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1. High rate of recurrent venous thromboembolism in patients with myeloproliferative neoplasms and effect of prophylaxis with vitamin K antagonists

Author

De Stefano, V, Ruggeri, M, Cervantes, F, Alvarez-Larrán, A, Iurlo, A, Randi, M L, Elli, E, Finazzi, M C, Finazzi, G, Zetterberg, E, Vianelli, N, Gaidano, G, Rossi, E, Betti, S, Nichele, I, Cattaneo, D, Palova, M, Ellis, M H, Cacciola, R, Tieghi, A, Hernandez-Boluda, J C, Pungolino, E, Specchia, G, Rapezzi, D, Forcina, A, Musolino, C, Carobbio, A, Griesshammer, M, Sant’Antonio, E, Vannucchi, A M, and Barbui, T

Published
2016
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2. Arterial thrombosis in Philadelphia-negative myeloproliferative neoplasms predicts second cancer: A case-control study

Author

De Stefano, V., Ghirardi, A., Masciulli, A., Carobbio, A., Palandri, F., Vianelli, N., Rossi, E., 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., Rapezzi, D., 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., Marchetti, M., Griesshammer, M., Alvarez-Larran, A., Vannucchi, A. M., Rambaldi, A., Barbui, T., De Stefano V. (ORCID:0000-0002-5178-5827), Rossi E. (ORCID:0000-0002-7572-9379), De Stefano, V., Ghirardi, A., Masciulli, A., Carobbio, A., Palandri, F., Vianelli, N., Rossi, E., 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., Rapezzi, D., 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., Marchetti, M., Griesshammer, M., Alvarez-Larran, A., Vannucchi, A. M., Rambaldi, A., Barbui, T., De Stefano V. (ORCID:0000-0002-5178-5827), and Rossi E. (ORCID:0000-0002-7572-9379)

Abstract

Patients with Philadelphia-negative myeloproliferative neoplasm (MPN) are prone to the development of second cancers, but the factors associated with these events have been poorly explored. In an international nested case-control study, we recruited 647 patients with carcinoma, nonmelanoma skin cancer, hematological second cancer, and melanoma diagnosed concurrently or after MPN diagnosis. Up to 3 control patients without a history of cancer and matched with each case for center, sex, age at MPN diagnosis, date of diagnosis, and MPN disease duration were included (n 5 1234). Cases were comparable to controls for MPN type, driver mutations and cardiovascular risk factors. The frequency of thrombosis preceding MPN was similar for cases and controls (P 5 .462). Thrombotic events after MPN and before second cancer were higher in cases than in controls (11.6% vs 8.1%; P 5 .013), because of a higher proportion of arterial thromboses (6.2% vs 3.7%; P 5 .015). After adjustment for confounders, the occurrence of arterial thrombosis remained independently associated with the risk of carcinoma (odds ratio, 1.97; 95% confidence interval, 1.14-3.41), suggesting that MPN patients experiencing arterial events after MPN diagnosis deserve careful clinical surveillance for early detection of carcinoma.

Published
2020

3. 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., Rambaldi, A., De Stefano V. (ORCID:0000-0002-5178-5827), 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., Rambaldi, A., and De Stefano V. (ORCID:0000-0002-5178-5827)

Abstract

N/A

Published
2020

4. Second cancers in MPN: Survival analysis from an international study

Author

Marchetti, M., Ghirardi, A., Masciulli, A., Carobbio, A., Palandri, F., Vianelli, N., Rossi, Elena, 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., Rapezzi, D., 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., Pane, F., De Stefano, Valerio, Griesshammer, M., Alvarez-Larran, A., Vannucchi, A. M., Rambaldi, A., Barbui, T., Rossi E. (ORCID:0000-0002-7572-9379), De Stefano V. (ORCID:0000-0002-5178-5827), Marchetti, M., Ghirardi, A., Masciulli, A., Carobbio, A., Palandri, F., Vianelli, N., Rossi, Elena, 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., Rapezzi, D., 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., Pane, F., De Stefano, Valerio, Griesshammer, M., Alvarez-Larran, A., Vannucchi, A. M., Rambaldi, A., Barbui, T., Rossi E. (ORCID:0000-0002-7572-9379), and De Stefano V. (ORCID:0000-0002-5178-5827)

