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Posted by on Aug 1, 2018 in Leukemia | 0 comments

In a nutshell

This study aimed to investigate the safety of obinutuzumab (Gazyva) in a range of patients with chronic lymphocytic leukemia. This study concluded that obinutuzumab is safe and tolerable for a range of patients with chronic lymphocytic leukemia.  

Some background

Obinutuzumab is a targeted therapy for chronic lymphocytic leukemia (CLL). It can be used alone or combined with chemotherapies. Such chemotherapies include fludarabine (Fludara) and cyclophosphamidine. Others include chlorambucil (Leukeran) and bendamustine (Levact).

It was not known how safe obinutuzumab was for patients with previously untreated or relapsed/refractory CLL.

Methods & findings

This study involved 971 patients who had CLL. Patients were a mix of previously untreated, fit and unfit and those with relapsed/refractory (RR) CLL. The main outcome measured was safety/tolerability. 13% were treated with obinutuzumab only. 20% were treated with obinutuzumab, fludarabine and cyclophosphamide. 12% received obinutuzumab and chlorambucil. 55% received obinutuzumab and bendamustine.

80.3% of patients experienced grade 3 or higher side effects. 49.9% of patients experienced neutropenia (low level of white blood cells), 16.4% experienced thrombocytopenia (low levels of platelets), 9.6% experienced anemia (low level of red blood cells) and 9% experienced pneumonia. Similar rates were seen in patients with untreated CLL or RR CLL, either fit and unfit.

Infusion-related reactions were observed in 65.4% of patients. Tumor lysis syndrome was seen in 6.4% of patients. This occurs when cancer cells are killed and contents are released into the blood stream. Infections were observed in 53.7% of patients.

Serious side effects were seen in 53.1% of patients while fatal adverse side effects were seen in 7.3% of patients.

Previously untreated patients experienced an overall response rate at 3 months of 80% of more.

The bottom line

This study concluded that obinutuzumab is safe and tolerable for previously untreated, fit and unfit patients and patients with relapsed/refractory CLL.  

The fine print

Further studies need to be carried out.

What’s next?

Consult your physician about obinutuzumab as a therapy for CLL.

Published By :

Haematologica

Date :

Jul 05, 2018

Original Title :

Safety of obinutuzumab alone or combined with chemotherapy for previously untreated or relapsed/refractory chronic lymphocytic leukemia in the Phase 3b GREEN study.

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