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1. Determinants of early triage for hospitalization in MPN patients with COVID-19

Author

Barbui T, Carobbio A, Ghirardi A, Iurlo A, Sobas M, Elli E, Rumi E, De Stefano V, Lunghi F, Marchetti M, Daffini R, Gasior Kabat M, Cuevas B, Fox M, Andrade-Campos M, Palandri F, Guglielmelli P, Benevolo G, Harrison C, Foncillas M, Bonifacio M, Alvarez-Larran A, Kiladjian J, Calderon E, Patriarca A, Quiroz Cervantes K, Griesshammer M, Garcia-Gutierrez V, Marin Sanchez A, Mazo E, Carli G, Hernandez-Boluda J, Osorio S, Carreno-Tarragona G, Serrano M, Kusec R, Elorza B, Angona A, Cirici B, Lopez Abadia E, Koschmieder S, Cattaneo D, Bucelli C, Cichocka E, de Nalecz A, Cavalca F, Borsani O, Betti S, Bellini M, Curto-Garcia N, Rambaldi A, and Vannucchi A

Published
2022

2. Reply to: Second primary malignancies in myeloproliferative neoplasms and the role of aspirin

Author

Barbui, T., Ghirardi, A., Vannucchi, A. M., Marchetti, M., De Stefano, Valerio, Masciulli, A., Carobbio, A., Palandri, F., Vianelli, N., Betti, S., Di Veroli, A., Iurlo, A., Cattaneo, D., Finazzi, G., Bonifacio, M., Scaffidi, L., Patriarca, A., Rumi, E., Casetti, I. C., Stephenson, C., Guglielmelli, P., Elli, E. M., Palova, M., Bertolotti, L., Erez, D., Gomez, M., Wille, K., Perez-Encinas, M., Lunghi, F., Angona, A., Fox, M. L., Beggiato, E., Benevolo, G., Carli, G., Cacciola, R., Mcmullin, M. F., Tieghi, A., Recasens, V., Isfort, S., Griesshammer, M., Alvarez-Larran, A., and Rambaldi, A.

Subjects
Oncology, Cancer Research, medicine.medical_specialty, Aspirin, business.industry, Hematology, Second primary cancer, Settore MED/15 - MALATTIE DEL SANGUE, Internal medicine, medicine, business, Myelopriferative neoplasms, medicine.drug
Published
2019

3. Bendamustine and rituximab combination is safe and effective as salvage regimen in Waldenström macroglobulinemia

Author

Tedeschi, A, Picardi, P, Ferrero, S, Benevolo, G, Margiotta, Casaluci, G, Varettoni, M, Baratè, C, Motta, M, Gini, G, Goldaniga, Mc, Visco, C, Zaja, Francesco, Belsito Petrizi, V, Ravelli, E, Gentile, M, Urbano, Ma, Franceschetti, S, Ghione, P, Orsucci, L, Frustaci, Am, Gaidano, G, Vitolo, U, Morra, E., Tedeschi, A, Picardi, P, Ferrero, S, Benevolo, G, Margiotta Casaluci, G, Varettoni, M, Baratè, C, Motta, M, Gini, G, Goldaniga, Mc, Visco, C, Zaja, Francesco, Belsito Petrizi, V, Ravelli, E, Gentile, M, Urbano, Ma, Franceschetti, S, Ghione, P, Orsucci, L, Frustaci, Am, Gaidano, G, Vitolo, U, and Morra, E.

Subjects
Bendamustine, Male, medicine.medical_specialty, Cancer Research, Salvage therapy, Aggressive lymphoma, Neutropenia, Gastroenterology, rituximab, salvage, Recurrence, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, 80 and over, Medicine, Bendamustine Hydrochloride, Humans, Aged, Retrospective Studies, Waldenström macroglobulinemia, Aged, 80 and over, Salvage Therapy, business.industry, Secondary Myelodysplastic Syndrome, refractory, relapsed, Female, Follow-Up Studies, Middle Aged, Retreatment, Rituximab, Treatment Outcome, Waldenstrom Macroglobulinemia, Hematology, Oncology, Waldenstrom macroglobulinemia, medicine.disease, Surgery, business, Diffuse large B-cell lymphoma, medicine.drug
Abstract

According to the European Society for Medical Oncology and National Comprehensive Cancer Network guidelines on Waldenström macroglobulinemia, bendamustine (B) may be considered a suitable therapeutic option. To address the role of B in combination with rituximab (BR), we analyzed the outcome of 71 patients with relapsed/refractory disease, median age 72 years, treated with R 375 mg/m(2) day 1 and B days 1 and 2 (dosage ranging from 50 to 90 mg/m(2)). Patients had previously received a median number of 2 lines of treatment (range 1-5). Overall and major response rates were 80.2% and 74.6%. Major toxicity was grade 3/4 neutropenia occurring in 13% of courses. There was no significant association between baseline features or patients' characteristics and response achievement. Median progression-free survival was not reached after a median follow-up of 19 months (range 3-54). None of the patients developed aggressive lymphoma or secondary myelodysplastic syndrome/acute myeloid leukemia. BR was found to be an active and well-tolerated salvage regimen leading to rapid disease control.

