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1. Ruxolitinib after fedratinib failure in patients with myelofibrosis: A real‐world case series.

Author

Palandri, F., Branzanti, F., Benevolo, G., Beggiato, E., Morsia, E., Dedola, A., Loffredo, M., Fontana, G., Palumbo, G. A., Breccia, M., and Tiribelli, M.

Subjects
BROMODOMAIN-containing proteins, LEUCOCYTES, ADVERSE health care events, URINARY tract infections, ACUTE kidney failure, MYELOFIBROSIS
Abstract

The article discusses the use of ruxolitinib after fedratinib failure in patients with myelofibrosis. It presents a case series of 14 patients who received ruxolitinib after fedratinib therapy, detailing their clinical outcomes and responses. The study highlights the potential clinical benefit of second-line ruxolitinib, achieving spleen and symptoms response in a subset of patients. The findings suggest that sequential use of ruxolitinib after fedratinib may be beneficial for selected patients, with no observed excess toxicity in the second-line setting. [Extracted from the article]

Published
2024
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2. Gilteritinib as Post-Transplant Maintenance for Acute Myeloid Leukemia With Internal Tandem Duplication Mutation of FLT3

Author

Levis, M, Hamadani, M, Logan, B, Jones, R, Singh, A, Litzow, M, Wingard, J, Papadopoulos, E, Perl, A, Soiffer, R, Ustun, C, Ueda Oshima, M, Uy, G, Waller, E, Vasu, S, Solh, M, Mishra, A, Muffly, L, Kim, H, Mikesch, J, Najima, Y, Onozawa, M, Thomson, K, Nagler, A, Wei, A, Marcucci, G, Geller, N, Hasabou, N, Delgado, D, Rosales, M, Hill, J, Gill, S, Nuthethi, R, King, D, Wittsack, H, Mendizabal, A, Devine, S, Horowitz, M, Chen, Y, Agura, E, Altman, J, Anagnostopoulos, A, Anand, S, Artz, A, Aulitzky, W, Balderman, S, Ballen, K, Becker, M, Beguin, Y, Berkahn, L, Berneman, Z, Bhatt, V, Bilmon, I, Bonifazi, F, Briggs, A, Bruno, B, Brunstein, C, Byrne, M, Byrne, J, Cabrero, M, Cairoli, R, Carrum, G, Cerny, J, Cheong, J, Ciceri, F, Colorado, M, Cook, R, Couriel, D, Craddock, C, Damon, L, Deol, A, Desbrosses, Y, Di Grazia, C, Di Stasi, A, Dias, A, Dorritie, K, Essell, J, Eto, T, Farag, S, Forcade, E, Frankfurt, O, Fujiwara, S, Fukuda, T, Fukushima, K, Furst, S, Goto, T, Hall, A, Hatta, S, Hicheri, Y, Horwitz, M, Hou, H, How, J, Howard, D, Hsu, W, Huynh, A, Irvine, D, Ishikawa, T, Jamieson, K, Jedrzejczak, W, Jethava, Y, Jimenez, A, Jung, C, Kanda, J, Karakasis, D, Kato, J, Kekre, N, Khera, N, Klein, A, Kobbe, G, Kornblit, B, Kota, V, Lachance, S, Leber, B, Lee, C, Lee, J, Lin, T, Liu, T, Martelli, M, Martinez, C, Matsuoka, K, Mccarty, J, Mendez, L, Michelis, F, Mineishi, S, Mohty, M, Moors, I, Motyckova, G, Mueller, L, Nakamae, H, Nakano, N, Nathan, S, Nicholson, E, Norkin, M, Ogawa, Y, Olesen, G, Oluwole, O, Pantin, J, Paulson, K, Pemberton, L, Perera, T, Piatkowska-Jakubas, B, Poire, X, Protheroe, R, Rambaldi, A, Ritchie, D, Ross, K, Rubio, M, Santarone, S, Sanz Caballer, J, Sawa, M, Schaar, D, Scheid, C, Schriber, J, Seropian, S, Shah, N, Shore, T, Gil, J, Sobecks, R, Socie, G, Sprague, K, Spyridonidis, A, Stelljes, M, Stiff, P, Stuart, R, Tanaka, M, Tandra, A, Tholouli, E, Thomas, X, Tiribelli, M, Tomlinson, B, Tsirigotis, P, Tzachanis, D, Uchida, N, Ueda, M, Valcarcel Ferreiras, D, Wagner, E, Watson, A, Weisdorf, D, Wolschke, C, Wrobel, T, Yakoub-Agha, I, Yamauchi, T, Yared, J, Yeh, S, Yoon, S, Yoshihara, S, Null, N, Levis, Mark J., Hamadani, Mehdi, Logan, Brent, Jones, Richard J., Singh, Anurag K., Litzow, Mark, Wingard, John R., Papadopoulos, Esperanza B., Perl, Alexander E., Soiffer, Robert J., Ustun, Celalettin, Ueda Oshima, Masumi, Uy, Geoffrey L., Waller, Edmund K., Vasu, Sumithra, Solh, Melhem, Mishra, Asmita, Muffly, Lori, Kim, Hee-Je, Mikesch, Jan-Henrik, Najima, Yuho, Onozawa, Masahiro, Thomson, Kirsty, Nagler, Arnon, Wei, Andrew H., Marcucci, Guido, Geller, Nancy L., Hasabou, Nahla, Delgado, David, Rosales, Matt, Hill, Jason, Gill, Stanley C., Nuthethi, Rishita, King, Denise, Wittsack, Heather, Mendizabal, Adam, Devine, Steven M., Horowitz, Mary M., Chen, Yi-Bin, Agura, Ed, Altman, Jessica, Anagnostopoulos, Achiles, Anand, Sarah, Artz, Andrew, Aulitzky, Walter, Balderman, Sophia, Ballen, Karen, Becker, Michael, Beguin, Yves, Berkahn, Leanne, Berneman, Zwi, Bhatt, Vijaya, Bilmon, Ian, Bonifazi, Francesca, Briggs, Adrienne, Bruno, Benedetto, Brunstein, Claudio, Byrne, Michael, Byrne, Jenny, Cabrero, Monica, Cairoli, Roberto, Carrum, George, Cerny, Jan, Cheong, June-Won, Ciceri, Fabio, Colorado, Mercedes, Cook, Rachel, Couriel, Daniel, Craddock, Charles, Damon, Lloyd, Deol, Abhinav, Desbrosses, Yohan, Devine, Steve, Di Grazia, Carmela, Di Stasi, Antonio, Dias, Ajoy, Dorritie, Kathy, Essell, James, Eto, Tetsuya, Farag, Sherif, Forcade, Edouard, Frankfurt, Olga, Fujiwara, Shinichiro, Fukuda, Takahiro, Fukushima, Kentaro, Furst, Sabine, Goto, Tatsunori, Hall, Aric, Hatta, Shunsuke, Hicheri, Yosr, Horwitz, Mitchell, Hou, Hsin-An, How, Jonathan, Howard, Dianna, Hsu, Wei-Hsun (Blake), Huynh, Anne, Irvine, David, Ishikawa, Takayuki, Jamieson, Katarzyna, Jedrzejczak, Wieslaw, Jethava, Yogesh, Jimenez, Antonio, Jung, Chul Won, Kanda, Junya, Karakasis, Dimitrios, Kato, Jun, Kekre, Natasha, Khera, Nandita, Klein, Andreas, Kobbe, Guido, Kornblit, Brian, Kota, Vamsi, Lachance, Silvy, Leber, Brian, Lee, Catherine, Lee, Je Hwan, Lin, Tung-Liang, Liu, Ta-Chih, Martelli, Maurizio, Martinez, Carmen, Matsuoka, Kenichi, McCarty, John, Mendez, Lourdes, Michelis, Fotios, Mineishi, Shin, Mohty, Mohamad, Moors, Ine, Motyckova, Gabriela, Mueller, Lutz, Nakamae, Hirohisa, Nakano, Nobuaki, Nathan, Sunita, Nicholson, Emma, Norkin, Maxim, Ogawa, Yoshiaki, Olesen, Gitte, Oluwole, Olalekan, Pantin, Jeremy, Paulson, Kristjan, Pemberton, Lucy, Perera, Travis, Piatkowska-Jakubas, Beata, Poire, Xavier, Protheroe, Rachel, Rambaldi, Alessandro, Ritchie, David, Ross, Kelly, Rubio, Marie-Therese, Santarone, Stella, Sanz Caballer, Jaime, Sawa, Masashi, Schaar, Dale, Scheid, Christoph, Schriber, Jeffrey, Seropian, Stuart, Shah, Nilay, Shah, Nirav, Shore, Tsiporah, Gil, Jorge Sierra, Singh, Anurag, Sobecks, Ronald, Socie, Gerard, Soiffer, Robert, Sprague, Kellie, Spyridonidis, Alexandros, Stelljes, Matthias, Stiff, Patrick, Stuart, Robert, Tanaka, Masatsugu, Tandra, Anand, Tholouli, Eleni, Thomas, Xavier, Tiribelli, Mario, Tomlinson, Benjamin, Tsirigotis, Panagiotis, Tzachanis, Dimitrios, Uchida, Naoyuki, Ueda, Masumi, Valcarcel Ferreiras, David, Wagner, Eva, Watson, Anne-Marie, Weisdorf, Daniel, Wolschke, Christine, Wrobel, Tomasz, Yakoub-Agha, Ibrahim, Yamauchi, Takuji, Yared, Jean, Yeh, Su-Peng, Yoon, Sung-Soo, Yoshihara, Satoshi, null, null, Levis, M, Hamadani, M, Logan, B, Jones, R, Singh, A, Litzow, M, Wingard, J, Papadopoulos, E, Perl, A, Soiffer, R, Ustun, C, Ueda Oshima, M, Uy, G, Waller, E, Vasu, S, Solh, M, Mishra, A, Muffly, L, Kim, H, Mikesch, J, Najima, Y, Onozawa, M, Thomson, K, Nagler, A, Wei, A, Marcucci, G, Geller, N, Hasabou, N, Delgado, D, Rosales, M, Hill, J, Gill, S, Nuthethi, R, King, D, Wittsack, H, Mendizabal, A, Devine, S, Horowitz, M, Chen, Y, Agura, E, Altman, J, Anagnostopoulos, A, Anand, S, Artz, A, Aulitzky, W, Balderman, S, Ballen, K, Becker, M, Beguin, Y, Berkahn, L, Berneman, Z, Bhatt, V, Bilmon, I, Bonifazi, F, Briggs, A, Bruno, B, Brunstein, C, Byrne, M, Byrne, J, Cabrero, M, Cairoli, R, Carrum, G, Cerny, J, Cheong, J, Ciceri, F, Colorado, M, Cook, R, Couriel, D, Craddock, C, Damon, L, Deol, A, Desbrosses, Y, Di Grazia, C, Di Stasi, A, Dias, A, Dorritie, K, Essell, J, Eto, T, Farag, S, Forcade, E, Frankfurt, O, Fujiwara, S, Fukuda, T, Fukushima, K, Furst, S, Goto, T, Hall, A, Hatta, S, Hicheri, Y, Horwitz, M, Hou, H, How, J, Howard, D, Hsu, W, Huynh, A, Irvine, D, Ishikawa, T, Jamieson, K, Jedrzejczak, W, Jethava, Y, Jimenez, A, Jung, C, Kanda, J, Karakasis, D, Kato, J, Kekre, N, Khera, N, Klein, A, Kobbe, G, Kornblit, B, Kota, V, Lachance, S, Leber, B, Lee, C, Lee, J, Lin, T, Liu, T, Martelli, M, Martinez, C, Matsuoka, K, Mccarty, J, Mendez, L, Michelis, F, Mineishi, S, Mohty, M, Moors, I, Motyckova, G, Mueller, L, Nakamae, H, Nakano, N, Nathan, S, Nicholson, E, Norkin, M, Ogawa, Y, Olesen, G, Oluwole, O, Pantin, J, Paulson, K, Pemberton, L, Perera, T, Piatkowska-Jakubas, B, Poire, X, Protheroe, R, Rambaldi, A, Ritchie, D, Ross, K, Rubio, M, Santarone, S, Sanz Caballer, J, Sawa, M, Schaar, D, Scheid, C, Schriber, J, Seropian, S, Shah, N, Shore, T, Gil, J, Sobecks, R, Socie, G, Sprague, K, Spyridonidis, A, Stelljes, M, Stiff, P, Stuart, R, Tanaka, M, Tandra, A, Tholouli, E, Thomas, X, Tiribelli, M, Tomlinson, B, Tsirigotis, P, Tzachanis, D, Uchida, N, Ueda, M, Valcarcel Ferreiras, D, Wagner, E, Watson, A, Weisdorf, D, Wolschke, C, Wrobel, T, Yakoub-Agha, I, Yamauchi, T, Yared, J, Yeh, S, Yoon, S, Yoshihara, S, Null, N, Levis, Mark J., Hamadani, Mehdi, Logan, Brent, Jones, Richard J., Singh, Anurag K., Litzow, Mark, Wingard, John R., Papadopoulos, Esperanza B., Perl, Alexander E., Soiffer, Robert J., Ustun, Celalettin, Ueda Oshima, Masumi, Uy, Geoffrey L., Waller, Edmund K., Vasu, Sumithra, Solh, Melhem, Mishra, Asmita, Muffly, Lori, Kim, Hee-Je, Mikesch, Jan-Henrik, Najima, Yuho, Onozawa, Masahiro, Thomson, Kirsty, Nagler, Arnon, Wei, Andrew H., Marcucci, Guido, Geller, Nancy L., Hasabou, Nahla, Delgado, David, Rosales, Matt, Hill, Jason, Gill, Stanley C., Nuthethi, Rishita, King, Denise, Wittsack, Heather, Mendizabal, Adam, Devine, Steven M., Horowitz, Mary M., Chen, Yi-Bin, Agura, Ed, Altman, Jessica, Anagnostopoulos, Achiles, Anand, Sarah, Artz, Andrew, Aulitzky, Walter, Balderman, Sophia, Ballen, Karen, Becker, Michael, Beguin, Yves, Berkahn, Leanne, Berneman, Zwi, Bhatt, Vijaya, Bilmon, Ian, Bonifazi, Francesca, Briggs, Adrienne, Bruno, Benedetto, Brunstein, Claudio, Byrne, Michael, Byrne, Jenny, Cabrero, Monica, Cairoli, Roberto, Carrum, George, Cerny, Jan, Cheong, June-Won, Ciceri, Fabio, Colorado, Mercedes, Cook, Rachel, Couriel, Daniel, Craddock, Charles, Damon, Lloyd, Deol, Abhinav, Desbrosses, Yohan, Devine, Steve, Di Grazia, Carmela, Di Stasi, Antonio, Dias, Ajoy, Dorritie, Kathy, Essell, James, Eto, Tetsuya, Farag, Sherif, Forcade, Edouard, Frankfurt, Olga, Fujiwara, Shinichiro, Fukuda, Takahiro, Fukushima, Kentaro, Furst, Sabine, Goto, Tatsunori, Hall, Aric, Hatta, Shunsuke, Hicheri, Yosr, Horwitz, Mitchell, Hou, Hsin-An, How, Jonathan, Howard, Dianna, Hsu, Wei-Hsun (Blake), Huynh, Anne, Irvine, David, Ishikawa, Takayuki, Jamieson, Katarzyna, Jedrzejczak, Wieslaw, Jethava, Yogesh, Jimenez, Antonio, Jung, Chul Won, Kanda, Junya, Karakasis, Dimitrios, Kato, Jun, Kekre, Natasha, Khera, Nandita, Klein, Andreas, Kobbe, Guido, Kornblit, Brian, Kota, Vamsi, Lachance, Silvy, Leber, Brian, Lee, Catherine, Lee, Je Hwan, Lin, Tung-Liang, Liu, Ta-Chih, Martelli, Maurizio, Martinez, Carmen, Matsuoka, Kenichi, McCarty, John, Mendez, Lourdes, Michelis, Fotios, Mineishi, Shin, Mohty, Mohamad, Moors, Ine, Motyckova, Gabriela, Mueller, Lutz, Nakamae, Hirohisa, Nakano, Nobuaki, Nathan, Sunita, Nicholson, Emma, Norkin, Maxim, Ogawa, Yoshiaki, Olesen, Gitte, Oluwole, Olalekan, Pantin, Jeremy, Paulson, Kristjan, Pemberton, Lucy, Perera, Travis, Piatkowska-Jakubas, Beata, Poire, Xavier, Protheroe, Rachel, Rambaldi, Alessandro, Ritchie, David, Ross, Kelly, Rubio, Marie-Therese, Santarone, Stella, Sanz Caballer, Jaime, Sawa, Masashi, Schaar, Dale, Scheid, Christoph, Schriber, Jeffrey, Seropian, Stuart, Shah, Nilay, Shah, Nirav, Shore, Tsiporah, Gil, Jorge Sierra, Singh, Anurag, Sobecks, Ronald, Socie, Gerard, Soiffer, Robert, Sprague, Kellie, Spyridonidis, Alexandros, Stelljes, Matthias, Stiff, Patrick, Stuart, Robert, Tanaka, Masatsugu, Tandra, Anand, Tholouli, Eleni, Thomas, Xavier, Tiribelli, Mario, Tomlinson, Benjamin, Tsirigotis, Panagiotis, Tzachanis, Dimitrios, Uchida, Naoyuki, Ueda, Masumi, Valcarcel Ferreiras, David, Wagner, Eva, Watson, Anne-Marie, Weisdorf, Daniel, Wolschke, Christine, Wrobel, Tomasz, Yakoub-Agha, Ibrahim, Yamauchi, Takuji, Yared, Jean, Yeh, Su-Peng, Yoon, Sung-Soo, Yoshihara, Satoshi, and null, null