Abstract

One out of ten patients with Philadelphia-negative myeloproliferative neoplasms (MPN) develop a second cancer (SC): in such patients we aimed at assessing the survival impact of SC itself and of MPN-specific therapies. Data were therefore extracted from an international nested case-control study, recruiting 798 patients with SC diagnosed concurrently or after the MPN. Overall, 2995 person-years (PYs) were accumulated and mortality rate (MR) since SC diagnosis was 5.9 (5.1-6.9) deaths for every 100 PYs. A “poor prognosis” SC (stomach, esophagus, liver, pancreas, lung, ovary, head-and-neck or nervous system, osteosarcomas, multiple myeloma, aggressive lymphoma, acute leukemia) was reported in 26.3% of the patients and was the cause of death in 65% of them (MR 11.0/100 PYs). In contrast, patients with a “non-poor prognosis” SC (NPPSC) incurred a MR of 4.6/100 PYs: 31% of the deaths were attributed to SC and 15% to MPN evolution. At multivariable analysis, death after SC diagnosis was independently predicted (HR and 95% CI) by patient age greater than 70 years (2.68; 1.88-3.81), the SC prognostic group (2.57; 1.86-3.55), SC relapse (1.53; 10.6-2.21), MPN evolution (2.72; 1.84-4.02), anemia at SC diagnosis (2.32; 1.49-3.59), exposure to hydroxyurea (1.89; 1.26-2.85) and to ruxolitinib (3.63; 1.97-6.71). Aspirin was protective for patients with a NPPSC (0.60; 0.38-0.95). In conclusion, SC is a relevant cause of death competing with MPN evolution. Prospective data are awaited to confirm the role of cytoreductive and anti-platelet drugs in modulating patient survival after the occurrence of a SC.

Published
2020

5. Effect of CALR and JAK2 mutations on the clinical and hematological phenotypes of the disease in patients with myelofibrosis - long-term experience from a single center

Author

Tomáš Szotkowski, Hlusi A, J Navratilova, Karel Indrak, Palova M, Tomas Papajik, and Martina Divoka

Subjects
Oncology, Cancer Research, medicine.medical_specialty, Myeloid, medicine.medical_treatment, Hematopoietic stem cell transplantation, Polycythemia vera, hemic and lymphatic diseases, Internal medicine, Medicine, Humans, Myelofibrosis, Janus kinase 2, biology, business.industry, Essential thrombocythemia, Janus Kinase 2, medicine.disease, medicine.anatomical_structure, Phenotype, B symptoms, Primary Myelofibrosis, Mutation, biology.protein, medicine.symptom, business, Calreticulin
Abstract

Primary myelofibrosis (PMF) is a chronic clonal myeloid disorder. Together with essential thrombocythemia (ET) and polycythemia vera (PV), it belongs to a group of Philadelphia chromosome-negative myeloproliferative neoplasms. An integral part of laboratory tests carried out in this disease group is detecting the presence of mutations in the Janus kinase 2 gene at position 617 (JAK2 V617F) and in the gene encoding for the receptor for thrombopoietin (myeloproliferative leukemia virus oncogene, MPL) found in approximately 60% of PMF patients. The discovery of mutations affecting exon 9 of the calreticulin (CALR) gene was of great benefit to the diagnosis of the diseases in JAK2 V617F and MPL unmutated cases. This is a study of the effect of a mutation in the CALR gene on the clinical course in patients with primary, post-ET and post-PV myelofibrosis. Analysis of 66 patients (54.5% JAK2 V617F; 34.8% CALR; 6.1% MPL; 3.0% triple negative; 1.5% coincidence of CALR and JAK2 V617F) confirmed a different phenotype of the disease in CALR-mutated patients as compared with CALR-unmutated individuals. Those with CALR mutation were significantly younger and had borderline higher platelet counts, less pronounced splenomegaly and less frequent B symptoms at diagnosis. The study suggests that the driver mutation types define variations in the biological basis, clinical manifestations and course of the disease. The presence of CALR mutation has been shown to be an independent prognostic favorable factor. Careful risk stratification of these patients is of great importance to adequate therapeutic decision-making and aids in selecting high-risk patients eligible for allogeneic hematopoietic stem cell transplantation which continues to be the only treatment modality for myelofibrosis having curative potential.

