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25 results on '"De Fabritiis, P."'

1. Lenalidomide treatment of myelodysplastic syndromes with chromosome 5q deletion: Results from the National Registry of the Italian Drug Agency

Author

Arcioni, F., Roncadori, A., Di Battista, V., Tura, S., Covezzoli, A., Cundari, S., Mecucci, C., Abbadessa, A., Alterini, R., Santini, V., Cantonetti, M., Buccisano, F., Bacigalupo, A., Sessarego, M., Tonso, A., Ferrero, D., D'Ardia, S., Tarella, C., Cascavilla, N., Bassan, R., Sancetta, R., Cortelezzi, A., Reda, G., Maria D'Arco, A., De Fabritiis, P., Di Renzo, N., Falini, B., Alimena, G., Avanzini, P., Ilariucci, F., Iuliano, F., La Nasa, G., Caocci, G., Defina, M., Latte, G., Palmas, A., Levis, A., Leone, G., Teresa Voso, M., Leoni, P., Poloni, A., Fozza, C., Crugnola, M., Montanaro, M., Spedini, P., Lanza, F., Pizzuti, M., Pane, F., Paolini, R., Borin, L., Rambaldi, A., Rossi, G., Maria Pelizzari, A., Russo, D., D'Emilio, A., Ruggeri, M., Semenzato, G., Specchia, G., Tagariello, G., Sartori, R., Testore, F., Ciravegna, G., Marasca, R., Cimarosto, L., Fontanive, O., Visani, G., Arcioni, F., Roncadori, A., Di Battista, V., Tura, S., Covezzoli, A., Cundari, S., Mecucci, C., Abbadessa, A., Alterini, R., Santini, V., Cantonetti, M., Buccisano, F., Bacigalupo, A., Sessarego, M., Tonso, A., Ferrero, D., D'Ardia, S., Tarella, C., Cascavilla, N., Bassan, R., Sancetta, R., Cortelezzi, A., Reda, G., Maria D'Arco, A., De Fabritiis, P., Di Renzo, N., Falini, B., Alimena, G., Avanzini, P., Ilariucci, F., Iuliano, F., La Nasa, G., Caocci, G., Defina, M., Latte, G., Palmas, A., Levis, A., Leone, G., Teresa Voso, M., Leoni, P., Poloni, A., Fozza, C., Crugnola, M., Montanaro, M., Spedini, P., Lanza, F., Pizzuti, M., Pane, F., Paolini, R., Borin, L., Rambaldi, A., Rossi, G., Maria Pelizzari, A., Russo, D., D'Emilio, A., Ruggeri, M., Semenzato, G., Specchia, G., Tagariello, G., Sartori, R., Testore, F., Ciravegna, G., Marasca, R., Cimarosto, L., Fontanive, O., and Visani, G.

Subjects
Oncology, Myeloid, Male, Group B, Immunologic Factor, 0302 clinical medicine, Retrospective Studie, hemic and lymphatic diseases, del(5q), Prospective Studies, Registries, Prospective cohort study, Hematology, Leukemia, registry study, Standard treatment, Remission Induction, General Medicine, Middle Aged, lenalidomide, myelodysplastic syndromes, Aged, Chromosomes, Human, Pair 5, Disease Progression, Female, Humans, Immunologic Factors, Italy, Karyotyping, Lenalidomide, Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Retrospective Studies, Thalidomide, Chromosome Deletion, 030220 oncology & carcinogenesis, Pair 5, medicine.drug, Human, medicine.medical_specialty, Myelodysplastic Syndrome, Acute, Chromosomes, NO, 03 medical and health sciences, Internal medicine, medicine, business.industry, Myelodysplastic syndromes, Retrospective cohort study, medicine.disease, Settore MED/15, Prospective Studie, business, 030215 immunology
Abstract

Objective The most typical cytogenetic aberration in myelodysplastic syndromes is del(5q), which, when isolated, is associated with refractory anaemia and good prognosis. Based on high rates of erythroid response and transfusion independence, Lenalidomide (LEN) became the standard treatment. This multi-centre study was designed to supplement Italian Registry data on LEN by addressing prescription, administration appropriateness, haematological and cytogenetic responses and disease evolution. Methods MORE study was an observational, non-interventional, multi-centre, retrospective and prospective study. Cases were recruited from 45 Haematological Centres throughout Italy. Data were collected from the Italian National Registry for Lenalidomide administration and supplemented by a MORE data form. Results Data from 190/213 patients were analysed. In all, 149 had been diagnosed by conventional cytogenetics (GROUP A) and 41 only by FISH (GROUP B). Overall erythroid response was obtained in 92.8% of cases. Overall cytogenetic remission was achieved in 22.6% of cases. Disease progression occurred in 15.6% of cases. Clonal cytogenetic evolution characterised progression to AML but not to higher risk MDS. Conclusions Erythroid response to Lenalidomide was similar in MDS with isolated del(5q) and with del(5q) plus one anomaly. Progression to AML or higher risk MDS showed different cytogenetic features.

Published
2018

2. Monoclonal Gammopathy Responsive to Decitabine Given for Acute Myeloid Leukemia in a Frail Patient

Author

Pasquale Niscola, de Fabritiis P, Benedetta Neri, and Morino L

Subjects
Myeloid, Male, 0301 basic medicine, Antimetabolites, Decitabine, Acute, Monoclonal Gammopathy of Undetermined Significance, 03 medical and health sciences, medicine, Humans, Aged, Leukemia, business.industry, Myeloid leukemia, Hematology, General Medicine, Antimetabolites, Antineoplastic, Leukemia, Myeloid, Acute, Treatment Outcome, Antineoplastic, Settore MED/01, Monoclonal gammopathy, 030104 developmental biology, Cancer research, medicine.symptom, business, medicine.drug
Published
2018

3. Managing myelodysplastic syndromes in very old patients: a teaching case report

Author

Andrea Tendas, de Fabritiis P, M. M. Trawinska, Alessio Perrotti, Giovannini M, Massimiliano Palombi, Pasquale Niscola, and Laura Scaramucci

Subjects
medicine.medical_specialty, azacitidine, Antimetabolites, Antineoplastic, Azacitidine, Case Report, Appropriate use, Quality of life, medicine, Combined Modality Therapy, Humans, Blood Transfusion, Intensive care medicine, Old patients, Aged, 80 and over, business.industry, Myelodysplastic syndromes, RC952-954.6, General Medicine, Settore MED/15, medicine.disease, older patients, Home Care Services, Geriatrics, Myelodysplastic Syndromes, Life expectancy, Physical therapy, Functional status, Female, Geriatrics and Gerontology, business, medicine.drug
Abstract

Pasquale Niscola, Massimiliano Palombi, Malgorzata Monika Trawinska, Andrea Tendas, Marco Giovannini, Laura Scaramucci, Alessio Perrotti, Paolo de Fabritiis Hematology Unit, Sant'Eugenio Hospital, Rome, Italy Abstract: The introduction of hypomethylating agents in the treatment of myelodysplastic syndromes (MDS) has significantly changed the clinical scenario of these diseases, which afflict predominantly older individuals. However, some concerns regarding the optimal application of these innovative and costly agents in the treatment of geriatric high-risk MDS remain. We report here the case of a nonagenarian treated with hypomethylating agents achieving a long-lasting clinical response and a significant improvement in her functional status. Our case confirmed that functional status and biological status, rather than the chronological age alone, can substantially guide the plan of an appropriate treatment strategy in high-risk MDS patients; moreover, the current case emphasizes the need for targeted studies in the field of geriatric MDS in order to formulate guidelines on the appropriate use of these costly agents, so that candidate patients can receive adequate treatment to preserve their quality of life and life expectancy, but at the same time avoiding unnecessary costs deriving from the use of high-cost drugs for those in whom a significant therapeutic result cannot be reasonably expected. Keywords: myelodysplastic syndromes, azacitidine, older patients

Published
2013

4. Carfilzomib and dexamethasone versus bortezomib and dexamethasone for patients with relapsed or refractory multiple myeloma (ENDEAVOR): And randomised, phase 3, open-label, multicentre study

