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1. miR-126 identifies a quiescent and chemo-resistant human B-ALL cell subset that correlates with minimal residual disease

Author

Caserta, C, Nucera, S, Barcella, M, Fazio, G, Naldini, M, Pagani, R, Pavesi, F, Desantis, G, Zonari, E, D'Angio, M, Capasso, P, Lombardo, A, Merelli, I, Spinelli, O, Rambaldi, A, Ciceri, F, Silvestri, D, Valsecchi, M, Biondi, A, Cazzaniga, G, Gentner, B, Caserta C., Nucera S., Barcella M., Fazio G., Naldini M. M., Pagani R., Pavesi F., Desantis G., Zonari E., D'Angio M., Capasso P., Lombardo A., Merelli I., Spinelli O., Rambaldi A., Ciceri F., Silvestri D., Valsecchi M. G., Biondi A., Cazzaniga G., Gentner B., Caserta, C, Nucera, S, Barcella, M, Fazio, G, Naldini, M, Pagani, R, Pavesi, F, Desantis, G, Zonari, E, D'Angio, M, Capasso, P, Lombardo, A, Merelli, I, Spinelli, O, Rambaldi, A, Ciceri, F, Silvestri, D, Valsecchi, M, Biondi, A, Cazzaniga, G, Gentner, B, Caserta C., Nucera S., Barcella M., Fazio G., Naldini M. M., Pagani R., Pavesi F., Desantis G., Zonari E., D'Angio M., Capasso P., Lombardo A., Merelli I., Spinelli O., Rambaldi A., Ciceri F., Silvestri D., Valsecchi M. G., Biondi A., Cazzaniga G., and Gentner B.

Abstract

Complete elimination of B-cell acute lymphoblastic leukemia (B-ALL) by a risk-adapted primary treatment approach remains a clinical key objective, which fails in up to a third of patients. Recent evidence has implicated subpopulations of B-ALL cells with stem-like features in disease persistence. We hypothesized that microRNA-126, a core regulator of hematopoietic and leukemic stem cells, may resolve intratumor heterogeneity in B-ALL and uncover therapy-resistant subpopulations. We exploited patient-derived xenograft (PDX) models with B-ALL cells transduced with a miR-126 reporter allowing the prospective isolation of miR-126(high) cells for their functional and transcriptional characterization. Discrete miR-126(high) populations, often characterized by MIR126 locus demethylation, were identified in 8/9 PDX models and showed increased repopulation potential, in vivo chemotherapy resistance and hallmarks of quiescence, inflammation and stress-response pathway activation. Cells with a miR-126(high) transcriptional profile were identified as distinct disease subpopulations by single-cell RNA sequencing in diagnosis samples from adult and pediatric B-ALL. Expression of miR-126 and locus methylation were tested in several pediatric and adult B-ALL cohorts, which received standardized treatment. High microRNA-126 levels and locus demethylation at diagnosis associate with suboptimal response to induction chemotherapy (MRD > 0.05% at day +33 or MRD+ at day +78). [Figure not available: see fulltext.].

Published
2023

2. Standardisation and consensus guidelines for minimal residual disease assessment in Philadelphia-positive acute lymphoblastic leukemia (Ph + ALL) by real-time quantitative reverse transcriptase PCR of e1a2 BCR-ABL1

Author

Pfeifer, H., Cazzaniga, G., van der Velden, V. H. J., Cayuela, J. M., Schäfer, B., Spinelli, O., Akiki, S., Avigad, S., Bendit, I., Borg, K., Cavé, H., Elia, L., Reshmi, S. C., Gerrard, G., Hayette, S., Hermanson, M., Juh, A., Jurcek, T., Chillón, M. C., Homburg, C., Martinelli, G., Kairisto, V., Lange, T., Lion, T., Mueller, M. C., Pane, F., Rai, L., Damm-Welk, C., Sacha, T., Schnittger, S., Touloumenidou, T., Valerhaugen, H., Vandenberghe, P., Zuna, J., Serve, H., Herrmann, E., Markovic, S., Dongen, J. J. M. van, and Ottmann, O. G.

Published
2019
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3. Dysmetabolism, Diabetes and Clinical Outcomes in Patients Cured of Chronic Hepatitis C: A Real-Life Cohort Study

Author

Valenti, L, Pelusi, S, Aghemo, A, Gritti, S, Pasulo, L, Bianco, C, Iegri, C, Cologni, G, Degasperi, E, D'Ambrosio, R, del Poggio, P, Soria, A, Puoti, M, Carderi, I, Pigozzi, M, Carriero, C, Spinetti, A, Zuccaro, V, Memoli, M, Giorgini, A, Vigano, M, Rumi, M, Re, T, Spinelli, O, Colombo, M, Quirino, T, Menzaghi, B, Lorini, G, Pan, A, D'Arminio Monforte, A, Buscarini, E, Autolitano, A, Bonfanti, P, Terreni, N, Aimo, G, Mendeni, M, Prati, D, Lampertico, P, Fagiuoli, S, Valenti L., Pelusi S., Aghemo A., Gritti S., Pasulo L., Bianco C., Iegri C., Cologni G., Degasperi E., D'Ambrosio R., del Poggio P., Soria A., Puoti M., Carderi I., Pigozzi M. G., Carriero C., Spinetti A., Zuccaro V., Memoli M., Giorgini A., Vigano M., Rumi M. G., Re T., Spinelli O., Colombo M. C., Quirino T., Menzaghi B., Lorini G., Pan A., D'Arminio Monforte A., Buscarini E., Autolitano A., Bonfanti P., Terreni N., Aimo G., Mendeni M., Prati D., Lampertico P., Colombo M., Fagiuoli S., Valenti, L, Pelusi, S, Aghemo, A, Gritti, S, Pasulo, L, Bianco, C, Iegri, C, Cologni, G, Degasperi, E, D'Ambrosio, R, del Poggio, P, Soria, A, Puoti, M, Carderi, I, Pigozzi, M, Carriero, C, Spinetti, A, Zuccaro, V, Memoli, M, Giorgini, A, Vigano, M, Rumi, M, Re, T, Spinelli, O, Colombo, M, Quirino, T, Menzaghi, B, Lorini, G, Pan, A, D'Arminio Monforte, A, Buscarini, E, Autolitano, A, Bonfanti, P, Terreni, N, Aimo, G, Mendeni, M, Prati, D, Lampertico, P, Fagiuoli, S, Valenti L., Pelusi S., Aghemo A., Gritti S., Pasulo L., Bianco C., Iegri C., Cologni G., Degasperi E., D'Ambrosio R., del Poggio P., Soria A., Puoti M., Carderi I., Pigozzi M. G., Carriero C., Spinetti A., Zuccaro V., Memoli M., Giorgini A., Vigano M., Rumi M. G., Re T., Spinelli O., Colombo M. C., Quirino T., Menzaghi B., Lorini G., Pan A., D'Arminio Monforte A., Buscarini E., Autolitano A., Bonfanti P., Terreni N., Aimo G., Mendeni M., Prati D., Lampertico P., Colombo M., and Fagiuoli S.

Abstract

The aim of this study was to examine the impact of features of dysmetabolism on liver disease severity, evolution, and clinical outcomes in a real-life cohort of patients treated with direct acting antivirals for chronic hepatitis C virus (HCV) infection. To this end, we considered 7,007 patients treated between 2014 and 2018, 65.3% with advanced fibrosis, of whom 97.7% achieved viral eradication (NAVIGATORE-Lombardia registry). In a subset (n = 748), liver stiffness measurement (LSM) was available at baseline and follow-up. Higher body mass index (BMI; odds ratio [OR] 1.06 per kg/m2, 1.03-1.09) and diabetes (OR 2.01 [1.65-2.46]) were independently associated with advanced fibrosis at baseline, whereas statin use was protective (OR 0.46 [0.35-0.60]; P < 0.0001 for all). The impact of BMI was greater in those without diabetes (P = 0.003). Diabetes was independently associated with less pronounced LSM improvement after viral eradication (P = 0.001) and in patients with advanced fibrosis was an independent predictor of the most frequent clinical events, namely de novo hepatocellular carcinoma (HCC; hazard ratio [HR] 2.09 [1.20-3.63]; P = 0.009) and cardiovascular events (HR 2.73 [1.16-6.43]; P = 0.021). Metformin showed a protective association against HCC (HR 0.32 [0.11-0.96]; P = 0.043), which was confirmed after adjustment for propensity score (P = 0.038). Diabetes diagnosis further refined HCC prediction in patients with compensated advanced chronic liver disease at high baseline risk (P = 0.024). Conclusion: Metabolic comorbidities were associated with advanced liver fibrosis at baseline, whereas statins were protective. In patients with advanced fibrosis, diabetes increased the risk of de novo HCC and of cardiovascular events. Optimization of metabolic comorbidities treatment by a multi-disciplinary management approach may improve cardiovascular and possibly liver-related

Published
2022

5. Correction: Standardisation and consensus guidelines for minimal residual disease assessment in Philadelphia-positive acute lymphoblastic leukemia (Ph+ALL) by real-time quantitative reverse transcriptase PCR of e1a2 BCR-ABL1

Author

Pfeifer, H., Cazzaniga, G., van der Velden, V. H. J., Cayuela, J. M., Schäfer, B., Spinelli, O., Akiki, S., Avigad, S., Bendit, I., Borg, K., Cavé, H., Elia, L., Reshmi, S. C., Gerrard, G., Hayette, S., Hermanson, M., Juh, A., Jurcek, T., Chillón, M. C., Homburg, C., Martinelli, G., Kairisto, V., Lange, T., Lion, T., Mueller, M. C., Pane, F., Rai, L., Damm-Welk, C., Sacha, T., Schnittger, S., Touloumenidou, T., Valerhaugen, H., Vandenberghe, P., Zuna, J., Serve, H., Herrmann, E., Markovic, S., van Dongen, J. J. M., and Ottmann, O. G.

Published
2020
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6. Identification of Human SARS-CoV-2 Monoclonal Antibodies from Convalescent Patients Using EBV Immortalization

Author

Valgardsdottir, R, Cattaneo, I, Napolitano, G, Raglio, A, Spinelli, O, Salmoiraghi, S, Castilletti, C, Lapa, D, Capobianchi, M, Farina, C, Golay, J, Valgardsdottir R, Cattaneo I, Napolitano G, Raglio A, Spinelli O, Salmoiraghi S, Castilletti C, Lapa D, Capobianchi MR, Farina C, Golay J, Valgardsdottir, R, Cattaneo, I, Napolitano, G, Raglio, A, Spinelli, O, Salmoiraghi, S, Castilletti, C, Lapa, D, Capobianchi, M, Farina, C, Golay, J, Valgardsdottir R, Cattaneo I, Napolitano G, Raglio A, Spinelli O, Salmoiraghi S, Castilletti C, Lapa D, Capobianchi MR, Farina C, and Golay J

Abstract

We report the isolation of two human IgG1k monoclonal antibodies (mAbs) directed against the SARS-CoV-2 spike protein. These mAbs were isolated from two donors who had recovered from COVID-19 infection during the first pandemic peak in the Lombardy region of Italy, the first European and initially most affected region in March 2020. We used the method of EBV immortalization of purified memory B cells and supernatant screening with a spike S1/2 assay for mAb isolation. This method allowed rapid isolation of clones, with one donor showing about 7% of clones positive against spike protein, whereas the other donor did not produce positive clones out of 91 tested. RNA was extracted from positive clones 39–47 days post-EBV infection, allowing VH and VL sequencing. The same clones were sequenced again after a further 100 days in culture, showing that no mutation had taken place during in vitro expansion. The B cell clones could be expanded in culture for more than 4 months after EBV immortalization and secreted the antibodies stably during that time, allowing to purify mg quantities of each mAb for functional assays without generating recombinant proteins. Unfortunately, neither mAb had significant neutralizing activity in a virus infection assay with several different SARS-CoV-2 isolates. The antibody sequences are made freely available.

