No link between progression-free survival benefits and improved quality of life, study argues
pharmafile | October 2, 2018 | News story | Manufacturing and Production, Research and Development | Cancer, clinical trials, pharma
A study of randomised clinical trials, conducted by Canada’s McMaster University and published in the Journal of the American Medical Association (JAMA) Internal Medicine, has found that there is a tendency to prioritise the virtue of improvements to progression-free survival, neglecting the importance of improving a patient’s health-related quality of life.
The investigation involved a review and analysis of 52 articles reporting on 38 randomised clinical trials conducted between January 2000 and May 2016, covering 13,979 patients with 12 different types of cancer. Additionally, a list of FDA-approved drugs with progression-free survival benefit was included, and no language limitations were set, in order to make the study more comprehensive.
“Given the increased use of progression-free survival as the primary outcome in new oncology drug trials, and uncertainty of overall survival, it remains possible that patients are receiving toxic and/or expensive treatments without experiencing important benefit,” said Feng Xie, Senior Author of the study and a professor of the Department of Health Research Methods, Evidence, and Impact at McMaster University.
“There are only two reasons to use progression-free survival as a valid end point in oncology,” he continued. “One is that it is a valid surrogate marker for overall survival. The second is the assumption that patients who live longer without disease progression will have better health-related quality of life, even without longer survival.”
However, 35,960 records were screened in total, and the researchers found that there was no significant association between progression-free survival and health-related quality of life.
“Access to these types of drugs is costing our healthcare system a lot of money, and the troubling fact is that we do not have strong enough evidence to show that some of these drugs can extend a patient’s life or improve their quality of life,” Xie added. “Therefore, to ensure patients are truly obtaining important benefit from cancer therapies, clinical trial investigators should measure health-related quality of life directly and accurately, ensuring adequate duration and follow-up, and publish it.”
Matt Fellows
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