In a nutshell
This study aimed to investigate the long-term safety and effectiveness of ibrutinib in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.
This study concluded that ibrutinib was safe and effective in the long-term in this group.
Ibrutinib (Imbruvica) is a type of targeted therapy called a tyrosine kinase inhibitor (TKI) used in treatment of B cell cancers such as chronic lymphocytic leukemia (CLL). It has shown very good results in short-term studies. However, the long-term safety and effectiveness of ibrutinib in patients with CLL or small lymphocytic leukemia (SLL) remain under investigation.
Methods & findings
This study involved 132 patients with first-time or relapsed/refractory CLL or SLL. All patients were treated with ibrutinib. Patients were followed for an average of 8 years.
The overall response rate (ORR) was 89%. The ORR for the first-line group was 87% and 89% in the relapsed/refractory group. The complete response (CR) was 35% for the first-line group and 10% in the relapsed/refractory group.
The estimated 7-year progression-free survival (PFS) rate was 83% in the first-line group and 34% in the relapsed/refractory group. The average PFS was not reached with first-line ibrutinib. In the relapsed/refractory group, the median PFS was 52 months overall.
The estimated 7-year overall survival (OS) rate was 84% in the first-line group and 55% in relapsed/refractory group.
28% of patients had hypertension (high blood pressure) as a serious side effect. 24% of patients had serious pneumonia and 18% of patients had serious neutropenia (low-level white blood cells). Side effects leading to ending treatment were only observed in the relapsed/refractory group.
The bottom line
This study concluded that ibrutinib was safe and effective in the long-term in patients with first-line or relapsed/refractory CLL or SLL.
The fine print
This study had a small number of participants. The study was funded by Pharmacyclics LLC, the manufacturer of ibrutinib.
Published By :
Clinical Cancer Research
Mar 24, 2020