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Posted by on Jul 25, 2018 in Leukemia | 0 comments

In a nutshell

This study aimed to investigate the effectiveness of nilotinib (Tasigna) as a consolidation therapy for chronic myeloid leukemia patients. This study concluded that nilotinib is safe and effective as a consolidation therapy in these patients.

Some background

Nilotinib is a targeted therapy used to treat chronic myeloid leukemia (CML). It can also be used as a consolidation therapy. This is a therapy given following an initial therapy. It is used to kill any cancer cells that may remain. Treatment-free remission is the time where therapy is ceased without relapse. 

It was unknown if nilotinib when used as a consolidation therapy can lead to treatment-free remission.

Methods & findings

This study involved 78 patients with CML who had a deep molecular response (DMR) to initial treatment. DMR is a low level of cancer DNA present. Patients were treated with 300mg nilotinib twice a day for two years. Treatment was then ended. The main outcome was treatment-free remission defined as no loss of DMR.

67.9% of patients did not lose DMR in the first 12 months. The 3-year treatment-free survival rate was 62.8%.

37% of patients experienced a loss of DMR during treatment-free remission and nilotinib was re-administered. DMR returned in 86.2% of these patients. 50% of patients achieved DMR within 3.5 months.

14% of all patients had withdrawal syndrome (muscle and bone pain) when nilotinib was stopped. 3-year treatment free survival was 75.6% for patients with undetectable molecular residual disease compared to 48.6% in patients without.

The bottom line

This study concluded that nilotinib is an effective consolidation therapy in CLL patients and can be safely stopped after two years.

The fine print

This study needs to be carried out in a more varied group of patients.

What’s next?

Consult your physician about nilotinib as a consolidation therapy.

Published By :


Date :

Jul 05, 2018

Original Title :

Treatment-free remission after two-year consolidation therapy with nilotinib in patients with chronic myeloid leukemia: STAT2 trial in Japan.

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