgaard, N., Hein, M., Eveillard, J. R., Yamani, A. E., Moreau, P., Sanhes, L., Lepeu, G., Laribi, K., Jourdan, E., Fitoussi, O., Allangba, O., Fleury, J., Escoffre, M., Benramdane, R., Cartron, G., Dine, G., Legouffe, E., Harich, H. -D., Illmer, T., Dorfel, S., Hannig, C. V., Koenigsmann, M., Prange-Krex, G., Tamm, I., Zeller, W., Maasberg, M., Schlag, R., Klausmann, M., Uhlig, J., Alkemper, B., Schutz, S., Tessen, H. -W., Mohr, B., Schmidt, P., Heinrich, B., Hebart, H., Seipelt, G., Zoeller, T., Heits, F., Muller-Naendrup, C., Hansen, R., Repp, R., Von Weikersthal, L. F., Schmits, R., Hessling, J., Krammer-Steiner, B., Janzen, V., Schauer, M., Gruner, M. W., Kisro, J., Denzlinger, C., Freier, W., Junghanss, C., Gorner, M., Laichinger, K., Ostermann, H., Durk, H., Hess, G., Reich, G., Matsouka, P., Pouli, A., Anagnostopoulos, A., Masszi, T., Ivanyi, J., Szomor, A., Nagler, A., Magen, H., Avivi, I., Quitt, M., Palumbo, A., Za, Tommaso, Vallisa, D., Foa, R., Bosi, A., Vacca, A., Lanza, F., Palazzo, G., Avvisati, G., Ferrara, F., Consoli, U., Cantonetti, M., Angelucci, E., Califano, C., Di Raimondo, F., Guarini, A., Musso, M., Pizzuti, M., Giuliani, N., Ardizzoia, A., Di Renzo, N., Gaidano, G., Gozzetti, A., Pitini, V., Farina, G., Centurioni, R., De Fabritiis, P., Iuliano, F., La Nasa, G., La Verde, G., Pane, F., Recine, U., La Targia, M., Mineo, G., Cangialosi, C., Fagnani, D., Federici, A., Romano, A., Specchia, G., Storti, Sergio, Bongarzoni, V., Bacigalupo, Andrea, Gobbi, M., Latte, G., Mannina, D., Capalbo, S., Jurgutis, M., Woszczyk, D., Holojda, J., Gornik, S., Pluta, A., Morawiec-Szymonik, E., Kyrcz-Krzemien, S., Homenda, W., Grosicki, S., Sulek, K., Lange, A., Kloczko, J., Starzak-Gwozdz, J., Hellmann, A., Komarnicki, M., Kuliczkowski, K., Viveiros, C., Goncalves, C., Esefyeva, N., Kaplanov, K., Volodicheva, E., Laricheva, E., Dergacheva, V., Chukavina, M., Volchenko, N., Nazarova, I., Anchukova, L., Ovanesova, E., Salogub, G., Magomedova, L., Kuznetsova, I., Osyunikhina, S., Serdyuk, O., Karyagina, E., Ivanova, V., Cernelc, S. P., Coetzee, C., Gunther, K., Moodley, D., Duran, S., Gutierrez, A. E., De Oteyza, J. P., Capote, F. J., Casanova, M., Sanchez, J. M., Rios-Herranz, E., Ibanez-Garcia, J., Herranz, M. J., Hernandez, B., Sanchez, S. S., Escalante, F., Carnicero, F., Lleonart, J. B., Gironella, M., Martinez, R., De La Guia, A. L., Palomera, L., Iglesias, R., Ramos, F. S., De La Serna, J., Sanchez, P. G., Vidal, J. B., Morfa, M. D., Beksac, T. -M., Vural, F., Aydin, Y., Unal, A., Goker, H., Bilgir, O., Guvenc, B., Turgut, M., Ozet, G. G., Ali, R., Kyselyova, M., Glushko, N., Vybyrana, R., Skrypnyk, I., Tretyak, N., Kharchevska, T., Dyagil, I., Popovs'Ka, T., Shimanskiy, V., Lysa, T., Oliynyk, H., Vilchevskaya, K., Kryachok, I., Popovych, Y., Romanyuk, N., Yushchenko, N., Kaplan, P., Rekhtman, G., Pylypenko, H., Kozlov, V., Drach, J., Harousseau, J. -L., Einsele, H., Goldschmidt, H., Facon, T., Michalet, M., Savchenko, V. G., De la Rubia, J., Cook, G., Mellqvist, U. -H., Ludwig, H., De Stefano V. (ORCID:0000-0002-5178-5827), Za T., Storti S. (ORCID:0000-0002-4374-3985), and Bacigalupo A. (ORCID:0000-0002-9119-567X)

