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Ultra-Fast Amplicon-Based Next-Generation Sequencing in Non-Squamous Non-Small Cell Lung Cancer
Published on: September 8, 2023
Barriers to enrollment in non-small cell lung cancer therapeutic clinical trials
Maria Q Baggstrom1, Saiama N Waqar, Ananth K Sezhiyan
1Division of Oncology, Department of Medicine, Washington University School of Medicine, St Louis, Missouri, USA.
Introduction:
Despite recent advances in treatment, lung cancer remains the leading cause of cancer-related mortality in the United States. Therefore, there is a strong need for developing clinical trials in lung cancer therapeutics. Only a small fraction of patients with lung cancer are enrolled in clinical trials. It is critical to understand the barriers to participation in lung cancer clinical trials.
Methods:
We reviewed the outpatient charts of consecutive patients with non-small cell lung cancer who presented for initial evaluation or consultation for further therapeutic management to the thoracic medical oncology group at the Alvin J. Siteman Cancer Center between January 1, 2006, and December 31, 2006. Available and appropriate clinical trials specific to the histologic subtype and stage were presented to the patients routinely, and reasons for nonenrollment were documented. We collected information on age, gender, ethnicity, histology, stage, performance status (PS), and insurance status.
Results:
During the study period, 263 patients with non-small cell lung cancer were identified for the study. After initial screening, 183 patients had clinical trials available, which were appropriate for their diagnosis and stage of disease. One hundred one patients (55.2%) were ineligible for enrollment in a clinical trial. The most common reasons for ineligibility were poor PS (18%), need for emergent radiation (12%), lack of adequate staging information (6%), and comorbid conditions (4.9%). Despite being eligible for participation, 57 patients (31.1%) did not enroll in a clinical trial. Patient refusal accounted for 8.7%. The problems with transportation and distance from the medical center were reasons given for nonparticipation by 7.1%. Eleven patients (6%) did not participate in a clinical trial because of insurance issues. Ultimately, 25 patients (13.7%) were enrolled in a clinical trial.
Conclusions:
Poor PS, the need for emergent radiation, and patient refusal were the most common reasons for not participating in a clinical trial.
Insights
Barriers like poor performance status and patient refusal limit lung cancer clinical trial enrollment. Addressing these challenges is key to increasing participation in lung cancer therapeutics research.
Area of Science:
- Oncology
- Clinical Trials
- Public Health
Background:
- Lung cancer is a leading cause of cancer mortality in the US.
- A small fraction of lung cancer patients enroll in clinical trials.
- Understanding barriers to participation is critical for advancing lung cancer therapeutics.
Purpose of the Study:
- To identify barriers to lung cancer clinical trial participation.
- To analyze reasons for ineligibility and nonenrollment in clinical trials for non-small cell lung cancer patients.
Main Methods:
- Retrospective chart review of 263 non-small cell lung cancer patients at a cancer center.
- Analysis of reasons for ineligibility and refusal to enroll in available clinical trials.
- Data collected included patient demographics, disease characteristics, and insurance status.
Main Results:
- 101 patients (55.2%) were ineligible, primarily due to poor performance status (18%) or need for emergent radiation (12%).
- 57 eligible patients (31.1%) did not enroll; common reasons included patient refusal (8.7%), transportation/distance (7.1%), and insurance issues (6%).
- Only 25 patients (13.7%) were ultimately enrolled in a clinical trial.
Conclusions:
- Poor performance status, need for emergent radiation, and patient refusal are significant barriers to lung cancer clinical trial enrollment.
- Addressing logistical and patient-related factors can improve clinical trial participation.
- Increasing enrollment in lung cancer clinical trials is essential for developing new treatments.
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