Henry Winter
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Study offers reassurance to CLL patients

Henry Winter
Posted by
06 Mar 2012

A clinical trial into the most common form of adult leukaemia has established that patients taking an aggressive but effective drug combination can return to a normal quality of life once they complete treatment.

Leukaemia & Lymphoma Research’s CLL4 trial offers the most complete information yet on the quality of life of patients with chronic lymphocytic leukaemia (CLL). The multinational study led by The Institute of Cancer Research (ICR) included data from 777 patients diagnosed between 1999 and 2004.

Patients in the study, which is published in the journal Leukemia & Lymphoma, regularly reported on key indicators of their physical, social and emotional quality of life for five years after beginning treatment. The patients were given one of three chemotherapy treatments – fludarabine, the ‘gentler’ chlorambucil, or a more toxic, but more effective, combination of fludarabine and cyclophosphamide (FC).

The combination of FC with the monoclonal antibody drug rituximab has since been shown to be the most effective treatment option for extending survival and this is now the standard treatment option. However, despite the benefits of prolonging survival times, there had been concerns that FC-based regimens may have unacceptable effects on patient’s quality of life.

The CLL4 study has proven for the first time that, while in the first few months of treatment FC may have more adverse impact on quality of life than treatment with other drugs, in the long term quality of life is just as good. Moreover, the quality of life of patients who achieved long remissions after treatment was similar to that of the normal population when matched by age and sex.

First author Monica Else from The Institute of Cancer Research said: “This is the first concrete evidence that FC treatment does not impair quality of life over the long term. Because FC is effective at creating long term remission, free of any serious symptoms, patients reported benefits from not constantly relapsing and having to receive repeated treatment.”

Senior author Emeritus Professor Daniel Catovsky from the ICR said: “The CLL4 clinical trial showed the benefits of FC for patients and is the basis for its use today, in combination with the drug rituximab, as the standard treatment of CLL. Additionally, it has helped doctors to customise treatment for each patient by establishing testing for different prognostic markers in CLL that can dictate how each individual’s disease will respond to therapy.”

FC is more toxic than chlorambucil or fludarabine alone and the study showed that in the first year of treatment, these patients did report greater fatigue and also more social exclusion, possibly due to the immunosuppressive nature of the drugs. However, after the first year, patients on all treatments reported similar quality of life. 

Dr David Grant, Scientific Director at Leukaemia & Lymphoma Research, said: “CLL is predominantly a disease of the elderly, so side-effects that drugs can have on patients are a major concern, with more aggressive drugs causing nausea, fatigue and susceptibility to infection. CLL remains an incurable cancer but this study offers reassurance that powerful initial treatment can allow patients to enjoy a high quality of life for years in remission.”  

Many patients on the CLL4 trial who relapsed after receiving chlorambucil were transferred to FC, as it was already becoming clear that it was more effective. Chlorambucil is still used today however for very elderly and weak patients who would not be able to tolerate treatment with FC.