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

Published: 2018-02-12

Total Pages: 145

ISBN-13: 0309457971

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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.

SITC’s Guide to Managing Immunotherapy Toxicity

SITC’s Guide to Managing Immunotherapy Toxicity PDF

Author: Marc S. Ernstoff, MD

Publisher: Springer Publishing Company

Published: 2019-03-15

Total Pages: 250

ISBN-13: 0826172156

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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

Precision Medicine in Oncology

Precision Medicine in Oncology PDF

Author: Bulent Aydogan

Publisher: John Wiley & Sons

Published: 2020-11-02

Total Pages: 288

ISBN-13: 1119432448

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A FRESH EXAMINATION OF PRECISION MEDICINE'S INCREASINGLY PROMINENT ROLE IN THE FIELD OF ONCOLOGY Precision medicine takes into account each patient's specific characteristics and requirements to arrive at treatment plans that are optimized towards the best possible outcome. As the field of oncology continues to advance, this tailored approach is becoming more and more prevalent, channelling data on genomics, proteomics, metabolomics and other areas into new and innovative methods of practice. Precision Medicine in Oncology draws together the essential research driving the field forward, providing oncology clinicians and trainees alike with an illuminating overview of the technology and thinking behind the breakthroughs currently being made. Topics covered include: Biologically-guided radiation therapy Informatics for precision medicine Molecular imaging Biomarkers for treatment assessment Big data Nanoplatforms Casting a spotlight on this emerging knowledge base and its impact upon the management of tumors, Precision Medicine in Oncology opens up new possibilities and ways of working – not only for oncologists, but also for molecular biologists, radiologists, medical geneticists, and others.

Immunotherapy of Hepatocellular Carcinoma

Immunotherapy of Hepatocellular Carcinoma PDF

Author: Tim F. Greten

Publisher: Springer

Published: 2018-08-22

Total Pages: 0

ISBN-13: 9783319879116

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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.

Personalized Medicine in Oncology

Personalized Medicine in Oncology PDF

Author: Ari VanderWalde

Publisher: Mdpi AG

Published: 2022-01-25

Total Pages: 190

ISBN-13: 9783036528212

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Nowhere is the explosion in comprehensive genomic testing more evident than in oncology. Multiple consensus guidelines now recommend molecular testing as the standard of care for most metastatic tumors. To aid in the advancement of this rapidly changing field, we intend this Special Issue of JPM to focus on technical developments in the genomic profiling of cancer, detail promising somatic alterations that either are, or have a high likelihood of being, relevant in the near future, and to address issues related to the pricing and value of these tests. The last few years have seen the cost of molecular testing decrease by orders of magnitude. In 2018, we saw the first "site-agnostic" drug approvals in cancer (for microsatellite unstable cancer (PD-1 inhibitors) and NTRK-fusions (TRK inhibitors)). Research on targetable mutations, determination of genetic "signatures" that can use multiple individual genes/pathways, development of targeted therapy, and insight into the value of new technology remains at the cutting edge of research in this field. We are soliciting papers that present new technologies to assess predictive biomarkers in cancer, original research (pre-clinical or clinical) that demonstrates promise for particular targeted therapies in cancer, and articles that explore the clinical and financial impacts of this paradigmatic shift in cancer diagnostics and treatment.

Advanced Drug Delivery Systems in the Management of Cancer

Advanced Drug Delivery Systems in the Management of Cancer PDF

Author: Kamal Dua

Publisher: Elsevier

Published: 2021-06-24

Total Pages: 572

ISBN-13: 0323900798

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Advanced Drug Delivery Systems in the Management of Cancer discusses recent developments in nanomedicine and nano-based drug delivery systems used in the treatment of cancers affecting the blood, lungs, brain, and kidneys. The research presented in this book includes international collaborations in the area of novel drug delivery for the treatment of cancer. Cancer therapy remains one of the greatest challenges in modern medicine, as successful treatment requires the elimination of malignant cells that are closely related to normal cells within the body. Advanced drug delivery systems are carriers for a wide range of pharmacotherapies used in many applications, including cancer treatment. The use of such carrier systems in cancer treatment is growing rapidly as they help overcome the limitations associated with conventional drug delivery systems. Some of the conventional limitations that these advanced drug delivery systems help overcome include nonspecific targeting, systemic toxicity, poor oral bioavailability, reduced efficacy, and low therapeutic index. This book begins with a brief introduction to cancer biology. This is followed by an overview of the current landscape in pharmacotherapy for the cancer management. The need for advanced drug delivery systems in oncology and cancer treatment is established, and the systems that can be used for several specific cancers are discussed. Several chapters of the book are devoted to discussing the latest technologies and advances in nanotechnology. These include practical solutions on how to design a more effective nanocarrier for the drugs used in cancer therapeutics. Each chapter is written with the goal of informing readers about the latest advancements in drug delivery system technologies while reinforcing understanding through various detailed tables, figures, and illustrations. Advanced Drug Delivery Systems in the Management of Cancer is a valuable resource for anyone working in the fields of cancer biology and drug delivery, whether in academia, research, or industry. The book will be especially useful for researchers in drug formulation and drug delivery as well as for biological and translational researchers working in the field of cancer. Presents an overview of the recent perspectives and challenges within the management and diagnosis of cancer Provides insights into how advanced drug delivery systems can effectively be used in the management of a wide range of cancers Includes up-to-date information on diagnostic methods and treatment strategies using controlled drug delivery systems

Vaccines for Cancer Immunotherapy

Vaccines for Cancer Immunotherapy PDF

Author: Nima Rezaei

Publisher: Academic Press

Published: 2018-10-17

Total Pages: 198

ISBN-13: 0128140402

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Therapeutic cancer vaccines represent a type of active cancer immunotherapy. Clinicians, scientists, and researchers working on cancer treatment require evidence-based and up-to-date resources relating to therapeutic cancer vaccines. Vaccines for Cancer Immunotherapy provides a reference for cancer treatment for clinicians and presents a well-organized resource for determining high-potential research areas. The book considers that this promising modality can be made more feasible as a treatment for cancer. Chapters cover cancer immunology, general approaches to cancer immunotherapy, vaccines, tumor antigens, the strategy of allogeneic and autologous cancer vaccines, personalized vaccines, whole-tumor antigen vaccines, protein and peptide vaccines, dendritic cell vaccines, genetic vaccines, candidate cancers for vaccination, obstacles to developing therapeutic cancer vaccines, combination therapy, future perspectives and concluding remarks on therapeutic cancer vaccines. Introduces the feasible immunotherapeutic vaccines for patients with different types of cancer Presents the status of past and current vaccines for cancer treatment Considers advantages and disadvantages of different therapeutic cancer vaccines Looks at the combination of vaccines and other modalities, including immunotherapeutic and conventional methods Analyzes obstacles to development of therapeutic cancer vaccines Gives a view on future perspectives in the application of therapeutic cancer vaccines