Published
2015

4. BACK TO LIFE -LIVING, TREATING, MANAGING MYELOFIBROSIS: THE BURDEN OF ILLNESS FOR PATIENTS AND THEIR FAMILIES

Author

Marini, M. G., Cappuccio, A., Abruzzese, E., Carella, A., Lunghi, M., Loiacono, I., Palumbo, G., Bonifacio, M., Cilloni, D., Iurlo, A., Andriani, A., Benevolo, G., Minoia, C., Turri, D., Elli, E. M., Falcone, A. P., Anaclerico, B., Traficante, A., Di Renzo, N., Tiribelli, M., Calistri, E., Zambello, R., Spinosa, C., Ricco, A., FRANCESCA PALANDRI, Raucci, L., Martino, B., Annunziata, M., D Alosio, M., Liberati, A. M., Caocci, G., Maffioli, M., Breccia, M., Pugliese, N., Betti, S., Giglio, G., and Reale, L.

Subjects
quality of life, myelofibrosis
Published
2014

7. Bortezomib, Melphalan, Prednisone and Thalidomide (vmpt) Versus Bortezomib, Melphalan and Prednisone (vmp) In Elderly Newly Diagnosed Myeloma Patients: A Prospective, Randomized, Phase Iii Study

Author

Palumbo, A., Bringhen, S., Rossi, D., Ria, R., Berretta, S., Offidani, M., Patriarca, F., Nozzoli, C., Levi, A., Guglielmelli, T., Benevolo, G., Callea, V., Liberati, Anna Marina, Crippa, C., Renzo, N. D., Catalano, L., Sabbata, G. D., Rizzi, R., Feo, C., Mazza, R., Farina, G., Spadano, A., Pisani, F., Podda, L., Aitoro, G., Magarotto, V., Astolfi, M., Raimondo, F. D., Gaidano, G., and Boccadoro, M.

Published
2009

9. GERIATRIC ASSESSMENT PREDICTS SURVIVAL AND RISK OF SERIOUS ADVERSE EVENTS FOR ELDERLY NEWLY DIAGNOSED MULTIPLE MYELOMA PATIENTS

Author

Mina, R., Larocca, A., Offidani, M., Bringhen, S., La Fauci, A., Roman Hajek, Montefusco, V., Brioli, A., Musolino, C., Falcone, A. P., Siniscalchi, A., Pautasso, C., Guglielmelli, T., Vincelli, I. D., Liberati, A. M., Muccio, V. E., Caraffa, P., Benevolo, G., Gentilini, F., Pulini, S., Pour, L., Musto, P., Petrucci, M. T., Sonneveld, P., Boccadoro, M., and Palumbo, A.

10. COMORBIDITY AND BODY MASS INDEX IN PATIENTS WITH POLYCYTHEMIA VERA: A PV-NET STUDY

Author

Benevolo, G., Elli, E., Cavazzini, F., Tieghi, A., D Addio, A., Bergamaschi, M., Polverelli, N., Palumbo, G. A., Di Pietro, C., Breccia, M., Auteri, G., Sabattini, E., Diral, E., Beggiato, E., Bartoletti, D., Codeluppi, K., Carmosino, I., Cuneo, A., Lanza, F., Di Raimondo, F., ROBERTO MASSIMO LEMOLI, Cavo, M., Vianelli, N., Latagliata, R., and Palandri, F.

11. HIGH MOLECULAR RISK MUTATIONS ARE ASSOCIATED WITH CLINICAL RESPONSE AND OUTCOME IN INTERMEDIATE-1 RISK MYELOFIBROSIS PATIENTS TREATED WITH RUXOLITINIB

Author

Palandri, F., Bartoletti, D., Bonifacio, M., Iurlo, A., Benevolo, G., Elli, E. M., Auteri, G., Beggiato, E., Tieghi, A., Crugnola, M., Bosi, C., Ottaviani, E., Caocci, G., Nicola Polverelli, Cavazzini, F., Tiribelli, M., Pugliese, N., Binotto, G., Isidori, A., Lemoli, R. M., Cilloni, D., Martino, B., Abruzzese, E., Bocchia, M., Latagliata, R., Cavo, M., Vianelli, N., Breccia, M., and Palumbo, G. A.

13. EPIDEMIOLOGY, OUTCOME AND RISK FACTORS FOR INFECTIOUS COMPLICATIONS IN MF PATIENTS RECEIVING RUXOLITINIB. A MULTICENTER STUDY ON 446 PATIENTS

Author

Polverelli, N., Binotto, G., Palumbo, G. A., Bonifacio, M., Breccia, M., Martino, B., D Adda, M., Catani, L., Sabattini, E., Abruzzese, E., Tiribelli, M., Bergamaschi, M., Sgherza, N., Tieghi, A., Benevolo, G., Cavazzini, F., Isidori, A., Ibatici, A., Heidel, F., Crugnola, M., Bosi, C., Latagliata, R., Russo, D., Cavo, M., Vianelli, N., and FRANCESCA PALANDRI

14. CYTOGENETIC ABNORMALITIES IN POST-POLYCYTHEMIA VERA AND POST-ESSENTIAL THROMBOCYTHEMIA MYELOFIBROSIS: CORRELATIONS WITH GENOTYPE AND PHENOTYPE IN THE MYSEC STUDY

Author

Mora, B., Giorgino, T., Guglielmelli, P., Rumi, E., Maffioli, M., Caramazza, D., Rambaldi, A., Caramella, M., Komrokji, R., Gotlib, J., Kiladjian, J. J., Cervantes, F., Devos, T., Palandri, F., Stefano, V., Ruggeri, M., Silver, R. T., Benevolo, G., Albano, F., Michele Merli, Pietra, D., Casalone, R., Barbui, T., Rotunno, G., Cazzola, M., Vannucchi, A. M., and Passamonti, F.

