Sat. Oct 16th, 2021

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Planned breaks from drug treatments for kidney cancer do not have a meaningful detrimental effect on patients’ life expectancy or quality of life, say doctors.

A 10-year research trial, led by the University of Leeds and the University of Sheffield, has found that patients being treated for advanced kidney cancer can take a planned break from their drug treatments without significantly affecting their life expectancy while reducing the impact of side effects.

More than 900 patients from across the UK took part in the STAR* trial that looked at patients treated with Sunitinib or Pazopanib – successful but expensive treatments, which can cause a number of side effects such as liver damage, painful blistering of the hands and feet, high blood pressure and tiredness.  

The STAR trial brought together researchers and clinicians from 60 centres across the UK and was funded by the National Institute for Health Research (NIHR), the research partner of the NHS.

Led by Dr Fiona Collinson, of Leeds’ Leeds Institute of Clinical Trials Research, and Professor Janet Brown, of the University of Sheffield and Weston Park Hospital in Sheffield, the trial was run through the Leeds Clinical Trials Research Unit (CTRU).

10-year trial

A total of 920 patients from across the UK joined the trial between 2012 and 2017 and participated up until December 2020. 

Dr Fiona Collinson said: “Clinical trials such as the STAR trial have to be run extremely carefully to prevent any bias in the results and to provide the rigorous evidence which is needed to change clinical practice.

“The STAR trial has taken almost 10 years and we are pleased that it is attracting wide international interest.” 

Kidney cancer is becoming more common and currently causes over 4,500 deaths per year in the UK. Sunitinib and Pazopanib are both biological targeted treatments that have been used to treat kidney cancer for many years. They are used to treat advanced kidney cancer which cannot be removed and cured by surgery. 

The side effects from these drugs can be so severe that the amount of treatment needs to be reduced or stopped completely. The research is the world’s largest trial so far to demonstrate the value of allowing ‘treatment holidays’ in kidney cancer management, a concept that clinicians are increasingly interested in.

Taking treatment breaks

Professor Brown said: ‘We are delighted that the STAR trial has demonstrated that patients may take a break in their treatment without endangering the benefits they receive from these drugs.

“Whilst these drugs have succeeded in prolonging life expectancy, we should not underestimate the burdens imposed on patients by the side effects of the drugs and the need for patients having to frequently attend hospital for blood tests. 

“The trial also demonstrated that taking treatment breaks was well-accepted by both patients and their clinicians.

“Indeed, many patients opted for more treatment breaks than the trial demanded. We hope that the rigorous evidence provided by the STAR trial will lead to changes in normal practice for the benefit of patients, clinicians and the NHS, which can potentially save millions of pounds annually. 

“We also hope that the trial will be an example to encourage patients and clinicians to consider the benefits of treatment breaks for other types of treatment and in other cancers.” 

In the STAR trial, half the patients received the standard continuous treatment with one of the drugs and the other half received standard treatment for six months, followed by a treatment break with regular monitoring on CT scans, before the drug was restarted.

The results showed that those patients who took a treatment break suffered no meaningful detriment to their life expectancy or their quality of life. Cost savings to the NHS of thousands of pounds per patient were an added benefit.

Quality of life

National Kidney Cancer Representative, Jackie Lowe, said: “As both the wife and sister-in-law of patients with advanced kidney cancer being treated with Sunitinib, I have seen first-hand the difference in quality of life that the breaks in treatment can bring. They enable holidays and trips to be planned, give the body time to recover from the drugs’ side effects and can reduce the number of hospital visits. 

“I sincerely hope that the results of the STAR trial will give both patients and clinicians the information needed to make more informed decisions about their treatment pathways. I wish my late husband could have benefitted from this approach.”

The key results of the trial were presented by Professor Brown at the Annual Conference of the European Society for Medical Oncology (ESMO) held in Paris 16 – 21 September 2021. 

The ESMO Annual Conference is one of the two main annual world cancer meetings in this field, typically attracting an audience of 20,000-40,000. 

Further information 

*STAR trial: a randomised multi-stage phase ii/iii study of Sunitinib comparing Temporary cessation with Allowing continuation, at the time of maximal radiological response, in the first-line treatment of locally advanced/metastatic Renal cancer.

For further details contact Ian Rosser, Media Relations, University of Leeds.

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