Published
2018

6. 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
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7. Second cancer in Philadelphia negative myeloproliferative neoplasms (MPN-K). A nested case-control study

Author

Barbui, T., Ghirardi, A., Masciulli, A., Carobbio, A., Palandri, F., Vianelli, N., De Stefano, Valerio, Betti, S., Di Veroli, A., Iurlo, A., Cattaneo, D., Delaini, F., 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., Marchetti, M., Griesshammer, M., Alvarez-Larran, A., Vannucchi, A. M., Finazzi, G., De Stefano V. (ORCID:0000-0002-5178-5827), Barbui, T., Ghirardi, A., Masciulli, A., Carobbio, A., Palandri, F., Vianelli, N., De Stefano, Valerio, Betti, S., Di Veroli, A., Iurlo, A., Cattaneo, D., Delaini, F., 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., Marchetti, M., Griesshammer, M., Alvarez-Larran, A., Vannucchi, A. M., Finazzi, G., and De Stefano V. (ORCID:0000-0002-5178-5827)

Abstract

We conducted a large international nested case-control study including 1881 patients with Philadelphia-negative myeloproliferative neoplasms (MPN). Cases (n = 647) were patients with second cancer (SC: carcinoma, non-melanoma skin cancer, hematological second cancer, and melanoma) and controls (n = 1234) were patients without SC, matched with cases for sex, age at MPN diagnosis, date of MPN diagnosis, and MPN disease duration. The aim was to evaluate the risk of SC after exposure to cytoreductive drugs. Patients exposed to hydroxyurea (HU) (median: 3 years) had a risk of SC similar to unexposed patients (OR = 1.06, 95% CI 0.82–1.38). In contrast, in cancer-specific stratified multivariable analysis, HU had two-fold higher risk of non-melanoma (NM) skin cancer (OR = 2.28, 95% CI 1.15–4.51). A significantly higher risk of NM-skin cancer was also documented for pipobroman (OR = 3.74, 95% CI 1.00–14.01), ruxolitinib (OR = 3.87, 95% CI 1.18–12.75), and for drug combination (OR = 3.47, 95% CI 1.55–7.75). These three drugs did not show excess risk of carcinoma and hematological second cancer compared with unexposed patients. Exposure to interferon, busulfan, and anagrelide did not increase the risk. In summary, while it is reassuring that no excess of carcinoma was documented, a careful dermatologic active surveillance before and during the course of treatments is recommended.

Published
2019

9. Short and Long-Term Risk of Major Cardiovascular Events after Ischemic Stroke or Transient Ischemic Attack in Myeloproliferative Neoplasms

Author

Barbui, T, De Stefano, V, Carobbio, A, Di Lazzaro, V, Guglielmelli, P, Iurlo, A, Finazzi, M, Rumi, E, Cervantes, F, Elli, E, Randi, Ml, Griesshammer, M, Palandri, F, Bonifacio, M, Hernandez, E, Cacciola, Rossella Rosaria, Cacciola, E, Palova, M, Carli, G, Beggiato, E, Martinelli, E, Musolino, C, Gaidano, G, Tieghi, A, Lunghi, F, Loscocco, G, Cattaneo, D, Cortelezzi, A, Betti, S, Rossi, E, Finazzi, G, Censori, B, Cazzola, M, Bellini, M, Arellano, V, Bertozzi, I, Sadiadian, P, Vianelli, N, and Scaffidi, L.

