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1772 Baseline Features, Treatment Choice and Early Frontline TKI Permanent Discontinuation in Patients with Newly Diagnosed Chronic Myeloid Leukemia Aged 50 – 60 Years: A “Campus CML” Study

Program: Oral and Poster Abstracts
Session: 632. Chronic Myeloid Leukemia: Clinical and Epidemiological: Poster I
Hematology Disease Topics & Pathways:
Adult, CML, Chronic Myeloid Malignancies, Diseases, Therapy sequence, Treatment Considerations, Myeloid Malignancies, Study Population, Human
Saturday, December 7, 2024, 5:30 PM-7:30 PM

Roberto Latagliata1*, Isabella Capodanno, MD2*, Maria Cristina Miggiano3*, Cristina Bucelli, MD4*, Sabrina Leonetti Crescenzi, MD5*, Sabina Russo, MD6*, Ida Carmosino, MD7*, Atelda Romano, MD8*, Federica Sorà9*, Massimiliano Bonifacio, MD10*, Luigiana Luciano, MD11, Giovanni Caocci, MD12, Giuseppina Loglisci, MD13*, Chiara Elena14*, Francesca Lunghi15*, Rikard Mullai, MD16*, Immacolata Attolico17*, Gianni Binotto, MD18*, Elena Crisà, MD19*, Paolo Sportoletti20*, Francesco Cavazzini, MD21*, Ambra Di Veroli, MD22*, Anna Rita Scortechini, MD23*, Anna Paola Leporace, MD24*, Alessandro Maggi, MD25*, Monica Crugnola, MD26*, Fabio Stagno, MD, PhD27, Marco Santoro28*, Pamela Murgano, MD29*, Davide Rapezzi, MD30*, Debora Luzi, MD31*, Jolanda Donatella Vincelli, MD32*, Sara Galimberti, MD33*, Monica Bocchia, MD34*, Carmen Fava, MD, PhD35*, Alessandra Malato36*, Elisabetta Abruzzese, MD37, Michele Pizzuti, MD38*, Alessandra Iurlo, MD, PhD39*, Giuseppe Saglio, MD40, Giorgina Specchia, MD, PhD41, Massimo Breccia42* and Mario Tiribelli, MD43*

1Hematology Unit, Ospedale Belcolle, Viterbo, Italy, Rome, ITA
2hematology, AUSL Reggio Emilia, Reggio Emilia, Italy
3Hematology Department, San Bortolo Hospital, Vicenza U.O.C. di Ematologia, Vicenza, ITA
4FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO, MILANO, Italy
5Division of Hematology, Azienda Ospedaliera San Giovanni Addolorata, Roma, Italy
6Division of Hematology, Dipartimento di Patologia Umana dell'Adulto e dell'Età Evolutiva,, Hematology Section, AOU Policlinico "G Martino", University of Messina, Italy, Messina, Italy
7Hematology, Department of Translational and Precision Medicine, Azienda Ospedaliera Policlinico Umberto I, Sapienza University of Rome, Rome, Italy
8IRCCS Regina Elena National Cancer Institute, Rome, ITA
9Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy
10Department of Engineering for Innovation Medicine, Section of Innovation Biomedicine, Hematology Area, University of Verona, Verona, Italy
11Hematology Unit, Federico II University, Napoli, Italy
12University of Cagliari, Monserrato, Italy
13Hematology, Vito Fazzi Hospital, Lecce, Lecce, ITA
14U.O.C Ematologia 1, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy
15Division of Hematology and BMT, IRCCS San Raffaele Hospital, Milan, Italy, Milan, Italy
16Division of Hematology and BMT, Department of Medical Area, University of Udine, Udine, Udine, Italy
17University of Bari, Department of Emergency and Organ Transplantation (D.E.T.O.), Hematology Section, Bari, Bari, Italy
18Department of Medicine, Hematology and Clinical Immunology, University of Padua, Padua, Italy
19Hematology, Ospedale Maggiore, Novara, Italy
20Department of Medicine and Surgery, Institute of Hematology, Centro di Ricerca Emato Oncologica (CREO), University of Perugia, Perugia, Italy
21Division of Hematology, Arcispedale Sant'Anna, University of Ferrara, Ferrara, ITA
22Hematology, Belcolle Hospital, Viterbo, Italy
23Division of Hematology, Department of Molecular and Clinical Sciences, University of Marche, Ancona, Italy, Ancona, Italy
2423. Hematology Unit Azienda Ospedaliero Universitaria Sant'Andrea, Rome, Rome, Italy
25Division of Hematology and Bone Marrow Transplant, Ospedale S.G. Moscati, Taranto, Italy
26Hematology Unit and BMT, University Hospital of Parma, Parma, Italy
27Hematology Section, Biomedical Sciences, Trecastagni, Catania, Italy
28Hematology Unit, University Hospital "Paolo Giaccone", Palermo, Italy
29Division of Hematology, Sant'Elia Hospital, Caltanissetta, Caltanissetta, Italy
30Department of Hematology, S. Croce e Carle Hospital, Cuneo, Italy
31Onco-Hematology Department, AO Santa Maria, Terni, Terni, Italy
32Hematology Unit, Hemato-Oncology and Radiotherapy Department, Grande Ospedale Metropolitano "Bianchi-Melacrino-Morelli", 89124 Reggio Calabria, RC, Italy, REGGIO CALABRIA, Italy
33Department of Clinical and Experimental Medicine, Hematology, University of Pisa, Pisa, Italy
34Hematology, Azienda Ospedaliera Universitaria Senese, University of Siena, Siena, Italy
35Hematology, Mauriziano Hospital, Torino, Turin, Italy
36Hospital Riuniti Villa Sofia Cervello, Palermo, Italy
37Department of Hematology, S. Eugenio Hospital, Tor Vergata University, ASL Roma 2, Roma, I, Italy
38Department of Onco-Hematology, “San Carlo” Regional Hospital, Potenza, Italy
39Hematology Division, Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano, Italy
40Dept. of Clinical and Biological Sciences, University of Turin, Turin, Italy
41Former Full Professor of Hematology, University of Bari, Bari, Italy
42Department of Translational and Precision Medicine, Az., Hematology-Sapienza University, Rome, Italy
43Division of Hematology and BMT, Department of Medical Area, University of Udine, Udine, Italy

