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

Mario Tiribelli^{1

2}, Roberto Latagliata³, Massimo Breccia⁴, Isabella Capodanno⁵, Maria Cristina Miggiano⁶, Francesco Cavazzini⁷, Cristina Bucelli⁸, Immacolata Attolico⁹, Sabrina Leonetti Crescenzi¹⁰, Sabina Russo¹¹, Mario Annunziata¹², Federica Sorà¹³, Massimiliano Bonifacio¹⁴, Olga Mulas¹⁵, Giuseppina Loglisci¹⁶, Alessandro Maggi¹⁷, Gianni Binotto¹⁸, Elena Crisà¹⁹, Anna Rita Scortechini²⁰, Anna Paola Leporace²¹, Rosaria Sancetta²², Pamela Murgano²³, Elisabetta Abruzzese²⁴, Fabio Stagno²⁵, Davide Rapezzi²⁶, Debora Luzi²⁷, Iolanda Vincelli²⁸, Monica Bocchia²⁹, Carmen Fava³⁰, Alessandra Malato³¹, Monica Crugnola³², Michele Pizzuti³³, Francesca Lunghi³⁴, Sara Galimberti³⁵, Matteo Dalmazzo³⁶, Renato Fanin^{1

2}, Emilia Scalzulli⁴, Robin Foà⁴, Alessandra Iurlo⁸, Giuseppe Saglio³⁰, Giorgina Specchia⁹

Affiliations

¹ Division of Hematology and Bone Marrow Transplant, Azienda Sanitaria Universitaria Friuli Centrale, Udine, Italy.
² Department of Medical Area, University of Udine, Udine, Italy.
³ Hematology Unit, Ospedale Belcolle, Viterbo, Italy.
⁴ Hematology, Department of Precision and Translational Medicine, "Sapienza" University, Rome, Italy.
⁵ Hematology Unit, Azienda Unità Sanitaria Locale-IRCCS, Reggio Emilia, Italy.
⁶ Hematology Department, San Bortolo Hospital, Vicenza, Italy.
⁷ Hematology Unit, University of Ferrara, Ferrara, Italy.
⁸ Division of Hematology, Foundation IRCCS Ca' Granda-Ospedale Maggiore Policlinico, Milan, Italy.
⁹ Hematology Section, Department of Emergency and Organ Transplantation, University of Bari, Bari, Italy.
¹⁰ Hematology, San Giovanni Hospital, Rome, Italy.
¹¹ Hematology, University of Messina, Messina, Italy.
¹² Hematology Unit, Presidio Ospedaliero Moscati, Aversa, Italy.
¹³ Institute of Hematology, Fondazione Policlinico Universitario A. Gemelli IRCCS, and Department of Radiological and Hematological Sciences, Cattolica University, Rome, Italy.
¹⁴ Section of Hematology, Department of Medicine, University of Verona, Verona, Italy.
¹⁵ Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy.
¹⁶ Hematology, Vito Fazzi Hospital, Lecce, Italy.
¹⁷ Hematology, Ospedale San Giuseppe Moscati, Taranto, Italy.
¹⁸ Hematology and Clinical Immunology, Department of Medicine, University of Padua, Padua, Italy.
¹⁹ Hematology, Ospedale Maggiore della Carità di Novara, University of Eastern Piedmont, Novara, Italy.
²⁰ Hematology Unit, Azienda Ospedaliero Universitaria Ospedali Riuniti, Ancona, Italy.
²¹ Hematology Unit, Azienda Ospedaliero Universitaria Sant'Andrea, Rome, Italy.
²² Hematology Unit, Dell'Angelo Hospital, Venezia-Mestre, Italy.
²³ Division of Hematology, Sant'Elia Hospital, Caltanissetta, Italy.
²⁴ Division of Hematology, S. Eugenio Hospital, Rome, Italy.
²⁵ Hematology Section and Bone Marrow Transplant Unit, Rodolico Hospital, Azienda Ospedaliero Universitaria Policlinico "Rodolico-San Marco", Catania, Italy.
²⁶ Hematology, Azienda Ospedaliera Santa Croce e Carle, Cuneo, Italy.
²⁷ Onco-Hematology Department, Azienda Ospedaliera Santa Maria, Terni, Italy.
²⁸ Hematology, Bianchi-Melacrino-Morelli Hospital, Reggio Calabria, Italy.
²⁹ Hematology, Azienda Ospedaliero Universitaria Senese, Siena, Italy.
³⁰ Department of Clinical and Biological Sciences, University of Turin, Turin, Italy.
³¹ Hematology, Cervello Hospital, Palermo, Italy.
³² Hematology and Stem Cell Transplant Unit, Azienda Ospedaliero Universitaria, Parma, Italy.
³³ Hematology, San Carlo Hospital, Potenza, Italy.
³⁴ Hematology, San Raffaele Hospital, Milan, Italy.
³⁵ Hematology, University of Pisa, Pisa, Italy.
³⁶ Division of Hematology and Internal Medicine, "San Luigi Gonzaga" University Hospital, Turin, Italy.