Published
2017

12. High rate of recurrent venous thromboembolism in patients with myeloproliferative neoplasms and effect of prophylaxis with Vitamin K antagonists

Author

De Stefano, Valerio, Ruggeri, M., Cervantes, F., Alvarez Larrán, A., Iurlo, A., Randi, M. L., Elli, E., Finazzi, M. C., Finazzi, G., Zetterberg, E., Vianelli, N., Gaidano, G., Rossi, Elena, Betti, Silvia, Nichele, I., Cattaneo, D., Palova, M., Ellis, M. H., Cacciola, R., Tieghi, A., Hernandez Boluda, J. C., Pungolino, E., Specchia, G., Rapezzi, D., Forcina, A., Musolino, C., Carobbio, A., Griesshammer, M., Sant'Antonio, E., Vannucchi, A. M., Barbui, T., De Stefano, Valerio (ORCID:0000-0002-5178-5827), Rossi, Elena (ORCID:0000-0002-7572-9379), De Stefano, Valerio, Ruggeri, M., Cervantes, F., Alvarez Larrán, A., Iurlo, A., Randi, M. L., Elli, E., Finazzi, M. C., Finazzi, G., Zetterberg, E., Vianelli, N., Gaidano, G., Rossi, Elena, Betti, Silvia, Nichele, I., Cattaneo, D., Palova, M., Ellis, M. H., Cacciola, R., Tieghi, A., Hernandez Boluda, J. C., Pungolino, E., Specchia, G., Rapezzi, D., Forcina, A., Musolino, C., Carobbio, A., Griesshammer, M., Sant'Antonio, E., Vannucchi, A. M., Barbui, T., De Stefano, Valerio (ORCID:0000-0002-5178-5827), and Rossi, Elena (ORCID:0000-0002-7572-9379)

Abstract

The optimal duration of treatment with vitamin K antagonists (VKA) after venous thromboembolism (VTE) in patients with Philadelphia-negative myeloproliferative neoplasms (MPNs) is uncertain. To tackle this issue, we retrospectively studied 206 patients with MPN-related VTE (deep venous thrombosis of the legs and/or pulmonary embolism). After this index event, we recorded over 695 pt-years 45 recurrences, venous in 36 cases, with an incidence rate (IR) of 6.5 per 100 pt-years (95% confidence interval (CI): 4.9-8.6). One hundred fifty-five patients received VKA; the IR of recurrent thrombosis per 100 pt-years was 4.7 (95% CI: 2.8-7.3) on VKA and 8.9 (95% CI: 5.7-13.2) off VKA (P=0.03). In patients receiving VKA, the IR of recurrent thrombosis per 100 pt-years was 5.3 (95% CI: 3.2-8.4) among 108 patients on long-term VKA and 12.8 (95% CI: 7.3-20.7) after discontinuation among the 47 who ceased treatment (P=0.008), with a doubled risk of recurrence after stopping VKA (hazard ratio: 2.21, 95% CI: 1.19-5.30). The IR of major bleeding per 100 pt-years was 2.4 (95%: CI: 1.1-4.5) on VKA and 0.7 (95% CI: 0.08-2.5) off VKA (P=0.08). In conclusion, in MPN patients with VTE recurrent thrombosis is significantly reduced by VKA and caution should be adopted in discontinuation; however, the incidence of recurrence on treatment remains high, calling for clinical trials aimed to improve prophylaxis in this setting.

