Published: 22 September 2021
Planned breaks from drug treatments for kidney cancer do not have a meaningful detrimental effect on patients’ life expectancy or quality of life, NIHR-funded researchers have found.
The STAR trial, led by the Universities of Sheffield and Leeds shows that patients being treated for advanced kidney cancer can take a planned break from their drug treatments without meaningful detriment to their life expectancy whilst reducing the impact of side effects, with the added benefit of saving costs for the NHS.
Over 900 patients from across the UK took part in the 10 year trial looking 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.
Kidney cancer is becoming more common and causes over 4,500 UK deaths annually.
Both drugs are biological targeted treatments used for many years and can treat advanced kidney cancer which cannot be removed and cured by surgery. But both drugs’ side effects can be so severe that 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.
Professor Janet Brown, the study’s Chief Investigator, from the University of Sheffield 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 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.”
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.
Professor Nick Lemoine, Medical Director of the NIHR Clinical Research Network (CRN), said: “We’ve come a long way in developing medicines to fight cancer. But the important findings from this trial add a new twist to the tale, by showing that we can provide a treatment break without reducing life expectancy. This is robust and welcome evidence for clinicians and policy makers at a time when the NHS needs to provide cost-effective services in the continuing pandemic.
"The researchers should be congratulated for their efforts in this long-term 10 year trial which will make huge differences to people's lives."
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 the Chief Investigator, Professor Janet Brown at the Annual Conference of the European Society for Medical Oncology (ESMO) held in Paris 16-21 September 2021.
The trial was funded by the NIHR’s Health Technology Assessment (HTA) Programme. Read more on the study’s project page.