PMID: 37354090
DOI: 10.1002/cncr.34923

Observational Study

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

Mario Tiribelli et al. Cancer. 2023.

. 2023 Sep 1;129(17):2637-2644.

doi: 10.1002/cncr.34923. Epub 2023 Jun 24.

Authors

Affiliations

¹ Division of Hematology and Bone Marrow Transplant, Azienda Sanitaria Universitaria Friuli Centrale, Udine, Italy.
² Department of Medical Area, University of Udine, Udine, Italy.
³ Hematology Unit, Ospedale Belcolle, Viterbo, Italy.
⁴ Hematology, Department of Precision and Translational Medicine, "Sapienza" University, Rome, Italy.
⁵ Hematology Unit, Azienda Unità Sanitaria Locale-IRCCS, Reggio Emilia, Italy.
⁶ Hematology Department, San Bortolo Hospital, Vicenza, Italy.
⁷ Hematology Unit, University of Ferrara, Ferrara, Italy.
⁸ Division of Hematology, Foundation IRCCS Ca' Granda-Ospedale Maggiore Policlinico, Milan, Italy.
⁹ Hematology Section, Department of Emergency and Organ Transplantation, University of Bari, Bari, Italy.
¹⁰ Hematology, San Giovanni Hospital, Rome, Italy.
¹¹ Hematology, University of Messina, Messina, Italy.
¹² Hematology Unit, Presidio Ospedaliero Moscati, Aversa, Italy.
¹³ Institute of Hematology, Fondazione Policlinico Universitario A. Gemelli IRCCS, and Department of Radiological and Hematological Sciences, Cattolica University, Rome, Italy.
¹⁴ Section of Hematology, Department of Medicine, University of Verona, Verona, Italy.
¹⁵ Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy.
¹⁶ Hematology, Vito Fazzi Hospital, Lecce, Italy.
¹⁷ Hematology, Ospedale San Giuseppe Moscati, Taranto, Italy.
¹⁸ Hematology and Clinical Immunology, Department of Medicine, University of Padua, Padua, Italy.
¹⁹ Hematology, Ospedale Maggiore della Carità di Novara, University of Eastern Piedmont, Novara, Italy.
²⁰ Hematology Unit, Azienda Ospedaliero Universitaria Ospedali Riuniti, Ancona, Italy.
²¹ Hematology Unit, Azienda Ospedaliero Universitaria Sant'Andrea, Rome, Italy.
²² Hematology Unit, Dell'Angelo Hospital, Venezia-Mestre, Italy.
²³ Division of Hematology, Sant'Elia Hospital, Caltanissetta, Italy.
²⁴ Division of Hematology, S. Eugenio Hospital, Rome, Italy.
²⁵ Hematology Section and Bone Marrow Transplant Unit, Rodolico Hospital, Azienda Ospedaliero Universitaria Policlinico "Rodolico-San Marco", Catania, Italy.
²⁶ Hematology, Azienda Ospedaliera Santa Croce e Carle, Cuneo, Italy.
²⁷ Onco-Hematology Department, Azienda Ospedaliera Santa Maria, Terni, Italy.
²⁸ Hematology, Bianchi-Melacrino-Morelli Hospital, Reggio Calabria, Italy.
²⁹ Hematology, Azienda Ospedaliero Universitaria Senese, Siena, Italy.
³⁰ Department of Clinical and Biological Sciences, University of Turin, Turin, Italy.
³¹ Hematology, Cervello Hospital, Palermo, Italy.
³² Hematology and Stem Cell Transplant Unit, Azienda Ospedaliero Universitaria, Parma, Italy.
³³ Hematology, San Carlo Hospital, Potenza, Italy.
³⁴ Hematology, San Raffaele Hospital, Milan, Italy.
³⁵ Hematology, University of Pisa, Pisa, Italy.
³⁶ Division of Hematology and Internal Medicine, "San Luigi Gonzaga" University Hospital, Turin, Italy.

PMID: 37354090
DOI: 10.1002/cncr.34923

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.

Keywords: CML; TKI; frontline therapy; imatinib; second-generation TKI.

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References

REFERENCES

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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

Affiliations

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

Authors

Affiliations

Abstract

References

REFERENCES

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Substances

LinkOut - more resources

Miscellaneous