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Posted by on Jun 13, 2020 in Leukemia | 0 comments

In a nutshell

This study aimed to investigate the safety and effectiveness of different chemotherapy and targeted therapy combinations given as frontline treatment in patients with chronic lymphocytic leukemia in a real-world setting. 

This study concluded that some treatments have a real-world activity that is comparable to clinical trial data.  

Some background

The standard treatment for older patients with previously untreated chronic lymphocytic leukemia (CLL) was a combination of anti-CD20 antibody and less intensive chemotherapy. Anti-CD20 antibody treatments are targeted therapies and include treatments like rituximab (Rituxan). Other targeted therapies include obinutuzumab (Gazyva). Chemotherapies used at a frontline treatment for CLL involve chlorambucil (Leukeran) and bendamustine (Treanda). 

 Often the results from clinical trials that test drug treatments do not correspond to real-world outcomes. This is mainly because participants are very carefully selected for clinical trials. It was unknown if different combinations of chemotherapy and targeted therapies would be safe and effective for previously untreated CLL in the real-world setting.  

Methods & findings

This study involved 398 patients with CLL. 63 patients were treated with obinutuzumab and chlorambucil (G-Clb). 78 patients were treated with rituximab and chlorambucil (R-Clb). 257 patients were treated with bendamustine and rituximab (BR).

The overall response rate (ORR) was 76.2% for the G-Clb group compared to 75.6% for the R-Clb group and 85.2% for the BR group. The average event-free survival (EFS; survival without complications from CLL) was 49 months for the G-Clb group compared to 20.3 months for the R-Clb group and 37 months for the BR group.  

A severe low level of white blood cells was experienced by 43% of G-Clb patients compared to 31% of R-Clb patients and 49% of BR patients. Infections of grade 3 or higher were experienced by 17% of G-Clb patients compared to 6.4% of R-Clb patients and 17% of BR patients.  

The bottom line

This study concluded that the real-world activity of G-Clb is comparable to the clinical trial data. It was also concluded that R-Clb provides good outcomes in older patients with additional medical conditions.  

The fine print

This study looked back to analyze medical records data. Information might have been missing. This might affect the results.

Published By :

Hematological Oncology

Date :

May 13, 2020

Original Title :

Real-world data on efficacy and safety of obinutuzumab plus chlorambucil, rituximab plus chlorambucil and rituximab plus bendamustine in the frontline treatment of chronic lymphocytic leukemia: The GO-CLLEAR Study by the Czech CLL Study Group.

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