The Drug Development Paradigm in Oncology

The Drug Development Paradigm in Oncology PDF Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309457971
Category : Medical
Languages : en
Pages : 145

Book Description
Advances in cancer research have led to an improved understanding of the molecular mechanisms underpinning the development of cancer and how the immune system responds to cancer. This influx of research has led to an increasing number and variety of therapies in the drug development pipeline, including targeted therapies and associated biomarker tests that can select which patients are most likely to respond, and immunotherapies that harness the body's immune system to destroy cancer cells. Compared with standard chemotherapies, these new cancer therapies may demonstrate evidence of benefit and clearer distinctions between efficacy and toxicity at an earlier stage of development. However, there is a concern that the traditional processes for cancer drug development, evaluation, and regulatory approval could impede or delay the use of these promising cancer treatments in clinical practice. This has led to a number of effortsâ€"by patient advocates, the pharmaceutical industry, and the Food and Drug Administration (FDA)â€"to accelerate the review of promising new cancer therapies, especially for cancers that currently lack effective treatments. However, generating the necessary data to confirm safety and efficacy during expedited drug development programs can present a unique set of challenges and opportunities. To explore this new landscape in cancer drug development, the National Academies of Sciences, Engineering, and Medicine developed a workshop held in December 2016. This workshop convened cancer researchers, patient advocates, and representatives from industry, academia, and government to discuss challenges with traditional approaches to drug development, opportunities to improve the efficiency of drug development, and strategies to enhance the information available about a cancer therapy throughout its life cycle in order to improve its use in clinical practice. This publication summarizes the presentations and discussions from the workshop.

Immunotherapy of Hepatocellular Carcinoma

Immunotherapy of Hepatocellular Carcinoma PDF Author: Tim F. Greten
Publisher: Springer
ISBN: 9783319879116
Category : Medical
Languages : en
Pages : 0

Book Description
In this book we provide insights into liver – cancer and immunology. Experts in the field provide an overview over fundamental immunological questions in liver cancer and tumorimmunology, which form the base for immune based approaches in HCC, which gain increasing interest in the community due to first promising results obtained in early clinical trials. Hepatocellular carcinoma (HCC) is the third most common cause of cancer related death in the United States. Treatment options are limited. Viral hepatitis is one of the major risk factors for HCC, which represents a typical “inflammation-induced” cancer. Immune-based treatment approaches have revolutionized oncology in recent years. Various treatment strategies have received FDA approval including dendritic cell vaccination, for prostate cancer as well as immune checkpoint inhibition targeting the CTLA4 or the PD1/PDL1 axis in melanoma, lung, and kidney cancer. Additionally, cell based therapies (adoptive T cell therapy, CAR T cells and TCR transduced T cells) have demonstrated significant efficacy in patients with B cell malignancies and melanoma. Immune checkpoint inhibitors in particular have generated enormous excitement across the entire field of oncology, providing a significant benefit to a minority of patients.

Immune Checkpoint Inhibitors in Cancer

Immune Checkpoint Inhibitors in Cancer PDF Author: Fumito Ito
Publisher: Elsevier Health Sciences
ISBN: 0323549500
Category : Medical
Languages : en
Pages : 271

Book Description
Get a quick, expert overview of the latest clinical information and guidelines for cancer checkpoint inhibitors and their implications for specific types of cancers. This practical title by Drs. Fumito Ito and Marc Ernstoff synthesizes the most up-to-date research and clinical guidance available on immune checkpoint inhibitors and presents this information in a compact, easy-to-digest resource. It's an ideal concise reference for trainee and practicing medical oncologists, as well as those in research. - Discusses the current understanding of how to best harness the immune system against different types of cancer at various stages. - Helps you translate current research and literature into practical information for daily practice. - Presents information logically organized by disease site. - Covers tumor immunology and biology; toxicities associated with immune checkpoint inhibitors; and future outlooks. - Consolidates today's available information on this timely topic into one convenient resource.

