PROs Enhance Oncology Care Despite No OS Gain
This transcript has been edited for clarity.
Hello. I'm Dr Maurie Markman, from City of Hope. I'd like to briefly discuss a very important paper that recently appeared in Nature Medicine , entitled, 'Symptom monitoring with electronic patient-reported outcomes during cancer treatment: final results of the PRO-TECT cluster-randomized trial.'
I think those in the oncology community who are participating in clinical research are increasingly aware of how important, based upon trial design, patient-reported outcomes (PROs) are. Increasingly, this strategy is being considered for standard of care in academic medical centers, community oncology centers, and individual practices.
Much of this enthusiasm comes out of the results of trials that have been reported in high-impact journals, which have suggested that, [in regards to] PROs, if you do this, you might actually improve survival in addition to improving quality of life.
Very importantly, the studies that have been conducted to date have really focused more on the academic medical centers, the cancer centers, and unique patient populations.
This study was an incredibly important follow-up trial from these earlier studies and really looked more at the population basis for the potential value of PROs. Again, this was a trial, but of course, we're looking at what the value may be outside of the clinical setting.
This was a large, cluster-randomized trial looking at 52 oncology practices that were randomized to either do these surveys of symptom management or usual care without the survey. The PRO practice patients were invited to complete weekly symptom surveys. For severe or worsening symptoms, importantly, alerts were sent to the care team.
Patients completed these weekly. If there was something that was severe or worsening, information went to the care team. Obviously, the individual practices that were not randomized to the PRO surveys did whatever program they might have had already.
The primary outcome was an improvement in overall survival (OS), again, based upon previous studies. Secondary outcomes included emergency room visits, time to deterioration of physical function, health-related quality of life, and quite frankly, satisfaction with this tool — were they interested in it and did it seem beneficial.
Here are the results. In all, 1191 patients were enrolled. In my opinion, not surprisingly, there was no difference in OS. Let me say, it would be very difficult to see in a study like this, with multiple different patient populations and a well-designed trial, that you could actually tease out an improvement in OS in a large patient population with all the other factors involved.
For OS, surely there might be patients who are undergoing intensive chemotherapy or patients getting bone marrow transplantation where you might be able to really find a major impact on survival. In this large patient population, which is what we're focusing on here, a statistical improvement in OS would be difficult, but not the only important endpoint.
Here are the rest of the results. The time to first emergency room visit was significantly prolonged in the patients who participated in the PRO survey. There was a 6% decrease overall in the emergency room visits — think of the time and effort for patients and cost that was eliminated. There were fewer overall visits at 12 months.
The use of the symptom survey significantly delayed the deterioration in physical function symptoms and improved health-related quality of life. These are critically important issues, every one of them, for the practice of oncology and our goals.
In addition, 77% of patients felt that the PRO survey tool improved their discussions with their care team and made them feel more in control of their own care. As evidence of the value here, 91.5% of the patients completed — on a weekly basis — these survey estimates. If they weren't interested and they didn't think it of value, surely that number would've been much lower.
Again, this is a very important study. The investigators said they're planning on doing additional studies not focusing on OS as the primary endpoint, which I certainly agree with. The results are very important, and clearly, this is the type of strategy that we need to consider cost-effective ways for implementation in our routine care.
Thank you for your attention.
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