Abstract

Purpose: Allogeneic hematopoietic cell transplantation (HCT) improves outcomes for patients with acute myeloid leukemia (AML) harboring an internal tandem duplication mutation of FLT3 (FLT3-ITD) AML. These patients are routinely treated with a FLT3 inhibitor after HCT, but there is limited evidence to support this. Accordingly, we conducted a randomized trial of post-HCT maintenance with the FLT3 inhibitor gilteritinib (ClinicalTrials.gov identifier: NCT02997202) to determine if all such patients benefit or if detection of measurable residual disease (MRD) could identify those who might benefit. Methods: Adults with FLT3-ITD AML in first remission underwent HCT and were randomly assigned to placebo or 120 mg once daily gilteritinib for 24 months after HCT. The primary end point was relapse-free survival (RFS). Secondary end points included overall survival (OS) and the effect of MRD pre- and post-HCT on RFS and OS. Results: Three hundred fifty-six participants were randomly assigned post-HCT to receive gilteritinib or placebo. Although RFS was higher in the gilteritinib arm, the difference was not statistically significant (hazard ratio [HR], 0.679 [95% CI, 0.459 to 1.005]; two-sided P = .0518). However, 50.5% of participants had MRD detectable pre- or post-HCT, and, in a prespecified subgroup analysis, gilteritinib was beneficial in this population (HR, 0.515 [95% CI, 0.316 to 0.838]; P = .0065). Those without detectable MRD showed no benefit (HR, 1.213 [95% CI, 0.616 to 2.387]; P = .575). Conclusion: Although the overall improvement in RFS was not statistically significant, RFS was higher for participants with detectable FLT3-ITD MRD pre- or post-HCT who received gilteritinib treatment. To our knowledge, these data are among the first to support the effectiveness of MRD-based post-HCT therapy.

Published
2024

3. Deferasirox in the management of iron overload in patients with myelofibrosis treated with ruxolitinib: The multicentre retrospective RUX-IOL study

Author

Elli, E, Di Veroli, A, Bartoletti, D, Iurlo, A, Carmosino, I, Benevolo, G, Abruzzese, E, Bonifacio, M, Bergamaschi, M, Polverelli, N, Caramella, M, Cilloni, D, Tiribelli, M, Pugliese, N, Caocci, G, Crisa, E, Porrini, R, Markovic, U, Renso, R, Auteri, G, Cattaneo, D, Trawinska, M, Scaffidi, L, Biale, L, Bucelli, C, Breccia, M, Gambacorti Passerini, C, Palumbo, G, Latagliata, R, Palandri, F, Elli E. M., Di Veroli A., Bartoletti D., Iurlo A., Carmosino I., Benevolo G., Abruzzese E., Bonifacio M., Bergamaschi M., Polverelli N., Caramella M., Cilloni D., Tiribelli M., Pugliese N., Caocci G., Crisa E., Porrini R., Markovic U., Renso R., Auteri G., Cattaneo D., Trawinska M. M., Scaffidi L., Biale L., Bucelli C., Breccia M., Gambacorti Passerini C., Palumbo G. A., Latagliata R., Palandri F., Elli, E, Di Veroli, A, Bartoletti, D, Iurlo, A, Carmosino, I, Benevolo, G, Abruzzese, E, Bonifacio, M, Bergamaschi, M, Polverelli, N, Caramella, M, Cilloni, D, Tiribelli, M, Pugliese, N, Caocci, G, Crisa, E, Porrini, R, Markovic, U, Renso, R, Auteri, G, Cattaneo, D, Trawinska, M, Scaffidi, L, Biale, L, Bucelli, C, Breccia, M, Gambacorti Passerini, C, Palumbo, G, Latagliata, R, Palandri, F, Elli E. M., Di Veroli A., Bartoletti D., Iurlo A., Carmosino I., Benevolo G., Abruzzese E., Bonifacio M., Bergamaschi M., Polverelli N., Caramella M., Cilloni D., Tiribelli M., Pugliese N., Caocci G., Crisa E., Porrini R., Markovic U., Renso R., Auteri G., Cattaneo D., Trawinska M. M., Scaffidi L., Biale L., Bucelli C., Breccia M., Gambacorti Passerini C., Palumbo G. A., Latagliata R., and Palandri F.

Abstract

Deferasirox (DFX) is used for the management of iron overload (IOL) in many haematological malignancies including myelofibrosis (MF). The ‘RUX-IOL’ study retrospectively collected 69 MF patients treated with ruxolitinib (RUX) and DFX for IOL to assess: safety, efficacy in term of iron chelation response (ICR) and erythroid response (ER), and impact on overall survival of the combination therapy. The RUX–DFX therapy was administered for a median time of 12.4 months (interquartile range 3.1–71.2). During treatment, 36 (52.2%) and 34 (49.3%) patients required RUX and DFX dose reductions, while eight (11.6%) and nine (13.1%) patients discontinued due to RUX- or DFX-related adverse events; no unexpected toxicity was reported. ICR and ER were achieved by 33 (47.8%) and 32 patients (46.4%) respectively. Thirteen (18.9%) patients became transfusion-independent. Median time to ICR and ER was 6.2 and 2 months respectively. Patients achieving an ER were more likely to obtain an ICR also (p = 0.04). In multivariable analysis, the absence of leukocytosis at baseline (p = 0.02) and achievement of an ICR at any time (p = 0.02) predicted improved survival. In many MF patients, the RUX–DFX combination provided ICR and ER responses that correlated with improved outcome in the absence of unexpected toxicities. This strategy deserves further clinical investigation.