Published
2021

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

Author

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, Foa, R, Chiaretti S, Messina M, Della Starza I, Piciocchi A, Cafforio L, Cavalli M, Taherinasab A, Ansuinelli M, Elia L, Petroni GA, La Starza R, Canichella M, Lauretti A, Puzzolo MC, 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, Foa R, 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, Foa, R, Chiaretti S, Messina M, Della Starza I, Piciocchi A, Cafforio L, Cavalli M, Taherinasab A, Ansuinelli M, Elia L, Petroni GA, La Starza R, Canichella M, Lauretti A, Puzzolo MC, 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

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-Ph-like 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.

Published
2021

8. High rates of sustained virological response despite premature discontinuation of directly acting antivirals in HCV-infected patients treated in a real-life setting

Author

Fabbiani, M, Lombardi, A, Colaneri, M, Del Poggio, P, Perini, P, D'Ambrosio, R, Degasperi, E, Dibenedetto, C, Giorgini, A, Pasulo, L, Maggiolo, F, Castelli, F, Brambilla, P, Spinelli, O, Re, T, Lleo, A, Rumi, M, Uberti-Foppa, C, Soria, A, Aghemo, A, Lampertico, P, Baiguera, C, Schiavini, M, Fagiuoli, S, Bruno, R, Borghi, M, Soffredini, R, Perbellini, R, Gori, A, Ferroni, V, Colpani, M, Manini, M, Cologni, G, Lazzaroni, S, Vinci, M, De Nicola, S, Mazzarelli, C, Angelini Zucchetti, T, Picciotto, V, Puoti, M, Rossotti, R, Landonio, S, Magni, C, Rizzardini, G, Colella, E, Columpsi, P, Gambaro, A, Spolti, A, Magnani, C, Vigano, P, Mena, M, Villa, M, Caramma, I, Basilico, C, Capelli, F, Biagiotti, S, Mazzone, A, Saladino, V, Baldacci, M, Gatti, F, Varalli, L, Morini, L, Menzaghi, B, Farinazzo, M, Meli, R, Plaz Torres, M, Fanetti, I, Orellana, D, Zermiani, P, Zuin, M, De Bona, A, D'Arminio Monforte, A, Capretti, A, Taddei, M, Soncini, M, Spinetti, A, Zaltron, S, Pigozzi, M, Rossini, A, Pan, A, Dal Zoppo, S, Zoncada, A, Memoli, M, Salpietro, S, Hamid, H, Messina, E, Colombo, A, Giglio, O, Bonfanti, P, Molteni, C, Terreni, N, Spinzi, G, Conforti, S, Clerici, E, Menozzi, F, Buscarini, E, Centenaro, R, Corbellini, A, Noventa, F, Gritti, S, Giani, P, Fabbiani M., Lombardi A., Colaneri M., Del Poggio P., Perini P., D'Ambrosio R., Degasperi E., Dibenedetto C., Giorgini A., Pasulo L., Maggiolo F., Castelli F., Brambilla P., Spinelli O., Re T., Lleo A., Rumi M., Uberti-Foppa C., Soria A., Aghemo A., Lampertico P., Baiguera C., Schiavini M., Fagiuoli S., Bruno R., Borghi M., Soffredini R., Perbellini R., Gori A., Ferroni V., Colpani M., Manini M., Cologni G., Lazzaroni S., Vinci M., De Nicola S., Mazzarelli C., Angelini Zucchetti T., Picciotto V., Puoti M., Rossotti R., Landonio S., Magni C. F., Rizzardini G., Colella E., Columpsi P., Gambaro A., Spolti A., Magnani C., Vigano P., Mena M., Villa M., Caramma I., Basilico C., Capelli F., Biagiotti S., Mazzone A., Saladino V., Baldacci M. P., Gatti F., Varalli L., Morini L., Menzaghi B., Farinazzo M., Meli R., Plaz Torres M. C., Fanetti I., Orellana D., Zermiani P., Zuin M., De Bona A., D'Arminio Monforte A., Capretti A., Taddei M. T., Soncini M., Spinetti A., Zaltron S., Pigozzi M. G., Rossini A., Pan A., Dal Zoppo S., Zoncada A., Memoli M., Salpietro S., Hamid H., Messina E., Colombo A. E., Giglio O., Bonfanti P., Molteni C., Terreni N., Spinzi G., Conforti S., Clerici E., Menozzi F., Buscarini E., Centenaro R., Corbellini A., Noventa F., Gritti S., Giani P., Fabbiani, M, Lombardi, A, Colaneri, M, Del Poggio, P, Perini, P, D'Ambrosio, R, Degasperi, E, Dibenedetto, C, Giorgini, A, Pasulo, L, Maggiolo, F, Castelli, F, Brambilla, P, Spinelli, O, Re, T, Lleo, A, Rumi, M, Uberti-Foppa, C, Soria, A, Aghemo, A, Lampertico, P, Baiguera, C, Schiavini, M, Fagiuoli, S, Bruno, R, Borghi, M, Soffredini, R, Perbellini, R, Gori, A, Ferroni, V, Colpani, M, Manini, M, Cologni, G, Lazzaroni, S, Vinci, M, De Nicola, S, Mazzarelli, C, Angelini Zucchetti, T, Picciotto, V, Puoti, M, Rossotti, R, Landonio, S, Magni, C, Rizzardini, G, Colella, E, Columpsi, P, Gambaro, A, Spolti, A, Magnani, C, Vigano, P, Mena, M, Villa, M, Caramma, I, Basilico, C, Capelli, F, Biagiotti, S, Mazzone, A, Saladino, V, Baldacci, M, Gatti, F, Varalli, L, Morini, L, Menzaghi, B, Farinazzo, M, Meli, R, Plaz Torres, M, Fanetti, I, Orellana, D, Zermiani, P, Zuin, M, De Bona, A, D'Arminio Monforte, A, Capretti, A, Taddei, M, Soncini, M, Spinetti, A, Zaltron, S, Pigozzi, M, Rossini, A, Pan, A, Dal Zoppo, S, Zoncada, A, Memoli, M, Salpietro, S, Hamid, H, Messina, E, Colombo, A, Giglio, O, Bonfanti, P, Molteni, C, Terreni, N, Spinzi, G, Conforti, S, Clerici, E, Menozzi, F, Buscarini, E, Centenaro, R, Corbellini, A, Noventa, F, Gritti, S, Giani, P, Fabbiani M., Lombardi A., Colaneri M., Del Poggio P., Perini P., D'Ambrosio R., Degasperi E., Dibenedetto C., Giorgini A., Pasulo L., Maggiolo F., Castelli F., Brambilla P., Spinelli O., Re T., Lleo A., Rumi M., Uberti-Foppa C., Soria A., Aghemo A., Lampertico P., Baiguera C., Schiavini M., Fagiuoli S., Bruno R., Borghi M., Soffredini R., Perbellini R., Gori A., Ferroni V., Colpani M., Manini M., Cologni G., Lazzaroni S., Vinci M., De Nicola S., Mazzarelli C., Angelini Zucchetti T., Picciotto V., Puoti M., Rossotti R., Landonio S., Magni C. F., Rizzardini G., Colella E., Columpsi P., Gambaro A., Spolti A., Magnani C., Vigano P., Mena M., Villa M., Caramma I., Basilico C., Capelli F., Biagiotti S., Mazzone A., Saladino V., Baldacci M. P., Gatti F., Varalli L., Morini L., Menzaghi B., Farinazzo M., Meli R., Plaz Torres M. C., Fanetti I., Orellana D., Zermiani P., Zuin M., De Bona A., D'Arminio Monforte A., Capretti A., Taddei M. T., Soncini M., Spinetti A., Zaltron S., Pigozzi M. G., Rossini A., Pan A., Dal Zoppo S., Zoncada A., Memoli M., Salpietro S., Hamid H., Messina E., Colombo A. E., Giglio O., Bonfanti P., Molteni C., Terreni N., Spinzi G., Conforti S., Clerici E., Menozzi F., Buscarini E., Centenaro R., Corbellini A., Noventa F., Gritti S., and Giani P.

Abstract

In routine clinical practice, hepatitis C virus-infected patients can prematurely discontinue the prescribed regimen for several reasons. The aim of our study was to investigate sustained virological response (SVR12) rates in patients who prematurely discontinued directly acting antiviral (DAA) regimens and to assess the shortest effective duration of DAA able to lead to SVR12. We retrospectively collected the SVR rates of patients, registered in the NAVIGATORE-Lombardia Network database from January 2015, who discontinued DAAs before the predefined end of treatment. Overall, we included 365 patients, males were the majority (213, 58.4%), mean age was 60.5 years, and 53 (14.5%) patients were HIV-co-infected. Liver cirrhosis was observed in 251 (68.8%) subjects, and the most represented genotypes were 1b (n = 168, 46%) and 3 (n = 59, 16.2%). DAA was discontinued a median of 1 (IQR 1–4) weeks before the predefined EOT, with 164 (44.9%) patients stopping DAAs at least 2 weeks before the planned schedule. In patients with F0–F3 liver fibrosis, lower rates of SVR12 were observed in patients treated for <4 weeks: 50% (n = 2/4) vs. 99.1% (n = 109/110) for ≥4 weeks, p = 0.003. In patients with liver cirrhosis, lower rates of SVR12 were observed in patients treated <8 weeks: 83.3% (n = 25/30) vs. 94.6% (n = 209/221) for ≥8 weeks, p = 0.038. Despite premature discontinuation of DAA, high SVR12 rates were observed in a real-life setting for treatment lasting at least 4 weeks in patients with liver fibrosis F0–F3 and 8 weeks in those with liver cirrhosis. On this basis, feasibility of reducing DAA treatment duration should be explored in randomized clinical trials.

Published
2021

9. S113: NATIONAL PEGASPARGASE-MODIFIED RISK-ORIENTED PROGRAM FOR PHILADELPHIA-NEGATIVE ADULT ACUTE LYMPHOBLASTIC LEUKEMIA/LYMPHOBLASTIC LYMPHOMA (PH− ALL/LL). GIMEMA LAL 1913 FINAL RESULTS.

