Broccoli Alessandro, Argnani Lisa, Morigi Alice, Nanni Laura, Casadei Beatrice, Pellegrini Cinzia, Stefoni Vittorio, Zinzani Pier Luigi
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Istituto di Ematologia "Seràgnoli", 40138 Bologna, Italy.
Dipartimento di Medicina Specialistica, Diagnostica e Sperimentale, Università di Bologna, 40138 Bologna, Italy.
J Clin Med. 2021 Dec 13;10(24):5845. doi: 10.3390/jcm10245845.
Ibrutinib has demonstrated a significant clinical impact in patients with de novo and relapsed/refractory chronic lymphocytic leukemia (CLL), even in cases with unfavorable cytogenetics and molecular markers. All CLL patients' data treated at our Institute with ibrutinib have been retrospectively reviewed. Forty-six patients received ibrutinib either as frontline (10) or second or more advanced treatment (36). Five patients presented with TP53 mutations; 11 had the deletion of chromosome 17p; 17 displayed an unmutated immunoglobulin variable heavy chain status. The median number of cycles administered was 26. Among patients treated frontline, the best overall response rate (ORR) was 90.0%. In patients receiving ibrutinib as a second or later line ORR was 97.2%. Median progression-free survival was 28.8 and 21.1 months for patients treated frontline and as second/later line, respectively. Median overall survival was not reached for those treated frontline and resulted in 4.9 years for patients treated as second/later line. Grade 3-4 hematological toxicities were neutropenia, thrombocytopenia, and anemia. Grade 3-4 extrahematological toxicities included diarrhea, cutaneous rash, utero-vesical prolapse, vasculitis, and sepsis. Ibrutinib is effective and well tolerated in CLL. Responses obtained in a real-life setting are durable and the safety profile of the drug is favorable.
伊布替尼已在初发和复发/难治性慢性淋巴细胞白血病（CLL）患者中显示出显著的临床疗效，即使是在细胞遗传学和分子标志物不利的情况下。我们研究所治疗的所有接受伊布替尼治疗的CLL患者的数据均进行了回顾性分析。46例患者接受伊布替尼治疗，其中10例为一线治疗，36例为二线或更晚期治疗。5例患者存在TP53突变；11例有17号染色体短臂缺失；17例显示免疫球蛋白重链可变区未突变状态。给药周期的中位数为26个。在一线治疗的患者中，最佳总缓解率（ORR）为90.0%。接受伊布替尼二线或更晚期治疗的患者的ORR为97.2%。一线治疗和二线/更晚期治疗患者的无进展生存期中位数分别为28.8个月和21.1个月。一线治疗患者的总生存期未达到中位数，二线/更晚期治疗患者的总生存期为4.9年。3-4级血液学毒性包括中性粒细胞减少、血小板减少和贫血。3-4级血液外毒性包括腹泻、皮疹、子宫膀胱脱垂、血管炎和败血症。伊布替尼在CLL中有效且耐受性良好。在实际临床环境中获得的缓解持久，且该药物的安全性良好。