Author

Dimopoulos, Ma, Moreau, P, Palumbo, A, Joshua, D, Pour, L, Hájek, R, Facon, T, Ludwig, H, Oriol, A, Goldschmidt, H, Rosiñol, L, Straub, J, Suvorov, A, Araujo, C, Rimashevskaya, E, Pika, T, Gaidano, G, Weisel, K, Goranova Marinova, V, Schwarer, A, Minuk, L, Masszi, T, Karamanesht, I, Offidani, M, Hungria, V, Spencer, A, Orlowski, Rz, Gillenwater, Hh, Mohamed, N, Feng, S, Chng, Wj, ENDEAVOR Investigators: Leahy, M, Kerridge, I, Durrant, S, Cooney, J, Horvath, N, Rowlings, P, Hahn, U, Fay, K, Renwick, W, Quach, H, Taylor, K, Ho, Sj, Johnston, A, Kasparu, H, Delforge, M, Schots, H, Vekemans, Mc, Offner, F, Wu, Kl, Doyen, C, Bittencourt, R, Duarte, G, Maiolino, A, Schaan, M, Scheliga, A, Zadra, C, Gercheva, L, Mihaylov, G, Grudeva Popova, Z, Sandhu, I, Reiman, A, Kanjeekal, S, Dueck, G, Leblanc, R, Tay, J, White, D, Maisnar, V, Scudla, V, Gregora, E, Hajek, R, Stoppa, Am, Karlin, L, Garderet, L, Fermand, Jp, Lenain, P, Rigaudeau, S, Eveillard, Jr, Escoffre Barbe, M, Knop, S, Kropff, M, Rollig, C, Munder, M, Langer, C, Mugge, Lo, Hanel, M, Niederwieser, D, Dimopoulos, M, Egyed, M, Szomor, A, Borbenyi, Z, Illes, A, Yehuda, Db, Benyamini, N, Nagler, A, Mittleman, M, Izhar, H, Cavo, M, De Fabritiis, P, Petrini, Mario, Foa, R, Gobbi, M, Rossi, G, Guglielmelli, T, Lazzaro, A, Musto, P, Gozzetti, A, Takazako, N, Izumi, T, Chou, T, Ozaki, S, Hatake, K, Suzuki, K, Uike, N, Asakura, S, Kosugi, H, Handa, H, Matsumoto, M, Tobinai, K, Iida, S, Kizaki, M, Miyamoto, T, Shibayama, H, Ando, K, Ishikawa, T, Ishida, T, Sugiura, I, Izutsu, K, Taniwaki, M, Lee, Jh, Kim, K, Kim, Js, Min, Ck, Yoon, Ss, Lee, Jo, Suh, C, Simpson, D, Ganly, P, Blacklock, H, Doocey, R, Chiruka, S, Hellmann, A, Gornik, S, Komarnicki, M, Malgorzata, Calbecka, Grosicki, S, Jurczyszyn, A, Stoia, R, Gheorghita, E, Danaila, Cd, Abdulkadyrov, K, Zaritskiy, A, Andreeva, N, Balakireva, T, Podoltseva, E, Rossiev, V, Pristupa, A, Hsieh, Ws, Gopalakrishnan, Sk, Mistrik, M, Rocafiguera, Ao, Mateos, V, Rubia, J, Dachs, Lr, Sanchez, Jm, Alegre, A, Bargay, J, de Oteyza JP, Martinez, J, Chen, Ty, Lin, Tl, Liu, Jh, Wang, Mc, Yeh, Sp, Huang, Sy, Vinnyk, Y, Kriachok, I, Pylypenko, H, Shparyk, Y, Kaplan, P, Karamanesht, L, Rekhtman, G, Romanyuk, N, Kaiser, M, Mehta, A, Williams, C, Basu, S, Rabin, N, Ramasamy, K, Hunter, H, Tholouli, E, Lebovic, D, Siegel, D, Wang, M, Niesvizky, R, Kovacsovics, T, Hurd, D, Gabrail, N, Matous, J, Pendergrass, K, Agrawal, M, Boccia, R, Chandra, S, Kassim, A, Stanisic, S, Coleman, M, Gersten, T, Braunschweig, I, Chowdhury, S, Sahovic, E., Dimopoulos, Meletios A, Moreau, Philippe, Palumbo, Antonio, Joshua, Dougla, Pour, Ludek, Hájek, Roman, Facon, Thierry, Ludwig, Heinz, Oriol, Albert, Goldschmidt, Hartmut, Rosiñol, Laura, Straub, Jan, Suvorov, Aleksandr, Araujo, Carla, Rimashevskaya, Elena, Pika, Toma, Gaidano, Gianluca, Weisel, Katja, Goranova-Marinova, Vesselina, Schwarer, Anthony, Minuk, Leonard, Masszi, Tamá, Karamanesht, Ievgenii, Offidani, Massimo, Hungria, Vania, Spencer, Andrew, Orlowski, Robert Z, Gillenwater, Heidi H, Mohamed, Nehal, Feng, Shibao, Chng, Wee-Joo, Cavo, M, Laboratory of Molecullar and Cellular Therapy, and Clinical sciences

Subjects
Oncology, Male, Clinical Trial, Phase III, Dexamethasone, Ixazomib, Bortezomib, chemistry.chemical_compound, 0302 clinical medicine, immune system diseases, hemic and lymphatic diseases, Antineoplastic Combined Chemotherapy Protocols, Elotuzumab, Multiple myeloma, education.field_of_study, Research Support, Non-U.S. Gov't, Medicine (all), Anemia, Multicenter Study, Survival Rate, 030220 oncology & carcinogenesis, Randomized Controlled Trial, Hypertension, Retreatment, Oligopeptide, Female, Multiple Myeloma, Oligopeptides, Human, medicine.drug, medicine.medical_specialty, Aged, Disease-Free Survival, Follow-Up Studies, Humans, Pneumonia, Thrombocytopenia, Population, Follow-Up Studie, 03 medical and health sciences, Internal medicine, medicine, Comparative Study, education, Antineoplastic Combined Chemotherapy Protocol, business.industry, medicine.disease, Carfilzomib, Surgery, chemistry, Proteasome inhibitor, business, 030215 immunology
Abstract

BACKGROUND: Bortezomib with dexamethasone is a standard treatment option for relapsed or refractory multiple myeloma. Carfilzomib with dexamethasone has shown promising activity in patients in this disease setting. The aim of this study was to compare the combination of carfilzomib and dexamethasone with bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma. METHODS: In this randomised, phase 3, open-label, multicentre study, patients with relapsed or refractory multiple myeloma who had one to three previous treatments were randomly assigned (1:1) using a blocked randomisation scheme (block size of four) to receive carfilzomib with dexamethasone (carfilzomib group) or bortezomib with dexamethasone (bortezomib group). Randomisation was stratified by previous proteasome inhibitor therapy, previous lines of treatment, International Staging System stage, and planned route of bortezomib administration if randomly assigned to bortezomib with dexamethasone. Patients received treatment until progression with carfilzomib (20 mg/m(2) on days 1 and 2 of cycle 1; 56 mg/m(2) thereafter; 30 min intravenous infusion) and dexamethasone (20 mg oral or intravenous infusion) or bortezomib (1·3 mg/m(2); intravenous bolus or subcutaneous injection) and dexamethasone (20 mg oral or intravenous infusion). The primary endpoint was progression-free survival in the intention-to-treat population. All participants who received at least one dose of study drug were included in the safety analyses. The study is ongoing but not enrolling participants; results for the interim analysis of the primary endpoint are presented. The trial is registered at ClinicalTrials.gov, number NCT01568866. FINDINGS: Between June 20, 2012, and June 30, 2014, 929 patients were randomly assigned (464 to the carfilzomib group; 465 to the bortezomib group). Median follow-up was 11·9 months (IQR 9·3-16·1) in the carfilzomib group and 11·1 months (8·2-14·3) in the bortezomib group. Median progression-free survival was 18·7 months (95% CI 15·6-not estimable) in the carfilzomib group versus 9·4 months (8·4-10·4) in the bortezomib group at a preplanned interim analysis (hazard ratio [HR] 0·53 [95% CI 0·44-0·65]; p

Published
2016

5. 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

6. Diagnosis of acute foetal distress does not preclude banking of umbilical cord blood units

Author

Picardi, A, Tamburini, A, Caravita, T, De Angelis, C, Ballatore, Spagnoli, G, A, Malerba, C, Calugi, A, DE FABRITIIS, P, and Amadori, S

Subjects
Meconium, Blood Donors, Umbilical cord, Fetal Distress, Donor Selection, Pregnancy, Humans, Settore MED/05 - Patologia Clinica, Medicine, reproductive and urinary physiology, Cryopreservation, Asphyxia, Asphyxia Neonatorum, Blood Specimen Collection, Donor criteria, business.industry, Contraindications, Infant, Newborn, Pregnancy Outcome, Cord blood banking, Foetal distress, Hematology, Fetal Blood, Distress, medicine.anatomical_structure, Blood Preservation, Cord blood, Anesthesia, embryonic structures, Apgar Score, Blood units, Female, Apgar score, medicine.symptom, Abnormality, business, Settore MED/15 - Malattie del Sangue
Abstract

Clinical diagnosis of acute foetal distress (AFD) is based on several parameters such as abnormal foetal heart rate (FHR) pattern and/or meconium liquid staining (MLS). Standards for cord blood (CB) banking indicate that AFD should be considered as exclusion criteria for CB collection, but precise guidelines on how to proceed with CB collection in the presence of AFD signs during labour are not available. We evaluated whether the presence of FHR abnormality and/or MLS during labour 1) reduced the CB collection activity; 2) were associated with the infant's acidaemia or asphyxia and 3) deteriorated the biological characteristics of CB units. Thirty-three units of CB were evaluated for biological parameters, gas values and newborn's Apgar score. The results were compared with a control group of 33 consecutive units previously banked. No differences were observed between the two groups and all but one newborn showed normal Apgar score and absence of metabolic acidaemia. The results showed that 1) AFD reduced the CB collection activity by 10% each year; 2) the majority of CB units collected in the presence of abnormal FHR and/or meconium have biological characteristics eligible for banking; 3) FHR alterations or meconium in the presence of normal gas analysis do not represent certain diagnosis of AFD.

Published
2006

7. A prospective survey of febrile events in hematological malignancies

Author

Pagano, L, Caira, M, Rossi, G, Tumbarello, M, Fanci, R, Garzia, Mg, Vianelli, N, Filardi, N, De Fabritiis, P, Beltrame, A, Musso, M, Piccin, A, Cuneo, Antonio, Cattaneo, C, Aloisi, T, Riva, M, Salvadori, U, Brugiatelli, M, Sannicolò, S, Morselli, M, Bonini, A, Viale, P, Nosari, A, Aversa, F, for the Hema e. Chart Group, Italy, Pagano L, Caira M, Rossi G, Tumbarello M, Fanci R, Garzia MG, Vianelli N, Filardi N, De Fabritiis P, Beltrame A, Musso M, Piccin A, Cuneo A, Cattaneo C, Aloisi T, Riva M, Salvadori U, Brugiatelli M, Sannicolò S, Morselli M, Bonini A, Viale P, Nosari A, and Aversa F

Subjects
medicine.medical_specialty, Registry, Fever, Epidemiology, Settore MED/17 - MALATTIE INFETTIVE, Hematological malignancies, Internal medicine, medicine, Humans, Prospective Studies, Prospective cohort study, Prospective survey, Febrile events, Hematology, business.industry, Coinfection, General Medicine, Bacterial Infections, medicine.disease, Settore MED/15, Surgery, Settore MED/15 - MALATTIE DEL SANGUE, Mycoses, Hematological malignancy, Virus Diseases, Hematologic Neoplasms, Cohort, HEMATOLOGICAL MALIGNANCY, business, Mixed infection
Abstract

The Hema e-Chart prospectively collected data on febrile events (FEs) in hematological malignancy patients (HMs). The aim of the study was to assess the number, causes and outcome of HM-related FEs. Data were collected in a computerized registry that systematically approached the study and the evolution of FEs developing in a cohort of adult HMs who were admitted to 19 hematology departments in Italy from March 2007 to December 2008. A total of 869 FEs in 3,197 patients with newly diagnosed HMs were recorded. Fever of unidentified origin (FUO) was observed in 386 cases (44.4%). The other causes of FE were identified as noninfectious in 48 cases (5.5%) and infectious in 435 cases (50.1%). Bacteria were the most common cause of infectious FEs (301 cases), followed by fungi (95 cases), and viruses (7 cases). Mixed agents were isolated in 32 episodes. The attributable mortality rate was 6.7% (58 FEs). No deaths were observed in viral infection or in the noninfectious groups, while 25 deaths were due to FUO, 16 to bacterial infections, 14 to fungal infections, and three to mixed infections. The Hema e-Chart provided a complete system for the epidemiological study of infectious complications in HMs.

