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
Related Content
EMA selects TrialAssure anonymisation platform for clinical trial documents
TrialAssure has announced that its ANONYMIZE platform has been selected by the European Medicines Agency …
Vesper Bio reports positive topline results for dementia candidate
Vesper Bio, a clinical-stage biotech developing novel oral therapies for neurodegenerative and neuropsychiatric disorders, has …
Von Willebrand disease – increasing awareness and access to vital care
Pharmafile talks to Anthea Cherednichenko, Vice President Franchise Head Haematology and Transplant at Takeda about …