15. RISK FACTORS FOR PROGRESSION TO BLAST PHASE IN PATIENTS WITH MYELOFIBROSIS TREATED WITH RUXOLITINIB: AN ITALIAN STUDY ON 589 PATIENTS

Author

Palandri, F., Breccia, M., Polverelli, N., Tiribelli, M., Benevolo, G., Tieghi, A., Binotto, G., Bonifacio, M., Martino, B., Iurlo, A., Elli, E. M., Abruzzese, E., Bergamaschi, M., Sgherza, N., Cavazzini, F., Crugnola, M., Bosi, C., Isidori, A., Auteri, G., Sutto, E., Latagliata, R., Griguolo, D., Codeluppi, K., Cattaneo, D., Trawinska, M., Bartoletti, D., Krampera, M., Semenzato, G., ROBERTO MASSIMO LEMOLI, Cuneo, A., Di Raimondo, F., Cavo, M., Vianelli, N., and Palumbo, G. A.

16. EFFICACY AND SAFETY OF RUXOLITINIB IN ELDERLY PATIENTS WITH MYELOFIBROSIS: A MULTICENTER SURVEY

Author

FRANCESCA PALANDRI, Benevolo, G., Palumbo, G. A., Bonifacio, M., Di Veroli, A., Polverelli, N., Andriani, A., Tieghi, A., Tiribelli, M., Binotto, G., Martino, B., Petriccione, L., D Adda, M., Crugnola, M., Cavazzini, F., Bergamaschi, M., Isidori, A., Trawinska, M., Ibatici, A., Bosi, C., Sgherza, N., Montanaro, M., Breccia, M., Sabattini, E., Catani, L., Vitolo, U., Merli, F., Aversa, F., Vallisa, D., Russo, D., Semenzato, P., Visani, G., Fanin, R., Cuneo, A., Cavo, M., Vianelli, N., and Latagliata, R.

19. RUXOLITINIB PROVES SUPERIOR TO BEST AVAILABLE THERAPY IN PATIENTS WITH POLYCYTHEMIA VERA (PV) AND A NONPALPABLE SPLEEN: RESULTS FROM THE PHASE IIIB RESPONSE-2 STUDY

Author

Passamonti, F., Griesshammer, M., FRANCESCA PALANDRI, Egyed, M., Benevolo, G., Devo, T., Callum, J., Vannucchi, A. M., Sivgin, S., Bensasson, C., Khan, M., Mounedji, N., Saydam, G., and Ege Üniversitesi

Subjects
population characteristics, social sciences, health care economics and organizations, geographic locations, humanities
Abstract

21st Congress of the European-Hematology-Association -- JUN 09-12, 2016 -- Copenhagen, DENMARK, WOS: 000379484600014, European Hematol Assoc

21. DIFFERENTIAL TREATMENT STRATEGY IN POLYCYTHEMIA VERA PATIENTS WITH STABLE SUBOPTIMAL RESPONSE TO HYDROXYUREA: CLINICAL CORRELATIONS AND IMPACT ON SURVIVAL

Author

FRANCESCA PALANDRI, Bartoletti, D., Rossi, E., Breccia, M., Benevolo, G., Elli, E. M., Auteri, G., Cavazzini, F., Binotto, G., Tieghi, A., Tiribelli, M., Bonifacio, M., Pugliese, N., Caocci, G., Crugnola, M., Mendicino, F., D Addio, A., Tomassetti, S., Martino, B., Di Pietro, C., Polverelli, N., Ceglie, S., Stella, R., Civettini, I., Pane, F., Cuneo, A., Krampera, M., Semenzato, G., Lemoli, R. M., Cavo, M., Vianelli, N., Palumbo, G. A., Stefano, V., Andriani, A., and Latagliata, R.

22. SECOND PRIMARY MALIGNANCY IN MYELOFIBROSIS PATIENTS TREATED WITH RUXOLITINIB

Author

Polverelli, N., Elli, E., Abruzzese, E., Palumbo, G. A., Benevolo, G., Breccia, M., Tiribelli, M., Bonifacio, M., Tieghi, A., Martino, B., Sgherza, N., D Adda, M., Bergamaschi, M., Crugnola, M., Cavazzini, F., Bosi, C., Binotto, G., Isidori, A., Bartoletti, D., Auteri, G., Latagliata, R., Gandolfi, L., Scaffidi, L., Cattaneo, D., Codeluppi, K., Trawinska, M., Griguolo, D., Cuneo, A., Krampera, M., Semenzato, G., Di Raimondo, F., Lemoli, R. M., Cavo, M., Vianelli, N., Russo, D., Iurlo, A., and FRANCESCA PALANDRI

24. PERIPHERAL BLASTS ARE ASSOCIATED WITH RESPONSE TO RUXOLITINIB AND OUTCOME IN PATIENTS WITH CHRONIC-PHASE MYELOFIBROSIS

Author

Palandri, F., Bartoletti, D., Abruzzese, E., Iurlo, A., Bonifacio, M., Caocci, G., Elli, E. M., Auteri, G., Tiribelli, M., Nicola Polverelli, Martino, B., Miglino, M., Tieghi, A., Benevolo, G., Beggiato, E., Fava, C., Cavazzini, F., Pugliese, N., Binotto, G., Bosi, C., Crugnola, M., Ottaviani, E., Di Pietro, C., Micucci, G., Trawinska, M., Cuneo, A., Bocchia, M., Krampera, M., Pane, F., Lemoli, R. M., Cilloni, D., Cavo, M., Vianelli, N., Palumbo, G. A., and Breccia, M.