Published
2012

8. 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

9. Diagnosis of myelodysplastic syndromes in individuals heterozygous for mutations in the α- and β-globin genes: a reminder for haematologists

Author

Niscola, P, Tendas, A, Giovannini, M, Scaramucci, L, Perrotti, A, and de Fabritiis, P

Subjects
Aged, 80 and over, Male, Heterozygote, Incidental Findings, Transfusion Medicine and Transfusion Complications, Delayed Diagnosis, beta-Globins, Settore MED/15, Diagnosis, Differential, Hemoglobins, Phenotype, alpha-Globins, Bone Marrow, Myelodysplastic Syndromes, Asymptomatic Diseases, Humans, Thalassemia, Blood Transfusion, Erythropoiesis, Female, Erythropoietin, Aged, Follow-Up Studies
Published
2014

10. Venetoclax: Bcl-2 inhibition for the treatment of chronic lymphocytic leukemia

Author

Maria Cantonetti, Francesco Buccisano, Sergio Amadori, Livio Pupo, Del Poeta G, Iannella E, Massimiliano Postorino, Luca Maurillo, Del Principe Mi, Benedetta Mariotti, Tamara Bittolo, de Fabritiis P, Adriano Venditti, Dal Bo M, and Gattei

Subjects
0301 basic medicine, Programmed cell death, Chronic lymphocytic leukemia, Antineoplastic Agents, Pharmacology, Venetoclax, Bridged Bicyclo Compounds, 03 medical and health sciences, chemistry.chemical_compound, 17p deletion/TP53 mutation, ABT-199, Bcl-2, Novel tyrosine kinase inhibitors, Antineoplastic Combined Chemotherapy Protocols, Bridged Bicyclo Compounds, Heterocyclic, Humans, Leukemia, Lymphocytic, Chronic, B-Cell, Proto-Oncogene Proteins c-bcl-2, Sulfonamides, medicine, Chronic, Leukemia, business.industry, Heterocyclic, B-Cell, medicine.disease, Lymphocytic, 030104 developmental biology, Prior Therapy, Mechanism of action, chemistry, Ibrutinib, Cancer research, medicine.symptom, Idelalisib, business, Settore MED/15 - Malattie del Sangue, Tyrosine kinase
Abstract

Venetoclax (ABT-199) is a small-molecule selective oral inhibitor of the antiapoptotic protein Bcl-2 that promotes programmed cell death of chronic lymphocytic leukemia (CLL) cells regulating the release of proapoptotic factors, such as Smac/Diablo, apoptosis-inducing factor (AIF) and cytochrome c. In April 2016, the U.S. Food and Drug Administration (FDA) granted accelerated approval to venetoclax for patients diagnosed with CLL with 17p deletion, as detected by an FDA-approved test, who have received at least one prior therapy. This review will focus on the mechanism of action, preclinical studies and clinical development of venetoclax both as a monotherapy and in combination with other drugs for CLL in the current milieu of therapy dominated by novel tyrosine kinase inhibitors such as ibrutinib and idelalisib.

Published
2016

11. Successful treatment of disseminated fusariosis with high dose liposomal amphotericin-B in a patient with acute lymphoblastic leukemia [4]

Author

Cudillo, L, Tendas, A, Picardi, A, Dentamaro, T, Del Principe, Mi, Amadori, S, and De Fabritiis, P

Subjects
Adult, Male, Antifungal Agents, Time Factors, Neutrophils, Hematology, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Prognosis, X-Ray Computed, Treatment Outcome, Fusarium, Mycoses, Amphotericin B, Humans, Settore MED/05 - Patologia Clinica, Tomography, X-Ray Computed, Tomography, Settore MED/15 - Malattie del Sangue
Published
2006

12. Therapy-induced Ph1 suppression in chronic myeloid leukemia: molecular and cytogenetic studies in patients treated with alpha-2b IFN, high-dose chemotherapy and autologous stem cell infusion

Author

LO COCO, F., Mandelli, F., Diverio, D., Alimena, G., DE FABRITIIS, P., Meloni, G., Cedrone, M., Frontani, M., Guerrasio, Angelo, and Saglio, Giuseppe

Subjects
Molecular Sequence Data, Messenger, Interferon alpha-2, Polymerase Chain Reaction, Dose-Response Relationship, Suppression, Genetic, Genetic, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Proto-Oncogene Proteins, Humans, RNA, Messenger, Chronic, Southern, Bone Marrow Transplantation, Suppression, Leukemia, Dose-Response Relationship, Drug, Base Sequence, Blotting, Interferon-alpha, Protein-Tyrosine Kinases, Hematopoietic Stem Cells, Recombinant Proteins, Blotting, Southern, Proto-Oncogene Proteins c-bcr, RNA, BCR-ABL Positive, Drug, Settore MED/15 - Malattie del Sangue, Myelogenous
Abstract

In this study, cytogenetic and molecular analyses were employed to assess the response to therapy in 29 chronic myeloid leukemia patients undergoing high dose chemotherapy followed by autologous stem cell infusion. Of these, 11 had previously achieved hematologic remission and cytogenetic improvement after alpha-2b interferon (IFN) treatment, whereas 18 underwent autografting in an early phase of the disease. In each case bone marrow samples were examined pre-treatment and at +2, +6 and +12 months in order to verify the degree of Ph1 suppression. In addition, the position of the breakpoint within the BCR region was mapped with multiple restriction enzymes. In 17 cases (59%) a significant Ph1 reduction was observed at +60 days (0-57% residual Ph1+ cells). In three of these cases, a complete cytogenetic response was confirmed at the DNA level by Southern blotting, but specific amplification of the BCR/ABL junction by the polymerase chain reaction (PCR), performed in two cases, still showed residual disease. The remaining 12 patients (41%) revealed a substantial persistence of Ph1+ metaphases (90-100%). Nine of 17 responding patients (53%) showed an increase of Ph1+ cells at 6 months, and five of 20 evaluated had a further increase at 12 months. With the exception of the results seen by PCR, comparison of molecular and cytogenetic techniques did not show significant differences. The variable degrees of Ph1 suppression observed did not appear to be associated with the position of BCR breakpoints. The factors predicting cytogenetic response to IFN and stem cell autograft and long-term durability of cytoconversion should be elucidated in further studies and with longer follow-up.

Published
1990

14. In vitro effects of human recombinant alpha-2b interferon on Ph1+ chronic myelogenous leukemia cells maintained in long term marrow cultures: a functional and morphological analysis

Author

Sandrelli A, De Fabritiis P, Arturo Cafolla, Nanni M, Simone F, De Felice L, Gd, Di Nucci, and Mandelli F

Subjects
Cytogenetics, Histocytochemistry, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Stem Cells, Interferon Type I, Neoplastic Stem Cells, Tumor Cells, Cultured, Humans, Interferon-alpha, Bone Marrow Cells, Interferon alpha-2, Cells, Cultured, Recombinant Proteins
Abstract

In this study in vitro results obtained with hu rec IFN-alpha 2b on Ph1+ stem cells from patients with chronic myelogenous leukemia in chronic phase (CML in CP) will be discussed: cells were incubated with different IFN concentrations (100, 1000, 10000 IU/ml) for different times (24, 96 hrs, 8, 15, days) and maintained in long term marrow cultures (LTMC); CFU-GM assay, cytochemistry and cytogenetic analyses were performed weekly. A high sensitivity of CML cells to the in vitro treatment with IFN was observed. Cell count in LTMC showed a progressive reduction inversely proportional to time of incubation and concentration of IFN; a marked decrease in colony growth was observed at the end of incubations and during the course of LTMC. Low concentrations of IFN permitted a morphological maturation and the expression of alkaline phosphatase. Cytogenetic analyses showed a marked reduction of mytoses in cultures treated with high concentrations of IFN as result of a combined cytostatic and cytolitic effect; the persistance of 100% Ph1+ cells in LTMC and in CFU-GM colonies might be related, as opposed to in vivo results, to different IFN exposure conditions or might be influenced by other factors.

Published
1989

15. Home care management of patients affected by hematologic malignancies: A review

Author

Niscola P, de Fabritiis P, Cartoni C, Romani C, francesco sorrentino, Dentamaro T, Piccioni D, Scaramucci L, Giovannini M, Amadori S, and Mandelli F

Subjects
Early discharge, Hematologic malignancies, Hematopoietic stem cell transplantation (HSCT), Home care, Managed care, Palliative care, Hematologic Neoplasms, Palliative Care, Disease Management, Humans, Settore MED/15 - Malattie del Sangue, Home Care Services
Abstract

Home care (HC) has an increasingly expanding role in the global management of patients affected by hematologic malignancies. Integrated strategies, including causal-targeted and supportive treatments according to hematologic expertise and a holistic approach inspired by the philosophy and practice of palliative medicine, may allow suitable management and the possibility for most patients to stay at home. Physical, social and psychological needs of patients are likely to vary according to the course of their disease and the treatments they are receiving. Therefore, consideration should be given to different models of care and how to tackle patients' diverse needs, as outlined by reported experiences which claimed that HC can provide appropriate solutions not only for terminally and chronically ill patients but also for those in other phases of disease. According to these studies and to our own experience, when appropriate measures and structured operating models are adopted, HC results in a safe, effective and economically realistic alternative to traditional in-hospital treatment. Therefore, all efforts should be made to overcome budget and administrative barriers and to ensure a more widespread use of this model of care.

