Eligibility of real-world patients with metastatic breast cancer for clinical trials. (December 2020)

• Record Type: Journal Article
• Authors: Batra, Atul; Kong, Shiying; Cheung, Winson Y.
• Is Part Of: Breast. Volume 54(2020)
• Page Start: 171
• Page End: 178
• Publication Date: 2020-12
• Subjects: Metastatic breast cancer -- Clinical-trial eligibility -- Inclusion criteria -- Exclusion criteria -- Real-world evidence; Breast -- Diseases -- Periodicals; Breast -- Tumors -- Periodicals; Breast -- Periodicals; Electronic journals; Periodicals; 616
• DOI: 10.1016/j.breast.2020.10.005
• Languages: English
• ISSNs: 0960-9776

Abstract

Abstract: Introduction: The results of clinical trials in metastatic breast cancer (MBC) are generalized to real-world patients. This study determines the proportion of real-world patients who would be eligible for clinical trials and compares outcomes in eligible versus ineligible patients. Methods: Patients diagnosed with MBC from 2004 to 2015 in a large Canadian province were included. Patients with one of the following criteria were considered ineligible: the presence of comorbid conditions (anemia, uncontrolled diabetes, heart disease, liver disease, and kidney disease) or a history of immunosuppression or prior malignancy. The likelihood of receiving cancer therapy was analysed using logistic regression models and factors affecting overall survival (OS) were assessed by Cox proportional hazards models. Results: A total of 1585 patients with MBC were identified. The median age at diagnosis was 63 years. Of these, 512 (32.3%) patients were deemed ineligible in whom the two most common reasons for ineligibility were renal dysfunction (17.2%), and previous immunosuppression (7.8%). In the real world, ineligible patients were less likely to receive chemotherapy (29.5% vs 45.8%; P < 0.001) but not radiation treatment (7.6% vs 9.6%; P = 0.196) or hormonal therapy (57.6% vs 60.6%; P = 0.261). The 5-year OS of ineligible patients who received systemic therapy in the real-world was significantly better than those who did not. Conclusions: Despite being ineligible for clinical trials based on common eligibility criteria, many real-world patients receive systemic treatment and derive possible benefit. Broadening of inclusion criteria in clinical trials will enhance the representation of real-world patients and increase the generalizability of results. Highlights: One third of patients with metastatic breast cancer are clinical trial ineligible. Renal dysfunction and prior immunosuppression are common reasons. Ineligible patients are less likely to receive chemotherapy, but not hormonal therapy. Systemic treatment, but not eligibility, is associated with overall survival. Eligibility criteria should be broadened to represent more real-world patients.