26. PREDICTORS FOR RESPONSE TO RUXOLITINIB IN REAL-LIFE: AN OBSERVATIONAL INDEPENDENT STUDY ON 266 PATIENTS WITH MYELOFIBROSIS

Author

Polverelli, N., Benevolo, G., Palumbo, G. A., Bonifacio, M., Tiribelli, M., Martino, B., Alessia Tieghi, Breccia, M., Ibatici, A., Crugnola, M., Bosi, C., Catani, L., Scaffidi, L., Marchi, F., Lazzaro, A., Aversa, F., Di Raimondo, F., Vallisa, D., Vitolo, U., Merli, F., Fanin, R., Alimena, G., Martinelli, G., Cavo, M., Vianelli, N., and Palandri, F.

Subjects
ruxolitinib, predictors of outcome, myelofibrosis, ruxolitinib, myelofibrosis, predictors of outcome

28. INFECTIOUS RISK IN MYELOFIBROSIS: EVALUATION ON 426 PATIENTS

Author

Nicola Polverelli, Breccia, M., Benevolo, G., Latagliata, R., Catani, L., Nicolosi, M., Perricone, M., Sollazzo, D., Romano, M., Colafigli, G., Forte, D., Campana, A., Testoni, N., Vitolo, U., Alimena, G., Martinelli, G., Cavo, M., Vianelli, N., and Palandri, F.

29. Ropeginterferon alfa-2b versus phlebotomy in low-risk patients with polycythaemia vera (Low-PV study): a multicentre, randomised phase 2 trial

Author

Alberto Ferrari, Cristina Bucelli, Elisa Rumi, Barbara Mora, Alessandra Carobbio, Fabrizio Pane, Tiziano Barbui, Gianni Tognoni, Andrea Patriarca, Francesca Palandri, Giuseppe Carli, Nicola Cascavilla, Elena Rossi, Sergio Siragusa, Alessandra Iurlo, Giuseppe Gaetano Loscocco, Fabio Ciceri, Maria Chiara Finazzi, Alessandro M. Vannucchi, Davide Rapezzi, Carmela Mannarelli, Giulia Benevolo, Arianna Masciulli, Marianna Caramella, Luigi Scaffidi, Arianna Ghirardi, Nicola Vianelli, Silvia Betti, Massimiliano Bonifacio, Alessandro Rambaldi, Valerio De Stefano, Marta Bellini, Paola Guglielmelli, Francesca Lunghi, Emma Cacciola, Alessandra Ricco, Caterina Musolino, Barbui T., Vannucchi A.M., De Stefano V., Masciulli A., Carobbio A., Ferrari A., Ghirardi A., Rossi E., Ciceri F., Bonifacio M., Iurlo A., Palandri F., Benevolo G., Pane F., Ricco A., Carli G., Caramella M., Rapezzi D., Musolino C., Siragusa S., Rumi E., Patriarca A., Cascavilla N., Mora B., Cacciola E., Mannarelli C., Loscocco G.G., Guglielmelli P., Betti S., Lunghi F., Scaffidi L., Bucelli C., Vianelli N., Bellini M., Finazzi M.C., Tognoni G., Rambaldi A., Barbui, T., Vannucchi, A. M., De Stefano, V., Masciulli, A., Carobbio, A., Ferrari, A., Ghirardi, A., Rossi, E., Ciceri, F., Bonifacio, M., Iurlo, A., Palandri, F., Benevolo, G., Pane, F., Ricco, A., Carli, G., Caramella, M., Rapezzi, D., Musolino, C., Siragusa, S., Rumi, E., Patriarca, A., Cascavilla, N., Mora, B., Cacciola, E., Mannarelli, C., Loscocco, G. G., Guglielmelli, P., Betti, S., Lunghi, F., Scaffidi, L., Bucelli, C., Vianelli, N., Bellini, M., Finazzi, M. C., Tognoni, G., and Rambaldi, A.

Subjects
Adult, Male, medicine.medical_specialty, Polycythaemia, Neutropenia, Adolescent, Policithemia vera, Interferon alpha-2, Polymorphism, Single Nucleotide, law.invention, Polyethylene Glycols, 03 medical and health sciences, Young Adult, 0302 clinical medicine, Randomized controlled trial, Phlebotomy, law, Bone Marrow, Internal medicine, medicine, Clinical endpoint, Data monitoring committee, Humans, Polycythemia Vera, business.industry, Standard treatment, Interferon-alpha, Hematology, Janus Kinase 2, Middle Aged, Interim analysis, medicine.disease, Recombinant Proteins, Regimen, Treatment Outcome, 030220 oncology & carcinogenesis, Quality of Life, Female, business, 030215 immunology
Abstract