Published
2022

4. Treatment discontinuation following low-dose TKIs in 248 chronic myeloid leukemia patients: Updated results from a campus CML real-life study

Author

Iurlo, A., primary, Cattaneo, D., additional, Consonni, D., additional, Castagnetti, F., additional, Miggiano, M. C., additional, Binotto, G., additional, Bonifacio, M., additional, Rege-Cambrin, G., additional, Tiribelli, M., additional, Lunghi, F., additional, Gozzini, A., additional, Pregno, P., additional, Abruzzese, E., additional, Capodanno, I., additional, Bucelli, C., additional, Pizzuti, M., additional, Artuso, S., additional, Iezza, M., additional, Scalzulli, E., additional, La Barba, G., additional, Maggi, A., additional, Russo, S., additional, Elena, C., additional, Scortechini, A. R., additional, Tafuri, A., additional, Latagliata, R., additional, Caocci, G., additional, Bocchia, M., additional, Galimberti, S., additional, Luciano, L., additional, Fava, C., additional, Foà, R., additional, Saglio, G., additional, Rosti, G., additional, and Breccia, M., additional

Published
2023
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5. Determinants of frontline tyrosine kinase inhibitor choice for patients with chronic-phase chronic myeloid leukemia: A study from the Registro Italiano LMC and Campus CML

Author

Tiribelli, M., Latagliata, R., Breccia, M., Capodanno, I., Miggiano, M. C., Cavazzini, F., Bucelli, C., Attolico, I., Crescenzi, S. L., Russo, S., Annunziata, M., Sora', Federica, Bonifacio, M., Mulas, O., Loglisci, G., Maggi, A., Binotto, G., Crisa, E., Scortechini, A. R., Leporace, A. P., Sancetta, R., Murgano, P., Abruzzese, E., Stagno, F., Rapezzi, D., Luzi, D., Vincelli, I., Bocchia, M., Fava, C., Malato, A., Crugnola, M., Pizzuti, M., Lunghi, F., Galimberti, S., Dalmazzo, M., Fanin, R., Scalzulli, E., Foa, R., Iurlo, A., Saglio, G., Specchia, G., Sora' F. (ORCID:0000-0002-9607-5298), Tiribelli, M., Latagliata, R., Breccia, M., Capodanno, I., Miggiano, M. C., Cavazzini, F., Bucelli, C., Attolico, I., Crescenzi, S. L., Russo, S., Annunziata, M., Sora', Federica, Bonifacio, M., Mulas, O., Loglisci, G., Maggi, A., Binotto, G., Crisa, E., Scortechini, A. R., Leporace, A. P., Sancetta, R., Murgano, P., Abruzzese, E., Stagno, F., Rapezzi, D., Luzi, D., Vincelli, I., Bocchia, M., Fava, C., Malato, A., Crugnola, M., Pizzuti, M., Lunghi, F., Galimberti, S., Dalmazzo, M., Fanin, R., Scalzulli, E., Foa, R., Iurlo, A., Saglio, G., Specchia, G., and Sora' F. (ORCID:0000-0002-9607-5298)

Abstract

Background: Imatinib, dasatinib, and nilotinib are tyrosine kinase inhibitors (TKIs) approved in Italy for frontline treatment of chronic-phase chronic myeloid leukemia (CP-CML). The choice of TKI is based on a combined evaluation of the patient’s and the disease characteristics. The aim of this study was to analyze the use of frontline TKI therapy in an unselected cohort of Italian patients with CP-CML to correlate the choice with the patient’s features. Methods: A total of 1967 patients with CP-CML diagnosed between 2012 and 2019 at 36 centers throughout Italy were retrospectively evaluated; 1089 patients (55.4%) received imatinib and 878 patients (44.6%) received a second-generation (2G) TKI. Results: Second-generation TKIs were chosen for most patients aged <45 years (69.2%), whereas imatinib was used in 76.7% of patients aged >65 years (p <.001). There was a predominant use of imatinib in intermediate/high European long–term survival risk patients (60.0%/66.0% vs. 49.7% in low-risk patients) and a limited use of 2G-TKIs in patients with comorbidities such as hypertension, diabetes, chronic obstructive pulmonary disease, previous neoplasms, ischemic heart disease, or stroke and in those with >3 concomitant drugs. We observed a greater use of imatinib (61.1%) in patients diagnosed in 2018–2019 compared to 2012–2017 (53.2%; p =.002). In multivariable analysis, factors correlated with imatinib use were age > 65 years, spleen size, the presence of comorbidities, and ≥3 concomitant medications. Conclusions: This observational study of almost 2000 cases of CML shows that imatinib is the frontline drug of choice in 55% of Italian patients with CP-CML, with 2G-TKIs prevalently used in younger patients and in those with no concomitant clinical conditions. Introduction of the generic formulation in 2018 seems to have fostered imatinib use.

Published
2023

6. Efficacy and safety of nilotinib as frontline treatment in elderly (> 65 years) chronic myeloid leukemia patients outside clinical trials

Author

Luciano, L., Latagliata, R., Gugliotta, G., Annunziata, M., Tiribelli, M., Martino, B., Sica, A., Esposito, M. R., Bocchia, M., Galimberti, S., Sora', Federica, Albano, F., Palmieri, R., Pregno, P., Dragani, M., Iovine, M., Sica, Simona, Iurlo, A., Castagnetti, F., Rosti, G., Breccia, M., Sora' F. (ORCID:0000-0002-9607-5298), Sica S. (ORCID:0000-0003-2426-3465), Luciano, L., Latagliata, R., Gugliotta, G., Annunziata, M., Tiribelli, M., Martino, B., Sica, A., Esposito, M. R., Bocchia, M., Galimberti, S., Sora', Federica, Albano, F., Palmieri, R., Pregno, P., Dragani, M., Iovine, M., Sica, Simona, Iurlo, A., Castagnetti, F., Rosti, G., Breccia, M., Sora' F. (ORCID:0000-0002-9607-5298), and Sica S. (ORCID:0000-0003-2426-3465)

Abstract

Here, we report real-world evidence on the safety and efficacy of nilotinib as a first-line treatment in elderly patients with chronic phase CML, treated in 18 Italian centers. Sixty patients aged > 65 years (median age 72 years (65–84)) were reported: 13 patients were older than 75 years. Comorbidities were recorded at baseline in 56/60 patients. At 3 months of treatment, all patients obtained complete hematological response (CHR), 43 (71.6%) an early molecular response (EMR), while 47 (78%) reached a complete cytogenetic response (CCyR). At last follow-up, 63.4% of patients still had a deep molecular response (MR4 or better), 21.6% reached MR3 as best response and 11.6% persisted without MR. Most patients (85%) started the treatment at the standard dose (300 mg BID), maintained at 3 months in 80% of patients and at 6 months in 89% of them. At the last median follow-up of 46.3 months, 15 patients discontinued definitively the treatment (8 due to side effects, 4 died for unrelated CML causes, 1 for failure, 2 were lost to follow-up). One patient entered in treatment-free remission. As to safety, 6 patients (10%) experienced cardiovascular events after a median time of 20.9 months from the start. Our data showed that nilotinib could be, as first-line treatment, effective and relatively safe even in elderly CML patients. In this setting, more data in the long term are needed about possible dose reduction to improve the tolerability, while maintaining the optimal molecular response.

Published
2023

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

Author

Salvi, F., Pini, M., Leoni, P., Rupoli, S., Galieni, P., Bigazzi, C., Cantore, N., Palmieri, F., Albano, F., Russo Rossi, A., Rambaldi, A., Intermesoli, T., Palandri, F., Testoni, N., Luatti, S., Soverini, S., Iacobucci, I., Bochicchio, M.T., Apolinari, M., Fogli, M., Cervello, I., Capucci, A., Malagola, M., Malpignano, A., Girasoli, M., Angelucci, E., Usala, E., Storti, S., De Biasi, E., Tagariello, G., Sartori, R., Di Raimondo, F., Vigneri, P., Impera, S., Molica, S., Lanza, F., Viganò, C., Grasso, M., Rapezzi, D., Cavazzini, F., Bosi, A., Santini, V., Capalbo, S.F., Spinosa, G., Pierri, I., Bergamaschi, M., Carella, A.M., Bacigalupo, A., De Blasio, A., Ciccone, F., Di Renzo, N., Musolino, C., Russo, S., Cortelezzi, A., Morra, E., Pungolino, E.M., Luppi, M., Marasca, R., Pogliani, E.M., Gambacorti-Passerini, C., Luciano, L., Ferrara, F., Annunziata, M., Latte, G., Noli, D., Rege-Cambrin, G., Fava, C., Semenzato, G., Binotto, G., Fabbiano, F., Turri, D., Siragusa, S., Caracciolo, C., Musso, M., Porretto, F., Aversa, F., Crugnola, M., Cazzola, M., Orlandi, E., Falini, B., Falzetti, F., Visani, G., Isidori, A., Fioritoni, G., Di Lorenzo, R., Vallisa, D., Trabacchi, E., Petrini, M., Galimberti, S., Pizzuti, M., Zaccaria, A., Salvucci, M., Ronco, F., Ielo, D., Merli, F., Avanzini, P., Tosi, P., Merli, A., Musto, P., De Stefano, V., Sica, S., Latagliata, R., De Fabritiis, P., Trawiska, M., Majolino, I., Pacilli, L., Ronci, B., Cedrone, M., Petti, M.C., Pisani, F., Tafuri, A., Montefusco, E., Iuliano, F., Dore, F., Pardini, S., Bocchia, M., Defina, M., Liberati, A.M., Luzzi, D., Boccadoro, M., Ferrero, D., Vitolo, U., Gherlinzoni, F., Calistri, E., Fanin, R., Pizzolo, G., Meneghini, V., Rodighiero, F., D'Emilio, A., Castagnetti, F., Gugliotta, G., Baccarani, M., Breccia, M., Specchia, G., Levato, L., Abruzzese, E., Rossi, G., Iurlo, A., Martino, B., Pregno, P., Stagno, F., Cuneo, A., Bonifacio, M., Gobbi, M., Russo, D., Gozzini, A., Tiribelli, M., de Vivo, A., Alimena, G., Cavo, M., Martinelli, G., Pane, F., Saglio, G., and Rosti, G.

Published
2015
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9. P1010: RUXOLITINIB IN MYELODEPLETIVE MYELOFIBROSIS: RESPONSE, TOXICITY, AND OUTCOME

Author

Palandri, F., primary, Bartoletti, D., additional, Breccia, M., additional, Auteri, G., additional, Elli, E. M., additional, Trawinska, M. M., additional, Polverelli, N., additional, Tiribelli, M., additional, Benevolo, G., additional, Iurlo, A., additional, Tieghi, A., additional, Heidel, F. H., additional, Caocci, G., additional, Beggiato, E., additional, Binotto, G., additional, Cavazzini, F., additional, Miglino, M., additional, Bosi, C., additional, Crugnola, M., additional, Bocchia, M., additional, Martino, B., additional, Pugliese, N., additional, Romagnoli, A. D., additional, Mazzoni, C., additional, Scaffidi, L., additional, Isidori, A., additional, Cattaneo, D., additional, Krampera, M., additional, Pane, F., additional, Cilloni, D., additional, Semenzato, G., additional, Lemoli, R. M., additional, Cuneo, A., additional, Abruzzese, E., additional, Vianelli, N., additional, Cavo, M., additional, Bonifacio, M., additional, and Palumbo, G. A., additional

Published
2022
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10. PB1899: DEVELOPMENT AND VALIDATION OF A PREDICTIVE SCORING SYSTEM FOR THE PROGNOSIS IN PATIENTS WITH CHRONIC MYELOID LEUKEMIA (CML) IN CHRONIC PHASE RECEIVING FIRST-LINE IMATINIB

Author

Bektaş, M., primary, Eşkazan, A. E., additional, Tiryaki, T. O., additional, Mullai, R., additional, Elverdi, T., additional, Salihoğlu, A., additional, Tiribelli, M., additional, Ar, M. C., additional, Öngören, S., additional, Başlar, Z., additional, Nalçaci, M., additional, and Soysal, T., additional

Published
2022
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11. P1706: CLINICAL UTILITY OF ONLINE MONITORING OF PATIENT-REPORTED SYMPTOMS IN NEWLY DIAGNOSED PATIENTS WITH CHRONIC MYELOID LEUKEMIA IN REAL-LIFE PRACTICE