Abstract

Multiple myeloma (MM) remains an incurable disease, with little information available on its management in real-world clinical practice. The results of the present prospective, noninterventional observational study revealed great diversity in the treatment regimens used to treat MM. Our results also provide data to inform health economic, pharmacoepidemiologic, and outcomes research, providing a framework for the design of protocols to improve the outcomes of patients with MM. Background: The present prospective, multinational, noninterventional study aimed to document and describe real-world treatment regimens and disease progression in multiple myeloma (MM) patients. Patients and Methods: Adult patients initiating any new MM therapy from October 2010 to October 2012 were eligible. A multistage patient/site recruitment model was applied to minimize the selection bias; enrollment was stratified by country, region, and practice type. The patient medical and disease features, treatment history, and remission status were recorded at baseline, and prospective data on treatment, efficacy, and safety were collected electronically every 3 months. Results: A total of 2358 patients were enrolled. Of these patients, 775 and 1583 did and did not undergo stem cell transplantation (SCT) at any time during treatment, respectively. Of the patients in the SCT and non-SCT groups, 49%, 21%, 14%, and 15% and 57%, 20%, 12% and 10% were enrolled at treatment line 1, 2, 3, and ≥ 4, respectively. In the SCT and non-SCT groups, 45% and 54% of the patients had received bortezomib-based therapy without thalidomide/lenalidomide, 12% and 18% had received thalidomide/lenalidomide-based therapy without bortezomib, and 30% and 4% had received bortezomib plus thalidomide/lenalidomide-based therapy as frontline treatment, respectively. The corresponding proportions of SCT and non-SCT patients in lines 2, 3, and ≥ 4 were 45% and 37%, 30% and 37%, and 12% and 3%, 33% and 27%, 35% and 32%, and 8% and

Published
2018

18. Role of flow-cytometric immunophenotyping in prediction of BCR/ABL1 gene rearrangement in adult B-cell acute lymphoblastic leukemia

Author

Corrente, Francesco, Bellesi, Silvia, Metafuni, Elisabetta, Puggioni, Pier Luigi, Marietti, S., Ciminello, A. M., Za, Tommaso, Sora', Federica, Fianchi, Luana, Sica, Simona, De Stefano, Valerio, Chiusolo, Patrizia, Corrente F., Bellesi S., Metafuni E., Puggioni P. L., Za T., Sora F. (ORCID:0000-0002-9607-5298), Fianchi L., Sica S. (ORCID:0000-0003-2426-3465), De Stefano V. (ORCID:0000-0002-5178-5827), Chiusolo P. (ORCID:0000-0002-1355-1587), Corrente, Francesco, Bellesi, Silvia, Metafuni, Elisabetta, Puggioni, Pier Luigi, Marietti, S., Ciminello, A. M., Za, Tommaso, Sora', Federica, Fianchi, Luana, Sica, Simona, De Stefano, Valerio, Chiusolo, Patrizia, Corrente F., Bellesi S., Metafuni E., Puggioni P. L., Za T., Sora F. (ORCID:0000-0002-9607-5298), Fianchi L., Sica S. (ORCID:0000-0003-2426-3465), De Stefano V. (ORCID:0000-0002-5178-5827), and Chiusolo P. (ORCID:0000-0002-1355-1587)

Abstract

We performed a retrospective analysis of 88 adult patients with B-ALL diagnosed in our center by a flow-cytometric assessment. Immunophenotypic expression of leukemic cells was explored by simultaneous evaluation of positivity, percentage of expressing cells and median fluorescence intensity (MFI). BCR/ABL1 fusion transcripts were assessed by RT-PCR analysis and were identified in 36 patients (40.9%). CD10 and CD34 were positive in the totality of BCR/ABL1-positive cases. Patients with gene rearrangement had a greater frequency of CD66c, CD13 and CD33 positivity compared with BCR/ABL1-negative cases. Moreover, BCR/ABL1-positive cases exhibited a greater median percentage and MFI values of CD13, CD33, CD66c, CD10, CD34 and CD25 expressions, but a lower median percentage and MFI values of CD38 and CD22 expressions than patients without gene rearrangement. Multivariate logistic regression analysis showed that CD10, CD38 and CD13 expressions were independent predictors for the presence of BCR/ABL1 rearrangement. Predictive probabilities of molecular occurrence based on these markers are proposed. © 2017 International Clinical Cytometry Society.

