Real-World Patients May Have More Side Effects to Immunotherapy for Lung Cancer Compared With Clinical Trial Data


Findings from a study focused on patient-reported experiences, found that aching joints, aching muscles and fatigue were more common than initially found in clinical trials.

Study findings based on patient-reported outcomes demonstrated that the rate of side effects from immune checkpoint inhibitors to treat lung cancer were higher than previously shown in clinical trials.

The study, which was published in Cancers, was one of the first studies to utilize patient-reported outcomes to assess this area compared with clinical trials, which often enroll healthier patients than those in the real-world setting.

“What’s really exciting about this study is that it focused on patients in the real world — primarily those not treated on a clinical trial — who had received immune checkpoint inhibitor therapy for lung cancer,” said Dr. Heather S.L. Jim, senior member of the department of health outcomes and behavior and co-leader of the health outcomes and behavior research program at the Moffitt Cancer Center in Tampa, Florida, in an interview with CURE®. “Patients who participate in clinical trials tend to be younger, healthier and less racially and ethnically diverse than patients who are treated with these agents as part of standard of care.”

Dr. Adam P. Dicker, senior vice president, professor and chair of the department of radiation oncology and director of Jefferson Center for Digital Health at the Sidney Kimmel Cancer Center at Thomas Jefferson University in Philadelphia, told CURE® some of the distinct differences of patients in a clinical trial compared with the real world. “In general, clinical trials … will have patients who are more fit, whose performance status is better or feeling better, etc., and people are certainly motivated to go on clinical trials. In the real world, the patient may not be as healthy and they have other comorbidities or other medical conditions that may not have allowed them necessarily to go on the clinical trial, but certainly allows them to use medication that is appropriate to treat their cancer.”

In this study, researchers analyzed outcomes reported by 226 patients (mean age, 61 years; 75% women) who participated in the GO2 Foundation’s Lung Cancer Registry. In particular, this registry included patients with lung cancer who were treated with immune checkpoint inhibitors such as Imfinzi (durvalumab), Tecentriq (atezolizumab), Keytruda (pembrolizumab) or Opdivo (nivolumab).

“When all of these checkpoint inhibitors came on the scene, it really was a paradigm shift because there are patients who previously were noncurable, and the disease this study focus on is lung cancer,” said Dr. Dicker. “There’s no question it’s a game changer. What’s been appreciated is that when you release the brakes on the immune system, there’s a variety of side effects that occur, and that hasn’t been as well studied as the clinical aspects in terms of whether patients respond or not, what the cure rate is, etc.”

All patients completed a survey focused on quality of life, which allowed researchers to evaluate the rates of common side effects with these immune checkpoint inhibitors.

Patient responses from these surveys showed that quality of life was worse compared with the U.S. population and patients from previous clinical trials. During treatment with immune checkpoint inhibitors, the most common side effects considered moderate to severe included aching muscles (20%), aching joints (27%) and fatigue (41%).

“One of the most striking findings in this particular study was the fact that fatigue and aching joints and muscles were among the most common side effects that patients reported,” said Dr. Jim. “That’s useful information because there are empirically supported treatments for fatigue, for aching joints and aching muscles in people with cancer, and so we can begin to address some of these issues with better supportive care for these patients.”

In addition, 11% of patients reported a visit to the emergency room, 25% reported a delay in treatment and 9% reported being hospitalized, all of which were associated with toxicity.

“It’s kind of eye opening that one out of ten patients is going to — or at least in the patients we looked at with lung cancer — are going to visit an emergency room and about the same percentage were hospitalized,” said Dr. Dicker.

Dr. Jim and Dr. Dicker both mentioned that a potential way to improve this may be through remote monitoring, or the ability to track a patient’s activity and side effects through technology. This is an active area of interest at the Jefferson Center for Digital Health and part of the Sidney Kimmel Medical College curriculum for medical students.

“We’re entering an exciting time in behavioral science,” said Dr. Jim. “With the rise of smartphones and smartwatches, people can become citizen scientists. If you view them as experts in their own experience, and they are able to share that experience with researchers, it really helps us understand larger patterns in cancer survivorship.” This is an active area of research for Dr. Jim and Dr. Dicker at their respective institutions.

She added that collecting data in this manner requires little effort from the patient. “This can be a form of passive monitoring in the sense that as long as the patient gives us permission to access this data, there’s really very little burden to them,” she said. “They’re just going about their daily routine. It’s really a treasure trove of data for behavioral scientists. The data are collected in a way that protects the privacy of patients.”

Dr. Dicker said that studies focusing on patients reporting their experience can potentially empower them to participate in more registries and studies. “By being at the table by contributing and making sure that these types of studies get more popular, and that they give back to the patient, I think you’ll get greater involvement,” he said. “Then ultimately, you want patients who are part of the design process of the registry process. People talk about patient advocates. It’s more than just advocating; they’re playing an active role in the design of that study. I think that really then comes full circle. This is a step in that direction.”

Not only do patients have the opportunity to report on their own experiences, but they also allow researchers to access more information on a broader patient population.

“It’s really important that we hear from a wide diversity of different patients because it helps us to better understand the patient experience more broadly,” said Dr. Jim. “Then we can use that information to provide better data to the patients themselves.”

In the meantime, Dr. Jim also emphasized the importance of talking with your doctor about any side effects you may be experiencing throughout treatment. She said, “If patients have questions about some of the side effects they’re experiencing, (they should) talk to their doctor as a reliable sources of information. Anecdotal stories from other patients may not be generalizable to their own experience. Seeking out good, reliable sources of information about their side effects is really critical.”

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