Author

Efficace, F., primary, Cottone, F., additional, Yanez, B., additional, Castagnetti, F., additional, Caocci, G., additional, Bonifacio, M., additional, Patriarca, A., additional, Capodanno, I., additional, Miggiano, M. C., additional, Tiribelli, M., additional, Breccia, M., additional, Luciano, L., additional, Giai, V., additional, Iurlo, A., additional, Abruzzese, E., additional, Fava, C., additional, Rosti, G., additional, Cortes, J., additional, Kota, V., additional, Vignetti, M., additional, and Cella, D., additional

Published
2022
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12. P1011: PREDICTORS OF COVID-19 DISEASE AND SURVIVAL TO COVID-19 IN MPN PATIENTS TREATED WITH RUXOLITINIB

Author

Palandri, F., primary, Bartoletti, D., additional, Elli, E. M., additional, Auteri, G., additional, Bonifacio, M., additional, Benevolo, G., additional, Heidel, F., additional, Trawinska, M. M., additional, Rossi, E., additional, Bosi, C., additional, Tieghi, A., additional, Tiribelli, M., additional, Iurlo, A., additional, Polverelli, N., additional, Caocci, G., additional, Binotto, G., additional, Cavazzini, F., additional, Beggiato, E., additional, Cilloni, D., additional, Tatarelli, C., additional, Mendicino, F., additional, Miglino, M., additional, Bocchia, M., additional, Crugnola, M., additional, Mazzoni, C., additional, Romagnoli, A. D., additional, Rindone, G., additional, Ceglie, S., additional, D’Addio, A., additional, Santoni, E., additional, Cattaneo, D., additional, Lemoli, R. M., additional, Krampera, M., additional, Cuneo, A., additional, Semenzato, G., additional, Latagliata, R., additional, Abruzzese, E., additional, Vianelli, N., additional, Cavo, M., additional, Andriani, A., additional, De Stefano, V., additional, Palumbo, G., additional, and Breccia, M., additional

Published
2022
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13. COVID-19 infection in chronic myeloid leukemia after one year of the pandemic in Italy Campus CML report

Author

Breccia, M, Abruzzese, E, Accurso, V, Attolico, I, Barulli, S, Bergamaschi, M, Binotto, G, Bocchia, M, Bonifacio, M, Caocci, G, Capodanno, I, Castagnetti, F, Cavazzini, F, Crisà, E, Crugnola, M, De Candia, M, Elena, C, Fava, C, Galimberti, S, Gozzini, A, Gugliotta, G, Intermesoli, T, Iurlo, A, La Barba, G, Latagliata, R, Crescenzi, Sl, Levato, L, Loglisci, G, Lucchesi, A, Luciano, L, Lunghi, F, Luzi, D, Malato, A, Miggiano, Mc, Pizzuti, M, Pregno, P, Rapezzi, D, Rege-Cambrin, G, Rosti, G, Russo, S, Sancetta, R, Scortechini, Ar, Sora', Federica, Sportoletti, P, Stagno, F, Tafuri, A, Tiribelli, M, Foà, R, Saglio, G, Sora, Federica (ORCID:0000-0002-9607-5298), Breccia, M, Abruzzese, E, Accurso, V, Attolico, I, Barulli, S, Bergamaschi, M, Binotto, G, Bocchia, M, Bonifacio, M, Caocci, G, Capodanno, I, Castagnetti, F, Cavazzini, F, Crisà, E, Crugnola, M, De Candia, M, Elena, C, Fava, C, Galimberti, S, Gozzini, A, Gugliotta, G, Intermesoli, T, Iurlo, A, La Barba, G, Latagliata, R, Crescenzi, Sl, Levato, L, Loglisci, G, Lucchesi, A, Luciano, L, Lunghi, F, Luzi, D, Malato, A, Miggiano, Mc, Pizzuti, M, Pregno, P, Rapezzi, D, Rege-Cambrin, G, Rosti, G, Russo, S, Sancetta, R, Scortechini, Ar, Sora', Federica, Sportoletti, P, Stagno, F, Tafuri, A, Tiribelli, M, Foà, R, Saglio, G, and Sora, Federica (ORCID:0000-0002-9607-5298)

Abstract

Limited information is available on the impact of the COVID-19 pandemic on the management of chronic myeloid leukaemia (CML). The Campus CML network collected retrospective information on 8 665 CML patients followed at 46 centres throughout Italy during the pandemic between February 2020 and January 2021. Within this cohort, we recorded 217 SARS-CoV-2-positive patients (2·5%). Most patients (57%) were diagnosed as having SARS-CoV-2 infection during the second peak of the pandemic (September 2020 to January 2021). The majority (35%) was aged between 50 and 65 years with a male prevalence (73%). Fifty-six percent of patients presented concomitant comorbidities. The median time from CML diagnosis to SARS-CoV-2 infection was six years (three months to 18 years). Twenty-one patients (9·6%) required hospitalization without the need of respiratory assistance, 18 (8·2%) were hospitalized for respiratory assistance, 8 (3·6%) were admitted to an intensive care unit, while 170 (78%) were only quarantined. Twenty-three percent of patients discontinued tyrosine kinase inhibitor (TKI) therapy during the infection. Twelve patients died due to COVID-19 with a mortality rate of 5·5% in the positive cohort and of 0·13% in the whole cohort. We could also document sequelae caused by the SARS-CoV-2 infection and an impact of the pandemic on the overall management of CML patients.

Published
2022

15. The proportion of different BCR-ABL1 transcript types in chronic myeloid leukemia. An international overview

Author

Baccarani, M, Castagnetti, F, Gugliotta, G, Rosti, G, Soverini, S, Albeer, A, Pfirrmann, M, Bekadja, Ma, Entasoltan, B, Nachi, M, Elghandour, A, El Sorady, M, Abdelfattah, R, El Nahass, Y, Samra, M, Azzazi, M, Elsobki, E, Moussa, M, Fahmy, O, Mattar, M, Shehata, Azmy, Se, (Azmy, E, 9 ), Emad), Bolarinwa, (Bolarinwa, Ra, ( 10 ), Rahman A., Eid, (Eid, S, Samir)( 11, ), Khelif, (Khelif, A, Abderrhaim)( 11, ), Hached, (Hached, F, Farhat)( 11, ), Menif, (Menif, S, Samia)( 12, ), Rahman, (Rahman, H, Hafizur)( 13, ), Huang, (Huang, Xj, Xiaojun)(, 14, 15, ), Jiang, (Jiang, Q, Qian)(, 14, (Ye, Yx, Yuanxin)( 16, ), Zhu, (Zhu, Hl, Huanling)( 16, ), Chen, (Chen, Sn, Suning)( 17, ), Varma, (Varma, N, Neelam)( 18, ), Ganesan, (Ganesan, P, Prasanth)( 19, ), Gundeti, (Gundeti, S, Sadashivudu)( 20, ), Malhotra, (Malhotra, H, Hemant)( 21, ), Radhakrishnan, (Radhakrishnan, Vs, ( 22 ), Vivek S., Kumar, (Kumar, L, Lalit)( 23, ), Sharawat, (Sharawat, Sk, Surender Kumar)( 23, ), Seth, (Seth, T, Tulika)( 24, ), Ausekar, (Ausekar, Bv, ( 25 ), B. V., Balasubramanian, (Balasubramanian, P, Poonkuzhali)( 26, ), Poopak, (Poopak, B, Behzad)(, 27, 28, ), Inokuchi, (Inokuchi, K, Koiti)( 29, ), Kim, (Kim, Dw, Dong-Wook)( 30, ), Kindi, Al, S (Al Kindi, Salam)( 31, ), Mirasol, (Mirasol, A, Angelina)( 32, ), Qari, (Qari, M, Mohammed)( 33, ), Goh, (Goh, Yt, Yeow Tee)( 34, ), Shih, (Shih, Ly, Lee-Yung)(, 35, 36, ), Branford, (Branford, S, Susan)(, 37, 38, ), Lion, (Lion, T, Thomas)( 39, ), Valent, (Valent, P, Peter)( 40, ), Burgstaller, (Burgstaller, S, Sonja)( 41, ), Thaler, (Thaler, J, Joseph)( 41, ), Labar, (Labar, B, Boris)( 42, ), Zadro, (Zadro, R, Renata)( 42, ), Mayer, (Mayer, J, Jiri)(, 43, 44, ), Zackova, (Zackova, D, Daniela)(, 43, Faber, (Faber, E, Edgar)( 45, ), Pallisgaard, (Pallisgaard, N, Niels)( 46, ), Xavier-Mahon, (Xavier-Mahon, F, Francois)( 47, ), Lippert, (Lippert, E, Eric)( 48, ), Cayuela, (Cayuela, Jm, Jean Michel)( 49, ), Rea, (Rea, D, Delphine)( 49, ), Millot, (Millot, F, Frederic)( 50, ), Suttorp, (Suttorp, M, Meinolf)( 51, ), Hochhaus, (Hochhaus, A, Andreas)( 52, ), Niederwieser, (Niederwieser, D, Dietger)( 53, ), Saussele, (Saussele, S, Susanne)( 54, ), Haferlach, (Haferlach, T, Torsten)( 55, ), Jeromine, (Jeromine, S, Sabine)( 55, ), Panayiotidis, (Panayiotidis, P, Panayiotis)(, 56, 57, ), Conneally, (Conneally, E, Eibhlin)( 58, ), Langabeer, (Langabeer, S, Steve)( 58, ), Nagler, (Nagler, A, Arnon)(, 59, 60, ), Rupoli, (Rupoli, S, Serena)( 61, ), Santoro, (Santoro, N, Nicola)( 62, ), Albano, (Albano, F, Francesco)( 63, ), Castagnetti, (Castagnetti, F, Fausto), Ottaviani, (Ottaviani, E, Emanuela)(, 64, 65, ), Rambaldi, (Rambaldi, A, Alessandro)(, 66, 67, ), Stagno, (Stagno, F, Fabio)( 68, ), Molica, (Molica, S, Stefano)( 69, ), Biagiotti, (Biagiotti, C, Caterina)( 70, ), Scappini, (Scappini, B, Barbara)( 70, ), Lemoli, (Lemoli, R, Roberto)( 71, ), Iurlo, (Iurlo, A, Alessandra)(, 72, 73, ), Pungolino, (Pungolino, E, Ester)( 74, ), Menna, (Menna, G, Giuseppe), Pane, (Pane, F, Fabrizio)( 76, ), Gottardi, (Gottardi, E, Enrico)(, 77, 78, ), Rege-Cambrin, (Rege-Cambrin, G, Giovanna)(, 77, Binotto, (Binotto, G, Gianni)( 79, ), Putti, (Putti, Mc, Maria Caterina)( 80, ), Falzetti, (Falzetti, F, Franca)( 81, ), Visani, (Visani, G, Giuseppe)( 82, ), Galimberti, (Galimberti, S, Sara)( 83, ), Musto, (Musto, P, Pellegrino)( 84, ), Abruzzese, (Abruzzese, E, Elisabetta)( 85, ), Breccia, (Breccia, M, Massimo)( 86, ), Giona, (Giona, F, Fiorina)( 86, ), Chiusolo, (Chiusolo, P, Patrizia)( 87, ), Sica, (Sica, S, Simona)( 87, ), Fava, (Fava, C, Carmen)( 88, ), Ferrero, (Ferrero, D, Dario)( 88, ), Tiribelli, (Tiribelli, M, Mario)( 89, ), Bonifacio, (Bonifacio, M, Massimiliano)( 90, ), Griskevicius, (Griskevicius, L, Laimonas)( 91, ), Musteata, (Musteata, V, Vasile)( 92, ), Janssen, (Janssen, J, Jeroen)( 93, ), Prejzner, (Prejzner, W, Witold)( 94, ), Sacha, (Sacha, T, Tomasz)( 95, ), Waclaw, (Waclaw, J, Joanna)( 95, ), Almeida, (Almeida, Am, Antonio Medina)( 96, ), Kulikov, (Kulikov, S, Sergei)( 97, ), Turkina, (Turkina, A, Anna)( 97, ), Bogdanovic, (Bogdanovic, A, Andrija)( 98, ), Zupan, (Zupan, I, Irena)( 99, ), Marce, (Marce, S, Silvia)( 100, ), Cervantes, (Cervantes, F, Francisco)( 101, ), Steegmann, (Steegmann, Jl, Juan Luis)( 102, ), Kotlyarchuk, (Kotlyarchuk, K, Konstyantyn)( 103, ), Milner, (Milner, Bj, ( 104 ), Benedict J., Rose, (Rose, S, Susan)( 105, ), Clench, (Clench, T, Tim)( 106, ), Waits, (Waits, P, Paula)( 107, ), Austin, (Austin, S, Steve)( 108, ), Wickham, (Wickham, C, Caroline)( 109, ), Clark, (Clark, R, Richard)( 110, ), Apperley, (Apperley, J, Jane), Claudiani, (Claudiani, S, Simone)( 111, ), Foroni, (Foroni, L, Letizia)( 111, ), Szydlo, (Szydlo, R, Richard)( 111, ), Burt, (Burt, E, Emma)( 112, ), Bescoby, (Bescoby, R, Ruth)( 113, ), Cork, (Cork, L, Leanne)( 113, ), O'Brien, (O'Brien, S, Stephen)( 113, ), Green, (Green, B, Bethaney)( 114, ), Hawtree, (Hawtree, S, Sarah)( 114, ), Watson, (Watson, M, Mark)( 114, ), Bengio, (Bengio, Rm, Raquel Maria)( 115, ), Larripa, (Larripa, I, Irene)( 115, ), Pavlovsky, (Pavlovsky, C, Carolina)( 116, ), Moiraghi, (Moiraghi, B, Beatriz)( 117, ), Pinna, De, CAR (Requiao de Pinna, Cristiane Almeida)( 118, ), Magalhaes, GHR (Romani Magalhaes, Gustavo Henrique)( 119, ), Pagnano, (Pagnano, K, Katia)( 120, ), Funke, (Funke, V, Vaneuza)( 121, ), Tavares, (Tavares, Rs, Renato Sampaio)( 122, ), Prado, (Prado, A, Adriana)( 123, ), Azevedo, (Azevedo, Aa, Alita Andrade)( 124, ), Fogliatto, (Fogliatto, L, Laura)( 125, ), Bonecker, (Bonecker, S, Simone)( 126, ), Centrone, (Centrone, R, Renato)( 127, ), Moellman, (Moellman, A, Artur)( 128, ), Conchon, (Conchon, M, Monika)( 130, ), Centurion, (Centurion, Me, Maria Elida)( 131, ), (Prado, Ai, Ana-Ines)( 132, ), Lopez, (Lopez, Jl, ( 133 ), J. L., Petruzziello, (Petruzziello, F, Fara)( 75, ), Bendit, (Bendit, I, Israel), Baccarani M., Castagnetti F., Gugliotta G., Rosti G., Soverini S., Albeer A., and Pfirrmann M.