Introduction: Median age at diagnosis in patients (pts) with Chronic Myeloid Leukemia (CML) is 58 - 60 years: while Second Generation Tyrosine-Kinase Inhibitors (2G-TKIs) are preferred in younger pts and imatinib (IMA) in elderly pts, there is no definite consensus on the best choice in middle-aged cases Aim: To analyze initial features, choice of frontline TKI and early adverse events leading to permanent TKI discontinuation in the first 12 months from TKI start in newly diagnosed subjects aged 50 - 60 in a large real-life cohort of CML pts Methods: Among 1967 CML pts newly diagnosed from 1/2012 to 12/2019 in 38 Italian Centers participating at the “Campus CML” project, 424 (21.5%) aged 50 - 60 years: their features at diagnosis and during the first year of TKI treatment were collected and analyzed in the present report Results: According to responsible physician choice, 191 pts (45.0%) received frontline IMA and 233 (55.0%) a 2G-TKI (dasatinib in 78, nilotinib in 135). Comparing the main clinical features at diagnosis according to frontline TKI, pts treated with 2G-TKI had higher WBC count (69.0 vs 48.8 x 109/l, p=0.002) and int/high-risk Sokal score (55.6 vs 42.2%, p=0.006), while pts treated with IMA had higher rates of comorbidities/concomitant drugs (p<0.001). Twenty-six pts had only baseline data and were not evaluable for early adverse events: among the remaining 398 pts, 73 (18.6%) needed permanent frontline TKI discontinuation in the first 12 months, due to hematologic toxicity (11 pts, 2.8%), extra-hematologic toxicity (19 pts, 4.8%), primary resistance (38 pts, 9.5%), secondary resistance (1 pts, 0.3%), evolution in blast phase (2 pts, 0.6%) and unrelated death (2 pts, 0.6%). On the whole, 51/185 pts treated with IMA (27.6%) discontinued frontline TKI treatment versus 22/213 (10.3%) treated with 2G-TKI (p<0.001). Cumulative incidence of discontinuation at 12 months was 25.8% (95%CI 19.5 – 32.1) in pts treated with IMA versus 9.5% (95%CI 5.6 – 13.4) in pts treated with 2G-TKI (p<0.001). The difference remained significant also considering different Sokal risk groups [17.8% versus 4.5% in low risk (p=0.004), 34.4% versus 13.1% in intermediate risk (p=0.002) and 55.6% versus 13.8% in high risk (p=0.003)] Conclusions: Frontline treatment of pts in this age group is still heterogenous in the current clinical practice: concomitant diseases, which are very rare in younger pts, start to be more common in this age group and represent an important criterion of TKI choice. Present data seem to encourage the use of frontline 2G-TKI in this subset, but data on molecular response and late toxicities are warranted to complete present analysis

Disclosures: Latagliata: BMS: Honoraria; Abbvie: Honoraria; Novartis: Consultancy, Honoraria. Capodanno: Celgene: Honoraria, Speakers Bureau; Novartis: Honoraria, Speakers Bureau; Incyte: Honoraria, Speakers Bureau; Pfizer: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; BMS: Honoraria. Bonifacio: Pfizer: Membership on an entity's Board of Directors or advisory committees; Amgen: Honoraria; Incyte: Membership on an entity's Board of Directors or advisory committees; Novartis: Membership on an entity's Board of Directors or advisory committees; BMS: Membership on an entity's Board of Directors or advisory committees. Sportoletti: Janssen; AstraZeneca, Abbvie; BeiGene: Honoraria, Membership on an entity's Board of Directors or advisory committees. Crugnola: BMS: Speakers Bureau; Novartis: Speakers Bureau. Stagno: Novartis: Honoraria, Speakers Bureau; Incyte: Honoraria, Speakers Bureau. Galimberti: Jazz: Honoraria, Other: support for attending meetings; Novartis: Honoraria, Other: support for attending meetings; Incyte: Honoraria; Roche: Honoraria, Other: support for attending meetings; Celgene: Honoraria; Pfizer: Honoraria; AstraZeneca: Honoraria, Other: support for attending meetings; AbbVie: Honoraria, Other: support for attending meetings; Janssen: Honoraria. Bocchia: Novartis: Honoraria, Other: travel grant; Incyte: Honoraria, Other: travel grant; Abbvie: Honoraria, Other: travel grants. Abruzzese: Ascentage: Consultancy; MorphoSys: Consultancy; Novartis: Consultancy; Pfizer: Consultancy; Incyte: Consultancy; BMS: Consultancy. Iurlo: AOP: Consultancy, Honoraria; BMS: Consultancy, Honoraria; Pfizer: Consultancy, Honoraria; GSK: Consultancy, Honoraria; Incyte: Consultancy, Honoraria; Novartis: Consultancy, Honoraria. Saglio: Hikma: Speakers Bureau; Ascentage Pharma: Consultancy; Novartis: Consultancy, Speakers Bureau. Breccia: Incyte: Honoraria; Pfizer: Honoraria; Abbvie: Honoraria; BMS: Honoraria; AOP: Honoraria; Novartis: Honoraria; GSK: Honoraria.

*signifies non-member of ASH