16. Hema e-Chart: Italian Registry for prospective analysis of epidemiology, management and outcome of febrile events in patients with hematological malignancies

Author

Pagano, L, Caira, M, Nosari, A, Rossi, G, Locatelli, F, Viale, P, Aversa, F, Chart Group Italy:CollaboratorsLevis A, Hema E., Leoni, P, Liso, V, Baccarani, M, Cortellazzo, S, Russo, D, La Nasa, G, Storti, S, Giustolisi, R, Morabito, F, Cuneo, Antonio, Bosi, A, Capalbo, Sf, Cascavilla, N, Ghio, R, Carella, A, Brugiatelli, M, Ciceri, F, Martinelli, G, Morra, E, Pogliani, E, Mettivier, V, Carli, M, Abbadessa, V, Musso, M, Aricò, M, Lazzarino, M, Visani, G, Fioritoni, G, Di Bartolomeo, P, Vallisa, D, Petrini, M, Favre, C, Olivieri, A, Gugliotta, L, Leone, G, Amadori, S, De Rossi, G, De Fabritiis, P, Majolino, I, D'Arco, A, Lauria, F, Mazza, P, Fagioli, F, Gherlinzoni, F, Chesesi, T, Rodeghiero, F., Pagano L, Caira M, Nosari A, Rossi G, Locatelli F, Viale P, Aversa F, Baccarani M, and Hema E-Chart Group Italy.

Subjects
medicine.medical_specialty, Pediatrics, Myeloid, Fever, medicine.medical_treatment, Hematopoietic stem cell transplantation, hemic and lymphatic diseases, Epidemiology, medicine, Humans, Pharmacology (medical), Prospective Studies, Registries, Medical diagnosis, Prospective cohort study, Multiple myeloma, Pharmacology, HAEMATOLOGY, business.industry, Incidence, Incidence (epidemiology), Hematopoietic Stem Cell Transplantation, FUNGI, Fungal infection, Hematological malignancies, medicine.disease, Surgery, Lymphoma, Settore MED/15 - MALATTIE DEL SANGUE, Infectious Diseases, medicine.anatomical_structure, Italy, Mycoses, Oncology, Hematologic Neoplasms, business
Abstract

The aim of the study was to create a prospective computerized registry to collect and analyze febrile events, particularly due to fungal infections, in patients with hematological malignancies. A systematic approach that starts from the registration of new diagnosis and complete follow-up can be of help for the study of treatment and evolution of these complications. The software allows several concurrent users to create and manage medical information in a website. Its aim is to improve the speed, quality and integration of information related to subjects with febrile event, ultimately resulting in improving patients' care.Patients included adults and children with acute and chronic myeloid or lymphoid leukemia, Hodgkin's and non-Hodgkin's lymphoma, myelodysplastic syndrome, or multiple myeloma. The registry also included data regarding event onset in hematopoietic stem cell transplants (HSCTs). In order to evaluate the incidence of febrile events, all new diagnoses of hematological malignancy and all HSCTs were reported.The Hema e-Chart can be a very useful network collecting information about febrile events in patients with hematological malignancy and HSCTs. Significant trends and treatment practices are expected to be observed. As enrollment continues, data will be analyzed and published, which will provide valuable information concerning the epidemiology, therapy, and outcome of infectious complications.

17. Case reports: zoster pain in haematological malignancies: effective pain relief with oxycodone in patients unresponsive to other analgesic measures

Author

Niscola P, Ap, Perrotti, del Poeta G, Romani C, Palombi M, Piccioni D, Scaramucci L, Tolu B, Tendas A, Cupelli L, elisabetta abruzzese, Elia Gm, D., Ga, Brunetti, Maurillo L, Giovannini M, Cartoni C, and de Fabritiis P

Subjects
Male, Analgesics, Cyclohexanecarboxylic Acids, Pain, Middle Aged, Herpes Zoster, Antiviral Agents, Neuralgia, Postherpetic, Acute Disease, Hematologic Neoplasms, Humans, Oxycodone, Aged, Amines, Drug Therapy, Combination, gamma-Aminobutyric Acid, Aged, 80 and over, Treatment Outcome, Female, Drug Therapy, Combination, 80 and over, Neuralgia, Postherpetic, Settore MED/15 - Malattie del Sangue

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

Author

D. Ielo, Mario Cazzola, A. De Vivo, Mario Petrini, G. Fioritoni, Simona Sica, Fausto Castagnetti, B. Falini, Miriam Fogli, Agostino Cortelezzi, C. Viganò, Giuliana Alimena, Maurizio Musso, G. Spinosa, Flavia Salvi, Giancarlo Latte, Michele Pizzuti, Nicola Cantore, D. Luzzi, B. Ronci, Francesco Merli, Mario Boccadoro, Diamante Turri, Monica Bocchia, Patrizia Tosi, A. M. Carella, Simona Luatti, G. Semenzato, Mariella Grasso, Nicoletta Testoni, Giovanni Martinelli, Ester Pungolino, Giuseppe Tagariello, A. Russo Rossi, Simona Soverini, Francesca Ronco, Franco Iuliano, Giovanni Rosti, Alberto Bosi, Tamara Intermesoli, Dario Ferrero, Sara Galimberti, Giovanna Rege-Cambrin, Ferdinando Porretto, Sabina Russo, Roberto Latagliata, Pellegrino Musto, E. Morra, Agostino Tafuri, Franca Falzetti, Francesco Cavazzini, P. Galieni, Marzia Salvucci, F. Rodighiero, Stefana Impera, Fausto Dore, P. De Fabritiis, V. Meneghini, Elisabetta Calistri, Paolo Vigneri, Ivana Pierri, Michele Cavo, Massimo Pini, Fabrizio Ciccone, Domenico Russo, E Trabacchi, Franco Gherlinzoni, Michele Baccarani, Ilaria Iacobucci, Roberto Sartori, Paolo Avanzini, D. Noli, Roberto Marasca, Simonetta Pardini, A. Malpignano, Maria Concetta Petti, Bruno Martino, M. Bergamaschi, Giovanni Pizzolo, Valeria Santini, E Orlandi, Catia Bigazzi, Serena Rupoli, Giuseppe Saglio, I. Cervello, Clementina Caracciolo, Anna Merli, R. Di Lorenzo, Enrico Pogliani, Francesco Lanza, Mariella Girasoli, M. Apolinari, Caterina Musolino, Francesco Fabbiano, D. Vallisa, Mario Annunziata, Gabriele Gugliotta, V. De Stefano, Ignazio Majolino, Sergio Storti, P. Leoni, Adele Capucci, Massimo Breccia, Alessandro Isidori, Carmen Fava, Gianni Binotto, Carlo Gambacorti-Passerini, L. Pacilli, Mario Tiribelli, Luciano Levato, Felicetto Ferrara, N. Di Renzo, Anna D'Emilio, Francesco Pisani, Fabio Stagno, Monica Crugnola, M. Trawiska, Patrizia Pregno, Marzia Defina, Stefano Molica, Mario Luppi, Michele Malagola, Davide Rapezzi, A. M. Liberati, E. De Biasi, A. Iurlo, Umberto Vitolo, Silvana Capalbo, Maria Teresa Bochicchio, F. Di Raimondo, Franco Aversa, Giuseppe Visani, Fausto Palmieri, Alessandro Rambaldi, Sergio Siragusa, Massimiliano Bonifacio, Luigiana Luciano, Giorgina Specchia, Elisabetta Abruzzese, A. De Blasio, Francesco Albano, Antonio Cuneo, Emilio Usala, Alfonso Zaccaria, R Fanin, Francesca Palandri, Fabrizio Pane, Enrico Montefusco, A. Gozzini, Giulio Rossi, Emanuele Angelucci, A. Bacigalupo, Marco Gobbi, Michele Cedrone, 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., on behalf of the, GIMEMA CML Working Party [.., Palandri, F., Testoni, N., Luatti, S., Soverini, S., Iacobucci, I., Bochicchio, M.T., Apolinari, M., Fogli, M., Cervello, I., ]., Castagnetti, Fausto, De Vivo, A., Pane, Fabrizio, 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., Bochicchio, M. T., 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, S. F., Spinosa, G., Pierri, I., Bergamaschi, M., Carella, A. M., Bacigalupo, A., De Blasio, A., Ciccone, F., Di Renzo, N., Musolino, C., Russo, S., Cortelezzi, A., Morra, E., Pungolino, E. M., Luppi, M., Marasca, R., Pogliani, E. M., 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, M. C., Pisani, F., Tafuri, A., Montefusco, E., Iuliano, F., Dore, F., Pardini, S., Bocchia, M., Defina, M., Liberati, A. M., Luzzi, D., Boccadoro, M., Ferrero, D., Vitolo, U., Gherlinzoni, F., Calistri, E., Fanin, R., Pizzolo, G., Meneghini, V., Rodighiero, F., D'Emilio, A., 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, M, 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, S, Spinosa, G, Pierri, I, Bergamaschi, M, Carella, A, Bacigalupo, A, De Blasio, A, Ciccone, F, Di Renzo, N, Musolino, C, Russo, S, Cortelezzi, A, Morra, E, Pungolino, E, Luppi, M, Marasca, R, Pogliani, E, 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, M, Pisani, F, Tafuri, A, Montefusco, E, Iuliano, F, Dore, F, Pardini, S, Bocchia, M, Defina, M, Liberati, A, Luzzi, D, Boccadoro, M, Ferrero, D, Vitolo, U, Gherlinzoni, F, Calistri, E, Fanin, R, Pizzolo, G, Meneghini, V, Rodighiero, F, and D'Emilio, A

