Badve Sunil, Kumar George (eds.) Predictive Biomarkers in Oncology: Applications in Precision Medicine

Springer, 2019. — 635 p. — ISBN: 978-3-319-95227-7This book provides a collection of ingeniously organized, well-illustrated and up-to-date authoritative chapters divided into five sections that are clear and easy to understand. Section one provides an overview of biomarkers, introduces the basic terminologies, definitions, technologies, tools and concepts associated with this subject in the form of illustrations/graphics, photographs and concise texts. Several recent biomarker endeavors that have been initiated and funded by the National Cancer Institute, National Institutes of Health, FDA and other International organizations are presented. Section two involves the signaling pathways controlling cell growth and differentiation altered in cancer. This section analyzes how predictive biomarkers are altered (expressed or amplified) across cancer types. Section three explores how predictive biomarkers play a role in patient stratification and tailored treatment in relationship to specific cancers. In addition, it includes discussion on the various precision medicine initiatives that are going on across the globe (e.g. TARGET, NCI-MATCH, BATTLE, SHIVA, etc.). Section four discusses: (a) how pharmaceutical companies validate predictive biomarker assays and accompanying companion diagnostics either internally or externally with partner companies such as central laboratories or clinical research organizations, and (b) how predictive biomarker tests fall under the oversight of US FDA, Centers for Medicare & Medicaid Services (CMS) and state laws. Section five wraps up novel agents and targets that are being used as targets for cancer therapeutics. The biomarkers associated with these protocols will also be presented. Throughout the book, sidebars, special interest boxes and illustrations are used to explain terms that are either newly introduced, uncommon, or specialized. Predictive Biomarkers in Oncology will serve as a definitive guide for practicing pathologists, oncologists, basic researchers, and personnel in the pharmaceutical or diagnostic industry interested in learning how “predictive biomarkers” are used in precision cancer therapy.Basic Principles and Methods
Introduction to Predictive Biomarkers: Definitions and Characteristics
Introduction to Clinical Trials, Clinical Trial Designs, and Statistical Terminology Used for Predictive Biomarker Research and Validation
Overview of Methods Used in Predictive Biomarker Studies in a Molecular Anatomic Pathology Laboratory
Significance of Immunohistochemistry and In Situ Hybridization Techniques for Predictive Biomarker Studies
Overview of PCR-Based Technologies and Multiplexed Gene Analysis for Biomarker Studies
Introduction to Microarray Technology
Digital and Computational Pathology for Biomarker Discovery
Detection of Predictive Biomarkers Using Liquid Biopsies
Measurement of Predictive Cancer Biomarkers by Flow Cytometry
Personalized Cancer Treatment and Patient Stratification Using Massive Parallel Sequencing (MPS) and Other OMICs Data
Bioinformatic Methods and Resources for Biomarker Discovery, Validation, Development, and Integration
Major Cell Signaling Pathways
Overview of Cell Signaling Pathways in Cancer
Steroid Hormone and Nuclear Receptor Signaling Pathways
Protein Kinase C Signaling in Carcinogenesis
Roles of Rho/ROCK in Cancer Signaling
Mitogen-Activated Protein Kinase (MAPK) Signaling
Notch Signaling Pathway in Carcinogenesis
Signaling of the ErbB Receptor Family in Carcinogenesis and the Development of Targeted Therapies
Angiogenic Signaling Pathways and Anti-angiogenic Therapies in Human Cancer
Role of PI3K/AKT/mTOR in Cancer Signaling
Met Signaling in Carcinogenesis
Role of Insulin-Like Growth Factor Receptors in Cancer Signaling
Role of Wnt/β-Catenin Pathway in Cancer Signaling
Hedgehog Signaling in Carcinogenesis
TGF-β and the SMAD Signaling Pathway in Carcinogenesis
Role of JAK-STAT Pathway in Cancer Signaling
NF-κB Signaling Pathways in Carcinogenesis
Immune Signaling in Carcinogenesis
Predictive Biomarkers and Targeted Therapies in Immuno-oncology
Role of Protein Tyrosine Phosphatases in Cancer Signaling
Predictive Biomarkers in Specific Organs
Predictive and Prognostic Biomarkers in Myeloid Neoplasms
Predictive Biomarkers and Targeted Therapies for Lymphoid Malignancies
Targeted Therapies for Pediatric Central Nervous System Tumors
Predictive Biomarkers and Targeted Therapies in Adult Brain Cancers
Predictive Biomarkers and Targeted Therapies in Breast Cancer
Predictive Biomarkers in Lung Cancer
Predictive Biomarkers and Targeted Therapies in Genitourinary Cancers
Predictive Biomarkers and Targeted Therapies in Colorectal Cancer
Predictive Markers and Targeted Therapies in Gastroesophageal Cancer (GEC)
Predictive Biomarkers and Targeted Therapies in Hepatic, Pancreatic, and Biliary Cancers
Predictive Biomarkers and Targeted Therapies in Gynecological Cancers
Predictive Biomarkers and Targeted Therapies in Head and Neck Cancer
Predictive Biomarkers and Targeted Therapies in the Skin
Predictive Biomarkers and Targeted Therapies in Sarcomas
Predictive Markers and Targeted Therapies in Thyroid Cancer and Selected Endocrine Tumors
The Response Evaluation Criteria in Solid Tumors (RECIST)
Regulatory Processes, Quality and Policy Issues, Companion Diagnostics, and Role of Central Laboratories
IVDs and FDA Marketing Authorizations: A General Overview of FDA Approval Process of an IVD Companion Diagnostic Device in Oncology
Quality Control of Immunohistochemical and In Situ Hybridization Predictive Biomarkers for Patient Treatment: Experience from International Guidelines and International Quality Control Schemes
Use of Companion Diagnostics (CDx) and Predictive Biomarkers for Cancer Targeted Therapy: Clinical Applications in Precision Medicine
Policy Issues in the Clinical Development and Use of Predictive Biomarkers for Molecular Targeted Therapies
Role of Central Laboratories in Research, Validation, and Application of Predictive Biomarkers
Precision Medicine Clinical Trials and FDA-Approved Targeted Therapies
Prominent Precision Medicine Clinical Trials in Oncology Around the World
Precision Medicine Clinical Trials: Successes and Disappointments, Challenges and Opportunities – Lessons Learnt
FDA-Approved Targeted Therapies in Oncology