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U.S. Food & Drug Administration
Continuing Education and Accreditation
Division of Learning and Organizational Development
Center for Drug Evaluation and Research
Activity Outline
Assessment of Stromal Tumor-Infiltrating Lymphocytes
March 1, 2023 - March 1, 2026


Activity Coordinators:
Brandon Gallas (Brandon.Gallas@fda.hhs.gov),  Victor Garcia (Victor.Garcia@fda.hhs.gov)
Description

Tumor-infiltrating lymphocytes have been established as a prognostic biomarker in early-stage triple negative breast cancer. The assessment of the density of stromal tumor-infiltrating lymphocytes at the time of diagnosis may improve the accuracy of prognosis determination and inform therapeutic decision-making. Objectives: 1) Describe the significance of stromal tumor-infiltrating lymphocytes in triple negative breast cancer. 2) Demonstrate knowledge of the approach to determining the density of stromal tumor-infiltrating lymphocytes. Course Content: 1) Introduction to stromal tumor-infiltrating lymphocytes: We discuss the immune systems' role in mediating tumor progression, and the statistics and literature that demonstrate how sTILs are prognostic biomarkers for patient outcomes and response to therapy in certain types of breast cancer. 2) TILs Education: What are TILs and their Assessment: Video description of the steps of the sTILs assessment. 3) Pitfalls in the sTILs Assessment: Discussion of example pitfalls encountered in the sTILs assessment. 4) The evaluation of tumor-infiltrating lymphocytes (TILs) in breast cancer: recommendations by an International TILs Working Group 2014.

References
  • Kos, Z. et al. Pitfalls in assessing stromal tumor infiltrating lymphocytes (sTILs) in breast cancer. npj Breast Cancer 6, 17 (2020)
  • What are TILs and why are they important ? - International TILS Working Group. https://www.tilsinbreastcancer.org/what-are-tils/
Learning Objectives
  • Describe the significance of stromal tumor infiltrating lymphocytes in triple negative breast cancer.
  • Demonstrate knowledge of the approach to determining the density of stromal tumor-infiltrating lymphocytes.
Target Audience
This activity is intended for physicians.
Continuing Education Accreditation
Jointly Accredited Provider
In support of improving patient care, FDA Center for Drug Evaluation and Research is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) to provide continuing education for the healthcare team.
CME
FDA Center for Drug Evaluation and Research designates this enduring material for a maximum of 3.00 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Requirements for Receiving CE Credit

Physicians and those claiming non-physician CME: participants must attest to their attendance and complete the final activity evaluation via the CE Portal (ceportal.fda.gov). For multi-day activities, participants must attest to their attendance and complete the faculty evaluation each day. Final activity evaluations must be completed within two weeks after the activity - no exceptions.

Important Note regarding completion of evaluations and receiving credit
Attendees have 14 days from the last day of the activity to log in, complete the required evaluation(s) and attest to your attendance to claim credit.Physicians may then view/print statement of credit.
Disclosure

Faculty
  • Ly, Amy, MD, Pathologist, Massachusetts General Hospital - nothing to disclose

Planning Committee
  • Gallas, Brandon, PhD, Mathematician, FDA/CDRH/OSEL/DIDSR - nothing to disclose
  • Blenman, Kim, PhD, MS, Assistant Professor, Yale University - nothing to disclose
  • Ly, Amy, MD, Pathologist, Massachusetts General Hospital - nothing to disclose
  • Elfer, Katherine, PhD, MPH, Interagency Oncology Cancer Prevention Fellow, National Cancer Institute - nothing to disclose
  • Hanna, Matthew, MD, Pathologist, Memorial Sloan Kettering Cancer Center - I have the following relationship(s): PaigeAI - Consultant; VolastraTx - Consultant; PathPresenter - Advisor
  • Peeters, Dieter, MD, PhD, Pathologist, University of Antwerp - I have the following relationship(s): CellCarta NV - Consultant/employee
  • Salgado, Roberto, MD, ZAS - I have the following relationship(s): Merck - Research support; BMS - Advisory Board; Exact Sciences - Speaker at scientific meetings and advisory board; BMS - Research support
  • Li, Xiaoxian, MD, PhD, Professor, Emory University - I have the following relationship(s): Eli Lilly - Advisor; Cancer Expert Now - Advisor; Champions Oncology - Research fund
  • Werness, Bruce, MD, Chairman of Pathology, Inova Fair Oaks Hospital - I have the following relationship(s): Arrivebio, LLC - Consultant
  • Ehinger, Anna, MD, Senior Consultant in Cytopathology, Laboratory Medicine, Lund University Hospital, Lund, Sweden - nothing to disclose
  • Garcia, Victor, MD, Staff Fellow, FDA/CDRH/OSEL/DIDSR - nothing to disclose

CE Consultation and Accreditation Team
  • Bueide, Rachel E., MPhil, Training Specialist, FDA/CDER/OEP/DLOD - nothing to disclose
  • Zawalick, Karen, CE Team Leader, FDA/CDER/OEP/DLOD - nothing to disclose
Any relationship shown above in italics has been divested within the last 24 months and is therefore considered mitigated.
All relevant financial relationships have been mitigated.
Registration Information
Registration is complimentary; therefore refunds are not applicable.
Requirements for Certificate of Completion (Non CE)
Must attend 100% of the activity.

Initial Release Date
March 1, 2023

Expiration Date
March 1, 2026