Summary Background There is no evidence that phlebotomy alone is sufficient to steadily maintain haematocrit on target level in low-risk patients with polycythaemia vera. This study aimed to compare the efficacy and safety of ropeginterferon alfa-2b on top of the standard phlebotomy regimen with phlebotomy alone. Methods In 2017, we launched the Low-PV study, a multicentre, open-label, two-arm, parallel-group, investigator-initiated, phase 2 randomised trial with a group-sequential adaptive design. The study involved 21 haematological centres across Italy. Participants were recruited in a consecutive order. Participants enrolled in the study were patients, aged 18–60 years, with a diagnosis of polycythaemia vera according to 2008–16 WHO criteria. Eligible patients were randomly allocated (1:1) to receive either phlebotomy and low-dose aspirin (standard group) or ropeginterferon alfa-2b on top of the standard treatment (experimental group). Randomisation sequence was generated using five blocks of variable sizes proportional to elements of Pascal's triangle. Allocation was stratified by age and time from diagnosis. No masking was done. Patients randomly allocated to the standard group were treated with phlebotomy (300 mL for each phlebotomy to maintain the haematocrit values of lower than 45%) and low-dose aspirin (100 mg daily), if not contraindicated. Patients randomly allocated to the experimental group received ropeginterferon alfa-2b subcutaneously every 2 weeks in a fixed dose of 100 μg on top of the phlebotomy-only regimen. The primary endpoint was treatment response, defined as maintenance of the median haematocrit values of 45% or lower without progressive disease during a 12-month period. Analyses were done by intention-to-treat principle. The study was powered assuming a higher percentage of responders in the experimental group (75%) than in the standard group (50%). Here we report results from the second planned interim analysis when 50 patients had been recruited to each group. The trial is ongoing, and registered with ClinicalTrials.gov , NCT03003325 . Findings Between Feb 2, 2017, and March 13, 2020, 146 patients were screened, and 127 patients were randomly assigned to the standard group (n=63) or the experimental group (n=64). The median follow-up period was 12·1 months (IQR 12·0–12·6). For the second pre-planned interim analysis, a higher response rate in the experimental group was seen (42 [84%] of 50 patients) than in the standard group (30 [60%] of 50 patients; absolute difference 24%, 95% CI 7–41%, p=0·0075). The observed z value (2·6001) crossed the critical bound of efficacy (2·5262), and the stagewise adjusted p value early showed superiority of experimental treatment. Thus, the data safety monitoring board decided to stop patient accrual for overwhelming efficacy and to continue the follow-up, as per protocol, for 2 years. Under the safety profile, no statistically significant difference between groups in frequency of adverse events of grade 3 or higher was observed; the most frequently reported adverse events were neutropenia (four [8%] of 50 patients) in the experimental group and skin symptoms (two [4%] of 50 patients) in the standard group. No grade 4 or 5 adverse events occurred. Interpretation Supplementing phlebotomy with ropeginterferon alfa-2b seems to be safe and effective in steadily maintaining haematocrit values on target in low-risk patients with polycythaemia vera. Findings from the current study might have implications for changing the current management of low-risk patients with polycythaemia vera. Funding AOP Orphan Pharmaceuticals, Associazione Italiana per la Ricerca sul Cancro

Published
2020

30. Impact of comorbidities and body mass index on the outcome of polycythemia vera patients

Author

Alessia Tieghi, Alessandra D'Addio, Florian H. Heidel, Roberto Latagliata, Elisa Bossi, Francesco Cavazzini, Giulia Benevolo, Nicola Vianelli, Michele Cavo, Roberto M. Lemoli, Mauro Krampera, Massimo Breccia, Massimiliano Bonifacio, Gianni Binotto, Antonio Cuneo, Giovanni Caocci, Daniela Bartoletti, Mario Tiribelli, Ida Carmosino, Lucia Catani, Giuseppe Auteri, Francesco Lanza, Giuseppe A. Palumbo, Nicola Polverelli, Francesca Palandri, Micaela Bergamaschi, Monica Crugnola, Elena Maria Elli, Benevolo G., Elli E.M., Bartoletti D., Latagliata R., Tiribelli M., Heidel F.H., Cavazzini F., Bonifacio M., Crugnola M., Binotto G., D'Addio A., Tieghi A., Bergamaschi M., Caocci G., Polverelli N., Bossi E., Auteri G., Carmosino I., Catani L., Cuneo A., Krampera M., Lanza F., Lemoli R.M., Vianelli N., Breccia M., Palumbo G.A., Cavo M., and Palandri F.

Subjects
Male, Cancer Research, Comorbidity, Overweight, Primary Myelofibrosi, 0302 clinical medicine, Retrospective Studie, Risk Factors, body mass index, cancer, Charlson comorbidity index, outcome, polycythemia vera, thrombotic risk, 80 and over, Cumulative incidence, Aged, 80 and over, Incidence, Incidence (epidemiology), Hazard ratio, Hematology, General Medicine, Middle Aged, Oncology, 030220 oncology & carcinogenesis, Thrombosi, Female, Underweight, medicine.symptom, Human, Adult, medicine.medical_specialty, NO, Follow-Up Studie, 03 medical and health sciences, Internal medicine, medicine, Humans, Aged, Retrospective Studies, business.industry, Risk Factor, Thrombosis, Retrospective cohort study, medicine.disease, Follow-Up Studies, Polycythemia Vera, Primary Myelofibrosis, Body Mass Index, Body Mass Index, Cancer, Charlson Comorbidity Index, Outcome, Polycythemia Vera, Thrombotic risk, business, Body mass index, 030215 immunology
Abstract