Subjects
Male, Pediatrics, Host response, BCR-ABL, Chronic myeloid leukemia, Prognosis, Tyrosine kinase inhibitors, Young adults, Adult, Age Factors, Aged, Aged, 80 and over, Antineoplastic Agents, Female, Humans, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Middle Aged, Prospective Studies, Protein Kinase Inhibitors, Protein-Tyrosine Kinases, Spleen, Splenomegaly, Young Adult, Oncology, Hematology, Tyrosine kinase inhibitor, Disease, Antineoplastic Agent, Tyrosin kinase inhibitor, Protein-Tyrosine Kinase, hemic and lymphatic diseases, 80 and over, Age Factor, Young adult, Chronic, Leukemia, Incidence (epidemiology), Myeloid leukemia, bcr-abl1, chronic myeloid leukemia, prognosis, tyrosine kinase inhibitors, young adults, Human, medicine.medical_specialty, Prognosi, Protein Kinase Inhibitor, NO, medicine, Adult patients, business.industry, medicine.disease, Clinical trial, Prospective Studie, Medicine (all), Immunology, BCR-ABL Positive, BCR-ABL, chronic myeloid leukemia, prognosis, tyrosine kinase inhibitors, young adults, business, Myelogenous
Abstract

BACKGROUND: The incidence of chronic myeloid leukemia (CML) increases with age, but it is unclear how the characteristics of the disease vary with age. In children, where CML is very rare, it presents with more aggressive features, including huge splenomegaly, higher cell count and higher blast cell percentage. PATIENTS AND METHODS: To investigate if after childhood the disease maintains or loses these characteristics of aggressiveness, we analyzed 2784 adult patients, at least 18 years old, registered by GIMEMA CML WP over a 40-year period. RESULTS: Young adults (YAs: 18-29 years old) significantly differed from adults (30-59 years old) and elderly patients (at least 60 years old) particularly for the frequency of splenomegaly (71%, 63% and 55%, P < 0.001), and the greater spleen size (median value: 4.5, 3.0 and 1.0 cm, P < 0.001). According to the EUTOS score, that is age-independent, high-risk patients were more frequent among YAs, than among adult and elderly patients (18%, 9% and 6%, P < 0.001). In tyrosine kinase inhibitors-treated patients, the rates of complete cytogenetic and major molecular response were lower in YAs, and the probability of transformation was higher (16%, 5% and 7%, P = 0.011). CONCLUSIONS: The characteristics of CML or the host response to leukemia differ with age. The knowledge of these differences and of their causes may help to refine the treatment and to improve the outcome. CLINICAL TRIAL NUMBERS: NCT00510926, NCT00514488, NCT00769327, NCT00481052. © The Author 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Published
2015

19. Bortezomib, thalidomide, and dexamethasone followed by double autologous haematopoietic stem-cell transplantation for newly diagnosed multiple myeloma (GIMEMA-MMY-3006): long-term follow-up analysis of a randomised phase 3, open-label study

Author

Paola Tacchetti, Lucia Pantani, Francesca Patriarca, Maria Teresa Petrucci, Elena Zamagni, Luca Dozza, Monica Galli, Francesco Di Raimondo, Claudia Crippa, Mario Boccadoro, Simona Barbato, Patrizia Tosi, Franco Narni, Vittorio Montefusco, Nicoletta Testoni, Antonio Spadano, Carolina Terragna, Norbert Pescosta, Giulia Marzocchi, Claudia Cellini, Piero Galieni, Sonia Ronconi, Marco Gobbi, Lucio Catalano, Antonio Lazzaro, Giovanni De Sabbata, Clotilde Cangialosi, Fabrizio Ciambelli, Pellegrino Musto, Francesca Elice, Michele Cavo, Renato Fanin, Roberto Foa', Alessandro Rambaldi, Giuseppe Rossi, Pietro Leoni, Paolo Corradini, Giuseppe Torelli, Giuseppe Fioritoni, Sergio Cortelazzo, Giorgio Lambertenghi Deliliers, Giorgio La Nasa, Alfonso Zaccaria, Paolo De Fabritiis, Nicola Cascavilla, Alberto Bosi, Gianpietro Semenzato, Luigi Gugliotta, Filippo Gherlinzoni, Emanuele Angelucci, Massimo Fabrizio Martelli, Maria Concetta Petti, Giuseppe Leone, Angelo Michele Carella, Fabio Ciceri, Armando Santoro, Felicetto Ferrara, Francesco Nobile, Alfonso Maria D'Arco, Alessandro Levis, Luciano Guardigni, Andrea Gallamini, Pier Paolo Fattori, Sergio Morandi, Dino Amadori, Bruno Rotoli, Salvatore Mirto, Giorgio Paladini, Ruggero Mozzana, Graziella Pinotti, Francesco Rodeghiero, Nicola Cantore, Vincenzo Pavone, Enrico Maria Pogliani, Anna Marina Liberati, Ignazio Majolino, Sergio Amadori, Francesco Lauria, Massimo Aglietta, Giovanni Quarta, Sergio Storti, Fortunato Morabito, Silvana Franca Capalbo, Alessandro Massimo Gianni, Vincenzo Mettivier, Vittorio Rizzoli, Carlo Bernasconi, Giuseppe Visani, Michele Pizzuti, Giacinto La Verde, Giuseppe Avvisati, Maurizio Longinotti, Eugenio Gallo, Franco Dammacco, Domenico Russo, Andrea Bacigalupo, Caterina Musolino, Tacchetti P., Pantani L., Patriarca F., Petrucci M.T., Zamagni E., Dozza L., Galli M., Di Raimondo F., Crippa C., Boccadoro M., Barbato S., Tosi P., Narni F., Montefusco V., Testoni N., Spadano A., Terragna C., Pescosta N., Marzocchi G., Cellini C., Galieni P., Ronconi S., Gobbi M., Catalano L., Lazzaro A., De Sabbata G., Cangialosi C., Ciambelli F., Musto P., Elice F., Cavo M., Fanin R., Foa' R., Rambaldi A., Rossi G., Leoni P., Corradini P., Torelli G., Fioritoni G., Cortelazzo S., Lambertenghi Deliliers G., La Nasa G., Zaccaria A., De Fabritiis P., Cascavilla N., Bosi A., Semenzato G., Gugliotta L., Gherlinzoni F., Angelucci E., Martelli M.F., Petti M.C., Leone G., Carella A.M., Ciceri F., Santoro A., Ferrara F., Nobile F., D'Arco A.M., Levis A., Guardigni L., Gallamini A., Fattori P.P., Morandi S., Amadori D., Rotoli B., Mirto S., Paladini G., Mozzana R., Pinotti G., Rodeghiero F., Cantore N., Pavone V., Pogliani E.M., Liberati A.M., Majolino I., Amadori S., Lauria F., Aglietta M., Quarta G., Storti S., Morabito F., Capalbo S.F., Gianni A.M., Mettivier V., Rizzoli V., Bernasconi C., Visani G., Pizzuti M., La Verde G., Avvisati G., Longinotti M., Gallo E., Dammacco F., Russo D., Bacigalupo A., and Musolino C.

Subjects
Adult, Male, medicine.medical_specialty, Transplantation Conditioning, Adolescent, Phases of clinical research, Transplantation, Autologous, Dexamethasone, Bortezomib, Young Adult, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, GIMEMA-MMY-3006 trial, bortezomib, thalidomide, dexamethasone, VTD, double autologous haematopoietic stem-cell transplantation, multiple myeloma, Multiple myeloma, Aged, Intention-to-treat analysis, business.industry, Hazard ratio, Hematopoietic Stem Cell Transplantation, Hematology, Middle Aged, medicine.disease, Thalidomide, Transplantation, Regimen, 030220 oncology & carcinogenesis, Female, Multiple Myeloma, business, Follow-Up Studies, 030215 immunology, medicine.drug
Abstract

Background: The phase 3 GIMEMA-MMY-3006 trial, which compared bortezomib, thalidomide, and dexamethasone (VTD) combination therapy with thalidomide and dexamethasone (TD) as induction therapy before and consolidation therapy after double autologous haematopoietic stem-cell transplantation (HSCT) for newly diagnosed multiple myeloma, showed the superiority of the triplet regimen over the doublet in terms of increased complete response rate and improved progression-free survival. We report the results from the final analysis of the study. Methods: In this randomised, open-label, phase 3 study, patients aged 18–65 years with previously untreated symptomatic multiple myeloma and a Karnofsky Performance Status of 60% or higher were enrolled at 73 centres in Italy. Patients were randomised (1:1) by a web-based system to receive three 21-day cycles of thalidomide (100 mg daily orally for the first 14 days and 200 mg daily thereafter) plus dexamethasone (total 320 mg per cycle; 40 mg on days 1–2, 4–5, 8–9, and 11–12 in the VTD regimen, and 40 mg on days 1–4 and 9–12 in the TD regimen), either alone (TD group) or with bortezomib (1·3 mg/m2 intravenously on days 1, 4, 8, and 11; VTD group). After double autologous HSCT, patients received two 35-day cycles of either the VTD or TD regimen, according to random assignment, as consolidation therapy. The primary outcome was the rate of complete response and near complete response after induction (already reported). In this updated analysis we assessed long-term progression-free survival and overall survival (secondary endpoints of the study) with an extended 10-year median follow-up, and analysed the variables influencing survival. Analysis was by intention to treat. The study is registered with ClinicalTrials.gov, NCT01134484. Findings: Between May 10, 2006, and April 30, 2008, 480 patients were enrolled and randomly assigned to receive VTD (241 patients) or TD (239 patients). Six patients withdrew consent before start of treatment. 236 (99 [42%] women) in the VTD group and 238 (102 [43%] women) in the TD group were included in the intention-to-treat analysis. The data cutoff date for this analysis was May 31, 2018. Median follow-up for surviving patients was 124·1 months (IQR 117·2–131·7). The 10-year progression-free survival estimate for patients in the VTD group was 34% (95% CI 28–41) compared with 17% (13–23) for the TD group (hazard ratio [HR] 0·62 [95% CI 0·50–0·77]; p

Published
2020

20. Carfilzomib with cyclophosphamide and dexamethasone or lenalidomide and dexamethasone plus autologous transplantation or carfilzomib plus lenalidomide and dexamethasone, followed by maintenance with carfilzomib plus lenalidomide or lenalidomide alone for patients with newly diagnosed multiple myeloma (FORTE): a randomised, open-label, phase 2 trial

Author

Francesca Gay, Pellegrino Musto, Delia Rota-Scalabrini, Luca Bertamini, Angelo Belotti, Monica Galli, Massimo Offidani, Elena Zamagni, Antonio Ledda, Mariella Grasso, Stelvio Ballanti, Antonio Spadano, Michele Cea, Francesca Patriarca, Mattia D'Agostino, Andrea Capra, Nicola Giuliani, Paolo de Fabritiis, Sara Aquino, Angelo Palmas, Barbara Gamberi, Renato Zambello, Maria Teresa Petrucci, Paolo Corradini, Michele Cavo, Mario Boccadoro, Gay F., Musto P., Rota-Scalabrini D., Bertamini L., Belotti A., Galli M., Offidani M., Zamagni E., Ledda A., Grasso M., Ballanti S., Spadano A., Cea M., Patriarca F., D'Agostino M., Capra A., Giuliani N., de Fabritiis P., Aquino S., Palmas A., Gamberi B., Zambello R., Petrucci M.T., Corradini P., Cavo M., and Boccadoro M.