Author

Bassan, R., primary, Chiaretti, S., additional, Della Starza, I., additional, Spinelli, O., additional, Santoro, A., additional, Elia, L., additional, De Propris, M. S., additional, Scattolin, A. M., additional, Paoloni, F., additional, Messina, M., additional, Audisio, E., additional, Marbello, L., additional, Borlenghi, E., additional, Zappasodi, P., additional, Vetro, C., additional, Martinelli, G., additional, Mattei, D., additional, Fracchiolla, N., additional, Bocchia, M., additional, De Fabritiis, P., additional, Bonifacio, M., additional, Candoni, A., additional, Cassibba, V., additional, Di Bartolomeo, P., additional, Latte, G., additional, Trappolini, S., additional, Guarini, A., additional, Vitale, A., additional, Fazi, P., additional, Vignetti, M., additional, Rambaldi, A., additional, and Foà, R., additional

Published
2022
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10. Comparison of three therapeutic regimens for genotype-3 hepatitis C virus infection in a large real-life multicentre cohort

Author

Soria, A, Fava, M, Bernasconi, D, Lapadula, G, Colella, E, Valsecchi, M, Migliorino, G, D'Ambrosio, R, Landonio, S, Schiavini, M, Spinetti, A, Carriero, C, Degasperi, E, Cologni, G, Gatti, F, Vigano, P, Hasson, H, Uberti-Foppa, C, Pasulo, L, Baiguera, C, Rossotti, R, Vinci, M, Puoti, M, Giorgini, A, Menzaghi, B, Lombardi, A, Pan, A, Aghemo, A, Grossi, P, Boldizzoni, R, Colombo, S, Vigano, M, Rumi, M, Del Poggio, P, Valenti, L, Giglio, O, De Bona, A, d'Arminio Monforte, A, Colombo, A, Spinelli, O, Pigozzi, M, Molteni, C, Bonfanti, P, Terreni, N, Perini, P, Capretti, A, Bella, D, Liani, C, Polo, S, Aimo, G, Pagnucco, L, Bhoori, S, Centenaro, R, Graffeo, M, Ciaccio, A, Dionigi, E, Lazzaroni, S, Carderi, I, Di Marco, M, Rizzardini, G, Noventa, F, Lampertico, P, Fagiuoli, S, Soria A., Fava M., Bernasconi D. P., Lapadula G., Colella E., Valsecchi M. G., Migliorino G. M., D'Ambrosio R., Landonio S., Schiavini M., Spinetti A., Carriero C., Degasperi E., Cologni G., Gatti F., Vigano P., Hasson H., Uberti-Foppa C., Pasulo L., Baiguera C., Rossotti R., Vinci M., Puoti M., Giorgini A., Menzaghi B., Lombardi A., Pan A., Aghemo A., Grossi P. A., Boldizzoni R., Colombo S., Vigano M., Rumi M. G., Del Poggio P., Valenti L., Giglio O., De Bona A., d'Arminio Monforte A., Colombo A., Spinelli O., Pigozzi M. G., Molteni C., Bonfanti P., Terreni N., Perini P., Capretti A., Bella D., Liani C., Polo S., Aimo G., Pagnucco L., Bhoori S., Centenaro R., Graffeo M., Ciaccio A., Dionigi E., Lazzaroni S., Carderi I., Di Marco M., Rizzardini G., Noventa F., Lampertico P., Fagiuoli S., Soria, A, Fava, M, Bernasconi, D, Lapadula, G, Colella, E, Valsecchi, M, Migliorino, G, D'Ambrosio, R, Landonio, S, Schiavini, M, Spinetti, A, Carriero, C, Degasperi, E, Cologni, G, Gatti, F, Vigano, P, Hasson, H, Uberti-Foppa, C, Pasulo, L, Baiguera, C, Rossotti, R, Vinci, M, Puoti, M, Giorgini, A, Menzaghi, B, Lombardi, A, Pan, A, Aghemo, A, Grossi, P, Boldizzoni, R, Colombo, S, Vigano, M, Rumi, M, Del Poggio, P, Valenti, L, Giglio, O, De Bona, A, d'Arminio Monforte, A, Colombo, A, Spinelli, O, Pigozzi, M, Molteni, C, Bonfanti, P, Terreni, N, Perini, P, Capretti, A, Bella, D, Liani, C, Polo, S, Aimo, G, Pagnucco, L, Bhoori, S, Centenaro, R, Graffeo, M, Ciaccio, A, Dionigi, E, Lazzaroni, S, Carderi, I, Di Marco, M, Rizzardini, G, Noventa, F, Lampertico, P, Fagiuoli, S, Soria A., Fava M., Bernasconi D. P., Lapadula G., Colella E., Valsecchi M. G., Migliorino G. M., D'Ambrosio R., Landonio S., Schiavini M., Spinetti A., Carriero C., Degasperi E., Cologni G., Gatti F., Vigano P., Hasson H., Uberti-Foppa C., Pasulo L., Baiguera C., Rossotti R., Vinci M., Puoti M., Giorgini A., Menzaghi B., Lombardi A., Pan A., Aghemo A., Grossi P. A., Boldizzoni R., Colombo S., Vigano M., Rumi M. G., Del Poggio P., Valenti L., Giglio O., De Bona A., d'Arminio Monforte A., Colombo A., Spinelli O., Pigozzi M. G., Molteni C., Bonfanti P., Terreni N., Perini P., Capretti A., Bella D., Liani C., Polo S., Aimo G., Pagnucco L., Bhoori S., Centenaro R., Graffeo M., Ciaccio A., Dionigi E., Lazzaroni S., Carderi I., Di Marco M., Rizzardini G., Noventa F., Lampertico P., and Fagiuoli S.

Abstract

Background & Aims: In the direct-acting antiviral era, treatment of genotype-3 HCV (HCV-GT3) is still challenging. Real-life comparisons between recommended regimens, sofosbuvir (SOF)+daclatasvir (DAC), SOF/velpatasvir (VEL), glecaprevir/pibrentasvir (GLE/PIB), are scarce. We aimed at filling this data gap. Methods: Sustained virological response 12 weeks after treatment completion (SVR12) was assessed for all HCV-GT3 patients consecutively treated within the Lombardia web-based Navigatore HCV-Network; differences in SVR12 across regimens were evaluated by logistic regression. Results: Of the 2082 subjects with HCV-GT3, 1544 were evaluable for comparisons between regimens: SOF + DAC (1023, 66.2%), SOF/VEL (369, 23.9%), GLE/PIB (152, 9.8%). Patients treated with former regimens were more frequently male, cirrhotic, HIV-positive, pretreated, used ribavirin in their regimen, and had lower baseline HCV-RNA. SVR12 was similar across groups: 94.8% in SOF + DAC, 97.6% in SOF/VEL, 96.7% in GLE/PIB (P =.065). At univariate analysis, SVR12 was associated with female gender (97.9% vs 94.8%, P =.007) and lower median pretreatment Log10HCV-RNA (5.87 vs 6.20, P =.001). At multivariate logistic regression analysis, treatment with SOF/VEL was associated with a higher likelihood of SVR12 than SOF + DAC, but only in the absence of ribavirin (98% vs 90.3%). Female gender and lower pretreatment HCV-RNA were independently associated with SVR12. Conclusions: In a large real-life setting of HCV-GT3-infected patients with a high proportion of cirrhosis, the success rate was remarkable. The slight advantage of SOF/VEL on SOF + DAC was significant only without ribavirin. The current prescription shift towards novel regimens (ie SOF/VEL and GLE/PIB) in easier-to-treat patients allows ribavirin-free and shorter schedules without mining SVR12 in this <> genotype.

Published
2020

11. Renal safety in 3264 HCV patients treated with DAA-based regimens: Results from a large Italian real-life study

Author

D'Ambrosio, R, Pasulo, L, Giorgini, A, Spinetti, A, Messina, E, Fanetti, I, Puoti, M, Aghemo, A, Vigano, P, Vinci, M, Menzaghi, B, Lombardi, A, Pan, A, Pigozzi, M, Grossi, P, Lazzaroni, S, Spinelli, O, Invernizzi, P, Maggiolo, F, Terreni, N, Monforte, A, Poggio, P, Taddei, M, Colombo, S, Pozzoni, P, Molteni, C, Brocchieri, A, Bhoori, S, Buscarini, E, Centenaro, R, Mendeni, M, Colombo, A, Di Marco, M, Dionigi, E, Bella, D, Borghi, M, Zuin, M, Zaltron, S, Noventa, F, Annalisa, D, Lampertico, P, Fagiuoli, S, D'Ambrosio R., Pasulo L., Giorgini A., Spinetti A., Messina E., Fanetti I., Puoti M., Aghemo A., Vigano P., Vinci M., Menzaghi B., Lombardi A., Pan A., Pigozzi M. G., Grossi P., Lazzaroni S., Spinelli O., Invernizzi P., Maggiolo F., Terreni N., Monforte A. D., Poggio P. D., Taddei M. T., Colombo S., Pozzoni P., Molteni C., Brocchieri A., Bhoori S., Buscarini E., Centenaro R., Mendeni M., Colombo A. E., Di Marco M., Dionigi E., Bella D., Borghi M., Zuin M., Zaltron S., Noventa F., Annalisa D. S., Lampertico P., Fagiuoli S., D'Ambrosio, R, Pasulo, L, Giorgini, A, Spinetti, A, Messina, E, Fanetti, I, Puoti, M, Aghemo, A, Vigano, P, Vinci, M, Menzaghi, B, Lombardi, A, Pan, A, Pigozzi, M, Grossi, P, Lazzaroni, S, Spinelli, O, Invernizzi, P, Maggiolo, F, Terreni, N, Monforte, A, Poggio, P, Taddei, M, Colombo, S, Pozzoni, P, Molteni, C, Brocchieri, A, Bhoori, S, Buscarini, E, Centenaro, R, Mendeni, M, Colombo, A, Di Marco, M, Dionigi, E, Bella, D, Borghi, M, Zuin, M, Zaltron, S, Noventa, F, Annalisa, D, Lampertico, P, Fagiuoli, S, D'Ambrosio R., Pasulo L., Giorgini A., Spinetti A., Messina E., Fanetti I., Puoti M., Aghemo A., Vigano P., Vinci M., Menzaghi B., Lombardi A., Pan A., Pigozzi M. G., Grossi P., Lazzaroni S., Spinelli O., Invernizzi P., Maggiolo F., Terreni N., Monforte A. D., Poggio P. D., Taddei M. T., Colombo S., Pozzoni P., Molteni C., Brocchieri A., Bhoori S., Buscarini E., Centenaro R., Mendeni M., Colombo A. E., Di Marco M., Dionigi E., Bella D., Borghi M., Zuin M., Zaltron S., Noventa F., Annalisa D. S., Lampertico P., and Fagiuoli S.