In 816 patients with 2016 World Health Organization-defined polycythemia vera (PV) enrolled in a multicenter retrospective study, we investigated the predictive value of Charlson comorbidity index (CCI) and body mass index (BMI) on thrombosis, progression to post-PV myelofibrosis (PPV-MF) and survival. Patients were subgrouped according to CCI=0 (58.1%, no comorbidities) or CCI≥1 (41.9%) and according to normal/underweight (BMI&nbsp

Published
2021

31. Ruxolitinib rechallenge in resistant or intolerant patients with myelofibrosis: Frequency, therapeutic effects, and impact on outcome

Author

Costanza Bosi, Nicola Vianelli, Fabrizio Pane, Giovanni Caocci, Massimiliano Bonifacio, Mario Tiribelli, Michele Cavo, Malgorzata Monika Trawinska, Daniela Bartoletti, Mauro Krampera, Giuseppe Auteri, Giulia Benevolo, Bruno Martino, Daniele Cattaneo, Roberto M. Lemoli, Giuseppe A. Palumbo, Nicola Polverelli, Massimo Breccia, Luigi Scaffidi, Monica Crugnola, Elisabetta Abruzzese, Antonio Cuneo, Florian H. Heidel, Elena Maria Elli, Elena Masselli, Francesca Palandri, Roberto Latagliata, Francesco Cavazzini, Alessandra Iurlo, Novella Pugliese, Rossella Stella, Giorgia Micucci, Alessia Tieghi, Gianpietro Semenzato, Gianni Binotto, Palandri F., Tiribelli M., Breccia M., Bartoletti D., Elli E.M., Benevolo G., Martino B., Cavazzini F., Tieghi A., Iurlo A., Abruzzese E., Pugliese N., Binotto G., Caocci G., Auteri G., Cattaneo D., Trawinska M.M., Stella R., Scaffidi L., Polverelli N., Micucci G., Masselli E., Crugnola M., Bosi C., Heidel F.H., Latagliata R., Pane F., Cuneo A., Krampera M., Semenzato G., Lemoli R.M., Cavo M., Vianelli N., Bonifacio M., and Palumbo G.A.

Subjects
Cancer Research, medicine.medical_specialty, Disease status, Ruxolitinib, ruxolitinib, rechallenge, myelofibrosis, NO, 03 medical and health sciences, 0302 clinical medicine, myelofibrosi, Internal medicine, Nitriles, Overall survival, Medicine, cancer, Humans, In patient, 030212 general & internal medicine, Myelofibrosis, Retrospective Studies, outcome, business.industry, Therapeutic effect, Retrospective cohort study, medicine.disease, Discontinuation, Pyrimidines, Treatment Outcome, Oncology, Primary Myelofibrosis, 030220 oncology & carcinogenesis, Pyrazoles, business, medicine.drug
Abstract

BACKGROUND: After ruxolitinib discontinuation, the outcome of patients with myelofibrosis (MF) is poor with scarce therapeutic possibilities. METHODS: The authors performed a subanalysis of an observational, retrospective study (RUX-MF) that included 703 MF patients treated with ruxolitinib to investigate 1) the frequency and reasons for ruxolitinib rechallenge, 2) its therapeutic effects, and 3) its impact on overall survival. RESULTS: A total of 219 patients (31.2%) discontinued ruxolitinib for ≥14 days and survived for ≥30 days. In 60 patients (27.4%), ruxolitinib was rechallenged for ≥14 days (RUX-again patients), whereas 159 patients (72.6%) discontinued it permanently (RUX-stop patients). The baseline characteristics of the 2 cohorts were comparable, but discontinuation due to a lack/loss of spleen response was lower in RUX-again patients (P =.004). In comparison with the disease status at the first ruxolitinib stop, at its restart, there was a significant increase in patients with large splenomegaly (P 10 mg twice daily predicted better spleen (P =.05) and symptom improvements (P =.02), the reasons for/duration of ruxolitinib discontinuation and the use of other therapies before rechallenge were not associated with rechallenge efficacy. At 1 and 2 years, 33.3% and 48.3% of RUX-again patients, respectively, had permanently discontinued ruxolitinib. The median overall survival was 27.9 months, and it was significantly longer for RUX-again patients (P =.004). CONCLUSIONS: Ruxolitinib rechallenge was mainly used in intolerant patients; there were clinical improvements and a possible survival advantage in many cases, but there was a substantial rate of permanent discontinuation. Ruxolitinib rechallenge should be balanced against newer therapeutic possibilities.