Advancing Progress in the Development of Combination Cancer Therapies with Immune Checkpoint Inhibitors

Advancing Progress in the Development of Combination Cancer Therapies with Immune Checkpoint Inhibitors PDF Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309490863
Category : Medical
Languages : en
Pages : 89

Book Description
In recent years, significant progress has been made in the clinical development and use of various types of cancer immunotherapy, all of which rely on the immune system to fight cancer. The majority of new cancer drug applications submitted to the Food and Drug Administration (FDA) are for immunotherapies or combinations involving immunotherapies. One type of immunotherapy is an immune checkpoint inhibitor. Cells in the human body have proteins that regulate the immune system response to foreign invaders (e.g., cancer cells, microorganisms). However, cancer cells can coopt these "checkpoint" proteins and thwart the immune system's ability to recognize and attack cancer cells. To help promote an immune response to cancer, researchers have developed immune checkpoint inhibitors that enable T-cells to recognize cancer cells as foreign and to prevent deactivation of an immune system response. To examine the challenges and opportunities to develop combination cancer therapies that include immune checkpoint inhibitors, the National Cancer Policy Forum held a workshop on July 16â€"17, 2018, in Washington, DC. This workshop convened stakeholders with a broad range of expertise, including cancer researchers, clinicians, patient advocates, and representatives from industry, academia, and government. This publication summarizes the presentations and discussions from the workshop.

Policy Issues in the Clinical Development and Use of Immunotherapy for Cancer Treatment

Policy Issues in the Clinical Development and Use of Immunotherapy for Cancer Treatment PDF Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 030944232X
Category : Medical
Languages : en
Pages : 135

Book Description
Immunotherapy is a form of cancer therapy that harnesses the body's immune system to destroy cancer cells. In recent years, immunotherapies have been developed for several cancers, including advanced melanoma, lung cancer, and kidney cancer. In some patients with metastatic cancers who have not responded well to other treatments, immunotherapy treatment has resulted in complete and durable responses. Given these promising findings, it is hoped that continued immunotherapy research and development will produce better cancer treatments that improve patient outcomes. With this promise, however, there is also recognition that the clinical and biological landscape for immunotherapies is novel and not yet well understood. For example, adverse events with immunotherapy treatment are quite different from those experienced with other types of cancer therapy. Similarly, immunotherapy dosing, therapeutic responses, and response time lines are also markedly different from other cancer therapies. To examine these challenges and explore strategies to overcome them, the National Academies of Sciences, Engineering, and Medicine held a workshop in February and March of 2016. This report summarizes the presentations and discussions from the workshop.

Highlights of Progress in Research on Cancer

Highlights of Progress in Research on Cancer PDF Author:
Publisher:
ISBN:
Category :
Languages : en
Pages : 60

Book Description


Statistical Methods in Drug Combination Studies

Statistical Methods in Drug Combination Studies PDF Author: Wei Zhao
Publisher: CRC Press
ISBN: 1482216752
Category : Mathematics
Languages : en
Pages : 236

Book Description
The growing interest in using combination drugs to treat various complex diseases has spawned the development of many novel statistical methodologies. The theoretical development, coupled with advances in statistical computing, makes it possible to apply these emerging statistical methods in in vitro and in vivo drug combination assessments. Howeve

SITC’s Guide to Managing Immunotherapy Toxicity

SITC’s Guide to Managing Immunotherapy Toxicity PDF Author: Marc S. Ernstoff, MD
Publisher: Springer Publishing Company
ISBN: 0826172156
Category : Medical
Languages : en
Pages : 275