Published
2018

19. HIWALAH DAN APLIKASINYA DALAM PRODUK BAI' AL-ISTISHNA' DI BANK SYARIAH

Author

ZA T. Abrar

Subjects
lcsh:Commerce, lcsh:HF1-6182, lcsh:Finance, lcsh:HG1-9999
Abstract

Hiwalah adalah pemindahan piutang dari tanggung jawab seseorang menjaditanggung jawab orang lain. Prinsip hiwalah diaplikasikan di bank syariah dalambentuk produk bai' al-istishna dan bai' al-salam. Produk bai' al-istishna merupakanmekanisme pertanggungan piutang oleh pihak bank syariah kepada pihak nasabahyang memiliki tanggungan utang atas pembiayaan proyek-proyek fisik. Bank syariahakan memperoleh keuntungan berdasarkan bagi hasil keuntungan dari proyek yangdikerjakan oleh pihak nasabah. Sedangkan produk bai' al-salam merupakanmekanisme pertanggungan piutang oleh pihak bank syariah kepada pihak nasabahyang melakukan suatu transaksi jual beli tidak secara tunai. Faktor-faktor pendukungpengembangan prinsip hiwalah dalam produk bai' al-istishna dan bai' al-salam dibank syariah adalah kinerja positif seluruh pimpinan, staf dan karyawan bank syariahmemiliki komitmen kuat terhadap pengembangan ekonomi syariah, kemampuanmanajerial yang baik, dan sikap mental (kejujuran) serta amanah untuk melayananmasyarakat sebaik-baiknya. Sedangkan faktor penghambatnya adalah masihrendahnya tingkat pemahaman masyarakat terhadap bank syariah, kurangnyasosialisasi hiwalah dalam produk bai' al-istishna dan bai' al-salam, masih lemahnyajaringan perbankan syariah dengan bank-bank lain serta belum optimalnya fasilitaspelayanan sistem jaringon antar bank online.

Published
2017

22. 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

23. 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

24. Cardiovascular events and intensity of treatment in polycythemia vera

Author

Marchioli, R, Finazzi, G, Specchia, G, Cacciola, R, Cavazzina, R, Cilloni, D, De Stefano, V, Elli, E, Iurlo, A, Latagliata, R, Lunghi, F, Lunghi, M, Marfisi, Rm, Musto, P, Masciulli, A, Musolino, C, Cascavilla, N, Quarta, G, Randi, M. L., Rapezzi, D, Ruggeri, M, Rumi, E, Scortechini, Ar, Santini, S, Scarano, M, Siragusa, S, Spadea, A, Tieghi, A, Angelucci, E, Visani, G, Vannucchi, Am, Specchia G, Barbui T., D'Amico, A, Ferri, B, Guido, C, Marfisi, L, Pera, C, Polidoro, A, Sacco, M, Levantesi, G, Tognoni, G, Barosi, G, Carobbio, A, Leoni, P, Mulattieri, S, Tomassetti, S, Honorati, E, Ricco, A, Albano, F, Pastore, D, Carluccio, P, Mazzone, Am, Rossi, Ar, Finazzi, Mc, Delaini, F, Falanga, A, Rambaldi, A, Guaragna, G, Giannotta, A, Usala, E, Simula, Mp, Pilo, F, Cacciola, E, Pezzella, F, Seria, E, Di Francesco, E, Gallamini, A, Bertolotti, L, Antonioli, E, Guglielmelli, P, Pieri, L, Susini, Mc, Bartalucci, N, Bosi, A, D'Angelo, A, Centorrino, R, Gerace, D, Allegra, A, Cortelezzi, A, De Philippis, C, Ferretti, E, Ciceri, F, Claudiani, S, Malato, S, Trinca, S, Pogliani, Em, Belotti, A, Lanzi, E, Elli, Em, Gaidano, G, Deambrogi, C, Rossi, D, Saglio, G, Rotolo, A, Zanone, C, Bertozzi, I, Tezza, F, Aneloni, V, Quintini, G, Saccullo, G, Caracciolo, C, Cazzola, M, Casetti, I, Elena, C, Landini, B, Barulli, S, Guiducci, B, Lucesole, M, Malerba, L, Isidori, A, Grossi, A, De Stefanis, M, Biagioni, C, Merli, F, Imovilli, A, Codeluppi, K, Rubagotti, S, Romano, N, Bonini, A, Bellesia, E, Martorelli, Mc, Villani, O, Zifarone, E, Zonno, A, Santopietro, V, Za, T, Rossi, E, Ciminello, Am, Betti, S, Alimena, G, Tafuri, A, Breccia, M, Carmosino, I, Pisani, F, Romano, A, D'Andrea, M, Nobile, M, Mantuano, Fs, Rossi, G, Tricarico, M, Rodeghiero, F, Bedin, F, Lissandrini, L, Finotto, S., Marchioli, R, Finazzi, G, Specchia, G, Cacciola, R, Cavazzina, R, Cilloni, D, De Stefano, V, Elli, E, Iurlo, A, Latagliata, R, Lunghi, F, Lunghi, M, Marfisi, RM, Musto, P, Masciulli, A, Musolino, C, Cascavilla, N, Quarta, G, Randi, ML, Rapezzi, D, Ruggeri, M, Rumi, E, Scortechini, AR, Santini, S, Scarano, M, Siragusa, S, Spadea, A, Tieghi, A, Angelucci, E, Visani, G, Vannucchi, AM, Barbui, T, and CYTO-PV Collaborative Group.