Published
2016

13. Splanchnic vein thrombosis in myeloproliferative neoplasms: Risk factors for recurrences in a cohort of 181 patients

Author

De Stefano, Valerio, Vannucchi, A. M., Ruggeri, M., Cervantes, F., Alvarez Larrán, A., Iurlo, A., Randi, M. L., Pieri, L., Rossi, Elena, Guglielmelli, P., Betti, Silvia, Elli, E., Finazzi, M. C., Finazzi, G., Zetterberg, E., Vianelli, N., Gaidano, G., Nichele, I., Cattaneo, D., Palova, M., Ellis, M. H., Cacciola, E., Tieghi, A., Hernandez Boluda, J. C., Pungolino, E., Specchia, G., Rapezzi, D., Forcina, A., Musolino, C., Carobbio, A., Griesshammer, M., Barbui, T., De Stefano, Valerio (ORCID:0000-0002-5178-5827), Rossi, Elena (ORCID:0000-0002-7572-9379), De Stefano, Valerio, Vannucchi, A. M., Ruggeri, M., Cervantes, F., Alvarez Larrán, A., Iurlo, A., Randi, M. L., Pieri, L., Rossi, Elena, Guglielmelli, P., Betti, Silvia, Elli, E., Finazzi, M. C., Finazzi, G., Zetterberg, E., Vianelli, N., Gaidano, G., Nichele, I., Cattaneo, D., Palova, M., Ellis, M. H., Cacciola, E., Tieghi, A., Hernandez Boluda, J. C., Pungolino, E., Specchia, G., Rapezzi, D., Forcina, A., Musolino, C., Carobbio, A., Griesshammer, M., Barbui, T., De Stefano, Valerio (ORCID:0000-0002-5178-5827), and Rossi, Elena (ORCID:0000-0002-7572-9379)

Abstract

We retrospectively studied 181 patients with polycythaemia vera (n=67), essential thrombocythaemia (n=67) or primary myelofibrosis (n=47), who presented a first episode of splanchnic vein thrombosis (SVT). Budd-Chiari syndrome (BCS) and portal vein thrombosis were diagnosed in 31 (17.1%) and 109 (60.3%) patients, respectively; isolated thrombosis of the mesenteric or splenic veins was detected in 18 and 23 cases, respectively. After this index event, the patients were followed for 735 patient years (pt-years) and experienced 31 recurrences corresponding to an incidence rate of 4.2 per 100 pt-years. Factors associated with a significantly higher risk of recurrence were BCS (hazard ratio (HR): 3.03), history of previous thrombosis (HR: 3.62), splenomegaly (HR: 2.66) and leukocytosis (HR: 2.8). Vitamin K-antagonists (VKA) were prescribed in 85% of patients and the recurrence rate was 3.9 per 100 pt-years, whereas in the small fraction (15%) not receiving VKA more recurrences (7.2 per 100 pt-years) were reported. Intracranial and extracranial major bleeding was recorded mainly in patients on VKA and the corresponding rate was 2.0 per 100 pt-years. In conclusion, despite anticoagulation treatment, the recurrence rate after SVT in myeloproliferative neoplasms is high and suggests the exploration of new avenues of secondary prophylaxis with new antithrombotic drugs and JAK-2 inhibitors.

Published
2016

14. Splanchnic vein thrombosis in myeloproliferative neoplasms: risk factors for recurrences in a cohort of 181 patients

Author

De Stefano, V, primary, Vannucchi, A M, additional, Ruggeri, M, additional, Cervantes, F, additional, Alvarez-Larrán, A, additional, Iurlo, A, additional, Randi, M L, additional, Pieri, L, additional, Rossi, E, additional, Guglielmelli, P, additional, Betti, S, additional, Elli, E, additional, Finazzi, M C, additional, Finazzi, G, additional, Zetterberg, E, additional, Vianelli, N, additional, Gaidano, G, additional, Nichele, I, additional, Cattaneo, D, additional, Palova, M, additional, Ellis, M H, additional, Cacciola, E, additional, Tieghi, A, additional, Hernandez-Boluda, J C, additional, Pungolino, E, additional, Specchia, G, additional, Rapezzi, D, additional, Forcina, A, additional, Musolino, C, additional, Carobbio, A, additional, Griesshammer, M, additional, and Barbui, T, additional

Published
2016
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15. Second cancers in MPN: Survival analysis from an international study.

Author

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

Subjects
Age Factors, Aged, Case-Control Studies, Disease-Free Survival, Female, Follow-Up Studies, Humans, Male, Middle Aged, Survival Rate, Hematologic Neoplasms mortality, Myeloproliferative Disorders mortality, Neoplasms, Second Primary mortality
Abstract