Subjects
Male, 0301 basic medicine, Cancer Research, bcr-abl, Fusion Proteins, bcr-abl, Global Health, 0302 clinical medicine, hemic and lymphatic diseases, 80 and over, Odds Ratio, Prevalence, Age Factor, Chronic, Young adult, Child, MOLECULAR RESPONSE, Leukemic, Aged, 80 and over, Leukemia, Hematology, Gene Expression Regulation, Leukemic, CHRONIC MYELOGENOUS LEUKEMIA, Age Factors, Myeloid leukemia, Middle Aged, Oncology, Child, Preschool, 030220 oncology & carcinogenesis, Female, Life Sciences & Biomedicine, Human, Adult, Transcriptional Activation, medicine.medical_specialty, Adolescent, Immunology, IMATINIB MESYLATE, DENDRITIC CELLS, CML PATIENTS, Young Adult, 03 medical and health sciences, Myelogenous, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Internal medicine, medicine, Humans, 1112 Oncology and Carcinogenesis, BCR/ABL TRANSCRIPT, Preschool, CYTOGENETIC RESPONSE, Aged, Science & Technology, CHRONIC-PHASE, business.industry, Infant, Newborn, Fusion Proteins, ABL FUSION PROTEINS, P190 BCR-ABL, Infant, 1103 Clinical Sciences, Odds ratio, Newborn, medicine.disease, International BCR-ABL Study Group, Settore MED/15 - MALATTIE DEL SANGUE, 030104 developmental biology, Imatinib mesylate, Gene Expression Regulation, BCR-ABL Positive, business, Chronic myelogenous leukemia
Abstract

There are different BCR-ABL1 fusion genes that are translated into proteins that are different from each other, yet all leukemogenic, causing chronic myeloid leukemia (CML) or acute lymphoblastic leukemia. Their frequency has never been systematically investigated. In a series of 45503 newly diagnosed CML patients reported from 45 countries, it was found that the proportion of e13a2 (also known as b2a2) and of e14a2 (also known as b3a2), including the cases co-expressing e14a2 and e13a2, was 37.9% and 62.1%, respectively. The proportion of these two transcripts was correlated with gender, e13a2 being more frequent in males (39.2%) than in females (36.2%), was correlated with age, decreasing from 39.6% in children and adolescents down to 31.6% in patients ≥ 80 years old, and was not constant worldwide. Other, rare transcripts were reported in 666/34561 patients (1.93%). The proportion of rare transcripts was associatedwith gender (2.27% in females and 1.69% in males) and with age (from 1.79% in children and adolescents up to 3.84% in patients ≥ 80 years old). These data show that the differences in proportion are not by chance. This is important, as the transcript type is a variable that is suspected to be of prognostic importance for response to treatment, outcome of treatment, and rate of treatment-free remission.

Published
2019

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

Author

Castagnetti, F., Gugliotta, G., Baccarani, M., Breccia, M., Specchia, G., Levato, L., Abruzzese, E., Rossi, G., Iurlo, A., Martino, B., Pregno, P., Stagno, F., Cuneo, A., Bonifacio, M., Gobbi, M., Russo, D., Gozzini, A., Tiribelli, M., de Vivo, A., Alimena, G., Cavo, M., Martinelli, G., Pane, F., Saglio, G., Rosti, G., Salvi, F., Pini, M., Leoni, P., Rupoli, S., Galieni, P., Bigazzi, C., Cantore, N., Palmieri, F., Albano, F., Russo Rossi, A., Rambaldi, A., Intermesoli, T., Palandri, F., Testoni, N., Luatti, S., Soverini, S., Iacobucci, I., Bochicchio, MT., Apolinari, M., Fogli, M., Cervello, I., Capucci, A., Malagola, M., Malpignano, A., Girasoli, M., Angelucci, E., Usala, E., Storti, S., De Biasi, E., Tagariello, G., Sartori, R., Di Raimondo, F., Vigneri, P., Impera, S., Molica, S., Lanza, F., Viganò, C., Grasso, M., Rapezzi, D., Cavazzini, F., Bosi, A., Santini, V., Capalbo, SF., Spinosa, G., Pierri, I., Bergamaschi, M., Carella, AM., Bacigalupo, A., De Blasio, A., Ciccone, F., Di Renzo, N., Musolino, C., Russo, S., Cortelezzi, A., Morra, E., Pungolino, EM., Luppi, M., Marasca, R., Pogliani, EM., Gambacorti-Passerini, C., Luciano, L., Ferrara, F., Annunziata, M., Latte, G., Noli, D., Rege-Cambrin, G., Fava, C., Semenzato, G., Binotto, G., Fabbiano, F., Turri, D., Siragusa, S., Caracciolo, C., Musso, M., Porretto, F., Aversa, F., Crugnola, M., Cazzola, M., Orlandi, E., Falini, B., Falzetti, F., Visani, G., Isidori, A., Fioritoni, G., Di Lorenzo, R., Vallisa, D., Trabacchi, E., Petrini, M., Galimberti, S., Pizzuti, M., Zaccaria, A., Salvucci, M., Ronco, F., Ielo, D., Merli, F., Avanzini, P., Tosi, P., Merli, A., Musto, P., De Stefano, V., Sica, S., Latagliata, R., De Fabritiis, P., Trawiska, M., Majolino, I., Pacilli, L., Ronci, B., Cedrone, M., Petti, MC., Pisani, F., Tafuri, A., Montefusco, E., Iuliano, F., Dore, F., Pardini, S., Bocchia, M., Defina, M., Liberati, AM., Luzzi, D., Boccadoro, M., Ferrero, D., Vitolo, U., Gherlinzoni, F., Calistri, E., Fanin, R., Pizzolo, G., Meneghini, V., Rodighiero, F., and DʼEmilio, A.

Published
2015
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18. Chronic myeloid leukemia management at the time of the COVID-19 pandemic in Italy. A campus CML survey

Author

Breccia, M., Abruzzese, E., Bocchia, M., Bonifacio, M., Castagnetti, F., Fava, C., Galimberti, S., Gozzini, A., Gugliotta, G., Iurlo, A., Latagliata, R., Luciano, L., Pregno, P., Rege-Cambrin, G., Rosti, G., Stagno, F., Tiribelli, M., Foa, R., Saglio, G., Mariacristina, M. M., Isabella, C., Vincenzo, A., Federica, S., Debora, L., Mario, A., Immacolata, A., Alessandra, M., Rosaria, S., Chiara, E., Sara, B., Rita, S. A., Sabrina, L. -C., Agostino, T., Francesco, C., Giovanni, C., Alessandro, L., Davide, R., Michele, P., Gianni, B., Tamara, I., Alessandro, M., Elena, C., Monica, C., Mariella, D. A., Germana, B., Francesca, L., Iolanda -Donatella, V., Grazia, S., Luca, F., Sabina, R., Gaetano, L. B., Breccia M., Abruzzese E., Bocchia M., Bonifacio M., Castagnetti F., Fava C., Galimberti S., Gozzini A., Gugliotta G., Iurlo A., Latagliata R., Luciano L., Pregno P., Rege-Cambrin G., Rosti G., Stagno F., Tiribelli M., Foa R., Saglio G., MariaCristina M.M., Isabella C., Vincenzo A., Federica S., Debora L., Mario A., Immacolata A., Alessandra M., Rosaria S., Chiara E., Sara B., Rita S.A., Sabrina L.-C., Agostino T., Francesco C., Giovanni C., Alessandro L., Davide R., Michele P., Gianni B., Tamara I., Alessandro M., Elena C., Monica C., Mariella D.A., Germana B., Francesca L., Iolanda -Donatella V., Grazia S., Luca F., Sabina R., and Gaetano L.B.

Subjects
Cancer Research, 2019-20 coronavirus outbreak, medicine.medical_specialty, Coronavirus disease 2019 (COVID-19), Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Pneumonia, Viral, Protein Kinase Inhibitor, Time-to-Treatment, Betacoronavirus, Myelogenous, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Surveys and Questionnaires, Correspondence, Pandemic, Surveys and Questionnaire, COVID-19, Coronavirus Infections, Disease Management, Humans, Infection Control, Italy, Pandemics, Practice Guidelines as Topic, Protein Kinase Inhibitors, SARS-CoV-2, Telemedicine, Medicine, Viral, Chronic, Disease management (health), Chronic myeloid leukaemia, Leukemia, Betacoronaviru, Coronavirus Infection, business.industry, Myeloid leukemia, Pneumonia, Hematology, medicine.disease, Oncology, Family medicine, BCR-ABL Positive, business, Haematological diseases, Human
Abstract

No abstract available.