Subjects
Male, Hematocrit, RECURRENT THROMBOSIS, law.invention, Aged, Antineoplastic Agents, Cardiovascular Diseases, Combined Modality Therapy, Female, Follow-Up Studies, Humans, Hydroxyurea, Janus Kinase 2, Middle Aged, Polycythemia Vera, Thrombosis, Phlebotomy, Medicine (all), LEUKOCYTOSIS, Polycythemia vera, Randomized controlled trial, law, hemic and lymphatic diseases, ESSENTIAL THROMBOCYTHEMIA, Clinical endpoint, Polycythemia Vera, Secondary Prophylaxis, ESSENTIAL THROMBOCYTHEMIA, RECURRENT THROMBOSIS, RISK-FACTOR, HEMATOCRIT, MANAGEMENT, LEUKOCYTOSIS, PREVENTION, DIAGNOSIS, EFFICACY, WARFARIN, medicine.diagnostic_test, Hazard ratio, General Medicine, medicine.medical_specialty, randomized trial, polycythemia vera, Cardiovascular event, DIAGNOSIS, WARFARIN, RISK-FACTOR, Internal medicine, MANAGEMENT, medicine, Myelofibrosis, Adverse effect, business.industry, EFFICACY, medicine.disease, PREVENTION, Surgery, Polycythemia Vera, Cardiovascular event, hematocrit, Settore MED/15 - MALATTIE DEL SANGUE, business
Abstract

A b s t r ac t Background Current treatment recommendations for patients with polycythemia vera call for maintaining a hematocrit of less than 45%, but this therapeutic strategy has not been tested in a randomized clinical trial. Methods We randomly assigned 365 adults with JAK2-positive polycythemia vera who were being treated with phlebotomy, hydroxyurea, or both to receive either more intensive treatment (target hematocrit

Published
2013

25. HTA of genetic testing for susceptibility to venous thromboembolism in Italiy

Author

Betti, S, Boccia, A, Boccia, Stefania, Casella, C, Coviello, D, Di Maria, E, Di Pietro, Maria Luisa, Giorgio, E, Gualano, M. R., Ivaldi, G, Izzotti, A, Manzoli, Lamberto, Marzuillo, C, Melegaro, A, Miani, A, Ricciardi, Walter, Simone, Benedetto, Tarricone, R, Teleman, A. A., Uliana, V, Vercelli, M, Villari, P, and Za, T.

Subjects
Italy, venous thromboembolism, HTA, Settore MED/42 - IGIENE GENERALE E APPLICATA, genetic testing
Published
2012

34. GIMENA MPD Working Party. Recurrent Thrombosis in patients with polycythemia vera or essential thrombocythemia: efficacy of treatment in preventing rethrombosis in different clinical settings

Author

DE STEFANO, V., Za, T., Rossi, E., Vannucchi, A. M., Ruggeri, M., Elli, E., Mico, C., Tieghi, A, Cacciola, Rossella Rosaria, Santoro, C., Gerli, G., Gugliemelli, P., Pieri, L., Scognamiglio, F., Rodeghiero, F., Pogliani, E. M., Finazzi, G., Gugliotta, L., Leone, G., and BARBUI AND THE, T.