One out of ten patients with Philadelphia-negative myeloproliferative neoplasms (MPN) develop a second cancer (SC): in such patients we aimed at assessing the survival impact of SC itself and of MPN-specific therapies. Data were therefore extracted from an international nested case-control study, recruiting 798 patients with SC diagnosed concurrently or after the MPN. Overall, 2995 person-years (PYs) were accumulated and mortality rate (MR) since SC diagnosis was 5.9 (5.1-6.9) deaths for every 100 PYs. A "poor prognosis" SC (stomach, esophagus, liver, pancreas, lung, ovary, head-and-neck or nervous system, osteosarcomas, multiple myeloma, aggressive lymphoma, acute leukemia) was reported in 26.3% of the patients and was the cause of death in 65% of them (MR 11.0/100 PYs). In contrast, patients with a "non-poor prognosis" SC (NPPSC) incurred a MR of 4.6/100 PYs: 31% of the deaths were attributed to SC and 15% to MPN evolution. At multivariable analysis, death after SC diagnosis was independently predicted (HR and 95% CI) by patient age greater than 70 years (2.68; 1.88-3.81), the SC prognostic group (2.57; 1.86-3.55), SC relapse (1.53; 10.6-2.21), MPN evolution (2.72; 1.84-4.02), anemia at SC diagnosis (2.32; 1.49-3.59), exposure to hydroxyurea (1.89; 1.26-2.85) and to ruxolitinib (3.63; 1.97-6.71). Aspirin was protective for patients with a NPPSC (0.60; 0.38-0.95). In conclusion, SC is a relevant cause of death competing with MPN evolution. Prospective data are awaited to confirm the role of cytoreductive and anti-platelet drugs in modulating patient survival after the occurrence of a SC., (© 2019 Wiley Periodicals, Inc.)

Published
2020
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16. Arterial thrombosis in Philadelphia-negative myeloproliferative neoplasms predicts second cancer: a case-control study.

Author

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

Subjects
Case-Control Studies, Follow-Up Studies, Humans, Kaplan-Meier Estimate, Multivariate Analysis, Arteries pathology, Myeloproliferative Disorders pathology, Neoplasms, Second Primary pathology, Philadelphia Chromosome, Thrombosis pathology
Abstract

Patients with Philadelphia-negative myeloproliferative neoplasm (MPN) are prone to the development of second cancers, but the factors associated with these events have been poorly explored. In an international nested case-control study, we recruited 647 patients with carcinoma, nonmelanoma skin cancer, hematological second cancer, and melanoma diagnosed concurrently or after MPN diagnosis. Up to 3 control patients without a history of cancer and matched with each case for center, sex, age at MPN diagnosis, date of diagnosis, and MPN disease duration were included (n = 1234). Cases were comparable to controls for MPN type, driver mutations and cardiovascular risk factors. The frequency of thrombosis preceding MPN was similar for cases and controls (P = .462). Thrombotic events after MPN and before second cancer were higher in cases than in controls (11.6% vs 8.1%; P = .013), because of a higher proportion of arterial thromboses (6.2% vs 3.7%; P = .015). After adjustment for confounders, the occurrence of arterial thrombosis remained independently associated with the risk of carcinoma (odds ratio, 1.97; 95% confidence interval, 1.14-3.41), suggesting that MPN patients experiencing arterial events after MPN diagnosis deserve careful clinical surveillance for early detection of carcinoma. This study was registered at www.clinicaltrials.gov as NCT03745378., (© 2020 by The American Society of Hematology.)

Published
2020
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17. Second cancer in Philadelphia negative myeloproliferative neoplasms (MPN-K). A nested case-control study.

Author

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

Subjects
Case-Control Studies, Humans, Hydroxyurea adverse effects, Nitriles, Pipobroman adverse effects, Polycythemia Vera genetics, Pyrazoles adverse effects, Pyrimidines, Thrombocythemia, Essential genetics, Antineoplastic Agents adverse effects, Neoplasms, Second Primary chemically induced, Philadelphia Chromosome, Polycythemia Vera drug therapy, Primary Myelofibrosis drug therapy, Thrombocythemia, Essential drug therapy
Abstract