Published
2021

32. Ruxolitinib discontinuation syndrome: incidence, risk factors, and management in 251 patients with myelofibrosis

Author

Bruno Martino, Daniele Cattaneo, Florian H. Heidel, Elisabetta Abruzzese, Gianni Binotto, Rossella Stella, Giulia Benevolo, Michele Cavo, Micaela Bergamaschi, Roberto Latagliata, Francesco Cavazzini, Novella Pugliese, Massimo Breccia, Alessandro Isidori, Gianpietro Semenzato, Daniela Bartoletti, Mauro Krampera, Malgorzata Monica Trawinska, Costanza Bosi, Giovanni Caocci, Fabrizio Pane, Alessia Tieghi, Francesca Palandri, Roberto M. Lemoli, Elena Maria Elli, Antonio Cuneo, Fiorella Ciantia, Alessandra Iurlo, Monica Crugnola, Giuseppe Auteri, Mario Tiribelli, Massimiliano Bonifacio, Nicola Vianelli, Luigi Scaffidi, Giuseppe A. Palumbo, Nicola Polverelli, Palandri F., Palumbo G.A., Elli E.M., Polverelli N., Benevolo G., Martino B., Abruzzese E., Tiribelli M., Tieghi A., Latagliata R., Cavazzini F., Bergamaschi M., Binotto G., Crugnola M., Isidori A., Caocci G., Heidel F., Pugliese N., Bosi C., Bartoletti D., Auteri G., Cattaneo D., Scaffidi L., Trawinska M.M., Stella R., Ciantia F., Pane F., Cuneo A., Krampera M., Semenzato G., Lemoli R.M., Iurlo A., Vianelli N., Cavo M., Breccia M., and Bonifacio M.

Subjects
Ruxolitinib, medicine.medical_specialty, Humans, Janus Kinases, Multivariate Analysis, Primary Myelofibrosis, Protein Kinase Inhibitors, Pyrazoles, Risk Factors, Treatment Outcome, medicine.medical_treatment, Splenectomy, lcsh:RC254-282, Nitriles, Pyrimidines, Ruxolitinib discontinuation syndrome, risk factors, myelofibrosis, NO, Myeloproliferative disease, Internal medicine, Correspondence, medicine, Risk factor, Bone pain, Myelofibrosis, Respiratory distress, business.industry, Incidence (epidemiology), Hematology, medicine.disease, lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens, Discontinuation, Oncology, medicine.symptom, business, Haematological diseases, medicine.drug
Abstract

No abstract available

Published
2020

33. Aspirin, Warfarin, or Enoxaparin Thromboprophylaxis in Patients With Multiple Myeloma Treated With Thalidomide: A Phase III, Open-Label, Randomized Trial

Author

Claudia Crippa, Alessandra Romano, Michele Cavo, Francesca Elice, Roberto Marasca, Mario Boccadoro, Massimo Offidani, Renato Zambello, Claudia Cellini, Valeria Magarotto, Vincenzo Callea, Monica Galli, Claudia Polloni, Patrizia Tosi, Angelo Michele Carella, Giulia Benevolo, Elena Zamagni, Andrea Evangelista, Fabiana Gentilini, Stefano Pulini, Antonio Palumbo, Vittorio Montefusco, Sara Bringhen, Chiara Nozzoli, Davide Rossi, Norbert Pescosta, Roberto Ria, Paola Tacchetti, Francesca Patriarca, Luca Baldini, Tommaso Caravita, Fortunato Morabito, Palumbo A., Cavo M., Bringhen S., Zamagni E., Romano A., Patriarca F., Rossi D., Gentilini F., Crippa C., Galli M., Nozzoli C., Ria R., Marasca R., Montefusco V., Baldini L., Elice F., Callea V., Pulini S., Carella A.M., Zambello R., Benevolo G., Magarotto V., Tacchetti P., Pescosta N., Cellini C., Polloni C., Evangelista A., Caravita T., Morabito F., Offidani M., Tosi P., and Boccadoro M.

Subjects
Male, Cancer Research, medicine.medical_specialty, Time Factors, multiple myeloma, thrombosis, prophylaxis, medicine.drug_class, Low molecular weight heparin, Antineoplastic Agents, Hemorrhage, Risk Assessment, Sudden death, Fibrinolytic Agents, MULTIPLE MYELOMA, Risk Factors, Thromboembolism, Internal medicine, Multicenter trial, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, Enoxaparin, THROMBOPROPHYLAXIS, Contraindication, Aged, wafarin, Aspirin, business.industry, Warfarin, Anticoagulants, Middle Aged, Thalidomide, Surgery, ASPIRIN, Treatment Outcome, Italy, Oncology, Cardiovascular Diseases, Female, business, Enoxaparin sodium, Platelet Aggregation Inhibitors, medicine.drug
Abstract

Purpose In patients with myeloma, thalidomide significantly improves outcomes but increases the risk of thromboembolic events. In this randomized, open-label, multicenter trial, we compared aspirin (ASA) or fixed low-dose warfarin (WAR) versus low molecular weight heparin (LMWH) for preventing thromboembolism in patients with myeloma treated with thalidomide-based regimens. Patients and Methods A total of 667 patients with previously untreated myeloma who received thalidomide-containing regimens and had no clinical indication or contraindication for a specific antiplatelet or anticoagulant therapy were randomly assigned to receive ASA (100 mg/d), WAR (1.25 mg/d), or LMWH (enoxaparin 40 mg/d). A composite primary end point included serious thromboembolic events, acute cardiovascular events, or sudden deaths during the first 6 months of treatment. Results Of 659 analyzed patients, 43 (6.5%) had serious thromboembolic events, acute cardiovascular events, or sudden death during the first 6 months (6.4% in the ASA group, 8.2% in the WAR group, and 5.0% in the LMWH group). Compared with LMWH, the absolute differences were +1.3% (95% CI, −3.0% to 5.7%; P = .544) in the ASA group and +3.2% (95% CI, −1.5% to 7.8%; P = .183) in the WAR group. The risk of thromboembolism was 1.38 times higher in patients treated with thalidomide without bortezomib. Three major (0.5%) and 10 minor (1.5%) bleeding episodes were recorded. Conclusion In patients with myeloma treated with thalidomide-based regimens, ASA and WAR showed similar efficacy in reducing serious thromboembolic events, acute cardiovascular events, and sudden deaths compared with LMWH, except in elderly patients where WAR showed less efficacy than LMWH.