Published
2006

35. Hydroxyurea-related toxicity in 3,411 patients with Ph'-negative MPN

Author

Antonioli, E, Guglielmelli, P, Pieri, L, Finazzi, M, Rumi, E, Martinelli, V, Vianelli, N, Luigia Randi, M, Bertozzi, I, De Stefano, V, Za, T, Rossi, E, Ruggeri, M, Elli, E, Cacciola, R, Cacciola, E, Pogliani, E, Rodeghiero, F, Baccarani, M, Passamonti, F, Finazzi, G, Rambaldi, A, Bosi, A, Cazzola, M, Barbui, T, Vannucchi, A, FINAZZI, MARIA CHIARA, ELLI, ELENA MARIA, POGLIANI, ENRICO MARIA, Vannucchi, A., Antonioli, E, Guglielmelli, P, Pieri, L, Finazzi, M, Rumi, E, Martinelli, V, Vianelli, N, Luigia Randi, M, Bertozzi, I, De Stefano, V, Za, T, Rossi, E, Ruggeri, M, Elli, E, Cacciola, R, Cacciola, E, Pogliani, E, Rodeghiero, F, Baccarani, M, Passamonti, F, Finazzi, G, Rambaldi, A, Bosi, A, Cazzola, M, Barbui, T, Vannucchi, A, FINAZZI, MARIA CHIARA, ELLI, ELENA MARIA, POGLIANI, ENRICO MARIA, and Vannucchi, A.

Abstract

Hydroxyurea (Hydroxycarbamide; HU) is commonly used for the long-term treatment of patients with Philadelphia-chromosome negative chronic myeloproliferative neoplasms (MPNs). It is considered a first-choice agent for the treatment of these disorders as underlined by the European Leukemia Net Consensus Conference [1], although it is formally approved for this indication in some countries only. The drug is reportedly well tolerated in the large majority of subjects, although systemic and/or localized toxicities have been reported. Consensus criteria for definition of “intolerance” to HU have been described; patients who develop intolerance are candidate for second-line therapy and, more recently, for investigational drugs. However, no epidemiologic information about the occurrence of the most clinically significant HU-associated adverse events is yet available. In this study, the authors report on a multicenter series of 3,411 patients who were treated with HU among which 184, accounting for 5% of total, developed significant drug-related toxicities. These data provide an estimate of the frequency and a detailed characterization of clinically significant HU-related toxicities; these information have relevance for the management of MPN patients who require second-line therapy after developing HU-related intolerance.

Published
2012

36. Increased risk of recurrent thrombosis in patients with essential thrombocythemia carrying the homozygous JAK2 V617F mutation

Author

De Stefano, V, Za, T, Rossi, E, Vannucchi, A, Ruggeri, M, Elli, E, Micò, C, Tieghi, A, Cacciola, R, Santoro, C, Vianelli, N, Guglielmelli, P, Pieri, L, Scognamiglio, F, Cacciola, E, Rodeghiero, F, Pogliani, E, Finazzi, G, Gugliotta, L, Leone, G, Barbui, T, Vannucchi, AM, Cacciola, RR, POGLIANI, ENRICO MARIA, Barbui, T., De Stefano, V, Za, T, Rossi, E, Vannucchi, A, Ruggeri, M, Elli, E, Micò, C, Tieghi, A, Cacciola, R, Santoro, C, Vianelli, N, Guglielmelli, P, Pieri, L, Scognamiglio, F, Cacciola, E, Rodeghiero, F, Pogliani, E, Finazzi, G, Gugliotta, L, Leone, G, Barbui, T, Vannucchi, AM, Cacciola, RR, POGLIANI, ENRICO MARIA, and Barbui, T.

Abstract

Evidence suggests that the JAK2 V617F mutation is associated with an increased risk of first thrombosis in patients with essential thrombocythemia (ET). Whether this mutation is also a risk factor for recurrent thrombosis is currently unknown. To investigate the impact of the JAK2 V617F mutation on the risk of recurrent thrombosis in patients with ET, we carried out a multicentre retrospective cohort study. We recruited 143 patients with previous arterial (64.4%) or venous major thrombosis (34.8%) or both (0.8%); 98 of them (68.5%) carried the mutation. Thrombosis recurred in 43 of the patients (30%); overall, after adjustment for sex, age, presence of vascular risk factors, and treatment after the first thrombosis, the presence of the JAK2 mutation did not predict recurrence (multivariable hazard ratio, HR, 0.88, 95% CI 0.46-1.68). Indeed, the individuals homozygous for the JAK2 V617F (allele burden >50%) mutation had an increased risk of recurrence in comparison with wild-type patients (HR 6.15, 95% CI 1.51-24.92). In conclusion, a homozygous JAK2 V617F mutation is an independent risk factor for recurrent thrombosis in patients with ET. © Springer-Verlag 2009.