Abstract

Background: Sofosbuvir (SOF)-based regimens have been associated with renal function worsening in HCV patients with estimated glomerular filtration rate (eGFR) ≤ 45 ml/min, but further investigations are lacking. Aim: To assess renal safety in a large cohort of DAA-treated HCV patients with any chronic kidney disease (CKD). Methods: All HCV patients treated with DAA in Lombardy (December 2014–November 2017) with available kidney function tests during and off-treatment were included. Results: Among 3264 patients [65% males, 67% cirrhotics, eGFR 88 (9–264) ml/min], CKD stage was 3 in 9.5% and 4/5 in 0.7%. 79% and 73% patients received SOF and RBV, respectively. During DAA, eGFR declined in CKD-1 (p < 0.0001) and CKD-2 (p = 0.0002) patients, with corresponding rates of CKD stage reduction of 25% and 8%. Conversely, eGFR improved in lower CKD stages (p < 0.0001 in CKD-3a, p = 0.0007 in CKD-3b, p = 0.024 in CKD-4/5), with 33–45% rates of CKD improvement. Changes in eGFR and CKD distribution persisted at SVR. Baseline independent predictors of CKD worsening at EOT and SVR were age (p < 0.0001), higher baseline CKD stages (p < 0.0001) and AH (p = 0.010 and p < 0.0001, respectively). Conclusions: During DAA, eGFR significantly declined in patients with preserved renal function and improved in those with lower CKD stages, without reverting upon drug discontinuation.

Published
2020

12. Immature immunoglobulin gene rearrangements are recurrent in B precursor adult acute lymphoblastic leukemia carrying TP53 molecular alterations

Author

Salmoiraghi, S, Cavagna, R, Montalvo, M, Ubiali, G, Tosi, M, Peruta, B, Intermesoli, T, Oldani, E, Salvi, A, Pavoni, C, Giussani, U, Bassan, R, Rambaldi, A, Spinelli, O, Salmoiraghi S., Cavagna R., Montalvo M. L. G., Ubiali G., Tosi M., Peruta B., Intermesoli T., Oldani E., Salvi A., Pavoni C., Giussani U., Bassan R., Rambaldi A., Spinelli O., Salmoiraghi, S, Cavagna, R, Montalvo, M, Ubiali, G, Tosi, M, Peruta, B, Intermesoli, T, Oldani, E, Salvi, A, Pavoni, C, Giussani, U, Bassan, R, Rambaldi, A, Spinelli, O, Salmoiraghi S., Cavagna R., Montalvo M. L. G., Ubiali G., Tosi M., Peruta B., Intermesoli T., Oldani E., Salvi A., Pavoni C., Giussani U., Bassan R., Rambaldi A., and Spinelli O.

Abstract

Here, we describe the immunoglobulin and T cell receptor (Ig/TCR) molecular rearrangements identified as a leukemic clone hallmark for minimal residual disease assessment in relation to TP53 mutational status in 171 Ph-negative Acute Lymphoblastic Leukemia (ALL) adult patients at diagnosis. The presence of a TP53 alterations, which represents a marker of poor prognosis, was strictly correlated with an immature DH/JH rearrangement of the immunoglobulin receptor (p < 0.0001). Furthermore, TP53-mutated patients were classified as pro-B ALL more frequently than their wild-type counterpart (46% vs. 25%, p = 0.05). Although the reasons for the co-presence of immature Ig rearrangements and TP53 mutation need to be clarified, this can suggest that the alteration in TP53 is acquired at an early stage of B-cell maturation or even at the level of pre-leukemic transformation.

Published
2020

13. Correction: Standardisation and consensus guidelines for minimal residual disease assessment in Philadelphia-positive acute lymphoblastic leukemia (Ph+ALL) by real-time quantitative reverse transcriptase PCR of e1a2 BCR-ABL1 (Leukemia, (2019), 33, 8, (1910-1922), 10.1038/s41375-019-0413-0)

Author

Pfeifer H., Pfeifer, H, Cazzaniga, G, van der Velden, V, Cayuela, J, Schafer, B, Spinelli, O, Akiki, S, Avigad, S, Bendit, I, Borg, K, Cave, H, Elia, L, Reshmi, S, Gerrard, G, Hayette, S, Hermanson, M, Juh, A, Jurcek, T, Chillon, M, Homburg, C, Martinelli, G, Kairisto, V, Lange, T, Lion, T, Mueller, M, Pane, F, Rai, L, Damm-Welk, C, Sacha, T, Schnittger, S, Touloumenidou, T, Valerhaugen, H, Vandenberghe, P, Zuna, J, Serve, H, Herrmann, E, Markovic, S, van Dongen, J, Ottmann, O, Pfeifer H., Cazzaniga G., van der Velden V. H. J., Cayuela J. M., Schafer B., Spinelli O., Akiki S., Avigad S., Bendit I., Borg K., Cave H., Elia L., Reshmi S. C., Gerrard G., Hayette S., Hermanson M., Juh A., Jurcek T., Chillon M. C., Homburg C., Martinelli G., Kairisto V., Lange T., Lion T., Mueller M. C., Pane F., Rai L., Damm-Welk C., Sacha T., Schnittger S., Touloumenidou T., Valerhaugen H., Vandenberghe P., Zuna J., Serve H., Herrmann E., Markovic S., van Dongen J. J. M., Ottmann O. G., Pfeifer H., Pfeifer, H, Cazzaniga, G, van der Velden, V, Cayuela, J, Schafer, B, Spinelli, O, Akiki, S, Avigad, S, Bendit, I, Borg, K, Cave, H, Elia, L, Reshmi, S, Gerrard, G, Hayette, S, Hermanson, M, Juh, A, Jurcek, T, Chillon, M, Homburg, C, Martinelli, G, Kairisto, V, Lange, T, Lion, T, Mueller, M, Pane, F, Rai, L, Damm-Welk, C, Sacha, T, Schnittger, S, Touloumenidou, T, Valerhaugen, H, Vandenberghe, P, Zuna, J, Serve, H, Herrmann, E, Markovic, S, van Dongen, J, Ottmann, O, Pfeifer H., Cazzaniga G., van der Velden V. H. J., Cayuela J. M., Schafer B., Spinelli O., Akiki S., Avigad S., Bendit I., Borg K., Cave H., Elia L., Reshmi S. C., Gerrard G., Hayette S., Hermanson M., Juh A., Jurcek T., Chillon M. C., Homburg C., Martinelli G., Kairisto V., Lange T., Lion T., Mueller M. C., Pane F., Rai L., Damm-Welk C., Sacha T., Schnittger S., Touloumenidou T., Valerhaugen H., Vandenberghe P., Zuna J., Serve H., Herrmann E., Markovic S., van Dongen J. J. M., and Ottmann O. G.

Abstract

An amendment to this paper has been published and can be accessed via a link at the top of the paper.

Published
2020

14. Shc Overexpression Induces Selective Hypersensitivity to GM-CSF and Prevents Apoptosis of the GM-CSF-Dependent Acute Myelogenous Leukemia Cell Line GF-D8

Author

Dotti, G. P., Carlo-Stella, C., Spinelli, O., Savoldo, B., Garau, D., Regazzi, E., Rizzoli, V., Barbui, T., Pelicci, P. G., Lanfrancone, L., Rambaldi, A., Hiddemann, W., editor, Büchner, T., editor, Wörmann, B., editor, Ritter, J., editor, Creutzig, U., editor, Keating, M., editor, and Plunkett, W., editor

Published
1998
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16. High rates of sustained virological response despite premature discontinuation of directly acting antivirals in HCV-infected patients treated in a real-life setting

Author

Fabbiani M., Lombardi A., Colaneri M., Del Poggio P., Perini P., D'Ambrosio R., Degasperi E., Dibenedetto C., Giorgini A., Pasulo L., Maggiolo F., Castelli F., Brambilla P., Spinelli O., Re T., Lleo A., Rumi M., Uberti-Foppa C., Soria A., Aghemo A., Lampertico P., Baiguera C., Schiavini M., Fagiuoli S., Bruno R., Borghi M., Soffredini R., Perbellini R., Gori A., Ferroni V., Colpani M., Manini M., Cologni G., Lazzaroni S., Vinci M., De Nicola S., Mazzarelli C., Angelini Zucchetti T., Picciotto V., Puoti M., Rossotti R., Landonio S., Magni C. F., Rizzardini G., Colella E., Columpsi P., Gambaro A., Spolti A., Magnani C., Vigano P., Mena M., Villa M., Caramma I., Basilico C., Capelli F., Biagiotti S., Mazzone A., Saladino V., Baldacci M. P., Gatti F., Varalli L., Morini L., Menzaghi B., Farinazzo M., Meli R., Plaz Torres M. C., Fanetti I., Orellana D., Zermiani P., Zuin M., De Bona A., D'Arminio Monforte A., Capretti A., Taddei M. T., Soncini M., Spinetti A., Zaltron S., Pigozzi M. G., Rossini A., Pan A., Dal Zoppo S., Zoncada A., Memoli M., Salpietro S., Hamid H., Messina E., Colombo A. E., Giglio O., Bonfanti P., Molteni C., Terreni N., Spinzi G., Conforti S., Clerici E., Menozzi F., Buscarini E., Centenaro R., Corbellini A., Noventa F., Gritti S., Giani P., Fabbiani, Massimiliano, Lombardi, Andrea, Colaneri, Marta, Del Poggio, Paolo, Perini, Paolo, D'Ambrosio, Roberta, Degasperi, Elisabetta, Dibenedetto, Clara, Giorgini, Alessia, Pasulo, Luisa, Maggiolo, Franco, Castelli, Francesco, Brambilla, Paola, Spinelli, Ombretta, Tiziana, Re, Lleo, Ana, Rumi, Mariagrazia, Uberti-Foppa, Caterina, Soria, Alessandro, Aghemo, Alessio, Lampertico, Pietro, Baiguera, Chiara, Schiavini, Monica, Fagiuoli, Stefano, Bruno, Raffaele, Fabbiani, M, Lombardi, A, Colaneri, M, Del Poggio, P, Perini, P, D'Ambrosio, R, Degasperi, E, Dibenedetto, C, Giorgini, A, Pasulo, L, Maggiolo, F, Castelli, F, Brambilla, P, Spinelli, O, Re, T, Lleo, A, Rumi, M, Uberti-Foppa, C, Soria, A, Aghemo, A, Lampertico, P, Baiguera, C, Schiavini, M, Fagiuoli, S, Bruno, R, Borghi, M, Soffredini, R, Perbellini, R, Gori, A, Ferroni, V, Colpani, M, Manini, M, Cologni, G, Lazzaroni, S, Vinci, M, De Nicola, S, Mazzarelli, C, Angelini Zucchetti, T, Picciotto, V, Puoti, M, Rossotti, R, Landonio, S, Magni, C, Rizzardini, G, Colella, E, Columpsi, P, Gambaro, A, Spolti, A, Magnani, C, Vigano, P, Mena, M, Villa, M, Caramma, I, Basilico, C, Capelli, F, Biagiotti, S, Mazzone, A, Saladino, V, Baldacci, M, Gatti, F, Varalli, L, Morini, L, Menzaghi, B, Farinazzo, M, Meli, R, Plaz Torres, M, Fanetti, I, Orellana, D, Zermiani, P, Zuin, M, De Bona, A, D'Arminio Monforte, A, Capretti, A, Taddei, M, Soncini, M, Spinetti, A, Zaltron, S, Pigozzi, M, Rossini, A, Pan, A, Dal Zoppo, S, Zoncada, A, Memoli, M, Salpietro, S, Hamid, H, Messina, E, Colombo, A, Giglio, O, Bonfanti, P, Molteni, C, Terreni, N, Spinzi, G, Conforti, S, Clerici, E, Menozzi, F, Buscarini, E, Centenaro, R, Corbellini, A, Noventa, F, Gritti, S, and Giani, P

