Bucelli C, Capodanno I, Miggiano M C, Cavazzini F, Crescenzi S Leonetti, Russo S, Carmosino I, Annunziata M, Sorà F, Bonifacio M, Luciano L, Caocci G, Loglisci G, Elena C, Lunghi F, Mullai R, Attolico I, Binotto G, Crisà E, Sportoletti P, Di Veroli A, Scortechini A R, Leporace A P, Maggi A, Crugnola M, Stagno F, Sancetta R, Murgano P, Rapezzi D, Luzi D, Vincelli D I, Galimberti S, Bocchia M, Fava C, Malato A, Abruzzese E, Saglio G, Specchia G, Breccia M, Iurlo A, Tiribelli M, Latagliata R
Hematology Division, Foundation IRCCS Ca' Granda-Ospedale Maggiore Policlinico, Milan, Italy.
Hematology Unit, Azienda Unità Sanitaria Locale-IRCCS, Reggio Emilia, Italy.
Eur J Haematol. 2025 Jan;114(1):37-44. doi: 10.1111/ejh.14299. Epub 2024 Sep 12.
The study aimed to evaluate the utilization of frontline TKI therapy in a large cohort of elderly CP-CML patients.
A retrospective analysis was conducted on 332 CP-CML patients aged 75 years or older among 1929 diagnosed from January 2012 to December 2019 followed at 36 participating Hematology Centers involved in the "Campus CML" project.
Among the patients analyzed, 85.8% received imatinib (IM) while 14.2% received second-generation TKIs (2G-TKI), 59.5% dasatinib, and 40.5% nilotinib. Most patients initiated IM at standard dose (67.3%) while 32.7% at reduced dose. A similar trend was observed with 2G-TKIs. The cumulative incidence of permanent TKI discontinuation at 12 months was 28.4%, primarily due to primary resistance (10.1%) and extra-hematologic toxicity (9.5%), with no significant difference between IM and 2G-TKI groups. Following the introduction of generic IM in Italy in 2018, IM usage increased significantly compared with 2G-TKIs.
IM was in our Centers the preferred frontline therapy for older CP-CML patients, with increasing utilization after the introduction of generic formulations. However, 2G-TKIs are still used in a substantial proportion of patients, suggesting individualized physician assessments regarding patient suitability and expectations. Further investigation is needed to assess efficacy and safety of reduced TKI doses in this patient population.
本研究旨在评估一线酪氨酸激酶抑制剂（TKI）疗法在一大群老年慢性期慢性髓性白血病（CP-CML）患者中的应用情况。
对参与“慢性髓性白血病研究项目”的36家血液学中心在2012年1月至2019年12月期间诊断的1929例患者中的332例75岁及以上的CP-CML患者进行回顾性分析。
在分析的患者中，85.8%接受伊马替尼（IM）治疗，14.2%接受第二代TKI（2G-TKI）治疗，其中59.5%接受达沙替尼，40.5%接受尼洛替尼。大多数患者开始使用标准剂量的IM（67.3%），而32.7%使用减量。2G-TKI也观察到类似趋势。12个月时永久停用TKI的累积发生率为28.4%，主要原因是原发性耐药（10.1%）和血液学外毒性（9.5%），IM组和2G-TKI组之间无显著差异。2018年意大利引入伊马替尼仿制药后，与2G-TKI相比，IM的使用显著增加。
在我们中心，IM是老年CP-CML患者首选的一线治疗方法，仿制药引入后使用率增加。然而，仍有相当比例的患者使用2G-TKI，这表明医生需要根据患者的适用性和期望进行个体化评估。需要进一步研究评估该患者群体中TKI减量的疗效和安全性。