Subjects
Male, Antibodies, Monoclonal, Antineoplastic Combined Chemotherapy Protocols, Bortezomib, Combined Modality Therapy, Cyclophosphamide, Dexamethasone, Female, Follow-Up Studies, Hematopoietic Stem Cell Transplantation, Humans, Lenalidomide, Melphalan, Middle Aged, Multiple Myeloma, Oligopeptides, Prognosis, Survival Rate, Thalidomide, Transplantation, Autologous, chemistry.chemical_compound, Maintenance therapy, Monoclonal, Medicine, multiple myeloma, newly diagnosed, carfilzomib, cyclophosphamide, lenalidomide, dexamethasone, induction treatment, autologous stem-cell transplantation, maintenance treatment, phase 2, trial, Multiple myeloma, carfilzomib, trial, induction treatment, Oncology, Oligopeptide, newly diagnosed, Autologous, Human, medicine.drug, medicine.medical_specialty, Prognosi, autologous stem-cell transplantation, Antibodies, Follow-Up Studie, Internal medicine, Autologous transplantation, Transplantation, Antineoplastic Combined Chemotherapy Protocol, maintenance treatment, business.industry, medicine.disease, Settore MED/15, Carfilzomib, chemistry, phase 2, business
Abstract

Background: Bortezomib-based induction followed by high-dose melphalan (200 mg/m2) and autologous stem-cell transplantation (MEL200-ASCT) and maintenance treatment with lenalidomide alone is the current standard of care for young and fit patients with newly diagnosed multiple myeloma. We aimed to evaluate the efficacy and safety of different carfilzomib-based induction and consolidation approaches with or without transplantation and of maintenance treatment with carfilzomib plus lenalidomide versus lenalidomide alone in newly diagnosed multiple myeloma. Methods: UNITO-MM-01/FORTE was a randomised, open-label, phase 2 trial done in 42 Italian academic and community practice centres. We enrolled transplant-eligible patients with newly diagnosed multiple myeloma aged 65 years or younger with a Karnofsky Performance Status of 60% or higher. Patients were stratified according to International Staging System stage (I vs II/III) and age (

Published
2021

21. ELN2017 risk stratification improves outcome prediction when applied to the prospective GIMEMA AML1310 protocol

Author

Luca Maurillo, Adriano Venditti, Maria Teresa Voso, Paolo de Fabritiis, Giovanni Martinelli, Marco Vignetti, Gabriella Storti, Mario Luppi, Francesco Buccisano, Francesco Lanza, Valentina Arena, Giovangiacinto Paterno, Lorella Melillo, Prassede Salutari, Roberto Cairoli, Serena Lavorgna, Paola Fazi, Anna Candoni, Tiziana Ottone, Alfonso Piciocchi, Maria Antonietta Irno Consalvo, Saveria Capria, Raffaele Palmieri, Maria Ilaria Del Principe, William Arcese, Valeria Calafiore, Buccisano, F, Palmieri, R, Piciocchi, A, Arena, V, Candoni, A, Melillo, L, Calafiore, V, Cairoli, R, de Fabritiis, P, Storti, G, Salutari, P, Lanza, F, Martinelli, G, Luppi, M, Capria, S, Maurillo, L, Del Principe, M, Paterno, G, Consalvo, M, Ottone, T, Lavorgna, S, Voso, M, Fazi, P, Vignetti, M, Arcese, W, Venditti, A, Buccisano, Francesco, Palmieri, Raffaele, Piciocchi, Alfonso, Arena, Valentina, Candoni, Anna, Melillo, Lorella, Calafiore, Valeria, Cairoli, Roberto, de Fabritiis, Paolo, Storti, Gabriella, Salutari, Prassede, Lanza, Francesco, Martinelli, Giovanni, Luppi, Mario, Capria, Saveria, Maurillo, Luca, Del Principe, Maria Ilaria, Paterno, Giovangiacinto, Irno Consalvo, Maria Antonietta, Ottone, Tiziana, Lavorgna, Serena, Voso, Maria Teresa, Fazi, Paola, Vignetti, Marco, Arcese, William, and Venditti, Adriano

Subjects
medicine.medical_specialty, Humans, Neoplasm, Residual, Prognosis, Prospective Studies, Risk Assessment, Transplantation, Homologous, autologous stem cell transplantation, post hoc analysi, overall survival, Article, remission, male, allogeneic stem cell transplantation, MED/15 - MALATTIE DEL SANGUE, Internal medicine, medicine, Overall survival, Mutational status, human, outcome assessment, business.industry, cytogenetic, adult, flow cytometry, Complete remission, Myeloid leukemia, Hematology, prediction, Settore MED/15, major clinical study, female, Acute myeloid leukemia, gimema aml1310, outcome prediction, risk stratification, Risk stratification, survival analysi, minimal residual disease, treatment outcome, Population study, Risk categorization, business, Outcome prediction, intermediate risk patient, prospective study
Abstract

The 2017 version of the European LeukemiaNet (ELN) recommendations, by integrating cytogenetics and mutational status of specific genes, divides patients with acute myeloid leukemia into 3 prognostically distinct risk categories: favorable (ELN2017-FR), intermediate (ELN2017-IR), and adverse (ELN2017-AR). We performed a post hoc analysis of the GIMEMA (Gruppo Italiano Malattie EMatologiche dell’Adulto) AML1310 trial to investigate the applicability of the ELN2017 risk stratification to our study population. In this trial, after induction and consolidation, patients in complete remission were to receive an autologous stem cell transplant (auto-SCT) if categorized as favorable risk or an allogeneic stem cell transplant (allo-SCT) if adverse risk. Intermediate-risk patients were to receive auto-SCT or allo-SCT based on the postconsolidation levels of measurable residual disease as measured by using flow cytometry. Risk categorization was originally conducted according to the 2009 National Comprehensive Cancer Network recommendations. Among 500 patients, 445 (89%) were reclassified according to the ELN2017 criteria: ELN2017-FR, 186 (41.8%) of 455; ELN2017-IR, 179 (40.2%) of 445; and ELN2017-AR, 80 (18%) of 455. In 55 patients (11%), ELN2017 was not applicable. Two-year overall survival (OS) was 68.8%, 51.3%, 45.8%, and 42.8% for the ELN2017-FR, ELN2017-IR, ELN2017-not classifiable, and ELN2017-AR groups, respectively (P < .001). When comparing the 2 different transplant strategies in each ELN2017 risk category, a significant benefit of auto-SCT over allo-SCT was observed among ELN2017-FR patients (2-year OS of 83.3% vs 66.7%; P = .0421). The 2 transplant procedures performed almost equally in the ELN2017-IR group (2-year OS of 73.9% vs 70.8%; P = .5552). This post hoc analysis of the GIMEMA AML1310 trial confirms that the ELN2017 classification is able to accurately discriminate patients with different outcomes and who may benefit from different transplant strategies. This trial was registered as EudraCT number 2010-023809-36 and at www.clinicaltrials.gov as #NCT01452646.

Published
2021

22. Philadelphia-like acute lymphoblastic leukemia is associated with minimal residual disease persistence and poor outcome. First report of the minimale residual disease-oriented GIMEMA LAL1913

Author

Roberto Cairoli, Robin Foà, Orietta Spinelli, Enrico Crea, Antonella Vitale, Alessandra Santoro, Loredana Elia, Monica Messina, Maria Ctristina Puzzolo, Sabina Chiaretti, Michela Ansuinelli, Chiara Cattaneo, Nicola Stefano Fracchiolla, Marzia Cavalli, Valerio Apicella, Valentina Pierini, Paolo de Fabritiis, Guglielmo Albertini Petroni, Alfonso Piciocchi, Cristina Mecucci, Irene Della Starza, Cristina Papayannidis, Anna Guarini, Luciana Cafforio, Alessia Lauretti, Daniele Mattei, Akram Taherinasab, Renato Bassan, Francesco Di Raimondo, Martina Canichella, Saveria Capria, Roberta La Starza, Alessandro Rambaldi, Marco Cerrano, Anna Candoni, Paola Fazi, Chiaretti, S, Messina, M, Della Starza, I, Piciocchi, A, Cafforio, L, Cavalli, M, Taherinasab, A, Ansuinelli, M, Elia, L, Petroni, G, La Starza, R, Canichella, M, Lauretti, A, Puzzolo, M, Pierini, V, Santoro, A, Spinelli, O, Apicella, V, Capria, S, Di Raimondo, F, De Fabritiis, P, Papayannidis, C, Candoni, A, Cairoli, R, Cerrano, M, Fracchiolla, N, Mattei, D, Cattaneo, C, Vitale, A, Crea, E, Fazi, P, Mecucci, C, Rambaldi, A, Guarini, A, Bassan, R, and Foa, R

