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Study designed to assess side effects of immunotherapy for non-small cell lung cancer
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The Lung Cancer Registry has launched a study designed to assess the side effects associated with use of immune checkpoint inhibitors for the treatment for non-small cell lung cancer.
The study is the first collaborative effort since the Bonnie J. Addario Lung Cancer Foundation and the American Lung Association joined with the International Association for the Study of Lung Cancer in December to expand the registry, a collection of patient-contributed information designed to help improve the understanding of lung cancer treatments and help researchers improve patient outcomes.
“This study is being led by a foundation that started with a lung cancer survivor, and it is only appropriate that the research be pushed to the leading edge by this type of organization,” Adam P. Dicker, MD, PhD, FASTRO, enterprise senior vice president and professor and chair of the department of radiation oncology at Sidney Kimmel Medical College and Cancer Center of Thomas Jefferson University, told HemOnc Today. “We are very fortunate to partner with the Bonnie J. Addario Lung Cancer Foundation to help them in their mission through improving the quality of science in this space.”
HemOnc Today spoke with Dicker and Heather S. Jim, PhD, behavioral scientist and associate member of the health outcomes and behavior department at Moffitt Cancer Center, about the scope of the study, the need for these types of insights, and the knowledge gaps the study findings may fill.
Question : Can you describe the scope of this study?
Dicker: Many drugs have been approved for patients with lung cancer. However, there is very little information from the patient perspective about how they are affected. We really wanted to understand — from the patient’s voice, and not filtered through the lens of the health care provider — what the patient is experiencing with treatment.
Q: How will the study be conducted?
Jim: We are looking for patients with lung cancer treated with immunotherapy to share their experiences with us by completing a short questionnaire. The questionnaire asks about the side effects of immunotherapy and quality of life. The registry also asks patients to provide basic demographic and clinical information. The survey can be accessed at www.lungcancerregistry.org.
Q: Why are these insights needed, and w hat knowledge gaps will the y fill?
Jim: We know a lot about existing treatments for lung cancer — such as chemotherapy and radiation — and the types of side effects they have for patients. However, we do not know much from patients’ perspectives about these new immune checkpoint inhibitors. We are interested not only in the types of toxicities patients may report, but also how these new drugs may benefit patients in terms of their disease symptoms and quality of life.
Q: What is the study timeline?
Dicker: For this initial pilot study, we are looking to accrue approximately 100 patients. At the current rate, we think we will complete this phase of the project by June.
Q: What do you expect to find?
Dicker: When we have an accurate picture through the patient’s voice collected in a scientific manner as we have set out to do, there are a number of different outputs for which they can be used. Certainly for clinical care, it allows for better shared decision-making between patients and providers in terms of expectations of what they are going to go through. This shared decision-making should be a part of every consultation that oncologists have with patients. There is a limited amount of information to give patients that is unfiltered. We are additionally interested in fine-tuning the patient’s voice in terms of symptomology and toxicity of treatment. If we can do this, there is a whole set of studies that we can embark upon to see if we can pick up on toxicity earlier through electronic patient-reported outcomes. Perhaps we can potentially circumvent toxicities patients are experiencing, because we are using more sensitive tools to pick up on this toxicity.
Jim: If we know more about the patient experience in terms of treatment toxicity, we may be able to offer additional supportive care interventions to help patients manage toxicities while they are being treated.
Q: Is there anything else that you would like to mention?
Dicker: This is a part of ‘citizen science’ and patients can from all over the world participate in the study. We have patients from North America, Australia and Europe included in the study so far. I think patients should be given a voice in this type of research. – by Jennifer Southall
For more information:
Adam P. Dicker, MD, can be reached at Thomas Jefferson University,
1020 Walnut St., Philadelphia, PA 19107; email: adam.dicker@jefferson.edu.
Heather S. Jim, PhD, can be reached at Moffitt Cancer Center, 12902 USF Magnolia Drive, Tampa, FL 33612; email: heather.jim@moffitt.org.
Disclosures: Dicker and Jim report no relevant financial disclosures.