Published
2011

34. Carfilzomib, cyclophosphamide, and dexamethasone in patients with newly diagnosed multiple myeloma: a multicenter, phase 2 study

Author

Pieter Sonneveld, Concetta Conticello, Massimo Offidani, Valeria Magarotto, Stefania Oliva, Fabiana Gentilini, Sara Bringhen, Luana Boccadifuoco, Mario Boccadoro, Vittorio Montefusco, Pellegrino Musto, Giulia Benevolo, Davide Rossi, Maria Teresa Petrucci, Alessandra Larocca, Paola Omedè, Paola Tacchetti, Tommaso Caravita, Giovannino Ciccone, Antonio Palumbo, Mariella Genuardi, Hematology, Bringhen, S, Petrucci, Mt, Larocca, A, Conticello, C, Rossi, D, Magarotto, V, Musto, P, Boccadifuoco, L, Offidani, M, Omedé, P, Gentilini, F, Ciccone, G, Benevolo, G, Genuardi, M, Montefusco, V, Oliva, S, Caravita, T, Tacchetti, P, Boccadoro, M, Sonneveld, P, and Palumbo, A

Subjects
Male, medicine.medical_specialty, Cyclophosphamide, Immunology, Phases of clinical research, Kaplan-Meier Estimate, Neutropenia, Biochemistry, Gastroenterology, Dexamethasone, Disease-Free Survival, chemistry.chemical_compound, Autologous stem-cell transplantation, MULTIPLE MYELOMA, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, Adverse effect, Multiple myeloma, Aged, Very Good Partial Response, carfilzomib, business.industry, Cell Biology, Hematology, medicine.disease, Carfilzomib, Surgery, Treatment Outcome, chemistry, Female, business, Oligopeptides, medicine.drug
Abstract

This multicenter, open-label phase 2 trial determined the safety and efficacy of carfilzomib, a novel and irreversible proteasome inhibitor, in combination with cyclophosphamide and dexamethasone (CCyd) in patients with newly diagnosed multiple myeloma (NDMM) ≥65 years of age or who were ineligible for autologous stem cell transplantation. Patients (N 5 58) received CCyd for up to 9 28-day cycles, followed by maintenance with carfilzomib until progression or intolerance. After a median of 9 CCyd induction cycles (range 1-9), 95% of patients achieved at least a partial response, 71% achieved at least a very good partial response, 49% achieved at least a near complete response, and 20% achieved stringent complete response. After a median follow-up of 18 months, the 2-year progression-free survival and overall survival rates were 76% and 87%, respectively. The most frequent grade 3 to 5 toxicities were neutropenia (20%), anemia (11%), and cardiopulmonary adverse events (7%). Peripheral neuropathy was limited to grades 1 and 2 (9%). Fourteen percent of patients discontinued treatment because of adverse events, and 21% of patients required carfilzomib dose reductions. In summary, results showed high complete response rates and a good safety profile. This trial was registered at clinicaltrials.gov as #NCT01346787. © 2014 by The American Society of Hematology.

Published
2014

35. Lenalidomide and low-dose dexamethasone for newly diagnosed primary plasma cell leukemia

Author

Giuseppe Pietrantuono, Giovanni D'Arena, Roberto Guariglia, F. Di Raimondo, Massimo Offidani, Paola Omedè, Attilio Olivieri, Nicola Cascavilla, Tommaso Caravita, Roberto Mina, Pellegrino Musto, Katia Todoerti, Maide Cavalli, Nunzio Filardi, Mario Boccadoro, Fortunato Morabito, Francesco Nobile, Sara Bringhen, Antonio Palumbo, Luca Agnelli, Maria Carmen Martorelli, Oreste Villani, Antonino Neri, Vittorio Simeon, G. Mansueto, A. Falcone, Giulia Benevolo, Rosa Lerose, M.T. Petrucci, Anna Levi, Musto, P, Simeon, V, Martorelli, M C, Petrucci, M T, Cascavilla, N, Di Raimondo, F, Caravita, T, Morabito, F, Offidani, M, Olivieri, A, Benevolo, G, Mina, R, Guariglia, R, D'Arena, G, Mansueto, G, Filardi, N, Nobile, F, Levi, A, Falcone, A, Cavalli, M, Pietrantuono, G, Villani, O, Bringhen, S, Omedè, P, Lerose, R, Agnelli, L, Todoerti, K, Neri, A, Boccadoro, M, and Palumbo, A

Subjects
Oncology, Adult, Male, Cancer Research, medicine.medical_specialty, medicine.medical_treatment, Newly diagnosed, Dexamethasone, Leukemia, Plasma Cell, Internal medicine, medicine, Humans, Lenalidomide, Aged, Plasma cell leukemia, Aged, 80 and over, Chemotherapy, business.industry, Low dose, Hematology, Middle Aged, medicine.disease, Surgery, Thalidomide, Female, business, medicine.drug
Published
2013

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