Opinion

Hope for patients with treatment-resistant chronic lymphocytic leukaemia

Living with the symptoms of a cancer such as chronic lymphocytic leukaemia (CLL) can have a considerable effect on patients’ physical and psychological well-being.
Chronic lymphocytic leukaemia

Living with the symptoms of a cancer such as chronic lymphocytic leukaemia (CLL) can have a considerable effect on patients physical and psychological well-being.

Although more than 50% of patients diagnosed with CLL are asymptomatic at diagnosis and often require no treatment initially, symptoms develop as the disease progresses.

These include fatigue, which can be so debilitating that patients forget what it feels like to be normal. As around 6 in 10 cases of CLL in the UK are diagnosed in people over the age of 70, such symptoms may be wrongly attributed to the ageing process.

Chlorambucil has been standard chemotherapy for CLL for more than 50 years. However, in the last 10 to 15 years there have been treatment advances for fitter patients, such as regimens like fludarabine, cyclophosphamide and rituximab (FCR).

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Living with the symptoms of a cancer such as chronic lymphocytic leukaemia (CLL) can have a considerable effect on patients’ physical and psychological well-being.

Although more than 50% of patients diagnosed with CLL are asymptomatic at diagnosis and often require no treatment initially, symptoms develop as the disease progresses.

Chronic lymphocytic leukaemia
Chronic lymphocytic leukaemia. Picture: Science Photo Library

These include fatigue, which can be so debilitating that patients forget what it feels like to be ‘normal’. As around 6 in 10 cases of CLL in the UK are diagnosed in people over the age of 70, such symptoms may be wrongly attributed to the ageing process.

Chlorambucil has been standard chemotherapy for CLL for more than 50 years. However, in the last 10 to 15 years there have been treatment advances for ‘fitter’ patients, such as regimens like fludarabine, cyclophosphamide and rituximab (FCR).

Treatment challenges

But there are significant treatment challenges in patients with more resistant forms of disease, including those with 17p deletion or TP53 gene mutation, and those relapsing on, or refractory to, B cell receptor (BCR) inhibitors.

Venetoclax is an investigational therapy of a new class, known as a BCL2-inhibitor. This is closely related to important regulators of the intrinsic apoptosis pathway and has offered hope to patients with 17p deletion and who are relapsing on, or refractory to, BCR inhibitors.

The results of a trial of venetoclax, published this year (Stilgenbauer et al 2016), informed the US Food and Drug Administration’s decision to fast-track its approval and make it available to patients there. In the UK, it is available through the Early Access to Medicines Scheme (EAMS).

Case study

At Leicester Royal Infirmary we have also worked on a number of trials using venetoclax over the past few years with promising results.

For example, a heavily pre-treated symptomatic patient was relapsing while taking a BCR inhibitor, before joining the trial she experienced fatigue, night sweats and recurrent infections, which were having a considerable adverse effect on her quality of life. Three months into treatment the patient was back doing light office work and was once again able to enjoy social activities. She has now completed 6 cycles and is working full time and contemplating going on holiday.

In our trials we have found the drug is generally well tolerated with a low side effect profile and as a tablet it can offer patients a more convenient treatment option.

However, initiating treatment during the dose escalation phase can provide challenges for nurses, particularly in patients with a high white cell count and bulky disease.

It is crucial to be aware of the potential risk of tumour lysis syndrome, a group of metabolic abnormalities that can occur as a complication of cancer treatment, most commonly for lymphomas and leukaemias. Local or trial protocols must be adhered to in order to minimise and manage this risk.

As a clinical research nurse supporting patients, I have been encouraged by the symptomatic benefits they have experienced with venetoclax. And in Leicester we now have our first patient receiving it through the EAMS.


References

Stilgenbauer S, Eichhorst B, Schetelig J et al (2016) Venetoclax in relapsed or refractory chronic lymphocytic leukaemia with 17p deletion: a multicentre, open-label, phase 2 study. The Lancet. Oncology. 17, 6, 768-778.    


About the author

Pam Fermahan

Pam Fermahan is a haematology clinical research nurse at The Hope Clinical Trials Facility, Leicester Royal Infirmary, Leicester

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