Molecular Solid Tumor Algorithm – Simplified Patient-Centric/Cost-Effective Approach by Pathologists

Abstract

Abstract Introduction/Objective The process from the time the patient is diagnosed with cancer and receives their first treatment is complex and time-consuming. It requires adherence to national comprehensive cancer network (NCCN) guidelines; is challenged with limited tissue, how and when to order tests, and reimbursement timelines with pre- authorizations. We evaluated the role of the pathologists, who are an integral part of patient care, along with oncologists and surgeons. Methods/Case Report 254 cases from various types of solid tumors (paraffin-embedded blocks) were collected from several pathology departments. Tests (two panels NGS-DNA/RNA expression, FISH, PD-L1, and IHC) were ordered as early as on the day of diagnosis to as late as 18 months following the diagnosis. Cancer cases reviewed were Colo-Rectal (72), Lung (48), Breast (24), Gastric (10), CNS (8), Melanoma (4), Head/Neck (20), GU (16), Sarcomas (8), Thyroid (6), Hepatic (8), Female Genital Tract (7) and Unknown Primary (23). Results (if a Case Study enter NA) We evaluated pathology reports, identified blocks, reviewed H&E slides, utilized NCCN guidelines in collaboration with oncologists. Tests were ordered using established billing criteria. Following tests were performed: PD-L1 (190 - 75%), FISH (50 - 20%), and NGS – two simple panel approach (215 - 85%). Using the aforesaid methods, our NGS results were successful in >95%. We were able to identify actionable and prognostic mutations in >80% of tumors. Conclusion Our algorithm has been designed considering NCCN guidelines and are updated frequently with new therapeutic targets and actionable mutations. The emphasis is to conserve diagnostic tissue and ensure timely ordering of tests as medically necessary. This can be adopted by pathologists in conjunction with clinical information, pathology reports, and be used as a part of diagnostic workups to reduce delays in treatment, avoid tissue loss, utilize current billing (inpatient/outpatient) practices, pre-authorization and eventually improving patient care as well as reduce overall healthcare costs.