Subjects
Adult, medicine.medical_specialty, Minimal Residual Disease Persistence, Neoplasm, Residual, Philadelphia-Like Acute Lymphoblastic Leukemia, Gastroenterology, Disease-Free Survival, Article, 03 medical and health sciences, 0302 clinical medicine, MED/15 - MALATTIE DEL SANGUE, Internal medicine, hemic and lymphatic diseases, medicine, Adults, Neoplasm, Humans, Philadelphia Chromosome, Child, Adult all, business.industry, Minimal residual disease, Editorials, Complete remission, breakpoint cluster region, Ph-like, Hematology, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Settore MED/15, Prognosis, medicine.disease, Ph-like ALL, GIMEMA LAL, minimal residual disease-oriented, Adult Acute Lymphoblastic Leukemia, 030220 oncology & carcinogenesis, Acute Disease, business, Human, 030215 immunology
Abstract

Early recognition of Philadelphia-like (Ph-like) acute lymphoblastic leukemia (ALL) cases could impact on the management and outcome of this subset of B-lineage ALL. In order to assess the prognostic value of the Ph-like status in a pediatric-inspired, minimal residual disease (MRD)- driven trial, we screened 88 B-lineage ALL cases negative for major fusion genes (BCR-ABL1, ETV6-RUNX1, TCF3-PBX1 and KTM2Ar) enrolled in the GIMEMA LAL1913 front-line protocol for adult BCR/ABL1-negative ALL. The screening - performed using the “BCR/ABL1-like predictor” - identified 28 Ph-like cases (31.8%), characterized by CRLF2 overexpression (35.7%), JAK/STAT pathway mutations (33.3%), IKZF1 (63.6%), BTG1 (50%) and EBF1 (27.3%) deletions, and rearrangements targeting tyrosine kinases or CRLF2 (40%). The correlation with outcome highlighted that: i) the complete remission rate was significantly lower in Ph-like compared to non-Phlike cases (74.1% vs. 91.5%, P=0.044); ii) at time point 2, decisional for transplant allocation, 52.9% of Ph-like cases versus 20% of non-Ph-like were MRD-positive (P=0.025); iii) the Ph-like profile was the only parameter associated with a higher risk of being MRD-positive at time point 2 (P=0.014); iv) at 24 months, Ph-like patients had a significantly inferior event-free and disease-free survival compared to non-Ph-like patients (33.5% vs. 66.2%, P=0.005 and 45.5% vs. 72.3%, P=0.062, respectively). This study documents that Ph-like patients have a lower complete remission rate, event-free survival and disease-free survival, as well as a greater MRD persistence also in a pediatric-oriented and MRD-driven adult ALL protocol, thus reinforcing that the early recognition of Ph-like ALL patients at diagnosis is crucial to refine risk-stratification and to optimize therapeutic strategies. Clinicaltrials gov. Identifier: 02067143.

Published
2020

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

Author

Mohamad Mohty, Evangelos Terpos, Maria-Victoria Mateos, Michele Cavo, Sandra Lejniece, Meral Beksac, Mohamed Amine Bekadja, Wojciech Legiec, Meletios Dimopoulos, Svetlana Stankovic, Maria Soledad Durán, Valerio De Stefano, Alessandro Corso, Yulia Kochkareva, Edward Laane, Christian Berthou, Hans Salwender, Zvenyslava Masliak, Valdas Pečeliūnas, Wolfgang Willenbacher, João Silva, Vernon Louw, Damir Nemet, Zita Borbényi, Uri Abadi, Robert Schou Pedersen, Peter Černelč, Anna Potamianou, Catherine Couturier, Caroline Feys, Florence Thoret-Bauchet, Mario Boccadoro, Mohamed Bekadja, Rose-Marie Hamladji, Hocine Ait Ali, Selma Hamdi, Hadj Touhami, Nourredine Sidi Mansour, Werner Linkesch, Robert Shou Pedersen, Niels Abildgaard, Marju Hein, Jean Richard Eveillard, Abderrazak el Yamani, Philippe Moreau, Laurence Sanhes, Gérard Lepeu, Kamel Laribi, Eric Jourdan, Olivier Fitoussi, Olivier Allangba, Joël Fleury, Martine Escoffre, Riad Benramdane, Guillaume Cartron, Gérard Dine, Eric Legouffe, Hanns-Detlev Harich, Thomas Illmer, Steffen Dörfel, Carla Verena Hannig, Michael Koenigsmann, Gabriele Prange-Krex, Ingo Tamm, Wolfgang Zeller, Michael Maasberg, Rudolf Schlag, Martine Klausmann, Jens Uhlig, Burkhard Alkemper, Stefan Schütz, Hans-Werner Tessen, Benno Mohr, Peter Schmidt, Bernhard Heinrich, Holger Hebart, Gernot Seipelt, Thomas Zoeller, Frank Heits, Clemens Müller-Naendrup, Richard Hansen, Roland Repp, Ludwig Fischer Von Weikersthal, Rudolf Schmits, Jörg Heßling, B. Krammer-Steiner, Viktor Janzen, Michael Schauer, Marcus W. Grüner, Jens Kisro, Claudio Denzlinger, Werner Freier, Christian Junghanss, Martin Görner, Katharina Laichinger, Helmut Ostermann, Heinz Dürk, Georg Hess, Gernot Reich, Panagiota Matsouka, Anastasia Pouli, Achilles Anagnostopoulos, Tamas Masszi, Janos Ivanyi, Arpad Szomor, Arnon Nagler, Hila Magen, Irit Avivi, Miriam Quitt, Antonio Palumbo, Tommaso Za, Daniele Vallisa, Roberto Foa, Alberto Bosi, Angelo Vacca, Francesco Lanza, Giulia Palazzo, Giuseppe Avvisati, Felicetto Ferrara, Ugo Consoli, Maria Cantonetti, Emanuele Angelucci, Catello Califano, Francesco Di Raimondo, Attilio Guarini, Maurizio Musso, Michele Pizzuti, Nicola Giuliani, Antonio Ardizzoia, Nicola Di Renzo, Gianluca Gaidano, Alessandro Gozzetti, Vincenzo Pitini, Gabriella Farina, Riccardo Centurioni, Paolo De Fabritiis, Francesco Iuliano, Giorgio La Nasa, Giacinto La Verde, Fabrizio Pane, Umberto Recine, Maria La Targia, Giuseppe Mineo, Clotilde Cangialosi, Daniele Fagnani, Augusto Federici, Atelda Romano, Giorgina Specchia, Sergio Storti, Velia Bongarzoni, Andrea Bacigalupo, Marco Gobbi, Giancarlo Latte, Donato Mannina, Silvana Capalbo, Mindaugas Jurgutis, Dariusz Woszczyk, Jadwiga Hołojda, Slawomir Gornik, Andrzej Pluta, Elzbieta Morawiec-Szymonik, Slawomira Kyrcz-Krzemien, Wojciech Homenda, Sebastian Grosicki, Kazimierz Sulek, Andrzej Lange, Janusz Kloczko, Jolanta Starzak-Gwozdz, Andrzej Hellmann, Mieczyslaw Komarnicki, Kazimierz Kuliczkowski, Carolina Viveiros, Cristina Gonçalves, Natalia Esefyeva, Julia Kochkareva, Kamil Kaplanov, Elena Volodicheva, Elena Laricheva, Valentina Dergacheva, Marina Chukavina, Natalia Volchenko, Irina Nazarova, Ludmila Anchukova, Elena Ovanesova, Taras Gritsenko, Galina Salogub, Ludmila Magomedova, Irina Kuznetsova, Svetlana Osyunikhina, Olga Serdyuk, Elena Karyagina, Valentina Ivanova, Slovenia Peter Černelč, Corlia Coetzee, Karen Gunther, Dhayanithi Moodley, Soledad Duran, Asunción Echeveste Gutiérrez, Jaime Perez De Oteyza, Francisco Javier Capote, Maria Casanova, Jesus Martin Sanchez, Eduardo Rios-Herranz, Jeronima Ibañez-Garcia, Maria Jose Herranz, Belen Hernandez, Sara Sanchez Sanchez, Fernando Escalante, Fernando Carnicero, Joan Bargay Lleonart, Mercedes Gironella, Rafael Martínez, Ana Lopez De La Guia, Luis Palomera, Rebeca Iglesias, Fernando Solano Ramos, Javier De La Serna, Pedro Garcia Sanchez, Juan Besalduch Vidal, Miguel Diaz Morfa, Turkey – Meral Beksac, Filiz Vural, Yildiz Aydin, Ali Unal, Hakan Goker, Oktay Bilgir, Birol Guvenc, Mehmet Turgut, Gulsum Gulistan Ozet, Ridvan Ali, Maryna Kyselyova, Nataliia Glushko, Renata Vybyrana, Igor Skrypnyk, Natalya Tretyak, Tetiana Kharchevska, Iryna Dyagil, Tetiana Popovs'ka, Vadim Shimanskiy, Tamila Lysa, Hanna Oliynyk, Kateryna Vilchevskaya, Iryna Kryachok, Yuriy Popovych, Natalia Romanyuk, Natalia Yushchenko, Polina Kaplan, Grygoriy Rekhtman, Halyna Pylypenko, Viktor Kozlov, Johannes Drach, Jean-Luc Harousseau, Hermann Einsele, Hartmut Goldschmidt, Thierry Facon, Mauricette Michalet, Valery G. Savchenko, Javier De la Rubia, Gordon Cook, Ulf-Henrik Mellqvist, Heinz Ludwig, Millennium Pharmaceuticals, Janssen Research and Development, Mohty, Mohamad, Terpos, Evangelo, Mateos, Maria-Victoria, Cavo, Michele, Lejniece, Sandra, Beksac, Meral, Bekadja, Mohamed Amine, Legiec, Wojciech, Dimopoulos, Meletio, Stankovic, Svetlana, Durán, Maria Soledad, De Stefano, Valerio, Corso, Alessandro, Kochkareva, Yulia, Laane, Edward, Berthou, Christian, Salwender, Han, Masliak, Zvenyslava, Pečeliūnas, Valda, Willenbacher, Wolfgang, Silva, João, Louw, Vernon, Nemet, Damir, Borbényi, Zita, Abadi, Uri, Pedersen, Robert Schou, Černelč, Peter, Potamianou, Anna, Couturier, Catherine, Feys, Caroline, Thoret-Bauchet, Florence, Boccadoro, Mario, 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, V., 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, 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., 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., Service d'hématologie clinique et de thérapie cellulaire [CHU Saint-Antoine], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU), Department of Clinical Therapeutics, Univesrity of Athens, Universidad de Salamanca- CSIC, The Institute of Hematology and Oncology L. and A. Seràgnoli, Alma Mater Studiorum Università di Bologna [Bologna] (UNIBO), Riga Stradins University (RSU), Ankara University, University of Oran Es-Senia [Oran] | Université d'Oran Es-Senia [Oran], Medical University of Lublin, Department of Clinical Therapeutics [Athens, Greece], National and Kapodistrian University of Athens (NKUA), University Clinic of Hematology, Skopje, Complejo Hospitalario de Jaén, Institute of Hematology, Catholic University, Division of Hematology, Foundation IRCCS Policlinico San Matteo, Università degli Studi di Pavia, State Budget Healthcare Insititution of Moscow, North Estonia Medical Centre, Service d'hématologie, Centre Hospitalier Régional Universitaire de Brest (CHRU Brest), Lymphocyte B et Auto-immunité (LBAI), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO), Asklepios Klinik Altona, Institute of Blood Pathology and Transfusion Medicine, Lviv, Vilnius University Hospital Santariskiu Clinics, Universitätsklinik Innsbruck Innere Medizin V (Innsbruck Austria & Oncotyrol), Instituto de Engenharia de Sistemas e Computadores Investigação e Desenvolvimento em Lisboa (INESC-ID), Instituto Superior Técnico, Universidade Técnica de Lisboa (IST)-Instituto de Engenharia de Sistemas e Computadores (INESC), University Health Network, University of the Free State [South Africa], Clinical Hospital Centre Zagreb, Szegedi Tudományegyetem, Meir Medical Center, Regionshospitalet i Holstebro, Medicinsk Afdeling, University Medical Centre Ljubljana [Ljubljana, Slovenia] (UMCL), Janssen-Cilag, Neuss, Janssen-Cilag [Issy-les-Moulineaux], Janssen Research & Development, Divisione di Ematologia dell' Università di Torino, and Azienda Ospedaliera S. Giovanni Battista di Torino