Book Description
The Society for Immunotherapy of Cancer's handbook,SITC’s Guide to Managing Immunotherapy Toxicity, is a practical reference to managing side effects associated with FDA-approved cancer immunotherapy drugs. Separated into two parts, Part I contains chapter-based overviews of immune checkpoint inhibitors in the clinic, starting with anti-CTLA4 agents, anti-PD1/PD-L1 agents, and approved immunotherapeutic combinations. These chapters cover relevant mechanisms of action, indications, and toxicities seen while combating early, advanced, and metastatic stages in cancer patients. Part II is structured by common and uncommon toxicities that affect major organ sites throughout the body. It begins with a general summary of principles and management options followed by chapters focusing on specific toxicities such as rash and mucosal irritation, muscle and joint toxicity, diarrhea and colitis, pneumonitis, endocrine toxicities, neurological toxicities, cardiac toxicity, renal toxicity, hematologic toxicity, and ocular toxicities. Each chapter provides guidance on how to assess and treat the toxicity and how to support the patient through acute and chronic effects with detailed summary tables for quick reference. Part II concludes with chapters covering management of special patient populations, including patients with autoimmune disease and geriatric patients, treatment and management of fatigue, and a final chapter dedicated to cost effectiveness and the toll of financial toxicity on patients and caregivers. With chapters written by world-recognized leaders in the immuno-oncology field, this text provides thorough coverage of the toxicity and management of adverse effects for immune checkpoint inhibitors. It is an indispensable resource for clinical oncologists, emergency physicians, hospitalists and other medical practitioners in both the hospital and community clinic settings, especially as the use of immune checkpoint inhibitors becomes a fixture in oncology care. Key Features: Outlines strategies for treating high-risk patients facing an acute or chronic side effect to immunotherapy Provides numerous tables that condense and highlight pertinent information for quick reference Describes the various clinical presentations and toxic reactions caused by immunotherapy Purchase includes access to the eBook for use on most mobile devices or computer

Thoracic Malignancies

Thoracic Malignancies PDF Author: Steven E. Schild, MD
Publisher: Demos Medical Publishing
ISBN: 1935281801
Category : Medical
Languages : en
Pages : 260

Book Description
Thoracic Malignancies: Thoracic Malignancies is the first title in Radiation Medicine Rounds. These tumors take more lives than any others and they are among the most preventable of tumors. Thus it is crucial for the practitioner to be up-to-date on the latest insights regarding their management. Thoracic Malignancies addresses the multi-disciplinary nature of the care of these tumors. There is representation from radiation oncology, medical oncology, and surgery ensuring a well-rounded summarization of current practice. Included are chapters on lung cancer, esophageal cancer, and thymomas providing coverage of the vast majority of thoracic tumors. The multi-disciplinary nature of the articles provides readers with an up-to-date summary and a well-rounded review regarding these tumors and their care. Expert authors provide reviews and assessments of the most recent data and its implications for current clinical practice, along with insights into emerging new trends of importance for the near future. About the Series Radiation Medicine Rounds is an invited review publication providing a thorough analysis of new scientific, technologic, and clinical advances in all areas of radiation medicine. There is an emphasis throughout on multidisciplinary approaches to the specialty, as well as on quality and outcomes analysis. Published three times a year Radiation Medicine Rounds provides authoritative, thorough assessments of a wide range of Ïhot topicsÓ and emerging new data for the entire specialty of radiation medicine. Features of Radiation Medicine Rounds include: Editorial board of nationally recognized experts across the spectrum of radiation medicine In-depth, up-to-date expert reviews and analysis of major new developments in all areas of Radiation Medicine Issues edited by an authority in specific subject area Focuses on major topics in Radiation Medicine with in-depth articles covering advances in radiation science radiation medicine technology, radiation medicine practice, and assessment of recent quality and outcomes studies Emphasizes multidisciplinary approaches to research and practice

Oncoimmunology

Oncoimmunology PDF Author: Laurence Zitvogel
Publisher: Springer
ISBN: 3319624318
Category : Medical
Languages : en
Pages : 700

Book Description
In this book, leading experts in cancer immunotherapy join forces to provide a comprehensive guide that sets out the main principles of oncoimmunology and examines the latest advances and their implications for clinical practice, focusing in particular on drugs with FDA/EMA approvals and breakthrough status. The aim is to deliver a landmark educational tool that will serve as the definitive reference for MD and PhD students while also meeting the needs of established researchers and healthcare professionals. Immunotherapy-based approaches are now inducing long-lasting clinical responses across multiple histological types of neoplasia, in previously difficult-to-treat metastatic cancers. The future challenges for oncologists are to understand and exploit the cellular and molecular components of complex immune networks, to optimize combinatorial regimens, to avoid immune-related side effects, and to plan immunomonitoring studies for biomarker discovery. The editors hope that this book will guide future and established health professionals toward the effective application of cancer immunology and immunotherapy and contribute significantly to further progress in the field.