Sylvester Researchers Study Quality of Life During Immunotherapy Treatment
Summary
- Immune checkpoint inhibitors have been a game-changer in oncology but have unique side effects for patients.
- A Sylvester researcher team is using a National Cancer Institute grant to investigate the nature of immune checkpoint inhibitor side effects.
- Dr. Moreno and her team will review the patient’s health and quality of life before and throughout treatment for two years using both medical records and surveys known as patient-reported outcomes.
Immune checkpoint inhibitors have been a game-changer in oncology. Tumors often have proteins on them that tell your immune system not to attack. Checkpoint inhibitors — which work by blocking these proteins so your immune system continues to fight the tumor — have provided new options for many people with advanced or metastatic cancer who were left with limited options.
Patricia Moreno, Ph.D., lead of Evidence-Based Survivorship Supportive Care at Sylvester Comprehensive Cancer Center, part of the University of Miami Miller School of Medicine, points out that these new drugs come with unique side effects that experts still need to understand better. The National Cancer Institute has awarded Dr. Moreno, a member of Sylvester’s Cancer Control Program, and co-investigators Jose Lutzky, M.D., and Gilberto Lopes, M.D., oncologists and members of Sylvester’s Translational Clinical Oncology Program, $5.2 million to follow patients for two years and identify what side effects they experience. This includes when side effects first emerge, how severe they are, whether they improve or worsen over time and how they impact patients’ quality of life and ability to continue their checkpoint inhibitor treatments. The team will also use machine learning to predict which patients are at higher risk of experiencing side effects throughout treatment.
“Immunotherapies have revolutionized the way we treat many people living with cancer today,” said Dr. Lopes, Sylvester’s associate director and medical director for international affairs and professor and chief of the Division of Medical Oncology at the Miller School. “This comes with new questions and a new set of adverse events and survivorship questions. This is what we aim to assess and improve with our project.”
Dr. Lutzky, director of cutaneous oncology services at Sylvester, added, “Because these drugs stimulate the immune system, most of the side effects that we see are related to overstimulation of the immune system, which sometimes turns against your own cells, not just the cancer cells. That generated a whole new type of adverse event that we’re not used to.”
Checkpoint Inhibitor Side Effects
Most of what is known about side effects on checkpoint inhibitors comes from clinical trials when doctors report their patients’ side effects. But Dr. Moreno explained that in many cases, patients won’t report milder side effects to their doctors, meaning they can be missed completely, even if they impact the person’s quality of life. Or a doctor may not observe a side effect until it has escalated and become more serious.
That is why it is critical that patients are directly and regularly asked about their symptoms and side effects so that we “catch things much earlier before they become bigger problems,” Dr. Moreno said. “If we catch patients early who report itching or skin changes, or changes in cognitive state, then we may be able to ultimately stop a domino effect that results in a severe adverse event.”
Clinical trials also tend to be narrow in scope. Only certain patients are eligible. For example, because the researchers want the cleanest data possible, they may not recruit participants who have illnesses other than the condition being treated, meaning they might exclude patients with high blood pressure, diabetes or other common conditions that can impact many people who will eventually take the drug once the FDA approves it.
“This limits the generalizability of the data and means we still need to learn more about what side effects patients experience on checkpoint inhibitors,” said Dr. Moreno.
Very little research has directly asked patients how they feel while they are taking checkpoint inhibitors. And the surveys that have commonly been used to assess symptoms and side effects among people receiving cancer treatment often don’t include many of the symptoms and side effects that are specific to checkpoint inhibitors.
Up to 95% of patients experience at least one side effect during treatment with checkpoint inhibitors. Some of the more severe adverse effects include hepatitis, pneumonitis, colitis and other autoimmune reactions that may require immediate management or hospitalization.
The New Study
Dr. Moreno and her team plan to recruit patients right before they start treatment with a checkpoint inhibitor. They will review the patient’s health and quality of life before and throughout treatment for two years, using both medical records and surveys known as patient-reported outcomes. These detailed surveys will provide critical information about the side effects patients experience, including rare side effects that can often be missed because they are unique to checkpoint inhibitors.
The new research will take place at Sylvester and the University of Texas Health San Antonio Mays Cancer Center. Dr. Moreno and her team will recruit more than 400 patients of different races, ethnicities and sociodemographic and medical characteristics to ensure representative results.
They will then use machine learning to analyze that data to predict who is likely to tolerate their treatment well and who experiences the most troublesome side effects. If that can be predicted, then researchers can develop interventions that might improve quality of life during and after treatment for those patients.
“Our grant really focuses on trying to understand the risk factors for developing these kinds of symptomatic toxicities,” Dr. Moreno said. “Who is at higher risk? What exactly are the symptomatic toxicities like? When do they occur? What do they look like? How severe are they? And then, what are their impacts on the things that we really care about. For example, whether or not someone has good quality of life, whether or not they need to be hospitalized or visit the emergency department, and even survival and the success of their treatment.”
“It’s really about supporting patients and helping them live as well as possible while they receive cancer treatment,” she concluded.
Other co-investigators of this study are:
Tags: cancer research, Dr. Frank Penedo, Dr. Gilberto Lopes, Dr. Jose Lutzky, Dr. Patricia Moreno, immunotherapy, Sylvester Comprehensive Cancer Center