We conducted a large international nested case-control study including 1881 patients with Philadelphia-negative myeloproliferative neoplasms (MPN). Cases (n = 647) were patients with second cancer (SC: carcinoma, non-melanoma skin cancer, hematological second cancer, and melanoma) and controls (n = 1234) were patients without SC, matched with cases for sex, age at MPN diagnosis, date of MPN diagnosis, and MPN disease duration. The aim was to evaluate the risk of SC after exposure to cytoreductive drugs. Patients exposed to hydroxyurea (HU) (median: 3 years) had a risk of SC similar to unexposed patients (OR = 1.06, 95% CI 0.82-1.38). In contrast, in cancer-specific stratified multivariable analysis, HU had two-fold higher risk of non-melanoma (NM) skin cancer (OR = 2.28, 95% CI 1.15-4.51). A significantly higher risk of NM-skin cancer was also documented for pipobroman (OR = 3.74, 95% CI 1.00-14.01), ruxolitinib (OR = 3.87, 95% CI 1.18-12.75), and for drug combination (OR = 3.47, 95% CI 1.55-7.75). These three drugs did not show excess risk of carcinoma and hematological second cancer compared with unexposed patients. Exposure to interferon, busulfan, and anagrelide did not increase the risk. In summary, while it is reassuring that no excess of carcinoma was documented, a careful dermatologic active surveillance before and during the course of treatments is recommended.

Published
2019
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18. Multianalyte Determination of NOACs Using LC-MS/MS and Comparison with Functional Coagulation Assays.

Author

Slavik L, Lukes J, Friedecky D, Zhanelova M, Nemcova M, Ulehlova J, Prochazkova J, Hlusi A, Palova M, and Vaclavik J

Subjects
Administration, Oral, Anticoagulants administration & dosage, Anticoagulants therapeutic use, Blood Coagulation drug effects, Dabigatran administration & dosage, Dabigatran blood, Dabigatran therapeutic use, Factor Xa Inhibitors administration & dosage, Factor Xa Inhibitors therapeutic use, Humans, Partial Thromboplastin Time, Prothrombin Time, Pulmonary Embolism prevention & control, Pyrazoles administration & dosage, Pyrazoles blood, Pyrazoles therapeutic use, Pyridones administration & dosage, Pyridones blood, Pyridones therapeutic use, Rivaroxaban administration & dosage, Rivaroxaban blood, Rivaroxaban therapeutic use, Thrombin metabolism, Venous Thrombosis prevention & control, Anticoagulants blood, Blood Coagulation Tests methods, Chromatography, Liquid methods, Factor Xa Inhibitors blood, Tandem Mass Spectrometry methods
Abstract

Background: Detection of new oral anticoagulant (NOAC) levels by screening, special and global tests, and liquid chromatography-coupled tandem mass spectrometry (LC-MS/MS) is important in clinical situations when the cause of bleeding needs to be determined., Methods: We compared a routine coagulation test, special function test for NOACs, global coagulation test, and an LC-MS/MS method that enables simultaneous determination of apixaban, dabigatran and rivaroxaban in human plasma within one analysis to determine the optimal indication of the comparison methods, including their limitations and interferences., Results: This study was conducted on a set of blood samples from 116 patients treated with NOACs. The results of both specific dilute thrombin time (dTT) tests for dabigatran provided the same results as the activated partial thromboplastin time (aPTT) screening test in comparison with LC-MS/MS as a reference. The dTT assay HemosIL® showed better results for low concentrations when compared to LC-MS/MS than dTT HYPHEN® as HemosIL® uses a non-linear calibration curve. Results of the specific anti-Xa assay yielded better results than the prothrombin time test in comparison with LC-MS/MS as a reference, especially for apixaban, but also for rivaroxaban. Our LC MS/MS method is simply feasible, but only in a specialized laboratory. The method is easy-to-use for the simultaneous determination of all dabigatran, apixaban and rivaroxaban by LC-MS/MS within three minutes with a concentration range of 1 to 500 µg/L without dilution., Conclusions: In the normal practice of the coagulation laboratory, it is advisable to use specific tests for NOAC determination as screening and global assays are not sufficiently specific. The dTT test is the optimal choice for dabigatran determination and for xabans to determine anti-Xa activity. The LC-MS/MS method is suitable as an arbitration method for serious conditions.

Published
2018
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