Subjects
Simeprevir, Male, medicine.medical_specialty, Cirrhosis, SVR, Sofosbuvir, Sustained Virologic Response, liver cirrhosis, antiviral treatment, Hepacivirus, Antiviral Agents, law.invention, Randomized controlled trial, law, Virology, Internal medicine, Medicine, Humans, chronic hepatitis C, Prospective cohort study, DAA, Retrospective Studies, Hepatology, liver cirrhosi, business.industry, Hepatitis C, Hepatitis C, Chronic, Middle Aged, medicine.disease, Discontinuation, Regimen, Infectious Diseases, Treatment Outcome, business, medicine.drug
Abstract

In routine clinical practice, hepatitis C virus-infected patients can prematurely discontinue the prescribed regimen for several reasons. The aim of our study was to investigate sustained virological response (SVR12) rates in patients who prematurely discontinued directly acting antiviral (DAA) regimens and to assess the shortest effective duration of DAA able to lead to SVR12. We retrospectively collected the SVR rates of patients, registered in the NAVIGATORE-Lombardia Network database from January 2015, who discontinued DAAs before the predefined end of treatment. Overall, we included 365 patients, males were the majority (213, 58.4%), mean age was 60.5years, and 53 (14.5%) patients were HIV-co-infected. Liver cirrhosis was observed in 251 (68.8%) subjects, and the most represented genotypes were 1b (n=168, 46%) and 3 (n=59, 16.2%). DAA was discontinued a median of 1 (IQR 1–4) weeks before the predefined EOT, with 164 (44.9%) patients stopping DAAs at least 2weeks before the planned schedule. In patients with F0–F3 liver fibrosis, lower rates of SVR12 were observed in patients treated for

Published
2021

18. Standardisation and consensus guidelines for minimal residual disease assessment in Philadelphia-positive acute lymphoblastic leukemia (Ph + ALL) by real-time quantitative reverse transcriptase PCR of e1a2 BCR-ABL1

Author

Pfeifer, H, Cazzaniga, G, van der Velden, V, Cayuela, J, Schäfer, B, Spinelli, O, Akiki, S, Avigad, S, Bendit, I, Borg, K, Cavé, H, Elia, L, Reshmi, S, Gerrard, G, Hayette, S, Hermanson, M, Juh, A, Jurcek, T, Chillón, M, Homburg, C, Martinelli, G, Kairisto, V, Lange, T, Lion, T, Mueller, M, Pane, F, Rai, L, Damm-Welk, C, Sacha, T, Schnittger, S, Touloumenidou, T, Valerhaugen, H, Vandenberghe, P, Zuna, J, Serve, H, Herrmann, E, Markovic, S, Dongen, J, Ottmann, O, Pfeifer, H., Cazzaniga, G., van der Velden, V. H. J., Cayuela, J. M., Schäfer, B., Spinelli, O., Akiki, S., Avigad, S., Bendit, I., Borg, K., Cavé, H., Elia, L., Reshmi, S. C., Gerrard, G., Hayette, S., Hermanson, M., Juh, A., Jurcek, T., Chillón, M. C., Homburg, C., Martinelli, G., Kairisto, V., Lange, T., Lion, T., Mueller, M. C., Pane, F., Rai, L., Damm-Welk, C., Sacha, T., Schnittger, S., Touloumenidou, T., Valerhaugen, H., Vandenberghe, P., Zuna, J., Serve, H., Herrmann, E., Markovic, S., Dongen, J. J. M. van, Ottmann, O. G., Pfeifer, H, Cazzaniga, G, van der Velden, V, Cayuela, J, Schäfer, B, Spinelli, O, Akiki, S, Avigad, S, Bendit, I, Borg, K, Cavé, H, Elia, L, Reshmi, S, Gerrard, G, Hayette, S, Hermanson, M, Juh, A, Jurcek, T, Chillón, M, Homburg, C, Martinelli, G, Kairisto, V, Lange, T, Lion, T, Mueller, M, Pane, F, Rai, L, Damm-Welk, C, Sacha, T, Schnittger, S, Touloumenidou, T, Valerhaugen, H, Vandenberghe, P, Zuna, J, Serve, H, Herrmann, E, Markovic, S, Dongen, J, Ottmann, O, Pfeifer, H., Cazzaniga, G., van der Velden, V. H. J., Cayuela, J. M., Schäfer, B., Spinelli, O., Akiki, S., Avigad, S., Bendit, I., Borg, K., Cavé, H., Elia, L., Reshmi, S. C., Gerrard, G., Hayette, S., Hermanson, M., Juh, A., Jurcek, T., Chillón, M. C., Homburg, C., Martinelli, G., Kairisto, V., Lange, T., Lion, T., Mueller, M. C., Pane, F., Rai, L., Damm-Welk, C., Sacha, T., Schnittger, S., Touloumenidou, T., Valerhaugen, H., Vandenberghe, P., Zuna, J., Serve, H., Herrmann, E., Markovic, S., Dongen, J. J. M. van, and Ottmann, O. G.

Abstract

Minimal residual disease (MRD) is a powerful prognostic factor in acute lymphoblastic leukemia (ALL) and is used for patient stratification and treatment decisions, but its precise role in Philadelphia chromosome positive ALL is less clear. This uncertainty results largely from methodological differences relating to the use of real-time quantitative PCR (qRT-PCR) to measure BCR-ABL1 transcript levels for MRD analysis. We here describe the first results by the EURO-MRD consortium on standardization of qRT-PCR for the e1a2 BCR-ABL1 transcript in Ph + ALL, designed to overcome the lack of standardisation of laboratory procedures and data interpretation. Standardised use of EAC primer/probe sets and of centrally prepared plasmid standards had the greatest impact on reducing interlaboratory variability. In QC1 the proportion of analyses with BCR-ABL1/ABL1 ratios within half a log difference were 40/67 (60%) and 52/67 (78%) at 10 −3 and 36/67 (53%) and 53/67 (79%) at 10 −4 BCR-ABL1/ABL1. Standardized RNA extraction, cDNA synthesis and cycler platforms did not improve results further, whereas stringent application of technical criteria for assay quality and uniform criteria for data interpretation and reporting were essential. We provide detailed laboratory recommendations for the standardized MRD analysis in routine diagnostic settings and in multicenter clinical trials for Ph + ALL.

Published
2019

19. Clinical significance of chromatin-spliceosome acute myeloid leukemia: a report from the Northern Italy Leukemia Group (NILG) randomized trial 02/06

Author

Caprioli, C, Lussana, F, Salmoiraghi, S, Cavagna, R, Buklijas, K, Elidi, L, Zanghi', P, Michelato, A, Delaini, F, Oldani, E, Intermesoli, T, Grassi, A, Gianfaldoni, G, Mannelli, F, Ferrero, D, Audisio, E, Terruzzi, E, De Paoli, L, Cattaneo, C, Borlenghi, E, Cavattoni, I, Tajana, M, Scattolin, A, Mattei, D, Corradini, P, Campiotti, L, Ciceri, F, Bernardi, M, Todisco, E, Cortelezzi, A, Falini, B, Pavoni, C, Bassan, R, Spinelli, O, Rambaldi, A, Caprioli, Chiara, Lussana, Federico, Salmoiraghi, Silvia, Cavagna, Roberta, Buklijas, Ksenija, Elidi, Lara, Zanghi', Pamela, Michelato, Anna, Delaini, Federica, Oldani, Elena, Intermesoli, Tamara, Grassi, Anna, Gianfaldoni, Giacomo, Mannelli, Francesco, Ferrero, Dario, Audisio, Ernesta, Terruzzi, Elisabetta, De Paoli, Lorella, Cattaneo, Chiara, Borlenghi, Erika, Cavattoni, Irene, Tajana, Monica, Scattolin, Anna Maria, Mattei, Daniele, Corradini, Paolo, Campiotti, Leonardo, Ciceri, Fabio, Bernardi, Massimo, Todisco, Elisabetta, Cortelezzi, Agostino, Falini, Brunangelo, Pavoni, Chiara, Bassan, Renato, Spinelli, Orietta, Rambaldi, Alessandro, Caprioli, C, Lussana, F, Salmoiraghi, S, Cavagna, R, Buklijas, K, Elidi, L, Zanghi', P, Michelato, A, Delaini, F, Oldani, E, Intermesoli, T, Grassi, A, Gianfaldoni, G, Mannelli, F, Ferrero, D, Audisio, E, Terruzzi, E, De Paoli, L, Cattaneo, C, Borlenghi, E, Cavattoni, I, Tajana, M, Scattolin, A, Mattei, D, Corradini, P, Campiotti, L, Ciceri, F, Bernardi, M, Todisco, E, Cortelezzi, A, Falini, B, Pavoni, C, Bassan, R, Spinelli, O, Rambaldi, A, Caprioli, Chiara, Lussana, Federico, Salmoiraghi, Silvia, Cavagna, Roberta, Buklijas, Ksenija, Elidi, Lara, Zanghi', Pamela, Michelato, Anna, Delaini, Federica, Oldani, Elena, Intermesoli, Tamara, Grassi, Anna, Gianfaldoni, Giacomo, Mannelli, Francesco, Ferrero, Dario, Audisio, Ernesta, Terruzzi, Elisabetta, De Paoli, Lorella, Cattaneo, Chiara, Borlenghi, Erika, Cavattoni, Irene, Tajana, Monica, Scattolin, Anna Maria, Mattei, Daniele, Corradini, Paolo, Campiotti, Leonardo, Ciceri, Fabio, Bernardi, Massimo, Todisco, Elisabetta, Cortelezzi, Agostino, Falini, Brunangelo, Pavoni, Chiara, Bassan, Renato, Spinelli, Orietta, and Rambaldi, Alessandro

Abstract

Secondary acute myeloid leukemia (sAML) after myelodysplastic or myeloproliferative disorders is a high-risk category currently identified by clinical history or specific morphological and cytogenetic abnormalities. However, in the absence of these features, uncertainties remain to identify the secondary nature of some cases otherwise defined as de novo AML. To test whether a chromatin-spliceosome (CS) mutational signature might better inform the definition of the de novo AML group, we analyzed a prospective cohort of 413 newly diagnosed AML patients enrolled into a randomized clinical trial (NILG AML 02/06) and provided with accurate cytogenetic and molecular characterization. Among clinically defined de novo AML, 17.6% carried CS mutations (CS-AML) and showed clinical characteristics closer to sAML (older age, lower white blood cell counts and higher rate of multilineage dysplasia). Outcomes in this group were adverse, more similar to those of sAML as compared to de novo AML (overall survival, 30% in CS-AML and 17% in sAML vs 61% in de novo AML, P<0.0001; disease free survival, 26% in CS-AML and 22% in sAML vs 54% of de novo AML, P<0.001) and independently confirmed by multivariable analysis. Allogeneic transplant in first complete remission improved survival in both sAML and CS-AML patients. In conclusion, these findings highlight the clinical significance of identifying CS-AML for improved prognostic prediction and potential therapeutic implications. (NILG AML 02/06: ClinicalTrials.gov Identifier: NCT00495287).

