Smart Pill Bottles Offer Novel Solution to Adherence Crisis in Breast Cancer Care: Steven Manobianco, MD

With real-world evidence suggesting that from 30% to 50% of patients may stop their oral adjuvant endocrine medication earlier than prescribed, there is a great need for improved support strategies. At the San Antonio Breast Cancer Symposium, Steven Manobianco, MD, presented results of a study undertaken to improve adherence, titled “Utilization of ePROs and Smart Pill Bottles to Improve Adherence to Adjuvant Endocrine Therapy in Early-Stage Breast Cancer.” He and his team compared standard-of-care monitoring to electronic patient-reported outcomes (ePROs) and the use of an interactive smart pill bottle that tracked real-time adherence. The primary analysis revealed that this technology significantly improved patient adherence over 12 months, demonstrating a clear advantage.

In an interview with The American Journal of Managed Care^®, Manobianco, an assistant professor of medical oncology at Sidney Kimmel Comprehensive Cancer Center, remarked, "The main finding that I think will be of interest to most people is that, with the smart pill bottle, we nearly doubled the odds of being adherent to that hormone therapy."

This transcript was lightly edited for clarity; captions were auto-generated.

Transcript

For context, could you explain the issue of nonadherence to adjuvant endocrine therapy and describe technologies offering new approaches to improve it?

Endocrine therapy is used in hormone receptor–positive breast cancer, which comprises at least 70% of breast cancers in the United States. Despite the fact that there's a wealth of data supporting their use for the last 50-plus years, unfortunately, they can be very challenging medicines to take. Real-world evidence suggests that anywhere from 30% to 50% of patients may stop earlier than their prescribed amount or be nonadherent with that medication. People have looked into a couple of different ways of improving this. Increased follow-up has been used with sort of mixed results. People have looked at different questionnaires or outreach programs. We endeavored to use a pretty novel approach, which was to use a new technology, a smart device, in this case a pill bottle, that could be set to alert patients when they need to take their medicine every day and can send a message to us as the clinical trial staff when someone didn't take their medicine; we set it to once every 5 days to kind of trigger that threshold for something that should be responded to. We also looked at the use of electronic patient-reported outcomes, which is a hot topic here at San Antonio, too, which is, instead of having the clinician ask questions at every so often visit, having patients respond preemptively with symptoms that they're having.

What was the primary objective of your study, and what methods did you use to investigate it?

Our primary objective was to improve adherence to adjuvant endocrine therapy in early-stage breast cancer. These were women who had either DCIS [ductal carcinoma in situ] or stage I through III breast cancer, and our end point was adherence at 12 months with any of these interventions, with the idea that we had 3 arms on our study: one to what we call standard-of-care treatment, one to receiving electronic patient-reported outcomes once every 3 weeks, and one to the smart pill bottle. We used a mixture of things: We used pharmacy reports, patient pill diaries, and readings from the smart pill bottle to track how adherent patients were over the course of their treatment.

Can you summarize the key findings? Were there any that particularly surprised you?

The first thing is that we found that across all 3 arms, all patients had a decrease in their adherence from 6 to 12 months, suggesting that these symptoms do build over time and people do, over time, worsen how adherent they are with these treatments. The main finding that I think will be of interest to most people is that, with the smart pill bottle, we nearly doubled the odds of being adherent to that hormone therapy. The odds ratio, which is how we measured that, was 1.97 at 12 months, which was statistically significant. We did not see that same effect with the electronic patient-reported outcomes. That was a non–statistically significant difference. I think there's a couple different reasons why that might be. Things like recall bias or maybe having patients more, I suppose you could say, accurately or frequently report their adherence maybe got the more true measure of how adherent they were vs the standard-of-care group.