Published
2020

27. outcome of very elderly chronic myeloid leukemia patients treated with imatinib frontline

Author

Crugnola, M, Castagnetti, F, Breccia, M, Ferrero, D, Trawinska, Mm, Abruzzese, E, Annunziata, M, Stagno, F, Tiribelli, M, Binotto, G, Bonifacio, M, Fava, C, Iurlo, A, Bucelli, C, Mansueto, G, Gozzini, A, Falzetti, F, Montefusco, E, Crisà, E, Gugliotta, G, Russo, S, Cedrone, M, Russorossi, A, Pregno, P, Isidori, A, Mauro, E, Atelda, R, Giglio, G, Celesti, F, Sora', Federica, Storti, S, D'Addosio, A, Galimberti, S, Orlandi, E, Calistri, E, Bocchia, M, Cavazzini, F, Cambrin, Gr, Orofino, N, Luciano, L, Sgherza, N, Rosti, G, Latagliata, R, Capodanno, I, Sora, Federica (ORCID:0000-0002-9607-5298), Crugnola, M, Castagnetti, F, Breccia, M, Ferrero, D, Trawinska, Mm, Abruzzese, E, Annunziata, M, Stagno, F, Tiribelli, M, Binotto, G, Bonifacio, M, Fava, C, Iurlo, A, Bucelli, C, Mansueto, G, Gozzini, A, Falzetti, F, Montefusco, E, Crisà, E, Gugliotta, G, Russo, S, Cedrone, M, Russorossi, A, Pregno, P, Isidori, A, Mauro, E, Atelda, R, Giglio, G, Celesti, F, Sora', Federica, Storti, S, D'Addosio, A, Galimberti, S, Orlandi, E, Calistri, E, Bocchia, M, Cavazzini, F, Cambrin, Gr, Orofino, N, Luciano, L, Sgherza, N, Rosti, G, Latagliata, R, Capodanno, I, and Sora, Federica (ORCID:0000-0002-9607-5298)

Abstract

Very elderly (> 75 years) chronic myeloid leukaemia (CML) patients at diagnosis are sometimes treated with different doses of imatinib (IM) based on concomitant diseases and physicians' judgement. However, data on long-term follow-up of these patients are still lacking. To investigate treatment response and outcome, we retrospectively revised an Italian database of 263 very elderly CML patients receiving IM from the time of diagnosis. Median age at diagnosis was 78.5 years and 56% of patients had 2 or 3 comorbidities. A complete haematological and cytogenetic response were achieved in 244 (92.8%) and 184 (69.9%) patients, respectively. In 148 cases (56.2%), a major molecular response was observed, which was deep in 63 cases (24%). A blastic phase occurred in 11 patients (4.2%). After a median follow-up of 45.0 months, 93 patients have died (9 from disease progression) and 104 (39.5%) are still in treatment with IM. Incidence of grades 3-4 haematological and non-haematological toxicity was similar to those reported in younger patients. Five-year event-free survival was 54.5% and 45.2% in patients ≤ 80 years and > 80 years, respectively (p = 0.098). Five years OS was 75.7% and 61.6% in patients ≤80 years and > 80 years, respectively (p = 0.003). These findings show that IM plays an important role in frontline treatment of very elderly CML patients without increased toxicity and any effort to treat these patients with standard doses should be made in order to achieve responses as in younger subjects

Published
2019

28. Efficacy and safety of ruxolitinib and hydroxyurea combination in patients with hyperproliferative myelofibrosis

Author

Breccia, M., Luciano, L., Pugliese, N., Rossi, Elena, Tiribelli, M., Scalzulli, E., Bonifacio, M., Martino, B., Latagliata, R., Benevolo, G., Caocci, G., Binotto, G., Martinelli, V., Cavo, M., Pane, F., De Stefano, Valerio, Foa, R., Palandri, F., Rossi E. (ORCID:0000-0002-7572-9379), De Stefano V. (ORCID:0000-0002-5178-5827), Breccia, M., Luciano, L., Pugliese, N., Rossi, Elena, Tiribelli, M., Scalzulli, E., Bonifacio, M., Martino, B., Latagliata, R., Benevolo, G., Caocci, G., Binotto, G., Martinelli, V., Cavo, M., Pane, F., De Stefano, Valerio, Foa, R., Palandri, F., Rossi E. (ORCID:0000-0002-7572-9379), and De Stefano V. (ORCID:0000-0002-5178-5827)

Abstract

Ruxolitinib is the only commercially available JAK1/2 inhibitor approved for the treatment of myelofibrosis-related splenomegaly and symptoms. During treatment, as rare conditions, leukocytosis and/or thrombocytosis could develop and the management of these situations is not well established. We report here 53 myelofibrosis patients that received a combination of hydroxyurea and ruxolitinib because of uncontrolled myeloproliferation. Both drugs were administered outside clinical trials. At 48 weeks, a significant reduction in leucocyte and platelet counts was observed (p = 0.02 and p = 0.04, respectively). Additionally, the spleen volume decreased from a median value of 10 cm below the left costal margin (range, 0–10) to 6 cm (range, 0–15). The rate of spleen response increased from 14% at the start of the combination to 45% after 48 weeks. The safety profile of the combination was consistent with that observed with ruxolitinib single agent. These data require further confirmation in large cohorts of patients prospectively assessed.

Published
2019

30. Frontline imatinib treatment of chronic myeloid leukemia: no impact of age on outcome, a survey by the GIMEMA CML Working Party

Author

Gugliotta, G, Castagnetti, F, Palandri, F, Breccia, M, Intermesoli, T, Capucci, A, Martino, B, Pregno, P, Rupoli, S, Ferrero, D, Gherlinzoni, F, Montefusco, E, Bocchia, M, Tiribelli, M, Pierri, Ivana, Grifoni, F, Marzocchi, G, Amabile, M, Testoni, N, Martinelli, G, Alimena, G, Pane, F, Saglio, G, Baccarani, M, Rosti, G, Gruppo Italiano Malattie Ematologiche dell'Adulto CML Working Party, Gugliotta, G, Castagnetti, F, Palandri, F, Breccia, M, Intermesoli, T, Capucci, A, Martino, B, Pregno, P, Rupoli, S, Ferrero, D, Gherlinzoni, F, Montefusco, E, Bocchia, M, Tiribelli, M, Pierri, I, Grifoni, F, Marzocchi, G, Amabile, M, Testoni, N, Martinelli, G, Alimena, G, Pane, Fabrizio, Saglio, G, Baccarani, M, Rosti, G, Gruppo Italiano Malattie Ematologiche dell'Adulto CML Working, Party, Gugliotta G., Castagnetti F., Palandri F., Breccia M., Intermesoli T., Capucci A., Martino B., Pregno P., Rupoli S., Ferrero D., Gherlinzoni F., Montefusco E., Bocchia M., Tiribelli M., Pierri I., Grifoni F., Marzocchi G., Amabile M., Testoni N., Martinelli G., Alimena G., Pane F., Saglio G., Baccarani M., and Rosti G.

Subjects
Myeloid, Male, chronic myeloid leukemia, imatinib, elderly, Biochemistry, Piperazines, hemic and lymphatic diseases, 80 and over, Young adult, Aged, 80 and over, Leukemia, Mortality rate, Myeloid leukemia, Hematology, Middle Aged, Phase III as Topic, Survival Rate, Treatment Outcome, Benzamides, Leukemia, Myeloid, Chronic-Phase, Disease Progression, Imatinib Mesylate, Female, Complete Hematologic Response, Adult, medicine.medical_specialty, Adolescent, Immunology, Alpha interferon, Antineoplastic Agents, Young Adult, Clinical Trials, Phase II as Topic, Internal medicine, medicine, Humans, Clinical Trials, bone-marrow-transplantation, chronic myelogenous leukemia, complete cytogenetic response, early chronic phase, elderly-patients, european-leukemianet, interferon-alpha, line treatment, mesylate therapy, patients receiving imatinib, Survival rate, Aged, business.industry, Clinical Trials, Phase III as Topic, Health Surveys, Pyrimidines, Phase II as Topic, Cell Biology, medicine.disease, Surgery, Imatinib mesylate, Chronic-Phase, business, CHRONIC MYELOID LEUKEMIA (CML), Chronic myelogenous leukemia
Abstract

The median age of chronic myeloid leukemia (CML) patients is ∼ 60 years, and age is still considered an important prognostic factor, included in Sokal and EURO risk scores. However, few data are available about the long-term outcome of older patients treated with imatinib (IM) frontline. We analyzed the relationship between age and outcome in 559 early chronic-phase CML patients enrolled in 3 prospective clinical trials of Gruppo Italiano Malattie Ematologiche dell'Adulto CML Working Party, treated frontline with IM, with a median follow-up of 60 months. There were 115 older patients (≥ 65 years; 21%). The complete cytogenetic and major molecular response rates were similar in the 2 age groups. In older patients, event-free survival (55% vs 67%), failure-free survival (78% vs 92%), progression-free survival (62% vs 78%), and overall survival (75% vs 89%) were significantly inferior (all P < .01) because of a higher proportion of deaths that occurred in complete hematologic response, therefore unrelated to CML progression (15% vs 3%, P < .0001). The outcome was similar once those deaths were censored. These data show that response to IM was not affected by age and that the mortality rate linked to CML is similar in both age groups. This trial was registered at www.clinicaltrials.gov as #NCT00514488 and #NCT00510926.

Published
2011

32. PF674 OUTCOME OF PATIENTS WITH MYELOFIBROSIS AFTER RUXOLITINIB DISCONTINUATION: ROLE OF DISEASE STATUS AND TREATMENT STRATEGIES IN 218 PATIENTS

Author

Palandri, F., primary, Breccia, M., additional, Bonifacio, M., additional, Polverelli, N., additional, Elli, E.M., additional, Benevolo, G., additional, Tiribelli, M., additional, Abruzzese, E., additional, Iurlo, A., additional, Heidel, F., additional, Bergamaschi, M., additional, Tieghi, A., additional, Crugnola, M., additional, Cavazzini, F., additional, Binotto, G., additional, Isidori, A., additional, Sgherza, N., additional, Bosi, C., additional, Martino, B., additional, Latagliata, R., additional, Auteri, G., additional, Scaffidi, L., additional, Griguolo, D., additional, Trawinska, M., additional, Cattaneo, D., additional, Catani, L., additional, Krampera, M., additional, Vitolo, U., additional, Lemoli, R.M., additional, Cuneo, A., additional, Semenzato, G., additional, Foà, R., additional, Raimondo, F. Di, additional, Bartoletti, D., additional, Cavo, M., additional, Palumbo, G.A., additional, and Vianelli, N., additional

Published
2019
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33. S123 SETD2 LOSS OF FUNCTION IS A RECURRENT EVENT IN ADVANCED-PHASE CHRONIC MYELOID LEUKEMIA INDUCED BY POST-TRANSLATIONAL MECHANISMS THAT CAN BE THERAPEUTICALLY TARGETED

Author

Mancini, M., primary, De Santis, S., additional, Monaldi, C., additional, Bavaro, L., additional, Martelli, M., additional, Castagnetti, F., additional, Gugliotta, G., additional, Rosti, G., additional, Fontana, M.C., additional, Dan, E., additional, Sinigallia, B., additional, Iurlo, A., additional, Orofino, N., additional, Abbruzzese, E., additional, Salvucci, M., additional, Pregno, P., additional, Gozzini, A., additional, Crugnola, M., additional, Albano, F., additional, Bonifacio, M., additional, Calistri, E., additional, Tiribelli, M., additional, Binotto, G., additional, Imovilli, A., additional, Trabacchi, E., additional, Galimberti, S., additional, Baratè, C., additional, Tenti, E., additional, Baccarani, M., additional, Martinelli, G., additional, Cavo, M., additional, and Soverini, S., additional

Published
2019
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34. S882 OPTIMIZATION OF TKI TREATMENT IN ELDERLY PATIENTS WITH PH+ CHRONIC MYELOID LEUKEMIA AND STABLE MR3.0 OR MR4.0: 1ST YEAR RESULTS OF THE ITALIAN MULTICENTRIC PHASE-III RANDOMIZED OPTKIMA STUDY

Author

Malagola, M., primary, Efficace, F., additional, Polverelli, N., additional, Cottone, F., additional, Abruzzese, E., additional, Iurlo, A., additional, Bucelli, C., additional, Stagno, F., additional, Bonifacio, M., additional, D’Adda, M., additional, Lunghi, M., additional, Crugnola, M., additional, Lunghi, F., additional, Castagnetti, F., additional, Rosti, G., additional, Ferrari, M.L., additional, Bergamaschi, M., additional, Binotto, G., additional, Sancetta, R., additional, Coppi, M.R., additional, Giai, V., additional, Rege Cambrin, G., additional, Romano, A., additional, Tiribelli, M., additional, Russo, S., additional, Aprile, L., additional, Falcone, A.P., additional, Rupoli, S., additional, Russo Rossi, A., additional, Usala, E., additional, Martino, B., additional, Gandolfi, L., additional, Bernardi, S., additional, Zanaglio, C., additional, Farina, M., additional, Baccarani, M., additional, and Russo, D., additional