Published
2021

20. Standardized MRD quantification in European ALL trials: Proceedings of the Second International Symposium on MRD assessment in Kiel, Germany, 18–20 September 2008

Author

Brüggemann, M, Schrauder, A, Raff, T, Pfeifer, H, Dworzak, M, Ottmann, O G, Asnafi, V, Baruchel, A, Bassan, R, Benoit, Y, Biondi, A, Cavé, H, Dombret, H, Fielding, A K, Foà, R, Gökbuget, N, Goldstone, A H, Goulden, N, Henze, G, Hoelzer, D, Janka-Schaub, G E, Macintyre, E A, Pieters, R, Rambaldi, A, Ribera, J-M, Schmiegelow, K, Spinelli, O, Stary, J, von Stackelberg, A, Kneba, M, Schrappe, M, and van Dongen, J J M

Published
2010
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25. GDNA qPCR is statistically more reliable than mRNA analysis in detecting leukemic cells to monitor CML

Author

Rainero, A, Angaroni, F, Conti, A, Pirrone, C, Micheloni, G, Tarara, L, Millefanti, G, Maserati, E, Valli, R, Spinelli, O, Buklijas, K, Michelato, A, Casalone, R, Barlassina, C, Barcella, M, Sirchia, S, Piscitelli, E, Caccia, M, Porta, G, Rainero A., Angaroni F., Conti A., Pirrone C., Micheloni G., Tarara L., Millefanti G., Maserati E., Valli R., Spinelli O., Buklijas K., Michelato A., Casalone R., Barlassina C., Barcella M., Sirchia S., Piscitelli E., Caccia M., Porta G., Rainero, A, Angaroni, F, Conti, A, Pirrone, C, Micheloni, G, Tarara, L, Millefanti, G, Maserati, E, Valli, R, Spinelli, O, Buklijas, K, Michelato, A, Casalone, R, Barlassina, C, Barcella, M, Sirchia, S, Piscitelli, E, Caccia, M, Porta, G, Rainero A., Angaroni F., Conti A., Pirrone C., Micheloni G., Tarara L., Millefanti G., Maserati E., Valli R., Spinelli O., Buklijas K., Michelato A., Casalone R., Barlassina C., Barcella M., Sirchia S., Piscitelli E., Caccia M., and Porta G.

Abstract

Chronic Myeloid Leukemia (CML) is a stem cell cancer that arises when t(9;22) translocation occurs in a hematopoietic stem cells. This event results in the expression of the BCR-ABL1 fusion gene, which codes for a constitutively active tyrosine kinase that is responsible for the transformation of a HSC into a CML stem cell, which then gives rise to a clonal myeloproliferative disease. The introduction of Tyrosine Kinase Inhibitors (TKIs) has revolutionized the management of the disease. However, these drugs do not seem to be able to eradicate the malignancy. Indeed, discontinuation trials (STIM; TWISER; DADI) for those patients who achieved a profound molecular response showed 50% relapsing within 12 months. We performed a comparative analysis on 15 CML patients and one B-ALL patient, between the standard quantitative reverse-transcriptase PCR (qRT-PCR) and our genomic DNA patient-specific quantitative PCR assay (gDNA qPCR). Here we demonstrate that gDNA qPCR is better than standard qRT-PCR in disease monitoring after an average follow-up period of 200 days. Specifically, we statistically demonstrated that DNA negativity is more reliable than RNA negativity in indicating when TKIs therapy can be safely stopped.

Published
2018

26. Characterization of a reference material for BCR-ABL (M-BCR) mRNA quantitation by real-time amplification assays: towards new standards for gene expression measurements

Author

Saldanha, J, Silvy, M, Beaufils, N, Arlinghaus, R, Barbany, G, Branford, S, Cayuela, J-M, Cazzaniga, G, Gonzalez, M, Grimwade, D, Kairisto, V, Miyamura, K, Lawler, M, Lion, T, Macintyre, E, Mahon, F-X, Muller, M C, Ostergaard, M, Pfeifer, H, Saglio, G, Sawyers, C, Spinelli, O, van der Velden, V H J, Wang, J Q, Zoi, K, Patel, V, Phillips, P, Matejtschuk, P, and Gabert, J

Published
2007
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27. Standardisation and consensus guidelines for minimal residual disease assessment in Philadelphia-positive acute lymphoblastic leukemia (Ph+ALL) by real-time quantitative reverse transcriptase PCR of e1a2 BCR-ABL1 (vol 32, pg 345, 2019)

Author

Pfeifer, H., Cazzaniga, G., Velden, V.H.J. van der, Cayuela, J.M., Schafer, B., Spinelli, O., Akiki, S., Avigad, S., Bendit, I., Borg, K., Cave, H., Elia, L., Reshmi, S.C., Gerrard, G., Hayette, S., Hermanson, M., Juh, A., Jurcek, T., Chillon, M.C., Homburg, C., Martinelli, G., Kairisto, V., Lange, T., Lion, T., Mueller, M.C., Pane, F., Rai, L., Damm-Welk, C., Sacha, T., Schnittger, S., Touloumenidou, T., Valerhaugen, H., Vandenberghe, P., Zuna, J., Serve, H., Herrmann, E., Markovic, S., Dongen, J.J.M. van, and Ottmann, O.G.

Abstract

An amendment to this paper has been published and can be accessed via a link at the top of the paper.

Published
2020

28. High throughput molecular characterization of normal karyotype acute myeloid leukemia in the context of the prospective trial 02/06 of the northern italy leukemia group (NILG)

Author

Salmoiraghi, S, Cavagna, R, Zanghì, P, Pavoni, C, Michelato, A, Buklijas, K, Elidi, L, Intermesoli, T, Lussana, F, Oldani, E, Caprioli, C, Stefanoni, P, Gianfaldoni, G, Audisio, E, Terruzzi, E, De Paoli, L, Borlenghi, E, Cavattoni, I, Mattei, D, Scattolin, A, Tajana, M, Ciceri, F, Todisco, E, Campiotti, L, Corradini, P, Fracchiolla, N, Bassan, R, Rambaldi, A, Spinelli, O, Salmoiraghi, Silvia, Cavagna, Roberta, Zanghì, Pamela, Pavoni, Chiara, Michelato, Anna, Buklijas, Ksenija, Elidi, Lara, Intermesoli, Tamara, Lussana, Federico, Oldani, Elena, Caprioli, Chiara, Stefanoni, Paola, Gianfaldoni, Giacomo, Audisio, Ernesta, Terruzzi, Elisabetta, De Paoli, Lorella, Borlenghi, Erika, Cavattoni, Irene, Mattei, Daniele, Scattolin, Annamaria, Tajana, Monica, Ciceri, Fabio, Todisco, Elisabetta, Campiotti, Leonardo, Corradini, Paolo, Fracchiolla, Nicola, Bassan, Renato, Rambaldi, Alessandro, Spinelli, Orietta, Salmoiraghi, S, Cavagna, R, Zanghì, P, Pavoni, C, Michelato, A, Buklijas, K, Elidi, L, Intermesoli, T, Lussana, F, Oldani, E, Caprioli, C, Stefanoni, P, Gianfaldoni, G, Audisio, E, Terruzzi, E, De Paoli, L, Borlenghi, E, Cavattoni, I, Mattei, D, Scattolin, A, Tajana, M, Ciceri, F, Todisco, E, Campiotti, L, Corradini, P, Fracchiolla, N, Bassan, R, Rambaldi, A, Spinelli, O, Salmoiraghi, Silvia, Cavagna, Roberta, Zanghì, Pamela, Pavoni, Chiara, Michelato, Anna, Buklijas, Ksenija, Elidi, Lara, Intermesoli, Tamara, Lussana, Federico, Oldani, Elena, Caprioli, Chiara, Stefanoni, Paola, Gianfaldoni, Giacomo, Audisio, Ernesta, Terruzzi, Elisabetta, De Paoli, Lorella, Borlenghi, Erika, Cavattoni, Irene, Mattei, Daniele, Scattolin, Annamaria, Tajana, Monica, Ciceri, Fabio, Todisco, Elisabetta, Campiotti, Leonardo, Corradini, Paolo, Fracchiolla, Nicola, Bassan, Renato, Rambaldi, Alessandro, and Spinelli, Orietta

Abstract

By way of a Next-Generation Sequencing NGS high throughput approach, we defined the mutational profile in a cohort of 221 normal karyotype acute myeloid leukemia (NK-AML) enrolled into a prospective randomized clinical trial, designed to evaluate an intensified chemotherapy program for remission induction. NPM1, DNMT3A, and FLT3-ITD were the most frequently mutated genes while DNMT3A, FLT3, IDH1, PTPN11, and RAD21 mutations were more common in the NPM1 mutated patients (p < 0.05). IDH1 R132H mutation was strictly associated with NPM1 mutation and mutually exclusive with RUNX1 and ASXL1. In the whole cohort of NK-AML, no matter the induction chemotherapy used, by multivariate analysis, the achievement of complete remission was negatively affected by the SRSF2 mutation. Alterations of FLT3 (FLT3-ITD) and U2AF1 were associated with a worse overall and disease-free survival (p < 0.05). FLT3-ITD positive patients who proceeded to alloHSCT had a survival probability similar to FLT3-ITD negative patients and the transplant outcome was no different when comparing high and low-AR-FLT3-ITD subgroups in terms of both OS and DFS. In conclusion, a comprehensive molecular profile for NK-AML allows for the identification of genetic lesions associated to different clinical outcomes and the selection of the most appropriate and effective treatment strategies, including stem cell transplantation and targeted therapies.

