Non-small cell lung cancer - Advanced disease: Barriers to inclusion in clinical trials and its impact on survival

Introduction: Inclusion in clinical trials allows patients to submit to innovative therapies and a meta-analysis showed that this may be associated with increased rates of survival. Aims: Identify reasons that hindered the inclusion of patients in clinical trials of first-line therapy; Compare overall survival (OS) and progression-free survival (PFS) between groups of included and excluded patients. Methods: This study was conducted over 36 months in a central hospital. Patients with well defined histology and candidates to chemotherapy were considered eligible for clinical trials. Reasons for non inclusion have been detailed. OS and PFS were compared. Results: We identified 199 eligible patients, mean age 64.9 +-10.7 years, 75.9% males, 61.8% with non-squamous cell carcinoma. From these 22.1% were included in trials. Among those not included 18.7% had performance status (Zubrod) 2 and 66.5% had other exclusion criteria, mainly heart disease (22.3%), respiratory disease (21.4%), brain metastases (15, 5%) or second malignancy (15.5%). About 15% of patients refused to be involved in trials. Of patients who had performance status 0/1 (N = 170), there was no statistically significant difference in analysis of OS or PFS between those included in trials and the excluded, whether by criteria (Cox Regression: OS p=0.705/ PFS p=0.807) or by refusal (Cox Regression: OS p=0.465; PFS=0.900). Conclusion: Liberalization of exclusion criteria and recognition of causes that lead to refusal are possible determinants of increased participation in clinical trials. Bibliography: CA Stiller(1994). Centralised treatment, entry to trials and survival. Br J Cancer.70,352-362.