Directly comparing randomized and real-world controls in adjuvant breast cancer.

Aim: We sought to directly compare contemporaneous real-world (RW) and randomized controlled trial (RCT) control arms to assess the feasibility of utilizing RW controls in early breast cancer treatment. Materials & methods: Women with human epidermal growth factor receptor 2-negative high-risk breast cancer receiving adjuvant docetaxel, doxorubicin and cyclophosphamide for six cycles between 29 May 2007 and 21 November 2013 were included, mirroring the control arm and study timeframe from our reference trial 'Anthracyclines in Early Breast Cancer: The ABC Trials'. Structured data was extracted from the iKnowMed electronic medical record system, which included both RW and trial patients allowing for their direct comparison. Propensity scores were used for baseline characteristic balancing, and Kaplan-Meier analysis was conducted.

Results

In the final sample of 306 patients (153 per arm drawn from 155 RCT patients and 703 RW patients in the study timeframe), the matching process yielded balanced cohorts along available covariates. Kaplan-Meier curves and disease-free survival distributions did not suggest significant differences between RW and trial arms (log rank p = 0.98).

Conclusion

Despite limitations, including the use of structured data only, the study suggests that RW data could have served as a synthetic control in this setting.