Published
2020

33. Impact of HBV infection in HCV/HBV coinfected patients treated with DAAs IN Northern Italy

Author

Fabris, P., primary, Noventa, F., additional, Pasulo, L., additional, Farina, F., additional, Carollo, G., additional, Carlotto, A., additional, Rovere, P., additional, Cavinato, S., additional, Romano, A., additional, Vario, A., additional, Fraceschet, I., additional, Panese, S., additional, Bertin, T., additional, Zappalà, F., additional, Alberti, A., additional, Lobello, S., additional, Aghemo, A., additional, Bruno, R., additional, Puoti, M., additional, Rizzardini, G., additional, Spinelli, O., additional, Pigozzi, MG., additional, Spinetti, A., additional, Menzaghi, B., additional, Pan, A., additional, Bella, D., additional, Re, T., additional, Borghi, M., additional, Lombardi, A., additional, Viganò, M., additional, Salpietro, S., additional, Lleo, A., additional, and Fagiuoli, S., additional

Published
2020
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34. PROGNOSTIC VALUE OF CLONAL HEMATOPOIESIS-MUTATIONS DETECTED AT DIAGNOSIS IN ACUTE MYELOID LEUKEMIA PATIENTS WITH NORMAL KARYOTYPE

Author

Caprioli, C, Spinelli, O, Salmoiraghi, S, Intermesoli, T, Zanghi, P, Cavagna, R, Michelato, A, Buklijas, K, Elidi, L, Delaini, F, Oldani, E, Gianfaldoni, G, Bosi, A, Marmont, F, Audisio, E, Ferrero, D, Terruzzi, E, De Paoli, L, Rossi, G, Borlenghi, E, Cavattoni, I, Tajana, M, Scattolin, Am, Mattei, D, Corradini, P, Campiotti, L, Ciceri, F, Bernardi, M, Todisco, E, Cortelezzi, A, Cortelazzo, S, Falini, B, Pavoni, C, Bassan, R, Rambaldi, A, and Lussana, F

Published
2019

36. Standardisation and consensus guidelines for minimal residual disease assessment in Philadelphia-positive acute lymphoblastic leukemia (Ph plus ALL) by real-time quantitative reverse transcriptase PCR of e1a2 BCR-ABL1

Author

Pfeifer, H., Cazzaniga, G., van der Velden, V. H. J., Cayuele, J. M., Schafer, B., Spinelli, O., Akiki, S., Avigad, S., Bendit, I, Borg, K., Cave, H., Elia, L., Reshmi, S. C., Gerrard, G., Hayette, S., Hermansson, Monica, Juh, A., Jurcek, T., Chillon, M. C., Homburg, C., Martinelli, G., Kairisto, V, Langen, T., Lion, T., Mueller, M. C., Pane, F., Rai, L., Damm-Welk, C., Sacha, T., Schnittger, S., Touloumenidou, T., Valerhaugen, H., Vandenberghe, P., Zuna, J., Server, H., Herrmann, E., Markovic, S., van Dongen, J. J. M., Ottmann, O. G., Pfeifer, H., Cazzaniga, G., van der Velden, V. H. J., Cayuele, J. M., Schafer, B., Spinelli, O., Akiki, S., Avigad, S., Bendit, I, Borg, K., Cave, H., Elia, L., Reshmi, S. C., Gerrard, G., Hayette, S., Hermansson, Monica, Juh, A., Jurcek, T., Chillon, M. C., Homburg, C., Martinelli, G., Kairisto, V, Langen, T., Lion, T., Mueller, M. C., Pane, F., Rai, L., Damm-Welk, C., Sacha, T., Schnittger, S., Touloumenidou, T., Valerhaugen, H., Vandenberghe, P., Zuna, J., Server, H., Herrmann, E., Markovic, S., van Dongen, J. J. M., and Ottmann, O. G.

Abstract

Minimal residual disease (MRD) is a powerful prognostic factor in acute lymphoblastic leukemia (ALL) and is used for patient stratification and treatment decisions, but its precise role in Philadelphia chromosome positive ALL is less clear. This uncertainty results largely from methodological differences relating to the use of real-time quantitative PCR (qRT-PCR) to measure BCR-ABL1 transcript levels for MRD analysis. We here describe the first results by the EURO-MRD consortium on standardization of qRT-PCR for the e1a2 BCR-ABL1 transcript in Ph + ALL, designed to overcome the lack of standardisation of laboratory procedures and data interpretation. Standardised use of EAC primer/probe sets and of centrally prepared plasmid standards had the greatest impact on reducing interlaboratory variability. In QC1 the proportion of analyses with BCR-ABL1/ABL1 ratios within half a log difference were 40/67 (60%) and 52/67 (78%) at 10(-3) and 36/67 (53%) and 53/67 (79%) at 10(-4)BCR-ABL1/ABL1. Standardized RNA extraction, cDNA synthesis and cycler platforms did not improve results further, whereas stringent application of technical criteria for assay quality and uniform criteria for data interpretation and reporting were essential. We provide detailed laboratory recommendations for the standardized MRD analysis in routine diagnostic settings and in multicenter clinical trials for Ph + ALL.

Published
2019
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37. Real-world effectiveness and safety of glecaprevir/pibrentasvir in 723 patients with chronic hepatitis C

Author

D'Ambrosio, R, Pasulo, L, Puoti, M, Vinci, M, Schiavini, M, Lazzaroni, S, Soria, A, Gatti, F, Menzaghi, B, Aghemo, A, Capelli, F, Rumi, M, Morini, L, Giorgini, A, Pigozzi, M, Rossini, A, Maggiolo, F, Pan, A, Memoli, M, Spinelli, O, Del Poggio, P, Saladino, V, Spinetti, A, De Bona, A, Capretti, A, Uberti-Foppa, C, Bonfanti, P, Terreni, N, Menozzi, F, Colombo, A, Giglio, O, Centenaro, R, Borghi, M, Baiguera, C, Picciotto, V, Landonio, S, Gori, A, Magnani, C, Noventa, F, Paolucci, S, Lampertico, P, Fagiuoli, S, D'Ambrosio, Roberta, Pasulo, Luisa, Puoti, Massimo, Vinci, Maria, Schiavini, Monica, Lazzaroni, Sergio, Soria, Alessandro, Gatti, Federico, Menzaghi, Barbara, Aghemo, Alessio, Capelli, Francesca, Rumi, Maria Grazia, Morini, Lorenzo, Giorgini, Alessia, Pigozzi, Marie Graciella, Rossini, Angelo, Maggiolo, Franco, Pan, Angelo, Memoli, Massimo, Spinelli, Ombretta, Del Poggio, Paolo, Saladino, Valeria, Spinetti, Angiola, De Bona, Anna, Capretti, Andrea, Uberti-Foppa, Caterina, Bonfanti, Paolo, Terreni, Natalia, Menozzi, Fernanda, Colombo, Alberto Eraldo, Giglio, Omar, Centenaro, Riccardo, Borghi, Marta, Baiguera, Chiara, Picciotto, Viviana, Landonio, Simona, Gori, Andrea, Magnani, Carlo, Noventa, Franco, Paolucci, Stefania, Lampertico, Pietro, Fagiuoli, Stefano, D'Ambrosio, R, Pasulo, L, Puoti, M, Vinci, M, Schiavini, M, Lazzaroni, S, Soria, A, Gatti, F, Menzaghi, B, Aghemo, A, Capelli, F, Rumi, M, Morini, L, Giorgini, A, Pigozzi, M, Rossini, A, Maggiolo, F, Pan, A, Memoli, M, Spinelli, O, Del Poggio, P, Saladino, V, Spinetti, A, De Bona, A, Capretti, A, Uberti-Foppa, C, Bonfanti, P, Terreni, N, Menozzi, F, Colombo, A, Giglio, O, Centenaro, R, Borghi, M, Baiguera, C, Picciotto, V, Landonio, S, Gori, A, Magnani, C, Noventa, F, Paolucci, S, Lampertico, P, Fagiuoli, S, D'Ambrosio, Roberta, Pasulo, Luisa, Puoti, Massimo, Vinci, Maria, Schiavini, Monica, Lazzaroni, Sergio, Soria, Alessandro, Gatti, Federico, Menzaghi, Barbara, Aghemo, Alessio, Capelli, Francesca, Rumi, Maria Grazia, Morini, Lorenzo, Giorgini, Alessia, Pigozzi, Marie Graciella, Rossini, Angelo, Maggiolo, Franco, Pan, Angelo, Memoli, Massimo, Spinelli, Ombretta, Del Poggio, Paolo, Saladino, Valeria, Spinetti, Angiola, De Bona, Anna, Capretti, Andrea, Uberti-Foppa, Caterina, Bonfanti, Paolo, Terreni, Natalia, Menozzi, Fernanda, Colombo, Alberto Eraldo, Giglio, Omar, Centenaro, Riccardo, Borghi, Marta, Baiguera, Chiara, Picciotto, Viviana, Landonio, Simona, Gori, Andrea, Magnani, Carlo, Noventa, Franco, Paolucci, Stefania, Lampertico, Pietro, and Fagiuoli, Stefano

Abstract

Background and Aims: The efficacy and safety of glecaprevir/pibrentasvir (G/P) for patients infected with hepatitis C virus (HCV) have only been investigated in clinical trials, with no real-world data currently available. The aim of our study was to investigate the effectiveness and safety of G/P in a real-world setting.Methods: All patients with HCV consecutively starting G/P between October 2017 and January 2018 within the NAVIGATORE-Lombardia Network were analyzed. G/P was administered according to drug label (8, 12 or 16 weeks). Fibrosis was staged either histologically or by liver stiffness measurement. Sustained virological response (SVR) was defined as undetectable HCV-RNA 12 weeks after the end of treatment.Results: A total of 723 patients (50% males) were treated with G/P, 89% for 8 weeks. The median age of our cohort was median liver stiffness measurement of 6.1 kPa; 84% were F0-2 and 16% were interferon-experienced. Median HCV-RNA was 1,102,600 IU/ml, and 49% of patients had HCV genotype 1 (32% 1b), 28% genotype 2, 10% genotype 3 and 13% genotype 4. The median estimated glomerular filtration rate was 90.2 ml/min, platelet count 209x10(3)/mm(3) and albumin 4.3 g/dl. The SVR rates were 94% in intention-to-treat and 99.3% in per protocol analysis (8-week vs. 12 or 16-week: 99.2% vs. 100%). Five patients failed therapy because of post-treatment relapse; a post-treatment NS5A resistance-associated substitution was detected in 1 case. SVR rates were lower in males (p = 0.002) and in HCV genotype-3 (p = 0.046) patients treated for 8 weeks, but independent of treatment duration, fibrosis stage, baseline HCV-RNA, HIV co-infection, chronic kidney disease stage and viral kinetics. Mild adverse events were reported in 8.3% of the patients, and 0.7% of them prematurely withdrew treatment. Three patients died of drug-unrelated causes.Conclusions: In a large real-world cohort of Italian patients, we confirmed the excellent effectiveness and safety of G/P administered f

Published
2019

39. MOLECULAR PROLIFE BY NEXT GENERATION SEQUENCING OF ACUTE MYELOID LEUKEMIA WITH NORMAL KARYOTYPE: CLINICAL RESULTS FROM THE PROSPECTIVE TRIAL 02/06 OF THE NORTHERN ITALY LEUKEMIA GROUP (NILG)

Author

Spinelli, O, Salmoiraghi, S, Zanghi, P, Cavagna, R, Michelato, A, Buklijas, K, Zannino, L, Intermesoli, T, Lussana, F, Delaini, F, Oldani, E, Caprioli, C, Stefanoni, P, Gianfaldoni, G, Marmont, F, Ferrero, D, Terruzzi, E, De Paoli, L, Rossi, G, Borlenghi, E, Cavattoni, I, Tajana, M, Scattolin, Am, Mattei, D, Corradini, P, Campiotti, L, Ciceri, F, Bernardi, M, Todisco, E, Cortelezzi, A, Cortelazzo, S, Audisio, E, Bosi, A, Falini, B, Pavoni, C, Bassan, R, and Rambaldi, A

Published
2018

40. PF227 PROGNOSTIC VALUE OF CLONAL HEMATOPOIESIS-MUTATIONS DETECTED AT DIAGNOSIS IN ACUTE MYELOID LEUKEMIA PATIENTS WITH NORMAL KARYOTYPE

