Identifying barriers associated with enrollment of patients with lung cancer into clinical trials

Abstract

Background: Enrollment of patients with lung cancer into clinical trials is required to accelerate the pace of new therapy development and contribute to a better understanding of the biological characteristics of cancer.

Methods: We conducted a retrospective chart review of all patients seen by the thoracic medical oncology team at the Vanderbilt Ingram Cancer Center (VICC) from November 2005 to November 2008 to determine the barriers associated with patient enrollment in to clinical trials.

Results: One thousand forty-three patient charts were audited: 32% of patients were eligible for enrollment, and 14% enrolled in a study. There were no significant differences in protocol availability or eligibility by sex, smoking status, or age. Patients living further from the cancer center were significantly less likely to have a study protocol available (P = .009), but if a protocol was available they were more likely to be eligible for enrollment (P < .001). Significantly more protocols were available for patients with non-small-cell lung cancer (NSCLC) compared with those who had small-cell lung cancer (SCLC) (63% vs. 48%; P < .001). Patients with advanced disease were more likely to have a protocol available (P < .001) and enter a study (P = .031). The most common reasons for patients not being eligible for enrollment were poor performance status (32%) and presence of comorbid disease (27%). The most common reasons for potentially eligible patients not enrolling in a study included preference for treatment closer to home (49%) and patient refusal (43%).

Conclusion: Additional strategies are required to increase accrual of patients into lung cancer trials, including development of protocols for early-stage disease and modifying eligibility and performance status criteria for this unique patient population.