Building a nationwide safety net for oral antitumor therapy: Update from the cluster-randomized stepped-wedge SafetyFIRST trial

Background: Oral antitumor therapies (OAT) present several challenges and require close patient management. As shown in the AMBORA study, an intensified interprofessional care program can improve medication safety and reduce side effects of OATs [1]. The objective of SafetyFIRST is to implement this evidence-based care program in heterogeneous structures nationwide and assess clinical outcomes.

Methods: A central SafetyFIRST competence center in Bonn and Erlangen was established to train 24 interprofessional study sites (tandems) consisting of community/hospital pharmacies and oncology ambulatory clinics/MVZ/specialized oncology practices. For evaluation, a cluster-randomized trial with stepped-wedge design is conducted. At least 600 patients starting a new OAT receive either standard care or the intensified interprofessional care program over 12 weeks. The primary outcome is a combined endpoint of severe side effects (CTCAE grade ≥3), treatment discontinuation, unscheduled hospital admission, and death (in concordance with the AMBORA study [1]).

Results: All 24 participating tandems successfully started patient recruitment and completed the first of five recruitment periods of 3 months each. In this period 115 patients were recruited, with 60 in the hospital sector and 55 in MVZ/specialized oncology practices. For the first five patients of each tandem medication reviews, classification of drug-related problems and documentation were peer-reviewed by the SafetyFIRST competence center to improve accuracy and data quality.

Discussion and Outlook: After patient recruitment is completed, it will be evaluated whether the intensified interprofessional care program improved patient-relevant endpoints. To guarantee a sustainable benefit, implementation of this additional care program into standard care will be discussed with relevant stakeholders based on the achieved results.