Author

Caprioli, C., primary, Spinelli, O., additional, Salmoiraghi, S., additional, Intermesoli, T., additional, Zanghì, P., additional, Cavagna, R., additional, Michelato, A., additional, Buklijas, K., additional, Elidi, L., additional, Delaini, F., additional, Oldani, E., additional, Gianfaldoni, G., additional, Bosi, A., additional, Marmont, F., additional, Audisio, E., additional, Ferrero, D., additional, Terruzzi, E., additional, De Paoli, L., additional, Rossi, G., additional, Borlenghi, E., additional, Cavattoni, I., additional, Tajana, M., additional, Scattolin, A.M., additional, Mattei, D., additional, Corradini, P., additional, Campiotti, L., additional, Ciceri, F., additional, Bernardi, M., additional, Todisco, E., additional, Cortelezzi, A., additional, Cortelazzo, S., additional, Falini, B., additional, Pavoni, C., additional, Bassan, R., additional, Rambaldi, A., additional, and Lussana, F., additional

Published
2019
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41. PF175 MULTICENTRE STANDARDIZATION OF MINIMAL RESIDUAL DISEASE DETECTION AND QUANTITATION USING THE EUROCLONALITY-NGS ASSAY

Author

Svaton, M., primary, Fronkova, E., additional, Kotrova, M., additional, Reigl, T., additional, Caye, A., additional, de Bie, M., additional, Genuardi, E., additional, Jelinkova, H., additional, Lim, E.H., additional, Nishijima, D., additional, Pal, K., additional, Salemi, D., additional, Sarasquete, M.E., additional, Songia, S., additional, Tosi, M., additional, Villarese, P., additional, Wakeman, S., additional, Cave, H., additional, Cazzaniga, G., additional, Ferrero, S., additional, Garcia Sanz, R., additional, Hancock, J., additional, Macintyre, E., additional, Plevova, K., additional, Sanada, M., additional, Santoro, A., additional, Spinelli, O., additional, van der Velden, V.H., additional, Yeoh, A.E. J., additional, Langerak, A.W., additional, Darzentas, N., additional, Brüggemann, M., additional, and Trka, J., additional

Published
2019
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42. Treatment of 320 genotype 3 cirrhotic patients with 12 weeks Sofosbuvir/Velpatasvir with or without ribavirin: real life experience from Italy

Author

Pasulo, L., primary, Gambato, M., additional, Spinetti, A., additional, D’Ambrosio, R., additional, Puoti, M., additional, Ciancio, A., additional, Di Marco, V., additional, Calvaruso, V., additional, Colombatto, P., additional, Brunetto, M., additional, Schiavini, M., additional, Fabris, P., additional, Sacchi, P., additional, Gulminetti, R., additional, Carolo, G., additional, Scotton, P., additional, Pozzan, C., additional, Vinci, M., additional, Viganò, M., additional, Lombardi, A., additional, Bello, S. Lo, additional, Zuin, M., additional, Aghemo, A., additional, Rumi, M.G., additional, Carrara, M., additional, Manfrin, V., additional, Uberti-Foppa, C., additional, Panese, S., additional, Paon, V., additional, Pan, A., additional, Spinelli, O., additional, D’Arminio Monforte, A., additional, Colli, A., additional, Spinzi, G., additional, Russo, F.P., additional, Chemello, L., additional, Vincenzi, V., additional, Grossi, P., additional, Buscarini, E., additional, Cardaci, G., additional, Soria, A., additional, Menzaghi, B., additional, Mendeni, M., additional, Soffredini, R., additional, Colpani, M., additional, Zaltron, S., additional, Gori, A., additional, Del Poggio, P., additional, Giorgini, A., additional, Cologni, G., additional, Cartabellotta, F., additional, Di Lorenzo, F., additional, Cacciola, I., additional, Albanese, A., additional, Di Rosolini, M.A., additional, Digiacomo, A., additional, Capretti, A., additional, Memoli, M., additional, Rossi, C., additional, Cavalletto, L., additional, Capra, F., additional, Colombo, A.E., additional, Dibenedetto, C., additional, Magni, C.F., additional, Noventa, F., additional, Lampertico, P., additional, Castelli, F., additional, Alberti, A., additional, and Fagiuoli, S., additional

Published
2019
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43. Efficacy and safety of Elbasvir/Grazoprevir in a large real-life cohort of HCV-infected patients

Author

Gambato, M., primary, Spinetti, A., additional, Pasulo, L., additional, D’ambrosio, R., additional, Puoti, M., additional, Schiavini, M., additional, Fabris, P., additional, Sacchi, P., additional, Gulminetti, R., additional, Carolo, G., additional, Scotton, P., additional, Franceschet, I., additional, Vinci, M., additional, Viganò, M., additional, Lobello, S., additional, Zuin, M.G., additional, Aghemo, A., additional, Rumi, M., additional, Carrara, M., additional, Manfrin, V., additional, Uberti-Foppa, C., additional, Panese, S., additional, Cattelan, F., additional, Paon, V., additional, Pan, A., additional, Spinelli, O., additional, Monforte, A. D’arminio, additional, Colli, A., additional, Spinzi, G., additional, Russo, F.P., additional, Chemello, L., additional, Vincenzi, V., additional, Grossi, P.A., additional, Buscarini, E., additional, Cardaci, G., additional, Soria, A., additional, Menzaghi, B., additional, Mendeni, M., additional, Degasperi, E., additional, Soffredini, R., additional, Colpani, M., additional, Comi, L., additional, Zuccaro, V., additional, Zaltron, S., additional, Gori, A., additional, Del Poggio, P., additional, Giorgini, A., additional, Capretti, A., additional, Memoli, M., additional, Pigozzi, M.G., additional, Rossi, M.C., additional, Cavalletto, L., additional, Capra, F., additional, Colombo, A., additional, Dibenedetto, C., additional, Landonio, S., additional, Noventa, F., additional, Lampertico, P., additional, Castelli, F., additional, Alberti, A., additional, and Fagiuoli, S., additional

Published
2019
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46. NEXT GENERATION SEQUENCING (NGS) CONFIRMED THE ADVERSE CLINICAL IMPACT OF RUNX1 MUTATIONS IN A SUBSET OF ACUTE MYELOID LEUKEMIA NORMAL KARYOTYPE PATIENTS NEGATIVE FOR RISK DEFINING GENES MUTATIONS AND HOMOGENOUSLY TREATED WITHIN A CLINICAL TRIAL (NILG AML 02/06)

Author

Salmoiraghi, S, Zanghi, P, Pavoni, C, Montalvo, Mlg, Ubiali, G, Intermesoli, T, Oldani, E, Marmont, F, Cavattoni, I, Mattei, D, Terruzzi, E, De Paoli, L, Rossi, G, Borlenghi, E, Ciceri, F, Campiotti, L, Corradini, P, Cortelezzi, A, Ferrero, D, Audisio, E, Bosi, A, Bassan, R, Rambaldi, A, and Spinelli, O

Published
2017

47. CLINICAL SIGNIFICANCE OF END OF INDUCTION MINIMAL RESIDUAL DISEASE IN ADULT PATIENTS WITH ACUTE LYMPHOBLASTIC LEUKEMIA IN COMPLETE REMISSION AFTER A SINGLE CHEMOTHERAPY COURSE

Author

Bassan, R, Masciulli, A, Intermesoli, T, Spinelli, O, Tosi, M, Pavoni, C, Audisio, E, Cattaneo, C, Fumagalli, M, Cassibba, V, Mattei, D, Romani, C, Cortelezzi, A, Ciceri, F, Scattolin, Am, Vitolo, U, Borlenghi, E, Gallamini, A, Depaoli, L, Campiotti, L, Bocchia, M, Di Bona, E, Oldani, E, and Rambaldi, A

Published
2017

48. LEUKEMIA RELAPSE AFTER ALLOGENENIC HSCT DISPLAYS A DISTINCTIVE IMMUNE-RELATED SIGNATURE, WITH FUNCTIONALLY RELEVANT ALTERATIONS IN HLA CLASS II ANTIGEN PRESENTATION AND T CELL COSTIMULATION

Author

Toffalori C, Riba M, Zito L, Oliveira G, Bucci G, Barcella M, Spinelli O, Crucitti L, Cieri N, Cittaro D, Lazarevic D, Peccatori J, Bernardi M, Bonini C, Rambaldi A, Barlassina C, Stupka E, Bianchi M, Ciceri F, Fleischhauer K, Vago L, Toffalori, C, Riba, M, Zito, L, Oliveira, G, Bucci, G, Barcella, M, Spinelli, O, Crucitti, L, Cieri, N, Cittaro, D, Lazarevic, D, Peccatori, J, Bernardi, M, Bonini, C, Rambaldi, A, Barlassina, C, Stupka, E, Bianchi, M, Ciceri, F, Fleischhauer, K, and Vago, L

Published
2015

49. LEUKEMIA RELAPSES AFTER ALLOGENENIC HSCT DISPLAY A DISTINCTIVE IMMUNE-RELATED SIGNATURE, WITH FUNCTIONALLY RELEVANT ALTERATIONS IN HLA CLASS II ANTIGEN PRESENTATION AND T CELL COSTIMULATION

Author

Toffalori, C., Riba, M., Zito, L., Oliveira, G., Bucci, G., Barcella, M., Spinelli, O., Crucitti, L., Cieri, N., Cittaro, D., Lazarevic, D., Peccatori, J., Bernardi, M., Bonini, C., Rambaldi, A., Barlassina, C., Stupka, E., Bianchi, M., Ciceri, F., Fleischhauer, Katharina, Vago, L., Toffalori, C, Riba, M, Zito, L, Oliveira, G, Bucci, G, Barcella, M, Spinelli, O, Crucitti, L, Cieri, N, Cittaro, D, Lazarevic, D, Peccatori, J, Bernardi, M, Bonini, C, Rambaldi, A, Barlassina, C, Stupka, E, Bianchi, M, Ciceri, F, Fleischhauer, K, and Vago, L

Subjects
Medizin
Published
2015

50. Real-life effectiveness and safety of Glecaprevir/Pibrentasvir among 723 Italian patients with chronic hepatitis C: The Navigator-II study

Author

D’Ambrosio, R., primary, Pasulo, L., additional, Puoti, M., additional, Schiavini, M., additional, Viganò, P., additional, Vinci, M., additional, Menzaghi, B., additional, Zuin, M.G., additional, Soria, A., additional, Spinetti, A., additional, Aghemo, A., additional, Rumi, M.G., additional, Uberti-Foppa, C., additional, Pan, A., additional, Spinelli, O., additional, D’arminio Monforte, A., additional, Capretti, A., additional, Colli, A., additional, Colombo, A., additional, Spinzi, G., additional, Centenaro, R., additional, Buscarini, E., additional, Soffredini, R., additional, Borghi, M., additional, Colpani, M., additional, Lazzaroni, S., additional, Maggiolo, F., additional, Gori, A., additional, Del Poggio, P., additional, Giorgini, A., additional, Morini, L., additional, Pigozzi, M.G., additional, Dibenedetto, C., additional, Giglio, O., additional, Magni, C.F., additional, Noventa, F., additional, Lampertico, P., additional, and Fagiuoli, S., additional

Published
2018
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