There has been an explosion of drugs in the last few years in the genitourinary oncology space and as more and more drugs are being developed and are coming out and more phase III trials are showing improvement in overall survival, it’s going to become and it is becoming hard to choose when there are comparable overall survival results between two agents. So when I have to pick between two agents and when there are similar overall survival results, the quality of life information could serve as a tiebreaker, it could give me that additional information, especially in subsequent lines. First line therapies are becoming more clear but when we look at subsequent lines of therapy, if I have to pick between two, it becomes a little bit more intuitive and more easier for me to pick an agent if I have that quality of life data.
How did you assess the quality of endpoint planning and reporting across these randomised controlled trials?
Basically, this was a systematic review of phase III clinical trials that were published between 2020 and 2024. We looked at PubMed and Embase as a database and we found 80 clinical trials that were published during this period of time. Then we went back and looked at clinicaltrials.gov, all their protocols, whichever was available, to see if they planned quality of life. If they planned then we looked at the publication to see if they reported it.
So what we saw was out of the 80 clinical trials that we analysed and we collected a large number of data from that, from trial-specific drugs that were used, to disease type, to journal impact factors, and what we found was out of the 80 trials 85% planned it but when we looked at the reporting only 47.5%, which is less than half, reported the quality of life data. So there is some discrepancy between planning and reporting of quality of life endpoint data.
What were the key findings regarding how consistently QoL endpoints are planned and reported?
Other key findings which I noted were basically positive trials were more likely to report quality of life, five times more likely. So that is something that I noted on the study. Then another thing that I noted was the trend of the quality of life reporting. We saw between early years, like 2020 and 2021, there was reporting of 50-60% reporting of quality of life but when we looked at 2024 the reporting went down significantly to 11%. So we understand that when we did the trials a lot of the publications that were done in 2024 may not have secondary publications coming in yet but at the same time in the total five-year period most of the quality of life data was reported in the primary publications. So there is some degree of decline, despite the FDA’s and ASCO’s and other organisations’ insistence of having that data to be included as a part of the publication or secondary publication.
Why are these results important and what is next for this study?
I think this gives clinicians and organisations an idea that even though planning is happening, there is some disconnect within the planning and the reporting of quality of life and that gives all the major organisations, the FDA and all the regulatory bodies, an idea that there is some disconnect. This gives insight to a lot of advocacy groups so that the quality of life data could be more clear and available to physicians as well as patients because tomorrow I go into a clinic and sit with a patient and I have to discuss between two drugs, so which one is better, I can tell them the overall survival but I can’t always tell how it’s going to impact their quality of life. I might have some information from the safety and toxicity but having a parameter which is multidimensional and covers all aspects of your being helps. And that is an important message that I’ve wanted to deliver with this report.
Do efficacy results and QoL go hand in hand?
They can go hand-in-hand but they don’t always have to because the toxicity profile of the drug might impact somebody’s quality of life even though it might improve overall survival. So that’s why we need to check it separately, rather than rely on just one parameter that is only, of course, overall survival will remain the king, and that is important, but at the same time this is an important avenue that one must look into.
Is there anything else you would like to add?
Yes, we as a group should keep watching for quality of life data to come on. I understand clinical trials have a hard time when negative results come and it’s hard to go ahead and keep on publishing but I think we can gain every bit of knowledge from whatever data we can find. One should try to report what they can when it comes to publishing a trial.