Published
2010

37. Leukocytosis is a risk factor for recurrent arterial thrombosis in young patients with polycythemia vera and essential thrombocythemia

Author

De Stefano, V, Za, T, Rossi, E, Vannucchi, A, Ruggeri, M, Elli, E, Micò, C, Tieghi, A, Cacciola, R, Santoro, C, Gerli, G, Guglielmelli, P, Pieri, L, Scognamiglio, F, Rodeghiero, F, Pogliani, E, Finazzi, G, Gugliotta, L, Leone, G, Barbui, T, Vannucchi, AM, Cacciola, RR, POGLIANI, ENRICO MARIA, Barbui, T., De Stefano, V, Za, T, Rossi, E, Vannucchi, A, Ruggeri, M, Elli, E, Micò, C, Tieghi, A, Cacciola, R, Santoro, C, Gerli, G, Guglielmelli, P, Pieri, L, Scognamiglio, F, Rodeghiero, F, Pogliani, E, Finazzi, G, Gugliotta, L, Leone, G, Barbui, T, Vannucchi, AM, Cacciola, RR, POGLIANI, ENRICO MARIA, and Barbui, T.

Abstract

There is evidence that leukocytosis is associated with an increased risk of first thrombosis in patients with polycythemia vera (PV) and essential thrombocythemia (ET). Whether it is a risk factor for recurrent thrombosis too is currently unknown. In the frame of a multicenter retrospective cohort study, we recruited 253 patients with PV (n = 133) or ET (n = 120), who were selected on the basis of a first arterial (70%) or venous major thrombosis (27.6%) or both (2.4%), and who were not receiving cytoreduction at the time of thrombosis. The probability of recurrent thrombosis associated with the leukocyte count recorded at the time of the first thrombosis was estimated by a receiver operating characteristic analysis and a multivariable Cox proportional hazards regression model. Thrombosis recurred in 78 patients (30.7%); multivariable analysis showed an independent risk of arterial recurrence (hazard ratio [HR] 2.16, 95% CI 1.12-4.18) in patients with a leukocyte count that was >12.4 x 109/L at the time of the first thrombotic episode. The prognostic role for leukocytosis was age-related, as it was only significant in patients that were aged <60 years (HR for arterial recurrence 3.35, 95% CI 1.22-9.19). © 2009 Wiley-Liss, Inc.

Published
2010

38. Recurrent thrombosis in patients with polycythemia vera and essential thrombocythemia: Incidence, risk factors, and effect of treatments

Author

De Stefano, V, Za, T, Rossi, E, Vannucchi, A, Ruggeri, M, Elli, E, Micò, C, Tieghi, A, Cacciola, R, Santoro, C, Gerli, G, Vianelli, N, Guglielmelli, P, Pieri, L, Scognamiglio, F, Rodeghiero, F, Pogliani, E, Finazzi, G, Gugliotta, L, Marchioli, R, Leone, G, Barbui, T, Vannucchi, AM, Cacciola, RR, Barbui, T., POGLIANI, ENRICO MARIA, De Stefano, V, Za, T, Rossi, E, Vannucchi, A, Ruggeri, M, Elli, E, Micò, C, Tieghi, A, Cacciola, R, Santoro, C, Gerli, G, Vianelli, N, Guglielmelli, P, Pieri, L, Scognamiglio, F, Rodeghiero, F, Pogliani, E, Finazzi, G, Gugliotta, L, Marchioli, R, Leone, G, Barbui, T, Vannucchi, AM, Cacciola, RR, Barbui, T., and POGLIANI, ENRICO MARIA

Abstract

Prior thrombosis is a well-established risk factor for re-thrombosis in polycythemia vera and essential thrombocythemia but scarce data are available on the rate of re-thrombosis and the optimal strategy for prevention of recurrence.

Published
2008

46. Incidence of the JAK2V617F mutation among patients with splanchnic or cerebral venous thrombosis and without overt chronic myeloproliferative disorders

Author

DE STEFANO, V., FIORINI, A., ROSSI, E., ZA, T., FARINA, G., CHIUSOLO, P., SICA, S., and LEONE, G.

Abstract

Summary.Background:Thrombosis of splanchnic or cerebral veins is a typical manifestation of polycythemia vera (PV) or essential thrombocythemia (ET). The recently identified Janus kinase 2 (JAK2) V617F somatic mutation is closely related to chronic myeloproliferative disorders (CMD).

Published
2007
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