Published
2019
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35. PB1930 CORRELATION BETWEEN LEVELS OF EARLY MOLECULAR RESPONSE AND BCR-ABL TRANSCRIPT TYPE IN STABLE DMR ATTAINMENT IN CML PATIENTS TREATED WITH IMATINIB

Author

Tiribelli, M., primary, Bonifacio, M., additional, Binotto, G., additional, Griguolo, D., additional, Scaffidi, L., additional, Frison, L., additional, Miggiano, M.C., additional, Calistri, E., additional, Stulle, M., additional, De Biasi, E., additional, Sartori, R., additional, Stella, R., additional, Tanasi, I., additional, Ruggeri, M., additional, Damiani, D., additional, Semenzato, G., additional, Krampera, M., additional, and Fanin, R., additional

Published
2019
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38. The BCR-ABL1 transcript type influences response and outcome in Philadelphia chromosome-positive chronic myeloid leukemia patients treated frontline with imatinib

Author

Castagnetti, F, Gugliotta, G, Breccia, M, Iurlo, A, Levato, L, Albano, F, Vigneri, Paolo, Abruzzese, E, Rossi, G, Rupoli, S, Cavazzini, F, Martino, B, Orlandi, E, Pregno, P, Annunziata, M, Usala, E, Tiribelli, M, Sica, S, Bonifacio, M, Fava, C, Gherlinzoni, F, Bocchia, M, Soverini, S, Bochicchio, Mt, Cavo, M, Giovanni, M, Saglio, G, Pane, F, Baccarani, M, Rosti, G, on behalf of the GIMEMA CML Working Party, Castagnetti, Fausto, Gugliotta, Gabriele, Breccia, Massimo, Iurlo, Alessandra, Levato, Luciano, Albano, Francesco, Vigneri, Paolo, Abruzzese, Elisabetta, Rossi, Giuseppe, Rupoli, Serena, Cavazzini, Francesco, Martino, Bruno, Orlandi, Ester, Pregno, Patrizia, Annunziata, Mario, Usala, Emilio, Tiribelli, Mario, Sica, Simona, Bonifacio, Massimiliano, Fava, Carmen, Gherlinzoni, Filippo, Bocchia, Monica, Soverini, Simona, Bochicchio, Maria Teresa, Cavo, Michele, Giovanni, Martinelli, Saglio, Giuseppe, Pane, Fabrizio, Baccarani, Michele, and Rosti, Gianantonio

Subjects
Oncology, Male, Transcription, Genetic, bcr-abl, Fusion Proteins, bcr-abl, BCR-ABL1, Chronic myeloid leukemia, Philadelphia chromosome, imatinib, prognosis, transcript type, cytogenetic response, 0302 clinical medicine, CHRONIC-PHASE, CYTOGENETIC RESPONSE, MOLECULAR-BIOLOGY, END-POINTS, 800 MG, RECOMMENDATIONS, SURVIVAL, CML, BREAKPOINT, E13A2, hemic and lymphatic diseases, 80 and over, Medicine, molecular biology, Chronic, Young adult, Prospective cohort study, Aged, 80 and over, breakpoint, Leukemia, Philadelphia Chromosome Positive, Myeloid leukemia, Hematology, Middle Aged, Prognosis, Treatment Outcome, 030220 oncology & carcinogenesis, Imatinib Mesylate, Female, Transcription, prognosi, medicine.drug, Adult, medicine.medical_specialty, Adolescent, Socio-culturale, Antineoplastic Agents, Aged, Humans, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Neoplasm Grading, Neoplasm Staging, Proportional Hazards Models, Protein Kinase Inhibitors, Young Adult, survival, 03 medical and health sciences, Genetic, Internal medicine, end points, chronic phase, cytogenetic response, molecular biology, end points, recommendations, survival, CML, breakpoint, chronic phase, business.industry, Proportional hazards model, Fusion Proteins, Imatinib, medicine.disease, Settore MED/15 - MALATTIE DEL SANGUE, Immunology, recommendations, BCR-ABL Positive, business, Myelogenous, 030215 immunology
Abstract

The most frequent BCR-ABL1 fusion transcripts in chronic myeloid leukemia (CML) are the e13a2 (b2a2) and the e14a2 (b3a2) ones. In the imatinib era few studies addressing the prognostic significance of the BCR-ABL1 transcript type in early chronic phase CML have been published. Overall, these studies suggest that in e14a2 patients the response to imatinib is faster and deeper. To evaluate if the BCR-ABL1 transcript type (e13a2 compared to e14a2) affect the response to imatinib and the clinical outcome in newly diagnosed adult CML patients, 559 patients enrolled in 3 prospective studies (NCT00514488, NCT00510926, observational study CML/023) were analyzed. A qualitative PCR was performed at baseline: 52% patients had a e14a2 transcript, 37% a e13a2 transcript, 11% co-expressed both transcripts and 1% had other rare transcripts. The median follow-up was 76 months (95% of the patients had at least a 5-year observation). The complete cytogenetic response rates were comparable in e14a2 and e13a2 patients. The median time to MR(3.0) (6 and 12 months) and MR(4.0) (41 and 61 months) was significantly shorter for e14a2 patients compared to e13a2 patients, with a higher cumulative probability of MR(3.0) (88% and 83%, p

Published
2017

39. Second Generation Tyrosine Kinase Inhibitors (2G-TKI) in the Frontline Treatment of Elderly Patients with Chronic Myeloid Leukemia

Author

Stagno, F, Latagliata, R, Annunziata, M, Abruzzese, E, Castagnetti, F, Iurlo, A, Bocchia, M, Crugnola, M, Sgherza, N, Guarini, A, Sora, F, Capodanno, I, Fava, C, Gozzini, A, Bonifacio, M, Leonetti, Sc, Galimberti, S, Feo, C, Montefusco, E, Tiribelli, M, Pregno, P, Bergamaschi, M, Rizzo, M, Antolino, A, Mauro, E, Rossi, Ar, Martino, B, Palmieri, R, Esposito, Mr, Iovine, M, Danise, P, Sica, A, Vigneri, P, Breccia, M, Rosti, G, Foa, R, and Luciano, L

Published
2017

41. LONG-TERM FOLLOW-UP IN VERY ELDERLY PATIENTS WITH CHRONIC MYELOID LEUKEMIA TREATED WITH IMATINIB FRONTLINE

Author

Crugnola, M, Latagliata, R, Breccia, M, Ferrero, D, Trawinska, Mm, Castagnetti, F, Annunziata, M, Stagno, F, Tiribelli, M, Binotto, G, Fava, C, Crisa, E, Mansueto, G, Gozzini, A, Falzetti, F, Montefusco, E, Iurlo, A, Russo, S, Cedrone, M, Rossi, Ar, Gugliotta, G, Pregno, P, Isidori, A, Mauro, E, Atelda, R, Giglio, G, Celesti, F, Sora, F, Storti, S, D'Addosio, Am, Galimberti, S, Orlandi, E, Calistri, E, Bocchia, M, Cavazzini, F, Cambrin, Gr, Luciano, L, Abruzzese, E, and Capodanno, I

Published
2017

42. Pleural effusion and molecular response in dasatinib-treated chronic myeloid leukemia patients in a real-life Italian multicenter series.

Author

Iurlo, A, Galimberti, S, Abruzzese, E, Annunziata, M, Bonifacio, M, Latagliata, R, Pregno, P, Ferrero, D, Sora', Federica, Orlandi, Em, Fava, Chiara, Cattaneo, Davide, Bucelli CBinotto, G, Pungolino, E, Tiribelli, M, Gozzini, A, Gugliotta, G, Castagnetti, F, Stagno, F, Rege-Cambrin, G, Martino, B, Luciano, L, Breccia, M, Sica, Simona, Bocchia, M, Pane, F, Saglio, G, Rosti, G, Specchia, G, Cortelezzi, A, Baccarani, M, Sorà F (ORCID:0000-0002-9607-5298), Sica S (ORCID:0000-0003-2426-3465), Iurlo, A, Galimberti, S, Abruzzese, E, Annunziata, M, Bonifacio, M, Latagliata, R, Pregno, P, Ferrero, D, Sora', Federica, Orlandi, Em, Fava, Chiara, Cattaneo, Davide, Bucelli CBinotto, G, Pungolino, E, Tiribelli, M, Gozzini, A, Gugliotta, G, Castagnetti, F, Stagno, F, Rege-Cambrin, G, Martino, B, Luciano, L, Breccia, M, Sica, Simona, Bocchia, M, Pane, F, Saglio, G, Rosti, G, Specchia, G, Cortelezzi, A, Baccarani, M, Sorà F (ORCID:0000-0002-9607-5298), and Sica S (ORCID:0000-0003-2426-3465)

Abstract

Pleural effusion (PE) represents the leading cause of dasatinib (DAS) discontinuation. However, the pathogenic mechanism of this adverse event (AE) is unknown and its management unclear. We investigated if a DAS dose reduction after the first PE would prevent the recurrence of this AE. We retrospectively collected data on all the cases of PE in CML-chronic phase (CP) DAS-treated patients from November 2005 to February 2017 in 21 Italian hematological centers. We identified 196 cases of PE in a series of 853 CML-CP DAS-treated patients (incidence 23.0%). DAS starting dose was 100 mg/day in 70.4% of patients, less than 100 mg/day in 14.3%, and more than 100 mg/day in the remaining cases. Median time from DAS start to PE was 16.6 months. At first PE development, 28.6% of patients were in MMR, and 37.8% in deep molecular response (DMR). DAS was temporary interrupted in 71.9% of cases, with a dose reduction in 59.2%. Recurrence was observed in 59.4% of the cases. Treatment was definitively discontinued due to PE in 29.1% of the cases. Interestingly, among patients whose DAS dosage was reduced, 59.5% experienced PE recurrence. DAS dose reduction after the first episode of PE did not prevent recurrence of this AE. Therefore, once a MMR or a DMR is achieved, different strategies of DAS dose management can be proposed prior to the development of PE, such as daily dose reduction or, as an alternative option, an on/off treatment with a weekend drug holiday.

Published
2017

43. Long term outcome of ph+ cml patients achieving complete cytogenetic remission with interferon based therapy moving from interferon to imatinib era

Author

Malagola M, Breccia M, Skert C, Cancelli V, Cattina F, Liberati AM, Tiribelli M, Annunziata M, Trabacchi E, De Vivo A, Fogli M, Stagno F, Pica G, Iurlo A, Pregno P, Abruzzese E, Pardini S, Bocchia M, Russo S, Pierri I, Lunghi M, Barulli S, Merante S, Mandelli F, Alimena G, Russo D., SOVERINI, SIMONA, IACOBUCCI, ILARIA, CASTAGNETTI, FAUSTO, MARTINELLI, GIOVANNI, ROSTI, GIANANTONIO, BACCARANI, MICHELE, Malagola M, Breccia M, Skert C, Cancelli V, Soverini S, Iacobucci I, Cattina F, Liberati AM, Tiribelli M, Annunziata M, Trabacchi E, De Vivo A, Castagnetti F, Martinelli G, Fogli M, Stagno F, Pica G, Iurlo A, Pregno P, Abruzzese E, Pardini S, Bocchia M, Russo S, Pierri I, Lunghi M, Barulli S, Merante S, Mandelli F, Alimena G, Rosti G, Baccarani M, and Russo D.