Subjects
Male, Cancer Research, Boronic Acid, [SDV]Life Sciences [q-bio], bortezomib, global, observational study, routine practice, stem cell transplantation, Salvage therapy, Practice Patterns, Dexamethasone, Bortezomib, Routine practice, 0302 clinical medicine, Global, Observational study, Stem cell transplantation, hemic and lymphatic diseases, Antineoplastic Combined Chemotherapy Protocols, 80 and over, Prospective Studies, Practice Patterns, Physicians', Prospective cohort study, Lenalidomide, ComputingMilieux_MISCELLANEOUS, Multiple myeloma, Aged, 80 and over, Hematology, Middle Aged, Boronic Acids, 3. Good health, Thalidomide, Survival Rate, Treatment Outcome, Local, Oncology, 030220 oncology & carcinogenesis, Female, Multiple Myeloma, Adult, Aged, Follow-Up Studies, Humans, Neoplasm Recurrence, Local, Salvage Therapy, medicine.drug, Human, medicine.medical_specialty, NO, Follow-Up Studie, 03 medical and health sciences, Internal medicine, medicine, Survival rate, Physicians', Antineoplastic Combined Chemotherapy Protocol, business.industry, Settore MED/15, medicine.disease, Transplantation, Settore MED/15 - MALATTIE DEL SANGUE, Prospective Studie, Neoplasm Recurrence, business, 030215 immunology
Abstract

© 2018 The Authors., [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., Writing support during the development of our report was provided by Laura Mulcahy and Catherine Crookes of FireKite, an Ashfield company, a part of UDG Healthcare plc, which was funded by Millennium Pharmaceuticals, Inc, and Janssen Global Services, LLC. The EMMOS study was supported by research funding from Janssen Pharmaceutical NV and Millennium Pharmaceuticals, Inc.

Published
2018

24. A simple prognostic scoring system for newly diagnosed cytogenetically normal acute myeloid leukemia: retrospective analysis of 530 patients

Author

Valeria Cancelli, Massimo F. Martelli, Patrizio Mazza, Anna Candoni, Daniela Damiani, Marco Vignetti, Francesco Nobile, Cristina Skert, Giuseppe Fioritoni, Giorgina Specchia, Francesco Di Raimondo, Nicola Cantore, Annalisa Peli, Monica Bocchia, Nicoletta Testoni, Francesco Lauria, Chiara Colombi, Cristina Mecucci, Marco Mancini, Franco Mandelli, Domenico Russo, Giovanni Martinelli, Michele Baccarani, Giuliana Alimena, Marco De Gobbi, Alfonso Zaccaria, Ilaria Iacobucci, Francesco Lo Coco, Michele Malagola, Alfonso Piciocchi, Francesco Fabbiano, Sergio Amadori, Giuseppe Visani, Marino Clavio, Mario Petrini, Robin Foà, Paolo de Fabritiis, Malagola M, Skert C, Vignetti M, Piciocchi A, Martinelli G, Alimena G, Mecucci C, Testoni N, Iacobucci I, Clavio M, Gobbi M, Candoni A, Damiani D, Bocchia M, Lauria F, Zaccaria A, Mazza P, Visani G, Peli A, Colombi C, Cancelli V, Mancini M, Fo R, Martelli M, Cantore N, Raimondo FD, Petrini M, de Fabritiis P, Fioritoni G, Nobile F, Fabbiano F, Specchia G, Baccarani M, Coco FL, Amadori S, Mandelli F, and Russo D.

Subjects
Adult, Myeloid, Male, Cancer Research, medicine.medical_specialty, Multivariate analysis, Adolescent, Acute, Prognostic factors, Gastroenterology, Young Adult, Cytogenetics, White blood cell, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, Medicine, Humans, Young adult, Acute leukemia, Survival analysis, Aged, Female, Karyotyping, Leukemia, Myeloid, Acute, Middle Aged, Prognosis, Survival Analysis, Treatment Outcome, Leukemia, business.industry, Myeloid leukemia, Hematology, medicine.disease, Surgery, medicine.anatomical_structure, Oncology, business, Settore MED/15 - Malattie del Sangue, ACUTE MYELOID LEUKAEMIA
Abstract

We retrospectively analyzed the data of 337 patients with cytogenetically normal (CN) acute myeloid leukemia (AML), aged ≤ 65 years (training set). A prognostic index score (PIS) was calculated by totaling the score derived from the regression coefficients of each clinical variable, significantly associated with prognosis by multivariate analysis. The variables that were independent prognostic factors for event-free survival (EFS) and overall survival (OS) in the training set were: age ≥ 50 years, secondary AML and white blood cell count (WBC) ≥ 20 × 10(9)/L. The patients of the training set were stratified into three groups: low-, intermediate- and high-risk. The median EFS was 25, 12 and 7 months in the low-, intermediate- and high-risk groups (p < 0.0001), respectively. The median OS was not reached in the low-risk group and was 19 and 10 months in the intermediate- and high-risk groups (p < 0.0001). This PIS was validated in a series of 193 patients with CN-AML. The median EFS was 66, 16, and 3 months (p < 0.0001) and the median OS was 66, 16, and 5 months in the three risk groups, respectively (p < 0.0001). This PIS may be useful for clinical decision-making in CN-AML and may be prospectively integrated with the newest biological markers which at present are not routinely assessed and need prognostic validation.

Published
2011

25. Long-term neuropsychological deficits after cerebellar infarctions in two young adult twins

Author

Franco FABBRO, Paolo De Fabritiis, Alessandro Tavano, Nereo Bresolin, Renato Borgatti, Stefania Corti, Paola De Fabritiis, Fabbro, F, Tavano, A, Corti, S, Bresolin, N, DE FABRITIIS, P, and Borgatti, R

Subjects
Adult, Male, medicine.medical_specialty, Cerebellum, Cognitive Neuroscience, Experimental and Cognitive Psychology, Audiology, Neuropsychological Tests, Cerebellar stroke, M-PSI/02 - PSICOBIOLOGIA E PSICOLOGIA FISIOLOGICA, Functional Laterality, Behavioral Neuroscience, Visual memory, Cerebellar Diseases, Cerebellar hemisphere, medicine, Diseases in Twins, Humans, Language disorder, Memory disorder, Stroke, Language Disorders, Cognitive disorder, Agrammatism, Visuospatial impairment, Linguistics, medicine.disease, Magnetic Resonance Imaging, medicine.anatomical_structure, Memory, Short-Term, Frontal lobe, Space Perception, Visual Perception, M-PSI/08 - PSICOLOGIA CLINICA, Psychology, Neuroscience
Abstract

Two young adult dizygotic twins with high schooling suffered two strokes at the ages of 26 and 30 years. On the first occasion, Case 2 suffered a stroke only a few months after Case 1; on the second occasion, Case 1 suffered a second stroke a few months after Case 2. In Case 1, lesions were mainly localized to the left cerebellar hemisphere in both stroke episodes. Case 2 suffered lesions localized to the right cerebellar hemisphere in the first stroke episode, and multiple lesions in both cerebellar hemispheres and the vermis, right pons and left thalamus during the second stroke episode. Seven years after the second stroke, despite full recovery of motor functions, the patients still show mild, yet selective, linguistic deficits (syntactic comprehension deficits, mild agrammatism, reading and writing disorders) without speech disturbances. They also present with selective dysfunctions in visuospatial short-term memory. Language disorders are ascribed to a dysfunction of the cerebellum in Case 1, while in Case 2 a dysfunction of the cerebellum and the thalamus is considered as both structures are part of the so-called 'frontal lobe system', which supports language generation. Visuospatial short-term memory disorders are attributed to an impaired ability to appreciate the organizing structure of the visual task and to poor planning strategies, which are in turn ascribed to cerebellar lesions. The role of the cerebellum in cognitive and linguistic functions is discussed.

Published
2004

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