Breccia Massimo, Chiodi Francesca, Nardozza Aurelio Pio, Valsecchi Diletta, Perrone Valentina, Sangiorgi Diego, Giacomini Elisa, Rendace Maria Chiara, Coco Paola, Premoli Eleonora, Degli Esposti Luca
Hematology, Department of Translational and Precision Medicine, Sapienza University Policlinico Umberto I, 00161 Rome, Italy.
Novartis Farma S.p.A., 21042 Origgio, Italy.
J Clin Med. 2022 Jun 22;11(13):3597. doi: 10.3390/jcm11133597.
Real world data are becoming a crucial tool to understand how cancer is treated in routine daily practice. This real-world analysis aims to describe the characteristics of patients with CML in 2nd or ≥3rd tyrosine kinase inhibitors (TKI) lines of therapy, to evaluate their treatment sequence and utilization in settings of Italian clinical practice in Italy. A retrospective analysis was performed using an administrative databases covering around 15.3 million cases. All adult patients prescribed with TKI as 2nd or ≥3rd lines (L) of therapy for CML during January 2015-December 2018 were included. A total of 491 patients in 2nd and 144 in ≥3rd L was included. In both cohorts, hypertension was the most reported comorbidity, followed by metabolic and blood count alterations. In each calendar inclusion year, an increment of 97.6% was observed in the number of patients treated in ≥3rd L. In the 2nd L cohort, 18.7% had a switch to 3rd L, while 26.4% of ≥3rd L patients switched to a subsequent line. Around 40% in both lines discontinued their treatment after a median time of 5.5 (2nd L) and 4.3 (≥3rd L) years. The results provided insights into CML management clinical practice, indicating a heavy disease burden for patients in later lines that showed an increasing complex management, and suggest that a need for novel treatment strategies might exists.
真实世界数据正成为了解癌症在日常常规治疗中如何进行的关键工具。这项真实世界分析旨在描述接受第二代或≥第三代酪氨酸激酶抑制剂(TKI)治疗的慢性粒细胞白血病(CML)患者的特征,评估其在意大利临床实践环境中的治疗顺序和使用情况。使用涵盖约1530万个病例的行政数据库进行了回顾性分析。纳入了2015年1月至2018年12月期间所有接受TKI作为CML二线或≥三线治疗的成年患者。二线治疗组共纳入491例患者,三线及以上治疗组纳入144例患者。在两个队列中,高血压是报告最多的合并症,其次是代谢和血细胞计数改变。在每个纳入年份的日历中,三线及以上治疗的患者数量增加了97.6%。在二线治疗队列中,18.7%的患者转换至三线治疗,而在三线及以上治疗组中,26.4%的患者转换至后续治疗线。两条治疗线中约40%的患者在中位时间5.5年(二线治疗)和4.3年(三线及以上治疗)后停止治疗。研究结果为CML管理临床实践提供了见解,表明后期治疗线的患者疾病负担沉重,管理日益复杂,并提示可能需要新的治疗策略。