Key Lessons Learned from Moffitt’s Molecular Tumor Board: The Clinical Genomics Action Committee Experience

Abstract

Background The increasing practicality of genomic sequencing technology has led to its incorporation into routine clinical practice. Successful identification and targeting of driver genomic alterations that provide proliferative and survival advantages to tumor cells have led to approval and ongoing development of several targeted cancer therapies. Within many major cancer centers, molecular tumor boards are constituted to shepherd precision medicine into clinical practice. Materials and Methods In July 2014, the Clinical Genomics Action Committee (CGAC) was established as the molecular tumor board companion to the Personalized Medicine Clinical Service (PMCS) at Moffitt Cancer Center in Tampa, Florida. The processes and outcomes of the program were assessed in order to help others move into the practice of precision medicine. Results Through the establishment and initial 1,400 patients of the PMCS and its associated molecular tumor board at a major cancer center, five practical lessons of broad applicability have been learned: transdisciplinary engagement, the use of the molecular report as an aid to clinical management, clinical actionability, getting therapeutic options to patients, and financial considerations. Value to patients includes access to cutting‐edge practice merged with individualized preferences in treatment and care. Conclusions Genomic‐driven cancer medicine is increasingly becoming a part of routine clinical practice. For successful implementation of precision cancer medicine, strategically organized molecular tumor boards are critical to provide objective evidence‐based translation of observed molecular alterations into patient‐centered clinical action. Molecular tumor board implementation models along with clinical and economic outcomes will define future treatment standards. Implications for Practice It is clear that the increasing practicality of genetic tumor sequencing technology has led to its incorporation as part of routine clinical practice. Subsequently, many cancer centers are seeking to develop a personalized medicine services and/or molecular tumor board to shepherd precision medicine into clinical practice. This article discusses the key lessons learned through the establishment and development of a molecular tumor board and personalized medicine clinical service. This article highlights practical issues and can serve as an important guide to other centers as they conceive and develop their own personalized medicine services and molecular tumor boards.

Quantitation of Targetable Somatic Mutations Among Patients Evaluated by a Personalized Medicine Clinical Service: Considerations for Off‐Label Drug Use

“…The growing number of patients undergoing molecular interrogation concomitantly with the ever‐expanding gene‐drug knowledge base and increasingly complicated genomic laboratory reports is resulting in the need for personalized medicine consultation services. In some health care settings, pharmacists are leading the implementation of these clinic services . However, relatively little data are available among somatic‐focused programs describing the impact of such clinical endeavors, such as the number of patients with actionable somatic mutations who qualify for on‐label drug eligibility or off‐label drug considerations …”

“…A molecular tumor board consisting of oncologists, pathologists, pharmacists, and basic scientists can be a vital resource for clinical decision making. Our PMCS utilizes a molecular tumor board for difficult cases when a patient harbors targetable mutations that qualify for off‐label drug consideration but outcome data are limited . If an off‐label drug is recommended, personalized medicine clinical services can consider collaborations with specialty pharmacy services.…”

“…Tumor NGS assay results for Foundation One and Foundation One Heme (Foundation Medicine Inc, Cambridge, MA), along with Guardant 360 (Guardant Health Inc., Redwood City, CA), are manually curated as discrete data in the Clinical Genomics Action Committee (CGAC) database . Age, gender, race, cancer type, stage, and number of prior therapies are included in manual curation.…”

“…Because the interpretation of genomic test results is becoming increasingly complex and time intensive, personalized medicine consultation services are beginning to emerge. These services have the goal of identifying drugs or clinical trials for which the patient is eligible based on reported actionable mutations . Most genomic‐targeted chemotherapeutic agents have on‐label indications listed in the FDA drug insert Indications and Usage section that identifies the somatic mutation and cancer type for which the drug is approved.…”

Perspective on Precision Medicine in Oncology

“…A molecular tumor board can aid the clinician by recommending treatments based on available literature and interdisciplinary expertise. They are increasingly used to interpret these highly specialized molecular testing reports, as there is variability in laboratory reporting, read depth, tissue sources, assay type, and many other factors …”