Subjects
Adult, Male, EUROPE, Fusion Proteins, bcr-abl, MULTICENTER, Antineoplastic Agents, Piperazines, RECOMMENDATIONS, Young Adult, CHRONIC MYELOID-LEUKEMIA, CHRONIC MYELOGENOUS LEUKEMIA, MOLECULAR RESPONSE, RESIDUAL DISEASE, T-LYMPHOCYTES, ALPHA, TRANSCRIPTS, INTERFERON THERAPY, hemic and lymphatic diseases, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Antineoplastic Combined Chemotherapy Protocols, Humans, BCR-ABL, Protein Kinase Inhibitors, Aged, Retrospective Studies, Drug Substitution, Remission Induction, Interferon-alpha, Middle Aged, Cross-Sectional Studies, Pyrimidines, Treatment Outcome, Benzamides, Imatinib Mesylate, Female, CHRONIC MYELOID LEUKEMIA (CML), Follow-Up Studies
Abstract

Interferon α (IFNα) prolongs survival of CML patients achieving CCyR and potentially synergizes with TKIs. We report on the molecular status and long term outcome of 121 patients who were treated in Italy between 1986 and 2000 with IFNα based therapy and who obtained CCyR. After a median follow up of 16.5 years, 74 (61%) patients were switched to standard imatinib: 48 (65%) lost the CCyR on IFNα, and 36 (75%) are alive and in CCyR; 26 (35%) were switched to imatinib when they were still in CCyR on IFNα, and all 26 are alive and in CCyR. Forty-seven patients (39%) were never switched to imatinib: 24 (51%) continued and 23 (49%) discontinued IFNα, respectively, and 39/47 (83%) are alive and in CCyR. At last follow-up, the BCR-ABL transcripts level was available in 96/101 living patients (95%) The BCR-ABL:ABL ratio was between 0.1 and 0.01% (MR(3.0) ) in 17%, and less than 0.01% (MR(4.0) ) in 81% of patients. No patient was completely molecular negative (MR(4.5) or MR(5.0) ). The OS at 10 and 20 years is 92 and 84%, respectively. This study confirms that CCyR achieved with IFNα and maintained with or without imatinib or any other therapy significantly correlates with long term survival in CML patients who mostly have MR(4.0) . Complete molecular response (MR(4.5) or MR(5.0) ) seems to be unnecessary for such a long survival. This study further supports development of studies testing the clinical effect of the combinations of TKIs with IFNα.

Published
2014

44. Real-life comparison of dasatinib and nilotinib as second-line therapy after imatinib failure for chronic phase CML

Author

Tiribelli, M., Massimiliano BONIFACIO, Binotto, G., Iurlo, A., Cibien, F., Maino, E., Guella, A., Festini, G., Minotto, C., Biasi, E., Marchi, F., Scaffidi, Luigi, Frison, L., Bucelli, C., Medeot, M., Calistri, E., Sancetta, R., Stulle, M., Krampera, Mauro, Gherlinzoni, F., Semenzato, G., Ambrosetti, Achille, and Fanin, R.

Subjects
chronic myeloid leukemia, dasatinib, prognosis, chronic myeloid leukemia, nilotinib, dasatinib, prognosis, nilotinib
Published
2016

45. BCR-ABL fusion transcript b2a2 is associated with a higher risk of non-optimal early response in CP-CML patients treated with standard dose imatinib: a study from Gruppo Triveneto LMC

Author

Binotto, G., Tiribelli, M., Massimiliano BONIFACIO, Frison, L., Narbergoj, M., Marchi, F., Scaffidi, Luigi, Medeot, M., Maino, E., Calistri, E., Bonalumi, A., Krampera, Mauro, Ambrosetti, Achille, Fanin, R., and Semenzato, G.

Subjects
chronic myeloid leukemia, chronic myeloid leukemia, fusion transcript, prognosis, fusion transcript, prognosis
Published
2016

46. THE EUTOS LONG-TERM SURVIVAL SCORE IS PREDICTIVE FOR RESPONSE AND OUTCOME IN CML PATIENTS TREATED FRONTLINE WITH NILOTINIB-BASED REGIMENS

Author

Castagnetti, F., Gugliotta, G., Breccia, M., Stagno, F., D’Adda, M., Levato, L., Carella, Am, Martino, B., Tiribelli, M., Fava, C., Binotto, G., Avanzini, P., Bocchia, M., Bergamaschi, M., Russo Rossi, A., Cavazzini, Francesco, Abruzzese, E., Soverini, S., Alimena, G., Cavo, M., Martinelli, G., Pane, F., Saglio, G., Baccarani, M., and Rosti, G.

Subjects
Socio-culturale
Published
2016

47. Predictors of stable deep molecular response in chronic phase chronic myeloid leukemia patients treated with dasatinib or nilotinib after imatinib failure

Author

Massimiliano BONIFACIO, Binotto, G., Tiribelli, M., Scaffidi, Luigi, Iurlo, A., Cibien, F., Maino, E., Guella, A., Festini, G., Minotto, C., Biasi, E., Frison, Luca, Marchi, F., Medeot, M., Bucelli, C., Calistri, E., Stulle, M., Gherlinzoni, F., Cortelezzi, A., Fanin, R., Semenzato, Giampietro, Krampera, Mauro, Pizzolo, Giovanni, and Ambrosetti, Achille

Subjects
chronic myeloid leukemia, nilotinib, dasatinib, deep molecular response, chronic myeloid leukemia, dasatinib, nilotinib, deep molecular response
Published
2016

48. Contribution of ABL kinase domain mutations to imatinib resistance in different subsets of Philadelphia-positive patients: by the GIMEMA Working Party on Chronic Myeloid Leukemia

Author

SOVERINI, SIMONA, COLAROSSI, SABRINA, GNANI, ALESSANDRA, ROSTI, GIANANTONIO, CASTAGNETTI, FAUSTO, POERIO, ANGELA, IACOBUCCI, ILARIA, AMABILE, MARILINA, BACCARANI, MICHELE, MARTINELLI, GIOVANNI, Abruzzese E, Orlandi E, Radaelli F, Ciccone F, Tiribelli M, di Lorenzo R, Caracciolo C, Izzo B, Pane F, Saglio G, on behalf of the GIMEMA Working Party on Chronic Myeloid Leukemia, Soverini, S, Colarossi, S, Gnani, A, Rosti, G, Castagnetti, F, Poerio, A, Iacobucci, I, Amabile, M, Abruzzese, E, Orlandi, E, Radaelli, F, Ciccone, F, Tiribelli, M, DI LORENZO, R, Caracciolo, C, Izzo, Barbara, Pane, Fabrizio, Saglio, G, Baccarani, M, Martinelli, G., Soverini S, Colarossi S, Gnani A, Rosti G, Castagnetti F, Poerio A, Iacobucci I, Amabile M, Abruzzese E, Orlandi E, Radaelli F, Ciccone F, Tiribelli M, di Lorenzo R, Caracciolo C, Izzo B, Pane F, Saglio G, Baccarani M, Martinelli G, and on behalf of the GIMEMA Working Party on Chronic Myeloid Leukemia (GIMEMA-CML)

Subjects
Adult, Cancer Research, Myeloid, Adolescent, DNA Mutational Analysis, Antineoplastic Agents, Genes, abl, Biology, IMATINIB, Piperazines, Myelogenous, Gene Frequency, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, hemic and lymphatic diseases, medicine, Humans, Chromatography, High Pressure Liquid, Aged, Neoplasm Staging, CHRONIC MYELOID LEUKEMIA, ABL, MUTATIONS, Myeloid leukemia, Imatinib, Middle Aged, medicine.disease, Hematologic Response, Protein Structure, Tertiary, Leukemia, Pyrimidines, Imatinib mesylate, medicine.anatomical_structure, Oncology, Drug Resistance, Neoplasm, ABL KINASE DOMAIN, Benzamides, Mutation, Imatinib Mesylate, Cancer research, Protein Kinases, RESISTANCE, medicine.drug
Abstract

Purpose: ABL kinase domain mutations have been implicated in the resistance to the BCR-ABL inhibitor imatinib mesylate of Philadelphia-positive (Ph+) leukemia patients. Experimental Design: Using denaturing high-performance liquid chromatography and sequencing, we screened for ABL kinase domain mutations in 370 Ph+ patients with evidence of hematologic or cytogenetic resistance to imatinib. Results: Mutations were found in 127 of 297 (43%) evaluable patients. Mutations were found in 27% of chronic-phase patients (14% treated with imatinib frontline; 31% treated with imatinib post-IFN failure), 52% of accelerated-phase patients, 75% of myeloid blast crisis patients, and 83% of lymphoid blast crisis/Ph+ acute lymphoblastic leukemia (ALL) patients. Mutations were associated in 30% of patients with primary resistance (44% hematologic and 28% cytogenetic) and in 57% of patients with acquired resistance (23% patients who lost cytogenetic response; 55% patients who lost hematologic response; and 87% patients who progressed to accelerated phase/blast crisis). P-loop and T315I mutations were particularly frequent in advanced-phase chronic myeloid leukemia and Ph+ ALL patients, and often accompanied progression from chronic phase to accelerated phase/blast crisis. Conclusions: We conclude that (a) amino acid substitutions at seven residues (M244V, G250E, Y253F/H, E255K/V, T315I, M351T, and F359V) account for 85% of all resistance-associated mutations; (b) the search for mutations is important both in case of imatinib failure and in case of loss of response at the hematologic or cytogenetic level; (c) advanced-phase chronic myeloid leukemia and Ph+ ALL patients have a higher likelihood of developing imatinib-resistant mutations; and (d) the presence of either P-loop or T315I mutations in imatinib-treated patients should warn the clinician to reconsider the therapeutic strategy.

Published
2007

49. High frequency of small insertions and deletions in the BCR-ABL Kinase Domain revealed by ultra-deep sequencing

Author

De Benedittis C, Soverini S, Machova Polakova K, Brouckova A, Castagnetti F, Gugliotta G, Palandri F, Papayannidis C, Klamova H, Bresciani P, Coluccio V, Salvucci M, Tiribelli M, Binotto G, Intermesoli T, Iacobucci I, Venturi C, Luppi M, Ottaviani E, Bochicchio MT, Cattina F, Mancini M, Leo E, Haferlach T, Kohlmann A, Russo D, Rosti G, Baccarani M, Cavo M, Martinelli G, and De Benedittis C, Soverini S, Machova Polakova K, Brouckova A, Castagnetti F,Gugliotta G, Palandri F, Papayannidis C, Klamova H, Bresciani P, Coluccio V, Salvucci M, Tiribelli M, Binotto G, Intermesoli T, Iacobucci I, Venturi C, Luppi M, Ottaviani E, Bochicchio MT, Cattina F, Mancini M, Leo E, Haferlach T, Kohlmann A, Russo D, Rosti G, Baccarani M, Cavo M, Martinelli G

Subjects
Philadelphia-positive Leukemia, 35-base insertion, Bcr-Abl kinase domain mutation, 35INS, deletion, deep-amplicon sequencing, resistance to tyrosine kinase inhibitor, insertion
Published
2013

50. VERY ELDERLY CP-CML PATIENTS TREATED WITH IMATINIB FRONTLINE: HAVE CONCOMITANT THERAPIES AN IMPACT ON OUTCOME AND TOXICITY?

Author

Iurlo, A, Latagliata, R, Bucelli, C, Ferrero, Dario, Castagnetti, F, Breccia, M, Abruzzese, E, Fava, Carmen, Annunziata, M, Stagno, F, Vigneri, P, Tiribelli, M, Cavazzini, F, Binotto, G, Mansueto, G, Gozzini, A, Russo, S, Falzetti, F, Montefusco, E, Gugliotta, G, Cattaneo, D, Djade, Cd, Cedrone, M, Rossi, Ar, Avanzini, P, Pregno, P, Mauro, E, Endri, M, Spadea, A, Celesti, F, Giglio, G, Isidori, A, Crugnola, M, Calistri, E, Sora, F, Sica, S, Storti, S, D'Addosio, A, Rege Cambrin, G, Luciano, L, Saglio, Giuseppe, Rosti, G, Alimena, G, Nobili, A, and Cortelezzi, A.

Published
2015

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