Biotechnology & Biotechnological Equipment, a fully open-access research journal, has published the Research Article regarding the real-world effectiveness and outcomes of targeted therapy in patients with advanced or metastatic hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer treated in routine Bulgarian clinical practice. 

Sqilline is extremely honoured to be a co-author alongside such outstanding healthcare professionals and experts in the field. Our advanced analytics software, Danny Platform, played a key role in the process and analysis of this fundamental article.

The National Council on Prices and Reimbursement of Medicinal Products (NCPRMP) has a leading role in this publication. Sqilline and the National Council united forces in 2019 when Danny Platform started gathering and processing all medical statistical data from EHRs received by the Council to allow analyses of clinical treatment outcomes and support research publications.

KEY SUMMARY POINTS

OBJECTIVES:

• Using all available medical records from EHR systems to validate findings from Randomized Controlled Trials (RCTs) against available real-world datasets.
• Compared the Clinical Benefit Rate (CBR, defined as complete remission [CR] or partial remission [PR] or stable disease [SD]) and Progression-free Survival (PFS) and Overall Survival (OS) with pivotal RCTs.

CHALLENGES:

• The shorter duration of treatment and follow-up observation in the RWE setting, the smaller number of patients at risk beyond certain time points, and some discrepancies in the way outcome parameters are assessed in clinical practice, limit the robustness of some comparisons.

SOLUTION:

• This analysis used Danny Platform’s deep learning natural language processing algorithms (NLPs) to extract and normalize both structured and unstructured free-text clinical data from Electronic Health Records (EHRs) of breast cancer patients who were undergoing ribociclib treatment.
• The Real-world Data (RWD) source for this study consisted of EHRs from 57 university, multispecialty and oncology hospitals in Bulgaria and included both reimbursed and donated therapy prescriptions.
• This study was based on secondary usage of anonymized data using hospital-integrated software.

RESULTS:

• Overall, there were 812 patients in the real-world dataset who were treated with ribociclib between 2018 and 2022.
• The number of patients at risk was statistically robust to compare PFS and OS during the earlier periods of the real-world data analysis with the corresponding RCTs.
• In the periods of adequate statistical robustness, PFS and OS were comparable within 95% confidence intervals (CIs) with RCT findings.
• Real-world effectiveness and outcomes of ribociclib combination therapy were comparable with observations from RCTs.

BENEFITS:

• Enables Health Authorities to analyze Real-World Evidence patient populations, compare them with Clinical Trials Results to empower efficiency in public spendings while improving patient outcomes.
• Optimizing Efforts of Healthcare Professionals with advanced analytics technology to save time and effort for scientific research.
• Unlocking Insights and Medical Knowledge with this open access publication to benefit researchers and provide valuable knowledge for breast cancer patient care.

AUTHORS:

• Manoela Manova (Department of organization and economics of pharmacy, Faculty of pharmacy, Medical University of Sofia, Bulgaria; NCPRMP, Sofia, Bulgaria)
• Jeliazko Arabadjiev (Medical Oncology, University Hospital Acibadem City Clinic Tokuda, Sofia, Bulgaria)
• Radoslav Mangaldzhiev (Specialized Hospital for Active Treatment of Oncological Diseases, Sofia, Bulgaria)
• Assen Dudov (Acibadem City Clinic Mladost Hospital, Sofia, Bulgaria)
• Daniel Penchev (Sqilline, Sofia, Bulgaria)
• Margit Hemetsberger (Hemetsberger Medical Services, Vienna, Austria)  
• Arkadi Sharkov (Department of Communication, Faculty of Journalism, Sofia University ‘St. Kliment Ohridski’, Sofia, Bulgaria)
• Boryana Zidarova (NCPRMP, Sofia, Bulgaria)
• Dimitrina Apostolova (NCPRMP, Sofia, Bulgaria)
• Maria Vasileva (NCPRMP, Sofia, Bulgaria)
• Silvia Terezova (NCPRMP Sofia, Bulgaria)
• Mila Vlaskovska (NCPRMP, Sofia, Bulgaria)
• Alexandra Savova (Department of organization and economics of pharmacy, Faculty of pharmacy, Medical University of Sofia, Bulgaria; NCPRMP, Sofia, Bulgaria)

Click here to read the full publication in Biotechnology & Biotechnological Equipment: