Efficacy and safety of ibrutinib in treatment of chronic lymphocytic leukemia / 白血病·淋巴瘤

ABSTRACT

Objective:To investigate the clinical efficacy and safety of ibrutinib in treatment of chronic lymphocytic leukemia (CLL).Methods:The clinical data of 68 patients with CLL in Fujian Medical University Union Hospital from May 1998 to October 2019 were retrospectively analyzed, including 39 cases receiving ibrutinib as the first therapy, 20 cases receiving ibrutinib as the second therapy, and 9 cases receiving ibrutinib as the second and above therapy. The clinical characteristics, IGHV gene mutation, the short-term therapeutic efficacy and survival of patients with stratified chromosomal karyotype were analyzed; the adverse events were also analyzed.Results:The median follow-up time was 53.2 months until May 2020. The objective remission rate (ORR) was 83.8% (57/68), including 8 cases (11.8%) of complete remission, 49 cases (72.1%) of partial remission, 5 cases (7.4%) of the stable disease, 6 cases (8.8%) of progression of the disease. The ORR of patients without IGHVmutation was higher than that of those with IGHV mutation [93.3% (28/30) vs. 76.3% (29/38), χ2=33.656, P<0.05]; the ORR of patients with low risk and low-moderate risk International Prognostic Index (IPI) score was higher than that of those with moderate-high risk and high risk [90.6% (29/32) vs. 77.8% (28/36), χ2=7.248, P = 0.007], and differences in the ORR of patients stratified by other factors were not statistically significant (all P > 0.05). Among 68 patients, 31 cases (45.6%) had adverse reactions and they insistently received the treatment; 26 cases (38.2%) had grade1-2 adverse reactions, 5 cases (7.4%) had grade 3 and above adverse reactions; 2 cases (2.9%) had drug withdrawal because of adverse reactions. The median progression-free survival (PFS) time and overall survival (OS) time of CLL patients treated with ibrutinib had not been reached. The 5-year PFS rate of patients with IGHV mutation was higher than that of patients with IGHV non-mutation (100.0% vs.72.1%, P = 0.020), the 5-year PFS rate of patients with normal chromosome karyotype was higher than that of those with abnormal chromosome karyotype (100.0% vs.74.3%, P = 0.019). Conclusion:Ibrutinib is effective and safe in treatment of CLL patients.